Contraception, Contraceptive Behavior
Conditions
Keywords
contraception, patient decision support, patient decision aid, shared decision making, Decision Making, Shared, Patient-Centered Outcomes Research
Brief summary
The investigators have designed a tablet-based decision support tool to help women learn more about their birth control options and support them in choosing a method they are happy with. The investigators will test whether the decision support tool helps women choose a birth control method they can continue using successfully by having some women use the tool before their birth control-related visit to a health care provider, and some women not use the tool before their visit. The investigators will then follow up with all the women at four months and seven months after their visit to see if they are still using the birth control method they chose at the visit and how happy they are with the method. Hypotheses: 1. Women who use the contraceptive decision support tool will be more likely to continue using their chosen method at 4 and 7 months follow-up, compared to women who receive usual care. 2. The contraceptive decision support tool will increase women's knowledge, choice of, and use of highly effective reversible contraception, compared to usual care. 3. The contraceptive decision support tool will decrease decision conflict, compared to usual care. 4. The contraceptive decision support tool will increase patient satisfaction with the clinic visit and with their method, compared to usual care. 5. Women who use the contraceptive decision support tool will have fewer unintended pregnancies during the follow-up period, compared to women who received usual care. 6. The contraceptive decision support tool will increase shared patient-provider decision making in contraceptive counseling visits, compared to usual care. 7. The contraceptive decision support tool will decrease provider frustration when providing contraceptive counseling and increase provider job satisfaction. 8. Women using the tool will be more likely to report use of any moderately or highly effective method of contraception at 4 and 7 months follow-up, compared to women not using the tool.
Detailed description
The impacts of unintended pregnancy include adverse maternal and infant outcomes for women who continue their pregnancies, with higher rates of infant low birth weight, infant mortality, and maternal mortality and morbidity for these pregnancies as compared to planned pregnancies. In addition, children resulting from unplanned pregnancies have been found to be more likely to experience developmental delay. Over the past several decades, the proportion of unintended pregnancy in the United States has remained stubbornly high at approximately 50%. Each year, one in 20 women of reproductive age experiences an unintended pregnancy, and it is estimated that over half of women will have an unintended pregnancy in their lifetime. This high rate of unintended pregnancy in the United States places a heavy burden on both women and the health care system. A disproportionate amount of this burden is experienced by minority women and women of lower socioeconomic status. Given the high rate of unintended pregnancies in this country, interventions designed to help women achieve their fertility goals could have a substantial impact on their health outcomes and life course. In addition, identifying strategies that are appropriate for use in high-risk, diverse populations could address disparities in women's ability to plan their pregnancies. The investigators propose a cluster randomized trial to investigate the effect of an interactive, tablet-based contraceptive decision support tool that women will use immediately prior to their contraceptive counseling visits. The goal of the tool is to facilitate shared decision-making between the woman and her health care provider, with the ultimate goal of helping the woman to choose a contraceptive method that is consistent with her values and preferences, and is therefore best suited to helping her to avoid an unplanned pregnancy. The tool will be available in both English and Spanish. The investigators will measure the tool's effect on women's contraceptive continuation, as well as on their experience of contraceptive counseling, measured both quantitatively and qualitatively. In addition, the investigators will collect quantitative and qualitative data to determine the impact of the implementation of this tool on the experiences of providers and the clinics in which they work.
Interventions
BEHAVIORALContraceptive Decision Support Tool
The decision support tool: * Provides an educational session about different aspects of contraception * Elicits patient preferences about different aspects of contraception * Identifies potential contraindications to certain contraceptive methods * Allows the patient to view details about and compare available contraceptive methods * Suggests methods most appropriate based on the patient's preferences * Collects questions the patient may have for her provider * Generates a printout the patient can bring to her contraceptive counseling visit
Sponsors
Patient-Centered Outcomes Research Institute
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Patients * Women of reproductive age (15-45) * Wish to discuss starting or changing a contraceptive method during their visit * Speak, read, and understand English or Spanish (Note: for the pre- and post-intervention audio recording phases, only patients who can speak, read, and understand English easily will be enrolled.) * History of sexual activity with men Providers * Provide contraceptive counseling in one of the participating clinics * Plan to remain in job role for at least six months Clinic staff * Work at one of the participating clinics * Had a job that included patient contact, but did not solely consist of family planning counseling at the time of the implementation of the intervention
Exclusion criteria
Patients * Previously enrolled in the study * Previously used the decision support tool at the Women's Community Clinic in San Francisco * Are unable to get pregnant * Appointment reason is for insertion of IUD or contraceptive implant * Currently pregnant * Desire pregnancy currently or in the next seven months (Note: The last criterion is designed to ensure we will have limited numbers of women that will discontinue their contraceptive methods during the study due to planning a pregnancy.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contraceptive Continuation | 4 and 7 months post-enrollment | Whether or not a participant is still using the contraceptive method she selected at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shared Decision Making - Provider Preference | Baseline (post-visit survey) | Patient report of whether or not provider had preference for contraceptive method choice, reported on a 5-point scale: no preference, slight preference, moderate preference, strong preference, extremely strong preference. Analyzed dichotomously as any preference versus no preference. |
| Patient Rating of Visit as Much Better Than Previous Family Planning Visit | Baseline (post-visit survey) | Patient report on 5-point Likert scale question asking patient to compare this visit to last family planning visit (1=Today was much worse; 5=today was much better). Analyzed dichotomously as top score of 5 versus \<5. |
| Total Clinic Visit Time | Baseline visit | Total amount of time a patient spends in a clinic for a family planning visit, from check-in to check-out. |
| Time Spent With Contraceptive Counseling Provider | Baseline visit | Total amount of time spent with the provider that is providing contraceptive counseling. |
| Maslach Burnout Inventory | Change between baseline and end of study (up to 24 months post-enrollment). In multivariate analysis, follow-up score analyzed controlling for site and score at baseline (Analyses 1-3). | Provider participants were asked to respond to the Maslach Burnout Inventory on workplace burnout among human services workers. The scale includes 22 items with response options on a Likert scale of 0-6. Individual scores were calculated at both baseline and follow-up for three subscales: emotional exhaustion (Range: 0-54, with higher score representing higher emotional exhaustion), depersonalization (Range: 0-30, with a higher score representing higher depersonalization), and personal accomplishment (Range: 0-48, with a higher score representing more personal accomplishment in the workplace). |
| Patient Contraceptive Counseling Satisfaction | Baseline, post-visit survey | Patient-reported score on an 11-item factor analysis-validated measure created by the PI to assess patients' satisfaction with the contraceptive counseling experience. The measure consists of 5-point Likert scale items on which patients evaluate provider performance, with item response options ranging from 1 (Poor) to 5 (Excellent). The score range for the total measure is11-55, with 11 as the worst possible score and 55 as the best possible score for provider performance. Analyzed dichotomously, top score (55) versus all lower scores. |
| Patient Satisfaction With Information Received About Side Effects During Counseling | Baseline (post-visit survey) | Patient response to a 5-point Likert scale item about satisfaction with information that their provider gave them about side effects of their chosen methods during their baseline visit (1=completely unsatisfied, 5=completely satisfied). Analyzed dichotomously as top score of 5 versus \<5. |
| Overall Satisfaction With Visit | Baseline (post-visit survey) | Patient report on 5-point Likert scale of satisfaction with baseline visit (1=completely unsatisfied, 5=completely satisfied). Analyzed dichotomously as top score of 5 versus \<5. |
| Shared Decision Making - Feelings About Provider Involvement | Baseline (post-visit) and up to 24 months | Patient report on 3-point scale of their feelings about provider involvement in contraceptive decision-making: I wish provider had been less involved, provider was involved the right amount, I wiss provider had been more involved. |
| Shared Decision Making - Provider Appropriately Expressed Preference | Baseline (post-visit survey) | Patient report of attitude on 3-point scale on how provider expressed preference for contraceptive method choice: Right amount, wish less strongly, wish more strongly. |
| Shared Decision Making - Satisfaction With How Provider Helped With Choice | Baseline (post-visit survey) | Patient report of satisfaction on a 5-point Likert scale (from 1=completely unsatisfied to 5=completely satisfied) of how the provider helped contraceptive method choice. Analyzed dichotomously as top score of 5 versus \<5. |
| Shared Decision Making - Who Made the Decision? | Baseline (post-visit) | Patient response to 5-point scale of who made decision on contraceptive method. The original 5 points were the provider by themselves, more provider, both equally, more patient, or provider by themselves. In analysis, these options were collapsed to three points: more provider, both equally, or more patient. |
| Patient Decisional Conflict in Contraceptive Choice | Baseline (post-visit) | Patient Decisional Conflict was measured using the Decisional Conflict Scale (DCS), a validated measure to assess patients' decisional conflict in medical decision making. The DCS includes 16 items about experience of conflict, with 5-point Likert response options ranging from 0 (Strongly disagree) to 4 (Strongly agree). Higher scores indicate less conflict. Top score on DCS (Range: 0-100, analyzed dichotomously as 100 versus \<100). Top scores on subscales also analyzed (Informed decision, Uncertainty, Effective decision, Values clarity, Support, all ranging 0-100 and analyzed dichotomously as 100 versus \<100). |
| Patient Knowledge of Contraceptive Options and Features | Baseline (post-visit) | Patient responses to items derived from National Survey of Reproductive Contraceptive Knowledge and previous studies of contraceptive knowledge and attitudes. All items analyzed as correct vs. incorrect. |
| Patient Chosen Contraceptive Method Satisfaction | Reported and analyzed at baseline (post-visit), 4 months and 7 months follow-up | 5-point Likert scale item regarding patient satisfaction with contraceptive method chosen at baseline visit. The item is a statement of method satisfaction, and response options range from 1 (Completely disagree) to 5 (Completely agree). A higher score indicates higher satisfaction. Analyzed dichotomously as top score (5) versus all lower scores. |
| Patient Current Contraceptive Method Satisfaction | 7 months follow-up | 5-point Likert scale question regarding patient satisfaction with the contraceptive method they are currently using. The item is a statement of method satisfaction, and response options range from 1 (Completely disagree) to 5 (Completely agree). A higher score indicates higher satisfaction. Analyzed dichotomously as top score of 5 versus \<5. |
| Patient Attitude Towards Use of Contraceptive Options | Baseline (post-visit survey) | Patient ratings of contraceptive methods on the 11-point Global Contraceptive Attitude scale, developed by the PI. To assess overall (or global) attitude towards use of various methods, patients are asked to respond the following with regard to each method listed in the data table: Overall, how would you rate each of the following as a birth control method for yourself, (even if you've never used it)? Response options range from 0 (Terrible method) to 10 (Great method). A higher score on an individual item indicates a more positive attitude towards a method. Analyzed as discrete items with responses of 0 to 10; item scores not combined into an overall scale score. |
| Newly Heard About Methods During Visit | Baseline (pre- and post-survey) | Percentage of patients who reported having heard about a method in the post-survey, but not the pre-survey. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up | 4 and 7 months post-enrollment | Patient report of whether or not patient is using a highly or moderately effective contraceptive method at 4 and 7 month follow-up survey. As defined by the Centers for Disease Control, moderately effective methods include injectables, pills, patch, vaginal ring, and diaphragm; typical failure rates range from 6-12%. Highly effective methods include implants, IUDs, and male and female sterilization; failure rates are less than 1%. |
| Unplanned Pregnancy | 4 months and 7 months from enrollment | Incidence of unplanned pregnancy among study participants, as determined by responses of patients who experienced a pregnancy to the 6-item London Measure of Unplanned Pregnancy. The London Measure includes items on attitude towards an experienced pregnancy and behaviors before pregnancy to determine the intendedness of pregnancy. The score range of the London Measure is 0-12, with a score of \<10 indicating unplanned pregnancy and a score of 10 or higher indicating planned pregnancy. We report the percentage of patients who report a pregnancy and report a score of \<10 on the London Measure. |
| Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up. | 4 and 7 months post-enrollment | Whether patient is using a highly effective contraceptive method at 4 and 7 month follow-up survey. Highly effective methods include implant, IUDs, and male and female sterilization. |
| Choice of a Highly Effective Method of Contraception at Baseline | Baseline (post-visit survey) | Patient report of whether or not patient chose highly effective method at baseline. Highly effective methods include implants, IUDs, and male and female sterilization. |
Countries
United States
Participant flow
Recruitment details
Female patients were approached to participate in the study before appointments at four San Francisco Bay Area clinics between December 2014 and March 2016. Patients are grouped in cluster by provider. Providers of family planning care at the four clinics were approached to participate in the study in October to December 2014.
Pre-assignment details
A total of 2,458 patients were approached to participate in the study. Of these, 1,700 were excluded before assignment (1,642 due to ineligibility, 58 refusals), and 758 enrolled. A total of 36 providers were approached to participate. Eight were excluded before assignment (7 due to ineligibility, 1 refusal), and 28 enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Contraceptive Decision Support Tool Patients Patients whose contraceptive counseling visits are scheduled with providers randomized to this arm will use the intervention immediately before their visit and bring the generated printout to their visit. Providers randomized to this arm will be free to integrate the tool and printout into their contraceptive counseling however they see fit.
Contraceptive Decision Support Tool: The decision support tool:
* Provides an educational session about different aspects of contraception
* Elicits patient preferences about different aspects of contraception
* Identifies potential contraindications to certain contraceptive methods
* Allows the patient to view details about and compare available contraceptive methods
* Suggests methods most appropriate based on the patient's preferences
* Collects questions the patient may have for her provider
* Generates a printout the patient can bring to her contraceptive counseling visit | 404 |
| Usual Care (Control) Patients Patients in this arm will receive usual family planning care. | 345 |
| Contraception Decision Support Tool Providers Family planning providers randomized to use the Contraceptive Decision Support tool with their patients. Providers were the unit of randomization in this cluster trial | 15 |
| Usual Care (Control) Providers Family planning providers randomized to practice usual care with their patients. Providers were the unit of randomization in this cluster trial | 13 |
| Total | 777 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Enrolled twice | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 49 | 55 | 0 | 0 |
| Overall Study | Pregnant at baseline | 3 | 5 | 0 | 0 |
Baseline characteristics
| Characteristic | Usual Care (Control) Patients | Contraception Decision Support Tool Providers | Contraceptive Decision Support Tool Patients | Usual Care (Control) Providers | Total |
|---|---|---|---|---|---|
| Age, Customized Age category 15-19 | 43 Participants | 0 Participants | 52 Participants | 0 Participants | 95 Participants |
| Age, Customized Age category 20-24 | 121 Participants | 2 Participants | 126 Participants | 1 Participants | 250 Participants |
| Age, Customized Age category 25-29 | 91 Participants | 2 Participants | 110 Participants | 3 Participants | 206 Participants |
| Age, Customized Age category 30-34 | 53 Participants | 1 Participants | 68 Participants | 3 Participants | 125 Participants |
| Age, Customized Age category 35-39 | 22 Participants | 2 Participants | 33 Participants | 1 Participants | 58 Participants |
| Age, Customized Age category 40-45 | 10 Participants | 4 Participants | 13 Participants | 1 Participants | 28 Participants |
| Age, Customized Age category Missing | 5 Participants | 0 Participants | 2 Participants | 0 Participants | 7 Participants |
| Age, Customized Age category Over 45 | 0 Participants | 4 Participants | 0 Participants | 4 Participants | 8 Participants |
| % Federal Poverty Line <100% | 141 Participants | 0 Participants | 183 Participants | 0 Participants | 324 Participants |
| % Federal Poverty Line 101-200% | 79 Participants | 0 Participants | 81 Participants | 0 Participants | 160 Participants |
| % Federal Poverty Line >200% | 65 Participants | 0 Participants | 76 Participants | 0 Participants | 141 Participants |
| % Federal Poverty Line Missing | 60 Participants | 0 Participants | 64 Participants | 0 Participants | 124 Participants |
| Language spoken during study participation English | 283 Participants | 15 Participants | 329 Participants | 13 Participants | 640 Participants |
| Language spoken during study participation Spanish | 62 Participants | 0 Participants | 75 Participants | 0 Participants | 137 Participants |
| Parental education 4-year college graduate or more | 133 Participants | 0 Participants | 129 Participants | 0 Participants | 262 Participants |
| Parental education 8th grade or less | 50 Participants | 0 Participants | 69 Participants | 0 Participants | 119 Participants |
| Parental education High school graduate or GED | 69 Participants | 0 Participants | 81 Participants | 0 Participants | 150 Participants |
| Parental education Missing | 6 Participants | 0 Participants | 4 Participants | 0 Participants | 10 Participants |
| Parental education Some college or 2-year degree | 58 Participants | 0 Participants | 83 Participants | 0 Participants | 141 Participants |
| Parental education Some high school, but did not graduate | 29 Participants | 0 Participants | 38 Participants | 0 Participants | 67 Participants |
| Parity Missing | 5 Participants | 0 Participants | 6 Participants | 0 Participants | 11 Participants |
| Parity Nulliparous | 236 Participants | 0 Participants | 265 Participants | 0 Participants | 501 Participants |
| Parity Parous | 104 Participants | 0 Participants | 133 Participants | 0 Participants | 237 Participants |
| Race/Ethnicity, Customized Race/ethnicity African American/Black | 34 Participants | 0 Participants | 46 Participants | 0 Participants | 80 Participants |
| Race/Ethnicity, Customized Race/ethnicity Asian or Pacific Islander | 62 Participants | 2 Participants | 59 Participants | 0 Participants | 123 Participants |
| Race/Ethnicity, Customized Race/ethnicity Hispanic/Latina | 128 Participants | 4 Participants | 160 Participants | 4 Participants | 296 Participants |
| Race/Ethnicity, Customized Race/ethnicity Missing | 4 Participants | 0 Participants | 2 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Race/ethnicity Other | 32 Participants | 1 Participants | 51 Participants | 0 Participants | 84 Participants |
| Race/Ethnicity, Customized Race/ethnicity White | 85 Participants | 8 Participants | 86 Participants | 9 Participants | 188 Participants |
| Sex: Female, Male Female | 345 Participants | 15 Participants | 404 Participants | 12 Participants | 776 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 407 | 0 / 351 | 0 / 15 | 0 / 13 |
| other Total, other adverse events | 0 / 407 | 0 / 351 | 0 / 15 | 0 / 13 |
| serious Total, serious adverse events | 0 / 407 | 0 / 351 | 0 / 15 | 0 / 13 |
Outcome results
Primary
Contraceptive Continuation
Whether or not a participant is still using the contraceptive method she selected at baseline.
Time frame: 4 and 7 months post-enrollment
Population: Analysis was modified intention to treat. In accordance with the statistical analysis plan, patients were excluded from analysis if they were pregnant at baseline (n=8) or enrolled in the study twice (n=1, in which case information from their second enrollment was excluded). Outcome observed in patients only.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Contraceptive Decision Support Tool | Contraceptive Continuation | 7 months post-enrollment | Not a continuous user of chosen method | 154 Participants |
| Contraceptive Decision Support Tool | Contraceptive Continuation | 7 months post-enrollment | Continuous user of chosen method | 201 Participants |
| Contraceptive Decision Support Tool | Contraceptive Continuation | 7 months post-enrollment | Missing | 49 Participants |
| Contraceptive Decision Support Tool | Contraceptive Continuation | 4 months post-enrollment | Continuous user of chosen method | 249 Participants |
| Contraceptive Decision Support Tool | Contraceptive Continuation | 4 months post-enrollment | Not a continuous user of chosen method | 115 Participants |
| Contraceptive Decision Support Tool | Contraceptive Continuation | 4 months post-enrollment | Missing | 40 Participants |
| Usual Care (Control) | Contraceptive Continuation | 4 months post-enrollment | Not a continuous user of chosen method | 83 Participants |
| Usual Care (Control) | Contraceptive Continuation | 4 months post-enrollment | Continuous user of chosen method | 228 Participants |
| Usual Care (Control) | Contraceptive Continuation | 7 months post-enrollment | Continuous user of chosen method | 174 Participants |
| Usual Care (Control) | Contraceptive Continuation | 7 months post-enrollment | Not a continuous user of chosen method | 118 Participants |
| Usual Care (Control) | Contraceptive Continuation | 4 months post-enrollment | Missing | 34 Participants |
| Usual Care (Control) | Contraceptive Continuation | 7 months post-enrollment | Missing | 53 Participants |
Comparison: Comparison at 7 months post-enrollmentp-value: 0.4695% CI: [0.65, 1.22]Regression, Logistic
Comparison: Comparison at 4 months post-enrollmentp-value: 0.1695% CI: [0.57, 1.1]Regression, Logistic
Secondary
Maslach Burnout Inventory
Provider participants were asked to respond to the Maslach Burnout Inventory on workplace burnout among human services workers. The scale includes 22 items with response options on a Likert scale of 0-6. Individual scores were calculated at both baseline and follow-up for three subscales: emotional exhaustion (Range: 0-54, with higher score representing higher emotional exhaustion), depersonalization (Range: 0-30, with a higher score representing higher depersonalization), and personal accomplishment (Range: 0-48, with a higher score representing more personal accomplishment in the workplace).
Time frame: Change between baseline and end of study (up to 24 months post-enrollment). In multivariate analysis, follow-up score analyzed controlling for site and score at baseline (Analyses 1-3).
Population: Observed in providers only
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Contraceptive Decision Support Tool | Maslach Burnout Inventory | Change in emotional exhaustion | -2.27 Units on a scale | Standard Deviation 9.22 |
| Contraceptive Decision Support Tool | Maslach Burnout Inventory | Change in depersonalization | -0.87 Units on a scale | Standard Deviation 4.1 |
| Contraceptive Decision Support Tool | Maslach Burnout Inventory | Change in personal accomplishment | -0.80 Units on a scale | Standard Deviation 3.99 |
| Usual Care (Control) | Maslach Burnout Inventory | Change in emotional exhaustion | 1.07 Units on a scale | Standard Deviation 9.38 |
| Usual Care (Control) | Maslach Burnout Inventory | Change in depersonalization | 0.46 Units on a scale | Standard Deviation 4.24 |
| Usual Care (Control) | Maslach Burnout Inventory | Change in personal accomplishment | 2.38 Units on a scale | Standard Deviation 5.3 |
Comparison: Test of follow-up score of emotional exhaustion subscale of Maslach Burnout Inventory, controlling for baseline score and sitep-value: 0.2495% CI: [-10.62, 2.68]Regression, Linear
Comparison: Linear regression of follow-up score for depersonalization subscale of Maslach Burnout Inventory, controlling for baseline score and site.p-value: 0.3695% CI: [-4.76, 1.72]Regression, Linear
Comparison: Linear regression of follow-up score for personal accomplishment subscale of Maslach Burnout Inventory, controlling for site and baseline score.p-value: 0.2895% CI: [-4.61, 1.34]Regression, Linear
Secondary
Newly Heard About Methods During Visit
Percentage of patients who reported having heard about a method in the post-survey, but not the pre-survey.
Time frame: Baseline (pre- and post-survey)
Population: Only calculated for those patients who reported not having heard of method in pre-survey, and then completed post-survey. All other patients missing for this item and excluded from analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of implant | Yes | 80 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of patch | Missing | 354 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of non-hormonal IUD | Missing | 277 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of ring | Yes | 61 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of hormonal IUD | No | 21 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of ring | No | 24 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of non-hormonal IUD | Yes | 104 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of ring | Missing | 319 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of implant | No | 30 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of male sterilization | Yes | 53 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of hormonal IUD | Yes | 79 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of male sterilization | No | 30 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of implant | Missing | 294 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of male sterilization | Missing | 321 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of patch | Yes | 39 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of female sterilization | Yes | 59 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of non-hormonal IUD | No | 23 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of female sterilization | No | 27 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of patch | No | 11 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of female sterilization | Missing | 318 Participants |
| Contraceptive Decision Support Tool | Newly Heard About Methods During Visit | Newly heard of hormonal IUD | Missing | 304 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of female sterilization | Missing | 275 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of hormonal IUD | Yes | 46 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of hormonal IUD | No | 18 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of hormonal IUD | Missing | 281 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of non-hormonal IUD | Yes | 84 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of non-hormonal IUD | No | 31 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of non-hormonal IUD | Missing | 230 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of implant | Yes | 58 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of implant | No | 26 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of patch | Yes | 38 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of patch | No | 19 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of patch | Missing | 288 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of ring | Yes | 41 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of ring | No | 23 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of ring | Missing | 281 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of male sterilization | Yes | 35 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of male sterilization | No | 24 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of male sterilization | Missing | 286 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of female sterilization | Yes | 44 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of female sterilization | No | 26 Participants |
| Usual Care (Control) | Newly Heard About Methods During Visit | Newly heard of implant | Missing | 261 Participants |
Comparison: Comparison of patients who newly heard of hormonal IUDp-value: 0.2795% CI: [0.71, 3.42]Regression, Logistic
Comparison: Comparison of patients who newly heard of non-hormonal IUDp-value: 0.1895% CI: [0.8, 3.4]Regression, Logistic
Comparison: Comparison of patients who newly heard of implantp-value: 0.595% CI: [0.62, 2.69]Regression, Logistic
Comparison: Comparison of patients who newly heard of the patchp-value: 0.3295% CI: [0.59, 4.89]Regression, Logistic
Comparison: Comparison of patients who newly heard of ringp-value: 0.3795% CI: [0.68, 2.81]Regression, Logistic
Comparison: Comparison of patients who newly heard of male sterilization (vasectomy)p-value: 0.3995% CI: [0.6, 3.73]Regression, Logistic
Comparison: Comparison of patients who newly heard of female sterilizationp-value: 0.3995% CI: [0.6, 3.73]Regression, Logistic
Secondary
Overall Satisfaction With Visit
Patient report on 5-point Likert scale of satisfaction with baseline visit (1=completely unsatisfied, 5=completely satisfied). Analyzed dichotomously as top score of 5 versus \<5.
Time frame: Baseline (post-visit survey)
Population: Observed in patients only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contraceptive Decision Support Tool | Overall Satisfaction With Visit | Completely satisfied | 338 Participants |
| Contraceptive Decision Support Tool | Overall Satisfaction With Visit | Less than completely satisfied | 56 Participants |
| Contraceptive Decision Support Tool | Overall Satisfaction With Visit | Missing | 10 Participants |
| Usual Care (Control) | Overall Satisfaction With Visit | Completely satisfied | 282 Participants |
| Usual Care (Control) | Overall Satisfaction With Visit | Less than completely satisfied | 54 Participants |
| Usual Care (Control) | Overall Satisfaction With Visit | Missing | 9 Participants |
p-value: 0.6295% CI: [0.74, 1.67]Regression, Logistic
Secondary
Patient Attitude Towards Use of Contraceptive Options
Patient ratings of contraceptive methods on the 11-point Global Contraceptive Attitude scale, developed by the PI. To assess overall (or global) attitude towards use of various methods, patients are asked to respond the following with regard to each method listed in the data table: Overall, how would you rate each of the following as a birth control method for yourself, (even if you've never used it)? Response options range from 0 (Terrible method) to 10 (Great method). A higher score on an individual item indicates a more positive attitude towards a method. Analyzed as discrete items with responses of 0 to 10; item scores not combined into an overall scale score.
Time frame: Baseline (post-visit survey)
Population: Observed in patients only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Contraceptive Decision Support Tool | Patient Attitude Towards Use of Contraceptive Options | Pill | 6.26 Units on a scale | Standard Error 0.24 |
| Contraceptive Decision Support Tool | Patient Attitude Towards Use of Contraceptive Options | Ring | 5.07 Units on a scale | Standard Error 0.18 |
| Contraceptive Decision Support Tool | Patient Attitude Towards Use of Contraceptive Options | Shot | 5.05 Units on a scale | Standard Error 0.18 |
| Contraceptive Decision Support Tool | Patient Attitude Towards Use of Contraceptive Options | Hormonal IUD | 6.61 Units on a scale | Standard Error 0.23 |
| Contraceptive Decision Support Tool | Patient Attitude Towards Use of Contraceptive Options | Non-hormonal IUD | 6.3 Units on a scale | Standard Error 0.21 |
| Contraceptive Decision Support Tool | Patient Attitude Towards Use of Contraceptive Options | Implant | 5.79 Units on a scale | Standard Error 0.16 |
| Contraceptive Decision Support Tool | Patient Attitude Towards Use of Contraceptive Options | Condoms | 6.33 Units on a scale | Standard Error 0.16 |
| Contraceptive Decision Support Tool | Patient Attitude Towards Use of Contraceptive Options | Withdrawal | 2.8 Units on a scale | Standard Error 0.15 |
| Contraceptive Decision Support Tool | Patient Attitude Towards Use of Contraceptive Options | Female sterilization | 4.44 Units on a scale | Standard Error 0.27 |
| Contraceptive Decision Support Tool | Patient Attitude Towards Use of Contraceptive Options | Male sterilization | 4.98 Units on a scale | Standard Error 0.25 |
| Contraceptive Decision Support Tool | Patient Attitude Towards Use of Contraceptive Options | Patch | 5.22 Units on a scale | Standard Error 0.2 |
| Usual Care (Control) | Patient Attitude Towards Use of Contraceptive Options | Patch | 5.4 Units on a scale | Standard Error 0.19 |
| Usual Care (Control) | Patient Attitude Towards Use of Contraceptive Options | Condoms | 6.87 Units on a scale | Standard Error 0.15 |
| Usual Care (Control) | Patient Attitude Towards Use of Contraceptive Options | Ring | 5.49 Units on a scale | Standard Error 0.26 |
| Usual Care (Control) | Patient Attitude Towards Use of Contraceptive Options | Male sterilization | 6.08 Units on a scale | Standard Error 0.28 |
| Usual Care (Control) | Patient Attitude Towards Use of Contraceptive Options | Shot | 5.35 Units on a scale | Standard Error 0.19 |
| Usual Care (Control) | Patient Attitude Towards Use of Contraceptive Options | Withdrawal | 2.98 Units on a scale | Standard Error 0.21 |
| Usual Care (Control) | Patient Attitude Towards Use of Contraceptive Options | Hormonal IUD | 6.24 Units on a scale | Standard Error 0.18 |
| Usual Care (Control) | Patient Attitude Towards Use of Contraceptive Options | Pill | 6.55 Units on a scale | Standard Error 0.289 |
| Usual Care (Control) | Patient Attitude Towards Use of Contraceptive Options | Non-hormonal IUD | 6.29 Units on a scale | Standard Error 0.17 |
| Usual Care (Control) | Patient Attitude Towards Use of Contraceptive Options | Female sterilization | 5.59 Units on a scale | Standard Error 0.24 |
| Usual Care (Control) | Patient Attitude Towards Use of Contraceptive Options | Implant | 6.06 Units on a scale | Standard Error 0.2 |
Comparison: Comparison of rating for hormonal IUD. Patients excluded from analysis if they had not heard of hormonal IUD.p-value: 0.1395% CI: [0.92, 1.6]Regression, Logistic
Comparison: Comparison of rating on non-hormonal IUD. Patients were excluded from this analysis if they reported not having heard of the non-hormonal IUD in the post-visit survey.p-value: 0.9295% CI: [0.75, 1.3]Regression, Logistic
Comparison: Comparison of rating of implantp-value: 0.1795% CI: [0.67, 1.07]Regression, Logistic
Comparison: Comparison of rating on condoms. Patients were excluded from this analysis if they reported not having heard of condoms in the post-visit survey.p-value: 0.00995% CI: [0.54, 0.92]Regression, Logistic
Comparison: Comparison of rating on the shot (Depo Provera). Patients were excluded from this analysis if they reported not having heard of the the shot (Depo Provera) in the post-visit survey.p-value: 0.2695% CI: [0.65, 1.12]Regression, Logistic
Comparison: Comparison of rating on the pill. Patients were excluded from this analysis if they reported not having heard of the pill in the post-visit survey.p-value: 0.2395% CI: [0.64, 1.11]Regression, Logistic
Comparison: Comparison of rating on the patch. Patients were excluded from this analysis if they reported not having heard of the patch in the post-visit survey.p-value: 0.5595% CI: [0.69, 1.22]Regression, Logistic
Comparison: Comparison of rating on the pull-out method. Patients were excluded from this analysis if they reported not having heard of the pull-out method in the post-visit survey.p-value: 0.8495% CI: [0.76, 1.25]Regression, Logistic
Comparison: Comparison of rating on the ring. Patients were excluded from this analysis if they reported not having heard of the ring in the post-visit survey.p-value: 0.0795% CI: [0.64, 1.02]Regression, Logistic
Comparison: Comparison of rating on female sterilization/tubal ligation. Patients were excluded from this analysis if they reported not having heard of female sterilization/tubal ligation in the post-visit survey.p-value: 0.00295% CI: [0.42, 0.82]Regression, Logistic
Comparison: Comparison of rating on male sterilization/vasectomy. Patients were excluded from this analysis if they reported not having heard of male sterilization/vasectomy in the post-visit survey.p-value: 0.00595% CI: [0.4, 0.85]Regression, Logistic
Secondary
Patient Chosen Contraceptive Method Satisfaction
5-point Likert scale item regarding patient satisfaction with contraceptive method chosen at baseline visit. The item is a statement of method satisfaction, and response options range from 1 (Completely disagree) to 5 (Completely agree). A higher score indicates higher satisfaction. Analyzed dichotomously as top score (5) versus all lower scores.
Time frame: Reported and analyzed at baseline (post-visit), 4 months and 7 months follow-up
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Contraceptive Decision Support Tool | Patient Chosen Contraceptive Method Satisfaction | Baseline | Top score of 5 | 249 Participants |
| Contraceptive Decision Support Tool | Patient Chosen Contraceptive Method Satisfaction | Baseline | Less than top score | 145 Participants |
| Contraceptive Decision Support Tool | Patient Chosen Contraceptive Method Satisfaction | Baseline | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Chosen Contraceptive Method Satisfaction | 4 months post-enrollment | Top score of 5 | 176 Participants |
| Contraceptive Decision Support Tool | Patient Chosen Contraceptive Method Satisfaction | 4 months post-enrollment | Less than top score | 183 Participants |
| Contraceptive Decision Support Tool | Patient Chosen Contraceptive Method Satisfaction | 4 months post-enrollment | Missing | 45 Participants |
| Contraceptive Decision Support Tool | Patient Chosen Contraceptive Method Satisfaction | 7 months post-enrollment | Missing | 47 Participants |
| Contraceptive Decision Support Tool | Patient Chosen Contraceptive Method Satisfaction | 7 months post-enrollment | Top score of 5 | 180 Participants |
| Contraceptive Decision Support Tool | Patient Chosen Contraceptive Method Satisfaction | 7 months post-enrollment | Less than top score | 177 Participants |
| Usual Care (Control) | Patient Chosen Contraceptive Method Satisfaction | 4 months post-enrollment | Less than top score | 148 Participants |
| Usual Care (Control) | Patient Chosen Contraceptive Method Satisfaction | Baseline | Top score of 5 | 199 Participants |
| Usual Care (Control) | Patient Chosen Contraceptive Method Satisfaction | 7 months post-enrollment | Missing | 55 Participants |
| Usual Care (Control) | Patient Chosen Contraceptive Method Satisfaction | Baseline | Less than top score | 137 Participants |
| Usual Care (Control) | Patient Chosen Contraceptive Method Satisfaction | 4 months post-enrollment | Missing | 40 Participants |
| Usual Care (Control) | Patient Chosen Contraceptive Method Satisfaction | Baseline | Missing | 9 Participants |
| Usual Care (Control) | Patient Chosen Contraceptive Method Satisfaction | 7 months post-enrollment | Less than top score | 130 Participants |
| Usual Care (Control) | Patient Chosen Contraceptive Method Satisfaction | 4 months post-enrollment | Top score of 5 | 157 Participants |
| Usual Care (Control) | Patient Chosen Contraceptive Method Satisfaction | 7 months post-enrollment | Top score of 5 | 160 Participants |
Comparison: Comparison of percentage of patients giving top score at baselinep-value: 0.2595% CI: [0.88, 1.61]Regression, Logistic
Comparison: Comparison of percentage of patients giving top score at 4 months post-enrollmentp-value: 0.595% CI: [0.66, 1.22]Regression, Logistic
Comparison: Comparison of percentage of patients giving a top score on the 5-point Likert scale at 7 months post-enrollment.p-value: 0.2395% CI: [0.6, 1.13]Regression, Logistic
Secondary
Patient Contraceptive Counseling Satisfaction
Patient-reported score on an 11-item factor analysis-validated measure created by the PI to assess patients' satisfaction with the contraceptive counseling experience. The measure consists of 5-point Likert scale items on which patients evaluate provider performance, with item response options ranging from 1 (Poor) to 5 (Excellent). The score range for the total measure is11-55, with 11 as the worst possible score and 55 as the best possible score for provider performance. Analyzed dichotomously, top score (55) versus all lower scores.
Time frame: Baseline, post-visit survey
Population: Observed in patients only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contraceptive Decision Support Tool | Patient Contraceptive Counseling Satisfaction | Top score of 55 | 261 Participants |
| Contraceptive Decision Support Tool | Patient Contraceptive Counseling Satisfaction | Less than top score of 55 | 133 Participants |
| Contraceptive Decision Support Tool | Patient Contraceptive Counseling Satisfaction | Missing | 10 Participants |
| Usual Care (Control) | Patient Contraceptive Counseling Satisfaction | Top score of 55 | 194 Participants |
| Usual Care (Control) | Patient Contraceptive Counseling Satisfaction | Less than top score of 55 | 143 Participants |
| Usual Care (Control) | Patient Contraceptive Counseling Satisfaction | Missing | 8 Participants |
p-value: 0.0395% CI: [1.03, 2.05]Regression, Logistic
Secondary
Patient Current Contraceptive Method Satisfaction
5-point Likert scale question regarding patient satisfaction with the contraceptive method they are currently using. The item is a statement of method satisfaction, and response options range from 1 (Completely disagree) to 5 (Completely agree). A higher score indicates higher satisfaction. Analyzed dichotomously as top score of 5 versus \<5.
Time frame: 7 months follow-up
Population: Observed in patients only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contraceptive Decision Support Tool | Patient Current Contraceptive Method Satisfaction | Completely satisfied | 209 Participants |
| Contraceptive Decision Support Tool | Patient Current Contraceptive Method Satisfaction | Missing | 48 Participants |
| Contraceptive Decision Support Tool | Patient Current Contraceptive Method Satisfaction | Less than completely satisfied | 147 Participants |
| Usual Care (Control) | Patient Current Contraceptive Method Satisfaction | Completely satisfied | 177 Participants |
| Usual Care (Control) | Patient Current Contraceptive Method Satisfaction | Less than completely satisfied | 113 Participants |
| Usual Care (Control) | Patient Current Contraceptive Method Satisfaction | Missing | 55 Participants |
p-value: 0.5595% CI: [0.66, 1.25]Regression, Logistic
Secondary
Patient Decisional Conflict in Contraceptive Choice
Patient Decisional Conflict was measured using the Decisional Conflict Scale (DCS), a validated measure to assess patients' decisional conflict in medical decision making. The DCS includes 16 items about experience of conflict, with 5-point Likert response options ranging from 0 (Strongly disagree) to 4 (Strongly agree). Higher scores indicate less conflict. Top score on DCS (Range: 0-100, analyzed dichotomously as 100 versus \<100). Top scores on subscales also analyzed (Informed decision, Uncertainty, Effective decision, Values clarity, Support, all ranging 0-100 and analyzed dichotomously as 100 versus \<100).
Time frame: Baseline (post-visit)
Population: Observed in patients only
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Support subscale | Less than top score | 187 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Uncertainty subscale | Top score | 164 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Values clarity subscale | Less than top score | 198 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Values clarity subscale | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Support subscale | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Overall score | Less than top score | 294 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Overall score | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Informed decision subscale | Top score | 199 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Informed decision subscale | Less than top score | 195 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Informed decision subscale | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Uncertainty subscale | Less than top score | 230 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Uncertainty subscale | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Effective decision subscale | Top score | 166 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Effective decision subscale | Less than top score | 228 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Effective decision subscale | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Values clarity subscale | Top score | 196 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Support subscale | Top score | 207 Participants |
| Contraceptive Decision Support Tool | Patient Decisional Conflict in Contraceptive Choice | Overall score | Top score | 100 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Support subscale | Top score | 172 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Informed decision subscale | Missing | 9 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Values clarity subscale | Top score | 154 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Uncertainty subscale | Top score | 112 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Values clarity subscale | Less than top score | 182 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Effective decision subscale | Less than top score | 204 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Support subscale | Less than top score | 164 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Uncertainty subscale | Less than top score | 224 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Support subscale | Missing | 9 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Overall score | Top score | 76 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Informed decision subscale | Top score | 145 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Values clarity subscale | Missing | 9 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Overall score | Less than top score | 260 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Uncertainty subscale | Missing | 9 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Overall score | Missing | 9 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Effective decision subscale | Missing | 9 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Effective decision subscale | Top score | 132 Participants |
| Usual Care (Control) | Patient Decisional Conflict in Contraceptive Choice | Informed decision subscale | Less than top score | 191 Participants |
Comparison: Comparison of overall scorep-value: 0.4195% CI: [0.8, 1.74]Regression, Logistic
Comparison: Comparison of informed decision subscalep-value: 0.049695% CI: [1, 1.8]Regression, Logistic
Comparison: Comparison of uncertainty subscale of DCSp-value: 0.0395% CI: [1.03, 2.05]Regression, Logistic
Comparison: Comparison of effective decision subscalep-value: 0.595% CI: [0.8, 1.59]Regression, Logistic
Comparison: Comparison of values clarity subscalep-value: 0.3195% CI: [0.86, 1.59]Regression, Logistic
Comparison: Comparison of support subscalep-value: 0.7395% CI: [0.76, 1.49]Regression, Logistic
Secondary
Patient Knowledge of Contraceptive Options and Features
Patient responses to items derived from National Survey of Reproductive Contraceptive Knowledge and previous studies of contraceptive knowledge and attitudes. All items analyzed as correct vs. incorrect.
Time frame: Baseline (post-visit)
Population: Observed in patients only
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Pills are more effective than condoms | Correct | 220 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Ring does not affect fertility | Incorrect | 124 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Depo is more effective than condoms | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Ring does not affect fertility | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | LARC can be removed early | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | IUDs are more effective than pills | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Depo does affect fertility | Incorrect | 295 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Copper IUDs can act as EC | Correct | 89 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Depo does affect fertility | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | IUDs are an option for nulliparous young women | Correct | 315 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Hormonal IUD does not affect fertility | Correct | 238 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Pills are more effective than condoms | Incorrect | 174 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Hormonal IUD does not affect fertility | Incorrect | 156 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | After sex, something to prevent pregnancy | Incorrect | 23 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Hormonal IUD does not affect fertility | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | IUDs are an option for nulliparous young women | Incorrect | 79 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Composite IUD knowledge | Missing | 0 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | After sex, something to prevent pregnancy | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Depo is more effective than condoms | Correct | 238 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | EC can prevent pregnancy after sex | Correct | 361 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Pills are more effective than condoms | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | IUDs are an option for nulliparous young women | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | EC can prevent pregnancy after sex | Incorrect | 43 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | LARC can be removed early | Correct | 261 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | LARC can be removed early | Incorrect | 133 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Copper IUDs can act as EC | Incorrect | 315 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | IUDs are more effective than pills | Incorrect | 115 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Copper IUDs can act as EC | Missing | 0 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | EC can prevent pregnancy after sex | Missing | 0 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | After sex, something to prevent pregnancy | Correct | 371 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Methods causing periods to stop are safe | Correct | 305 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Patch does not affect fertility | Incorrect | 117 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Pill does not affect fertility | Correct | 280 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Patch does not affect fertility | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Depo does affect fertility | Correct | 99 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Depo is more effective than condoms | Incorrect | 156 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Non-hormonal IUD does not affect fertility | Correct | 247 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Pill does not affect fertility | Incorrect | 114 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Non-hormonal IUD does not affect fertility | Incorrect | 147 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Methods causing periods to stop are safe | Incorrect | 89 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Non-hormonal IUD does not affect fertility | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Pill does not affect fertility | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Implant does not affect fertility | Correct | 233 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | IUDs are more effective than pills | Correct | 279 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Implant does not affect fertility | Incorrect | 161 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Patch does not affect fertility | Correct | 277 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Implant does not affect fertility | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Methods causing periods to stop are safe | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Composite IUD knowledge | Correct | 146 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Ring does not affect fertility | Correct | 270 Participants |
| Contraceptive Decision Support Tool | Patient Knowledge of Contraceptive Options and Features | Composite IUD knowledge | Incorrect | 258 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Ring does not affect fertility | Correct | 192 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Pills are more effective than condoms | Correct | 170 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | IUDs are more effective than pills | Correct | 162 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | IUDs are more effective than pills | Incorrect | 174 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | IUDs are more effective than pills | Missing | 9 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Depo is more effective than condoms | Correct | 156 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Depo is more effective than condoms | Incorrect | 180 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Depo is more effective than condoms | Missing | 9 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | IUDs are an option for nulliparous young women | Correct | 228 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | IUDs are an option for nulliparous young women | Incorrect | 108 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | IUDs are an option for nulliparous young women | Missing | 9 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Methods causing periods to stop are safe | Correct | 220 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Methods causing periods to stop are safe | Incorrect | 116 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | LARC can be removed early | Incorrect | 125 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | LARC can be removed early | Missing | 9 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Copper IUDs can act as EC | Correct | 33 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | After sex, something to prevent pregnancy | Correct | 320 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | After sex, something to prevent pregnancy | Incorrect | 16 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | After sex, something to prevent pregnancy | Missing | 9 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | EC can prevent pregnancy after sex | Correct | 315 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | EC can prevent pregnancy after sex | Incorrect | 29 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | EC can prevent pregnancy after sex | Missing | 1 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Pill does not affect fertility | Correct | 219 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Pill does not affect fertility | Incorrect | 117 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Pill does not affect fertility | Missing | 9 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Patch does not affect fertility | Missing | 9 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Ring does not affect fertility | Incorrect | 144 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Ring does not affect fertility | Missing | 9 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Depo does affect fertility | Correct | 86 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Depo does affect fertility | Incorrect | 250 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Depo does affect fertility | Missing | 9 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Hormonal IUD does not affect fertility | Correct | 165 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Hormonal IUD does not affect fertility | Incorrect | 171 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Composite IUD knowledge | Incorrect | 279 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Composite IUD knowledge | Missing | 0 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Pills are more effective than condoms | Incorrect | 166 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | LARC can be removed early | Correct | 211 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Pills are more effective than condoms | Missing | 9 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Methods causing periods to stop are safe | Missing | 9 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Copper IUDs can act as EC | Incorrect | 311 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Copper IUDs can act as EC | Missing | 1 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Patch does not affect fertility | Correct | 201 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Patch does not affect fertility | Incorrect | 135 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Hormonal IUD does not affect fertility | Missing | 9 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Non-hormonal IUD does not affect fertility | Correct | 176 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Non-hormonal IUD does not affect fertility | Incorrect | 160 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Non-hormonal IUD does not affect fertility | Missing | 9 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Implant does not affect fertility | Correct | 164 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Implant does not affect fertility | Incorrect | 172 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Implant does not affect fertility | Missing | 9 Participants |
| Usual Care (Control) | Patient Knowledge of Contraceptive Options and Features | Composite IUD knowledge | Correct | 66 Participants |
Comparison: Comparison of correct knowledge - pills are more effective than condomsp-value: 0.1295% CI: [0.94, 1.72]Regression, Logistic
Comparison: Comparison of correct knowledge - IUDs are more effective than pillsp-value: <0.000195% CI: [1.94, 3.62]Regression, Logistic
Comparison: Comparison of correct knowledge - depo is more effective than condomsp-value: 0.000495% CI: [1.29, 2.44]Regression, Logistic
Comparison: Comparison of correct knowledge - IUDs are an option for nulliparous young womenp-value: 0.000295% CI: [1.36, 2.71]Regression, Logistic
Comparison: Comparison of correct knowledge - Methods causing periods to stop are safe.p-value: 0.00195% CI: [1.28, 2.71]Regression, Logistic
Comparison: Comparison of correct knowledge - LARC can be removed earlyp-value: 0.3695% CI: [0.85, 1.57]Regression, Logistic
Comparison: Comparison of knowledge - Copper IUD can act as ECp-value: <0.000195% CI: [1.72, 4.41]Regression, Logistic
Comparison: Comparison of knowledge - After sex, there is something you can do to prevent pregnancyp-value: 0.4995% CI: [0.36, 1.63]Regression, Logistic
Comparison: Comparison of knowledge - EC can prevent pregnancy after sexp-value: 0.3195% CI: [0.39, 1.34]Regression, Logistic
Comparison: Comparison of correct knowledge - pill does not affect fertilityp-value: 0.0895% CI: [0.96, 1.84]Regression, Logistic
Comparison: Comparison of correct knowledge - patch does not affect fertilityp-value: 0.00295% CI: [1.2, 2.26]Regression, Logistic
Comparison: Comparison of correct knowledge - ring does not affect fertilityp-value: 0.00295% CI: [1.23, 2.35]Regression, Logistic
Comparison: Comparison of correct knowledge - Depo does affect fertilityp-value: 0.7795% CI: [0.62, 1.43]Regression, Logistic
Comparison: Comparison of correct knowledge - Hormonal IUD does not affect fertilityp-value: 0.00295% CI: [1.19, 2.17]Regression, Logistic
Comparison: Comparison of correct knowledge - Non-hormonal IUD does not affect fertilityp-value: 0.00495% CI: [1.15, 2.1]Regression, Logistic
Comparison: Comparison of correct knowledge - Implant does not affect fertilityp-value: 0.00595% CI: [1.14, 2.07]Regression, Logistic
Comparison: Comparison of correct knowledge - composite IUD knowledge item (all correct responses on items related to IUD knowledge, versus any incorrect)p-value: <0.000195% CI: [1.75, 3.49]Regression, Logistic
Secondary
Patient Rating of Visit as Much Better Than Previous Family Planning Visit
Patient report on 5-point Likert scale question asking patient to compare this visit to last family planning visit (1=Today was much worse; 5=today was much better). Analyzed dichotomously as top score of 5 versus \<5.
Time frame: Baseline (post-visit survey)
Population: Observed in patients only. Only calculated among those participants who reported ever having had a family planning visit. All others missing.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contraceptive Decision Support Tool | Patient Rating of Visit as Much Better Than Previous Family Planning Visit | Not much better | 144 Participants |
| Contraceptive Decision Support Tool | Patient Rating of Visit as Much Better Than Previous Family Planning Visit | Missing | 118 Participants |
| Contraceptive Decision Support Tool | Patient Rating of Visit as Much Better Than Previous Family Planning Visit | Much better | 142 Participants |
| Usual Care (Control) | Patient Rating of Visit as Much Better Than Previous Family Planning Visit | Much better | 104 Participants |
| Usual Care (Control) | Patient Rating of Visit as Much Better Than Previous Family Planning Visit | Not much better | 140 Participants |
| Usual Care (Control) | Patient Rating of Visit as Much Better Than Previous Family Planning Visit | Missing | 101 Participants |
Comparison: Patients excluded from test if they reported not having had a previous contraceptive counseling appointment.p-value: 0.1895% CI: [0.9, 1.81]Regression, Logistic
Secondary
Patient Satisfaction With Information Received About Side Effects During Counseling
Patient response to a 5-point Likert scale item about satisfaction with information that their provider gave them about side effects of their chosen methods during their baseline visit (1=completely unsatisfied, 5=completely satisfied). Analyzed dichotomously as top score of 5 versus \<5.
Time frame: Baseline (post-visit survey)
Population: Observed in patients only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contraceptive Decision Support Tool | Patient Satisfaction With Information Received About Side Effects During Counseling | Top score of 5, completely satisfied | 325 Participants |
| Contraceptive Decision Support Tool | Patient Satisfaction With Information Received About Side Effects During Counseling | Less than 5 | 64 Participants |
| Contraceptive Decision Support Tool | Patient Satisfaction With Information Received About Side Effects During Counseling | Missing | 15 Participants |
| Usual Care (Control) | Patient Satisfaction With Information Received About Side Effects During Counseling | Top score of 5, completely satisfied | 253 Participants |
| Usual Care (Control) | Patient Satisfaction With Information Received About Side Effects During Counseling | Less than 5 | 81 Participants |
| Usual Care (Control) | Patient Satisfaction With Information Received About Side Effects During Counseling | Missing | 11 Participants |
p-value: 0.0195% CI: [1.11, 2.33]Regression, Logistic
Secondary
Shared Decision Making - Feelings About Provider Involvement
Patient report on 3-point scale of their feelings about provider involvement in contraceptive decision-making: I wish provider had been less involved, provider was involved the right amount, I wiss provider had been more involved.
Time frame: Baseline (post-visit) and up to 24 months
Population: Observed in patients only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contraceptive Decision Support Tool | Shared Decision Making - Feelings About Provider Involvement | Right amount | 370 Participants |
| Contraceptive Decision Support Tool | Shared Decision Making - Feelings About Provider Involvement | Wish provider had been less involved | 8 Participants |
| Contraceptive Decision Support Tool | Shared Decision Making - Feelings About Provider Involvement | Wish provider had been more involved | 16 Participants |
| Contraceptive Decision Support Tool | Shared Decision Making - Feelings About Provider Involvement | Missing | 10 Participants |
| Usual Care (Control) | Shared Decision Making - Feelings About Provider Involvement | Missing | 9 Participants |
| Usual Care (Control) | Shared Decision Making - Feelings About Provider Involvement | Right amount | 305 Participants |
| Usual Care (Control) | Shared Decision Making - Feelings About Provider Involvement | Wish provider had been more involved | 21 Participants |
| Usual Care (Control) | Shared Decision Making - Feelings About Provider Involvement | Wish provider had been less involved | 10 Participants |
Comparison: Comparison of patients who wished provider had been less involved to right amount (ref)p-value: 0.8595% CI: [0.4, 3.04]Regression, Logistic
Comparison: Comparison of patients who reported they wished their providers had been more involved, compared to right amount (ref)p-value: 0.2495% CI: [0.73, 3.5]Regression, Logistic
Secondary
Shared Decision Making - Provider Appropriately Expressed Preference
Patient report of attitude on 3-point scale on how provider expressed preference for contraceptive method choice: Right amount, wish less strongly, wish more strongly.
Time frame: Baseline (post-visit survey)
Population: Observed in patients only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contraceptive Decision Support Tool | Shared Decision Making - Provider Appropriately Expressed Preference | No, I wish less | 16 Participants |
| Contraceptive Decision Support Tool | Shared Decision Making - Provider Appropriately Expressed Preference | No, I wish more | 21 Participants |
| Contraceptive Decision Support Tool | Shared Decision Making - Provider Appropriately Expressed Preference | Yes, exactly right | 357 Participants |
| Contraceptive Decision Support Tool | Shared Decision Making - Provider Appropriately Expressed Preference | Missing | 10 Participants |
| Usual Care (Control) | Shared Decision Making - Provider Appropriately Expressed Preference | Yes, exactly right | 297 Participants |
| Usual Care (Control) | Shared Decision Making - Provider Appropriately Expressed Preference | No, I wish less | 13 Participants |
| Usual Care (Control) | Shared Decision Making - Provider Appropriately Expressed Preference | Missing | 9 Participants |
| Usual Care (Control) | Shared Decision Making - Provider Appropriately Expressed Preference | No, I wish more | 26 Participants |
Comparison: Comparison of patients who wished provider had expressed preference less strongly to right amount (ref).p-value: 0.99795% CI: [0.45, 2.25]Regression, Logistic
Comparison: Comparison of patients who reported they wished provider had expressed preference more strongly, compared to right amount (ref).p-value: 0.1695% CI: [0.41, 1.16]Regression, Logistic
Secondary
Shared Decision Making - Provider Preference
Patient report of whether or not provider had preference for contraceptive method choice, reported on a 5-point scale: no preference, slight preference, moderate preference, strong preference, extremely strong preference. Analyzed dichotomously as any preference versus no preference.
Time frame: Baseline (post-visit survey)
Population: Observed in patients only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contraceptive Decision Support Tool | Shared Decision Making - Provider Preference | Provider had no preference | 200 Participants |
| Contraceptive Decision Support Tool | Shared Decision Making - Provider Preference | Provider had preference | 194 Participants |
| Contraceptive Decision Support Tool | Shared Decision Making - Provider Preference | Missing | 10 Participants |
| Usual Care (Control) | Shared Decision Making - Provider Preference | Provider had preference | 143 Participants |
| Usual Care (Control) | Shared Decision Making - Provider Preference | Provider had no preference | 193 Participants |
| Usual Care (Control) | Shared Decision Making - Provider Preference | Missing | 9 Participants |
p-value: 0.1295% CI: [0.94, 1.71]Regression, Logistic
Secondary
Shared Decision Making - Satisfaction With How Provider Helped With Choice
Patient report of satisfaction on a 5-point Likert scale (from 1=completely unsatisfied to 5=completely satisfied) of how the provider helped contraceptive method choice. Analyzed dichotomously as top score of 5 versus \<5.
Time frame: Baseline (post-visit survey)
Population: Observed in patients only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contraceptive Decision Support Tool | Shared Decision Making - Satisfaction With How Provider Helped With Choice | Completely satisfied | 303 Participants |
| Contraceptive Decision Support Tool | Shared Decision Making - Satisfaction With How Provider Helped With Choice | Less than completely satisfied | 91 Participants |
| Contraceptive Decision Support Tool | Shared Decision Making - Satisfaction With How Provider Helped With Choice | Missing | 10 Participants |
| Usual Care (Control) | Shared Decision Making - Satisfaction With How Provider Helped With Choice | Completely satisfied | 240 Participants |
| Usual Care (Control) | Shared Decision Making - Satisfaction With How Provider Helped With Choice | Less than completely satisfied | 96 Participants |
| Usual Care (Control) | Shared Decision Making - Satisfaction With How Provider Helped With Choice | Missing | 9 Participants |
p-value: 0.1395% CI: [0.93, 1.82]Regression, Logistic
Secondary
Shared Decision Making - Who Made the Decision?
Patient response to 5-point scale of who made decision on contraceptive method. The original 5 points were the provider by themselves, more provider, both equally, more patient, or provider by themselves. In analysis, these options were collapsed to three points: more provider, both equally, or more patient.
Time frame: Baseline (post-visit)
Population: Observed in patients only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contraceptive Decision Support Tool | Shared Decision Making - Who Made the Decision? | Both | 88 Participants |
| Contraceptive Decision Support Tool | Shared Decision Making - Who Made the Decision? | Patient | 286 Participants |
| Contraceptive Decision Support Tool | Shared Decision Making - Who Made the Decision? | Missing | 10 Participants |
| Contraceptive Decision Support Tool | Shared Decision Making - Who Made the Decision? | Provider | 20 Participants |
| Usual Care (Control) | Shared Decision Making - Who Made the Decision? | Missing | 9 Participants |
| Usual Care (Control) | Shared Decision Making - Who Made the Decision? | Patient | 244 Participants |
| Usual Care (Control) | Shared Decision Making - Who Made the Decision? | Both | 83 Participants |
| Usual Care (Control) | Shared Decision Making - Who Made the Decision? | Provider | 9 Participants |
Comparison: Comparison of patient decision to both (ref)p-value: 0.595% CI: [0.79, 1.61]Regression, Logistic
Comparison: Comparison of provider decision to both (ref)p-value: 0.0995% CI: [0.89, 5.15]Regression, Logistic
Secondary
Time Spent With Contraceptive Counseling Provider
Total amount of time spent with the provider that is providing contraceptive counseling.
Time frame: Baseline visit
Population: Observed in patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contraceptive Decision Support Tool | Time Spent With Contraceptive Counseling Provider | 44.0 minutes | Standard Deviation 1.21 |
| Usual Care (Control) | Time Spent With Contraceptive Counseling Provider | 44.4 minutes | Standard Deviation 1.29 |
p-value: 0.6395% CI: [-3.19, 5.29]Regression, Linear
Secondary
Total Clinic Visit Time
Total amount of time a patient spends in a clinic for a family planning visit, from check-in to check-out.
Time frame: Baseline visit
Population: Observed in patients only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contraceptive Decision Support Tool | Total Clinic Visit Time | 98.40 minutes | Standard Deviation 1.75 |
| Usual Care (Control) | Total Clinic Visit Time | 86.94 minutes | Standard Deviation 1.71 |
p-value: <0.00195% CI: [8.54, 18.66]Regression, Linear
Other Pre-specified
Choice of a Highly Effective Method of Contraception at Baseline
Patient report of whether or not patient chose highly effective method at baseline. Highly effective methods include implants, IUDs, and male and female sterilization.
Time frame: Baseline (post-visit survey)
Population: Observed in patients only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contraceptive Decision Support Tool | Choice of a Highly Effective Method of Contraception at Baseline | Chose highly effective method | 153 Participants |
| Contraceptive Decision Support Tool | Choice of a Highly Effective Method of Contraception at Baseline | Did not choose highly effective method | 249 Participants |
| Contraceptive Decision Support Tool | Choice of a Highly Effective Method of Contraception at Baseline | Missing | 2 Participants |
| Usual Care (Control) | Choice of a Highly Effective Method of Contraception at Baseline | Chose highly effective method | 120 Participants |
| Usual Care (Control) | Choice of a Highly Effective Method of Contraception at Baseline | Did not choose highly effective method | 221 Participants |
| Usual Care (Control) | Choice of a Highly Effective Method of Contraception at Baseline | Missing | 4 Participants |
p-value: 0.7895% CI: [0.69, 1.65]Regression, Logistic
Other Pre-specified
Unplanned Pregnancy
Incidence of unplanned pregnancy among study participants, as determined by responses of patients who experienced a pregnancy to the 6-item London Measure of Unplanned Pregnancy. The London Measure includes items on attitude towards an experienced pregnancy and behaviors before pregnancy to determine the intendedness of pregnancy. The score range of the London Measure is 0-12, with a score of \<10 indicating unplanned pregnancy and a score of 10 or higher indicating planned pregnancy. We report the percentage of patients who report a pregnancy and report a score of \<10 on the London Measure.
Time frame: 4 months and 7 months from enrollment
Population: Observed in patients only
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Contraceptive Decision Support Tool | Unplanned Pregnancy | At 4 months post-enrollment | Yes | 11 Participants |
| Contraceptive Decision Support Tool | Unplanned Pregnancy | At 4 months post-enrollment | No | 350 Participants |
| Contraceptive Decision Support Tool | Unplanned Pregnancy | At 4 months post-enrollment | Missing | 43 Participants |
| Contraceptive Decision Support Tool | Unplanned Pregnancy | At 7 months post-enrollment | Yes | 24 Participants |
| Contraceptive Decision Support Tool | Unplanned Pregnancy | At 7 months post-enrollment | No | 336 Participants |
| Contraceptive Decision Support Tool | Unplanned Pregnancy | At 7 months post-enrollment | Missing | 44 Participants |
| Usual Care (Control) | Unplanned Pregnancy | At 7 months post-enrollment | No | 280 Participants |
| Usual Care (Control) | Unplanned Pregnancy | At 4 months post-enrollment | Yes | 8 Participants |
| Usual Care (Control) | Unplanned Pregnancy | At 7 months post-enrollment | Yes | 11 Participants |
| Usual Care (Control) | Unplanned Pregnancy | At 4 months post-enrollment | No | 300 Participants |
| Usual Care (Control) | Unplanned Pregnancy | At 7 months post-enrollment | Missing | 54 Participants |
| Usual Care (Control) | Unplanned Pregnancy | At 4 months post-enrollment | Missing | 37 Participants |
Comparison: Comparison at 4 months post-enrollmentp-value: 0.6395% CI: [0.48, 3.37]Regression, Logistic
Comparison: Comparison at 7 months post-enrollmentp-value: 0.1195% CI: [0.88, 3.8]Regression, Logistic
Other Pre-specified
Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up.
Whether patient is using a highly effective contraceptive method at 4 and 7 month follow-up survey. Highly effective methods include implant, IUDs, and male and female sterilization.
Time frame: 4 and 7 months post-enrollment
Population: Observed in patients only
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Contraceptive Decision Support Tool | Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up. | At 4 months | Missing | 46 Participants |
| Contraceptive Decision Support Tool | Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up. | At 7 months | No | 99 Participants |
| Contraceptive Decision Support Tool | Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up. | At 4 months | No | 94 Participants |
| Contraceptive Decision Support Tool | Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up. | At 7 months | Missing | 47 Participants |
| Contraceptive Decision Support Tool | Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up. | At 7 months | Yes | 258 Participants |
| Contraceptive Decision Support Tool | Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up. | At 4 months | Yes | 264 Participants |
| Usual Care (Control) | Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up. | At 7 months | Yes | 201 Participants |
| Usual Care (Control) | Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up. | At 4 months | No | 76 Participants |
| Usual Care (Control) | Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up. | At 4 months | Missing | 39 Participants |
| Usual Care (Control) | Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up. | At 4 months | Yes | 230 Participants |
| Usual Care (Control) | Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up. | At 7 months | No | 90 Participants |
| Usual Care (Control) | Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up. | At 7 months | Missing | 54 Participants |
Comparison: Comparison at 4 months post-enrollmentp-value: 0.7595% CI: [0.66, 1.35]Regression, Logistic
Comparison: Comparison at 7 months post-enrollmentp-value: 0.7195% CI: [0.75, 1.53]Regression, Logistic
Other Pre-specified
Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up
Patient report of whether or not patient is using a highly or moderately effective contraceptive method at 4 and 7 month follow-up survey. As defined by the Centers for Disease Control, moderately effective methods include injectables, pills, patch, vaginal ring, and diaphragm; typical failure rates range from 6-12%. Highly effective methods include implants, IUDs, and male and female sterilization; failure rates are less than 1%.
Time frame: 4 and 7 months post-enrollment
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Contraceptive Decision Support Tool | Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up | At 4 months post-enrollment | Yes | 264 Participants |
| Contraceptive Decision Support Tool | Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up | At 4 months post-enrollment | No | 94 Participants |
| Contraceptive Decision Support Tool | Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up | At 4 months post-enrollment | Missing | 46 Participants |
| Contraceptive Decision Support Tool | Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up | At 7 months post-enrollment | Yes | 258 Participants |
| Contraceptive Decision Support Tool | Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up | At 7 months post-enrollment | No | 99 Participants |
| Contraceptive Decision Support Tool | Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up | At 7 months post-enrollment | Missing | 47 Participants |
| Usual Care (Control) | Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up | At 7 months post-enrollment | No | 90 Participants |
| Usual Care (Control) | Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up | At 4 months post-enrollment | Yes | 230 Participants |
| Usual Care (Control) | Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up | At 7 months post-enrollment | Yes | 201 Participants |
| Usual Care (Control) | Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up | At 4 months post-enrollment | No | 76 Participants |
| Usual Care (Control) | Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up | At 7 months post-enrollment | Missing | 54 Participants |
| Usual Care (Control) | Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up | At 4 months post-enrollment | Missing | 39 Participants |
Comparison: Comparison at 4 months post-enrollmentp-value: 0.7595% CI: [0.66, 1.34]Regression, Logistic
Comparison: Comparison at 7 months post-enrollmentp-value: 0.3795% CI: [0.83, 1.64]Regression, Logistic