Contraception
Conditions
Keywords
Shared Decision-Making, Patient-Provider Communication
Brief summary
Right For Me is a study that aims to improve the conversations patients and health care providers have about birth control. Right For Me will test two different strategies for improving these conversations. The first strategy is to give patients a video to watch that encourages them to ask three specific questions in their health care visit, as well as a prompt card that reminds them of the three questions. The second strategy is to give health care providers a set of decision aids that describe available birth control methods, as well as training in how to use them with patients during the health care visit. Right For Me will test whether introducing one or both of these strategies leads to better conversations than providing health care as usual.
Interventions
OTHERVideo + Prompt Card
1. A brief video (available in English and Spanish) intended to be viewed by patients immediately before the health care visit. The video aims to enhance patients' motivation, skills, and self-efficacy to ask their health care providers three specific questions: (1) What are my options? (2) What are the pros and cons of those options? and (3) How likely are those pros and cons to happen to me? 2. A prompt card (available in English and Spanish) intended to be provided to patients when they view the video and kept. The card aims to remind patients of the three questions presented in the video.
OTHERDecision Aids + Training
1. Seven one-page decision aids on contraceptive methods (available in English and Spanish) intended to be used by health care providers with patients during the health care visit. 2. A five-minute training video and accompanying written guidance (available in English) intended to be reviewed by health care providers before implementing the decision aids (and as frequently as desired thereafter). The training aims to enhance providers' motivation, skills, and self-efficacy to use the decision aids to facilitate shared decision-making in the health care visit.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
1. Completed a health care visit at a participating clinic 2. Assigned female sex at birth 3. Aged 15 to 49 years 4. Able to read and write English or Spanish 5. Not previously participated in the study
Exclusion criteria
1. Not completed a health care visit at a participating clinic (including a patient's parent or a person acting as a patient's legal proxy) 2. Not assigned female sex at birth 3. Aged under 15 or over 49 years 4. Unable to read and write English or Spanish 5. Previously participated in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shared Decision-making About Contraceptive Methods | Immediately after the index health care visit (Time 1 (T1)) [for both pre-implementation and post-implementation participants] | Shared decision-making about contraceptive methods in the health care visit, measured using the three-item CollaboRATE measure (Barr et al., 2014; Elwyn et al., 2013). We used the version of CollaboRATE with a five-point response scale and adopted the binary scoring approach, which yields a score of 0 (no shared decision-making) and 1 (shared decision-making) for each participant. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Values Concordance of Intended Contraceptive Method(s) | Immediately after the index health care visit (T1); 4 weeks after the index health care visit (Time 2 (T2)); 6 months after the index health care visit (Time 3 (T3)) [for both pre-implementation and post-implementation participants] | Participants' perceptions of the degree of concordance between the contraceptive method(s) they intend(ed) to use and their individual values, needs, and preferences, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Use of Intended Contraceptive Method(s) | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Whether participants used their intended contraceptive method(s) in the last four weeks, derived from data on intended contraceptive method(s) and contraceptive method(s) used. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Adherence to Contraceptive Method(s) Used | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Participants' adherence to the contraceptive method(s) they used in the last four weeks, measured using a self-developed, 21-item measure. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Satisfaction With Contraceptive Method(s) Used | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Participants' satisfaction with the contraceptive method(s) they used in the last four weeks, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Unintended Pregnancy (Pregnancy Timing Preferences) | 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Participants' experience of one or more unintended pregnancies since the health care visit (as defined by their pregnancy timing preferences), measured using an adapted item (Centers for Disease Control and Prevention, 2012). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Unintended Pregnancy (Pregnancy Seeking) | 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Participants' experience of one or more unintended pregnancies since the health care visit (as defined by their pregnancy seeking), measured using an adapted item (Kavanaugh & Schwarz, 2009). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Unwelcome Pregnancy | 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Participants' experience of one or more unwelcome pregnancies since the health care visit, measured using an adapted item (Centers for Disease Control and Prevention, 2012). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Conversation About Contraception | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Whether participants experienced a conversation about contraception in the health care visit, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Satisfaction With Conversation About Contraception | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Participants' satisfaction with the conversation about contraception in the health care visit, measured using an adapted item (Weisman et al., 2002). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Intended Contraceptive Method(s) | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | What, if any, contraceptive method(s) participants intend to use in the next four weeks, measured using a self-developed checklist. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Intention to Use a Highly Effective Contraceptive Method | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Whether participants intend to use at least one highly effective contraceptive method in the next four weeks, derived from data on intended contraceptive method(s). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Decision Regret About Intended Contraceptive Method(s) | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Participants' feelings of decision regret about the contraceptive method(s) they intended to use, measured using an adaptation of the five-item Decision Regret Scale (Brehaut et al., 2003; O'Connor, 1996). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Contraceptive Method(s) Used | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | What, if any, contraceptive method(s) participants used in the last four weeks, measured using a self-developed checklist. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Use of a Highly Effective Contraceptive Method | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Whether participants used at least one highly effective contraceptive method in the last four weeks, derived from data on contraceptive method(s) used. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of Three Questions | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Participants' use of each of the three patient questions in the health care visit, measured using three adapted items (Shepherd et al., 2015). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Exposure to Decision Aid(s) | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Participants' exposure to one or more of the decision aids and timing of exposure, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Acceptability of Video | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | The acceptability of the video to participants, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Acceptability of Decision Aid(s) | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | The acceptability of the decision aid(s) to participants, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Exposure to Video | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Participants' exposure to the video and timing of exposure, measured using an adapted item (Shepherd et al., 2015). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Exposure to Prompt Card | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Participants' exposure to the prompt card and timing of exposure, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
Countries
United States
Participant flow
Recruitment details
The recruitment period was April 1, 2016 to December 30, 2016. Recruitment took place in 16 primary care and/or reproductive health care clinics in the Northeast United States.
Pre-assignment details
This was a cluster randomized trial. The level of randomization was clinics.
Participants by arm
| Arm | Count |
|---|---|
| Video + Prompt Card A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video. | 1,245 |
| Decision Aids + Training A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter). | 1,141 |
| Video + Prompt Card and Decision Aids + Training A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video.
And A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter). | 1,388 |
| Usual Care Care as usual. | 1,244 |
| Total | 5,018 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Ineligible for T2 and T3 | 310 | 179 | 366 | 391 |
| Overall Study | Lost to Follow-up | 735 | 791 | 783 | 650 |
| Overall Study | Missing data on first outcome assessed | 11 | 2 | 5 | 2 |
Baseline characteristics
| Characteristic | Decision Aids + Training | Video + Prompt Card and Decision Aids + Training | Video + Prompt Card | Usual Care | Total |
|---|---|---|---|---|---|
| Age, Customized 15 to 19 years | 172 Participants | 181 Participants | 224 Participants | 180 Participants | 757 Participants |
| Age, Customized 20 to 24 years | 336 Participants | 369 Participants | 427 Participants | 359 Participants | 1491 Participants |
| Age, Customized 25 to 29 years | 299 Participants | 336 Participants | 341 Participants | 290 Participants | 1266 Participants |
| Age, Customized 30 to 34 years | 173 Participants | 234 Participants | 137 Participants | 165 Participants | 709 Participants |
| Age, Customized 35 to 39 years | 93 Participants | 127 Participants | 60 Participants | 109 Participants | 389 Participants |
| Age, Customized 40 to 44 years | 41 Participants | 77 Participants | 39 Participants | 79 Participants | 236 Participants |
| Age, Customized 45 to 49 years | 27 Participants | 64 Participants | 17 Participants | 62 Participants | 170 Participants |
| Current Gender Identity Female | 1120 Participants | 1370 Participants | 1224 Participants | 1233 Participants | 4947 Participants |
| Current Gender Identity Genderqueer | 13 Participants | 10 Participants | 13 Participants | 6 Participants | 42 Participants |
| Current Gender Identity Male | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Current Gender Identity Other | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Current Gender Identity Trans Man | 2 Participants | 4 Participants | 4 Participants | 1 Participants | 11 Participants |
| Current Gender Identity Trans Woman | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Current Gender Identity Two or more | 5 Participants | 3 Participants | 2 Participants | 1 Participants | 11 Participants |
| Educational attainment 12th grade or less | 118 Participants | 148 Participants | 64 Participants | 151 Participants | 481 Participants |
| Educational attainment After Bachelor's degree | 88 Participants | 145 Participants | 169 Participants | 130 Participants | 532 Participants |
| Educational attainment College or some college | 623 Participants | 705 Participants | 705 Participants | 652 Participants | 2685 Participants |
| Educational attainment High school graduate | 304 Participants | 367 Participants | 289 Participants | 293 Participants | 1253 Participants |
| Educational attainment Missing | 8 Participants | 23 Participants | 18 Participants | 18 Participants | 67 Participants |
| Ethnicity Missing | 12 Participants | 31 Participants | 21 Participants | 19 Participants | 83 Participants |
| Ethnicity Not of Hispanic, Latino, or Spanish origin | 1085 Participants | 1294 Participants | 1153 Participants | 1080 Participants | 4612 Participants |
| Ethnicity Of Hispanic, Latino, or Spanish origin(s) | 44 Participants | 63 Participants | 71 Participants | 145 Participants | 323 Participants |
| Health insurance coverage Medicaid | 296 Participants | 465 Participants | 186 Participants | 526 Participants | 1473 Participants |
| Health insurance coverage Missing | 9 Participants | 21 Participants | 21 Participants | 15 Participants | 66 Participants |
| Health insurance coverage None | 206 Participants | 231 Participants | 212 Participants | 98 Participants | 747 Participants |
| Health insurance coverage Other | 84 Participants | 105 Participants | 136 Participants | 88 Participants | 413 Participants |
| Health insurance coverage Private | 491 Participants | 526 Participants | 650 Participants | 481 Participants | 2148 Participants |
| Health insurance coverage Temporary Medicaid | 33 Participants | 24 Participants | 21 Participants | 22 Participants | 100 Participants |
| Health insurance coverage Two or more | 22 Participants | 16 Participants | 19 Participants | 14 Participants | 71 Participants |
| Health literacy Adequate | 912 Participants | 1069 Participants | 964 Participants | 949 Participants | 3894 Participants |
| Health literacy Limited | 221 Participants | 296 Participants | 264 Participants | 280 Participants | 1061 Participants |
| Health literacy Missing | 8 Participants | 23 Participants | 17 Participants | 15 Participants | 63 Participants |
| Number of abortions Missing | 21 Participants | 37 Participants | 28 Participants | 32 Participants | 118 Participants |
| Number of abortions None | 742 Participants | 1086 Participants | 899 Participants | 981 Participants | 3708 Participants |
| Number of abortions One | 258 Participants | 193 Participants | 203 Participants | 168 Participants | 822 Participants |
| Number of abortions Three or more | 31 Participants | 13 Participants | 33 Participants | 16 Participants | 93 Participants |
| Number of abortions Two | 89 Participants | 59 Participants | 82 Participants | 47 Participants | 277 Participants |
| Number of births Missing | 19 Participants | 39 Participants | 35 Participants | 27 Participants | 120 Participants |
| Number of births None | 732 Participants | 875 Participants | 1008 Participants | 804 Participants | 3419 Participants |
| Number of births One | 197 Participants | 198 Participants | 117 Participants | 152 Participants | 664 Participants |
| Number of births Three or more | 65 Participants | 91 Participants | 22 Participants | 107 Participants | 285 Participants |
| Number of births Two | 128 Participants | 185 Participants | 63 Participants | 154 Participants | 530 Participants |
| Number of miscarriages Missing | 21 Participants | 39 Participants | 35 Participants | 28 Participants | 123 Participants |
| Number of miscarriages None | 943 Participants | 1166 Participants | 1124 Participants | 1029 Participants | 4262 Participants |
| Number of miscarriages One | 142 Participants | 132 Participants | 66 Participants | 128 Participants | 468 Participants |
| Number of miscarriages Three or more | 8 Participants | 21 Participants | 10 Participants | 16 Participants | 55 Participants |
| Number of miscarriages Two | 27 Participants | 30 Participants | 10 Participants | 43 Participants | 110 Participants |
| Number of pregnancies Missing | 12 Participants | 31 Participants | 29 Participants | 22 Participants | 94 Participants |
| Number of pregnancies None | 496 Participants | 715 Participants | 800 Participants | 663 Participants | 2674 Participants |
| Number of pregnancies One | 250 Participants | 226 Participants | 180 Participants | 195 Participants | 851 Participants |
| Number of pregnancies Three or more | 208 Participants | 236 Participants | 137 Participants | 214 Participants | 795 Participants |
| Number of pregnancies Two | 175 Participants | 180 Participants | 99 Participants | 150 Participants | 604 Participants |
| Previous contraceptive method(s) Highly effective method(s) | 255 Participants | 334 Participants | 244 Participants | 327 Participants | 1160 Participants |
| Previous contraceptive method(s) Less effective method(s) | 609 Participants | 660 Participants | 624 Participants | 474 Participants | 2367 Participants |
| Previous contraceptive method(s) Missing | 1 Participants | 6 Participants | 4 Participants | 4 Participants | 15 Participants |
| Previous contraceptive method(s) No methods | 187 Participants | 154 Participants | 162 Participants | 164 Participants | 667 Participants |
| Previous contraceptive method(s) Not asked | 89 Participants | 234 Participants | 211 Participants | 275 Participants | 809 Participants |
| Race American Indian or Alaska Native | 9 Participants | 10 Participants | 11 Participants | 12 Participants | 42 Participants |
| Race Asian | 15 Participants | 15 Participants | 93 Participants | 16 Participants | 139 Participants |
| Race Black or African American | 12 Participants | 27 Participants | 49 Participants | 70 Participants | 158 Participants |
| Race Missing | 11 Participants | 27 Participants | 23 Participants | 22 Participants | 83 Participants |
| Race Native Hawaiian or Some other race(s) | 15 Participants | 18 Participants | 16 Participants | 52 Participants | 101 Participants |
| Race Two or more | 43 Participants | 53 Participants | 62 Participants | 54 Participants | 212 Participants |
| Race White | 1036 Participants | 1238 Participants | 991 Participants | 1018 Participants | 4283 Participants |
| Sex: Female, Male Female | 1141 Participants | 1388 Participants | 1245 Participants | 1244 Participants | 5018 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Survey language English | 1140 Participants | 1386 Participants | 1244 Participants | 1219 Participants | 4989 Participants |
| Survey language Spanish | 1 Participants | 2 Participants | 1 Participants | 25 Participants | 29 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 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Shared Decision-making About Contraceptive Methods
Shared decision-making about contraceptive methods in the health care visit, measured using the three-item CollaboRATE measure (Barr et al., 2014; Elwyn et al., 2013). We used the version of CollaboRATE with a five-point response scale and adopted the binary scoring approach, which yields a score of 0 (no shared decision-making) and 1 (shared decision-making) for each participant. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: Immediately after the index health care visit (Time 1 (T1)) [for both pre-implementation and post-implementation participants]
Population: Participants with valid data on the primary outcome of shared decision-making about contraceptive methods and all covariates included in the adjusted analytic model. Data were collected at three time points from samples receiving care before (pre-implementation) and after (post-implementation) introduction of any intervention(s).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Video + Prompt Card | Shared Decision-making About Contraceptive Methods | Pre-implementation | Shared decision-making | 165 Participants |
| Video + Prompt Card | Shared Decision-making About Contraceptive Methods | Pre-implementation | No shared decision-making | 131 Participants |
| Video + Prompt Card | Shared Decision-making About Contraceptive Methods | Post-implementation | Shared decision-making | 392 Participants |
| Video + Prompt Card | Shared Decision-making About Contraceptive Methods | Post-implementation | No shared decision-making | 307 Participants |
| Decision Aids + Training | Shared Decision-making About Contraceptive Methods | Pre-implementation | No shared decision-making | 142 Participants |
| Decision Aids + Training | Shared Decision-making About Contraceptive Methods | Post-implementation | Shared decision-making | 427 Participants |
| Decision Aids + Training | Shared Decision-making About Contraceptive Methods | Post-implementation | No shared decision-making | 190 Participants |
| Decision Aids + Training | Shared Decision-making About Contraceptive Methods | Pre-implementation | Shared decision-making | 272 Participants |
| Video + Prompt Card and Decision Aids + Training | Shared Decision-making About Contraceptive Methods | Post-implementation | Shared decision-making | 459 Participants |
| Video + Prompt Card and Decision Aids + Training | Shared Decision-making About Contraceptive Methods | Pre-implementation | No shared decision-making | 123 Participants |
| Video + Prompt Card and Decision Aids + Training | Shared Decision-making About Contraceptive Methods | Post-implementation | No shared decision-making | 313 Participants |
| Video + Prompt Card and Decision Aids + Training | Shared Decision-making About Contraceptive Methods | Pre-implementation | Shared decision-making | 222 Participants |
| Usual Care | Shared Decision-making About Contraceptive Methods | Post-implementation | No shared decision-making | 278 Participants |
| Usual Care | Shared Decision-making About Contraceptive Methods | Pre-implementation | No shared decision-making | 109 Participants |
| Usual Care | Shared Decision-making About Contraceptive Methods | Pre-implementation | Shared decision-making | 190 Participants |
| Usual Care | Shared Decision-making About Contraceptive Methods | Post-implementation | Shared decision-making | 360 Participants |
p-value: 0.8See below
p-value: 0.32See below
p-value: 0.99See below
p-value: 0.72See below
Secondary
Adherence to Contraceptive Method(s) Used
Participants' adherence to the contraceptive method(s) they used in the last four weeks, measured using a self-developed, 21-item measure. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
Secondary
Contraceptive Method(s) Used
What, if any, contraceptive method(s) participants used in the last four weeks, measured using a self-developed checklist. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
Secondary
Conversation About Contraception
Whether participants experienced a conversation about contraception in the health care visit, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Secondary
Decision Regret About Intended Contraceptive Method(s)
Participants' feelings of decision regret about the contraceptive method(s) they intended to use, measured using an adaptation of the five-item Decision Regret Scale (Brehaut et al., 2003; O'Connor, 1996). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
Secondary
Intended Contraceptive Method(s)
What, if any, contraceptive method(s) participants intend to use in the next four weeks, measured using a self-developed checklist. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Secondary
Intention to Use a Highly Effective Contraceptive Method
Whether participants intend to use at least one highly effective contraceptive method in the next four weeks, derived from data on intended contraceptive method(s). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Secondary
Satisfaction With Contraceptive Method(s) Used
Participants' satisfaction with the contraceptive method(s) they used in the last four weeks, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
Secondary
Satisfaction With Conversation About Contraception
Participants' satisfaction with the conversation about contraception in the health care visit, measured using an adapted item (Weisman et al., 2002). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Secondary
Unintended Pregnancy (Pregnancy Seeking)
Participants' experience of one or more unintended pregnancies since the health care visit (as defined by their pregnancy seeking), measured using an adapted item (Kavanaugh & Schwarz, 2009). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
Secondary
Unintended Pregnancy (Pregnancy Timing Preferences)
Participants' experience of one or more unintended pregnancies since the health care visit (as defined by their pregnancy timing preferences), measured using an adapted item (Centers for Disease Control and Prevention, 2012). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
Secondary
Unwelcome Pregnancy
Participants' experience of one or more unwelcome pregnancies since the health care visit, measured using an adapted item (Centers for Disease Control and Prevention, 2012). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
Secondary
Use of a Highly Effective Contraceptive Method
Whether participants used at least one highly effective contraceptive method in the last four weeks, derived from data on contraceptive method(s) used. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
Secondary
Use of Intended Contraceptive Method(s)
Whether participants used their intended contraceptive method(s) in the last four weeks, derived from data on intended contraceptive method(s) and contraceptive method(s) used. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
Secondary
Values Concordance of Intended Contraceptive Method(s)
Participants' perceptions of the degree of concordance between the contraceptive method(s) they intend(ed) to use and their individual values, needs, and preferences, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: Immediately after the index health care visit (T1); 4 weeks after the index health care visit (Time 2 (T2)); 6 months after the index health care visit (Time 3 (T3)) [for both pre-implementation and post-implementation participants]
Other Pre-specified
Acceptability of Decision Aid(s)
The acceptability of the decision aid(s) to participants, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Other Pre-specified
Acceptability of Video
The acceptability of the video to participants, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Other Pre-specified
Exposure to Decision Aid(s)
Participants' exposure to one or more of the decision aids and timing of exposure, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Other Pre-specified
Exposure to Prompt Card
Participants' exposure to the prompt card and timing of exposure, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Other Pre-specified
Exposure to Video
Participants' exposure to the video and timing of exposure, measured using an adapted item (Shepherd et al., 2015). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Other Pre-specified
Use of Three Questions
Participants' use of each of the three patient questions in the health care visit, measured using three adapted items (Shepherd et al., 2015). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time frame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]