Contraception, Decision Making, Evaluation, Satisfaction
Conditions
Brief summary
The purpose of this study is to conduct a randomized clinical trial of a web-based contraceptive decision aid compared to routine contraceptive counseling to evaluate the effect of the contraceptive decision aid on the contraceptive method selected by the participant. The investigators primary hypothesis is that women utilizing a computerized Contraceptive Decision Aid (CDA) will be more likely to choose highly effective contraception than women who undergo standard clinical contraceptive counseling.
Detailed description
Our primary specific aim is to test the CDA by conducting a randomized clinical trial comparing the CDA to routine contraceptive counseling. Our primary outcome of interest will be selection of highly effective contraception including the intrauterine device (IUD), the implant, and injectable contraception compared to all other reversible contraceptive methods. We will also complete the following secondary specific aims: 1. We will use the validated Decisional Conflict Scale to measure decisional conflict pre- and post-intervention and compare the change in decisional conflict score in women randomized to the CDA to women undergoing routine counseling. 2. We will also evaluate satisfaction with contraceptive counseling and contraceptive continuation and satisfaction at 3 and 6 months.
Interventions
OTHERCDM Tool
Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers
Sponsors
Society of Family Planning
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 18-45 years old * At risk for unintended pregnancy and seeking reversible contraception at Center of Advanced Medicine or Washington University Resident's Clinic * Willing and able to complete Contraceptive Decision Making tool * English speaking
Exclusion criteria
* Have had a hysterectomy, bilateral oophorectomy, have undergone female sterilization * Unable to give informed consent secondary to language barrier or cognitive limitation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict Scale Score | Pre-Visit and Post-Visit (same day) | Pre-Visit, Post-Visit and change in Decisional Conflict Scale (DCS) Score between Post-Visit (immediately following visit) and Pre-Visit (immediately prior to visit). The Decisional Conflict Scale scores range from 0 to 100; 0 represents no decisional conflict and 100 represents high decisional conflict. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contraceptive Method Chosen | Post-visit (immediately after visit) | Contraceptive method chosen at end of visit with healthcare provider as reported on the post-visit survey |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CDM Tool participants will be randomized to completing the CDM tool
CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers | 166 |
| Control Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out | 85 |
| Total | 251 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No decisional conflict scale responses | 0 | 2 |
| Overall Study | No post-visit survey | 5 | 3 |
| Overall Study | Tablet malfunction, no data saved | 1 | 1 |
Baseline characteristics
| Characteristic | CDM Tool | Control | Total |
|---|---|---|---|
| Age, Continuous | 28.5 years STANDARD_DEVIATION 6.2 | 28.4 years STANDARD_DEVIATION 6.2 | 28.5 years STANDARD_DEVIATION 6.2 |
| Race/Ethnicity, Customized Black | 62 Participants | 23 Participants | 85 Participants |
| Race/Ethnicity, Customized Other | 20 Participants | 7 Participants | 27 Participants |
| Race/Ethnicity, Customized White | 84 Participants | 55 Participants | 139 Participants |
| Region of Enrollment United States | 166 participants | 85 participants | 251 participants |
| Sex: Female, Male Female | 166 Participants | 85 Participants | 251 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 167 | 0 / 86 |
| other Total, other adverse events | 0 / 167 | 0 / 86 |
| serious Total, serious adverse events | 0 / 167 | 0 / 86 |
Outcome results
Primary
Decisional Conflict Scale Score
Pre-Visit, Post-Visit and change in Decisional Conflict Scale (DCS) Score between Post-Visit (immediately following visit) and Pre-Visit (immediately prior to visit). The Decisional Conflict Scale scores range from 0 to 100; 0 represents no decisional conflict and 100 represents high decisional conflict.
Time frame: Pre-Visit and Post-Visit (same day)
Population: 8 subjects did not complete the post-visit survey, so a post-visit DCS score and change in DCS score could not be calculated
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CDM Tool | Decisional Conflict Scale Score | Pre-Visit Score | 15 score on a scale |
| CDM Tool | Decisional Conflict Scale Score | Post-Visit Score | 0 score on a scale |
| CDM Tool | Decisional Conflict Scale Score | Change in Score | -10 score on a scale |
| Control | Decisional Conflict Scale Score | Pre-Visit Score | 10 score on a scale |
| Control | Decisional Conflict Scale Score | Post-Visit Score | 0 score on a scale |
| Control | Decisional Conflict Scale Score | Change in Score | -10 score on a scale |
Secondary
Contraceptive Method Chosen
Contraceptive method chosen at end of visit with healthcare provider as reported on the post-visit survey
Time frame: Post-visit (immediately after visit)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDM Tool | Contraceptive Method Chosen | Implant | 9 Participants |
| CDM Tool | Contraceptive Method Chosen | Vaginal ring | 8 Participants |
| CDM Tool | Contraceptive Method Chosen | Copper IUD | 9 Participants |
| CDM Tool | Contraceptive Method Chosen | Sterilization | 0 Participants |
| CDM Tool | Contraceptive Method Chosen | DMPA | 19 Participants |
| CDM Tool | Contraceptive Method Chosen | Condoms | 7 Participants |
| CDM Tool | Contraceptive Method Chosen | LNG-IUS | 45 Participants |
| CDM Tool | Contraceptive Method Chosen | Other | 1 Participants |
| CDM Tool | Contraceptive Method Chosen | Pills | 57 Participants |
| CDM Tool | Contraceptive Method Chosen | No method/undecided | 5 Participants |
| CDM Tool | Contraceptive Method Chosen | Contraceptive patch | 1 Participants |
| Control | Contraceptive Method Chosen | No method/undecided | 2 Participants |
| Control | Contraceptive Method Chosen | Contraceptive patch | 0 Participants |
| Control | Contraceptive Method Chosen | LNG-IUS | 21 Participants |
| Control | Contraceptive Method Chosen | Copper IUD | 3 Participants |
| Control | Contraceptive Method Chosen | Implant | 6 Participants |
| Control | Contraceptive Method Chosen | DMPA | 4 Participants |
| Control | Contraceptive Method Chosen | Pills | 29 Participants |
| Control | Contraceptive Method Chosen | Vaginal ring | 5 Participants |
| Control | Contraceptive Method Chosen | Sterilization | 3 Participants |
| Control | Contraceptive Method Chosen | Condoms | 4 Participants |
| Control | Contraceptive Method Chosen | Other | 3 Participants |