Randomized Clinical Trial of a Computerized Contraceptive Decision Aid
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 253
- Primary Endpoint
- Decisional Conflict Scale Score
Study Overview
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:
- 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.
- We will also evaluate satisfaction with contraceptive counseling and contraceptive continuation and satisfaction at 3 and 6 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
Decisional Conflict Scale Score
Time Frame: 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 Outcomes
- Contraceptive Method Chosen(Post-visit (immediately after visit))