Computerized Contraceptive Decision Aid

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Clinical Trial of a Computerized Contraceptive Decision Aid

Conditions
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Contraception, Decision Making, Satisfaction, Evaluation

Intervention / Treatment
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* Other: CDM Tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDM Tool<br>participants will be randomized to completing the CDM tool | Other: CDM Tool<br>* Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers<br>|
| No Intervention: Control<br>Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre-Visit and Post-Visit (same day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contraceptive Method Chosen | Contraceptive method chosen at end of visit with healthcare provider as reported on the post-visit survey | Post-visit (immediately after visit) |