Computerized Contraceptive Decision Aid

Not Applicable

Completed

• Conditions: Decision Making; Satisfaction; Contraception; Evaluation
• Interventions: Other: CDM Tool

• Registration Number: NCT01479985
• Lead Sponsor: Washington University School of Medicine

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2011-11-25
• Study First Posted: 2011-11-28
• Study Start: 2014-01
• Primary Completion: 2014-08
• Study Completion: 2015-07
• Results First Submitted: 2016-11-09
• Results First Submitted QC: 2018-03-19
• Results First Posted: 2018-11-02
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 253

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

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Exclusion Criteria

• Have had a hysterectomy, bilateral oophorectomy, have undergone female sterilization
• Unable to give informed consent secondary to language barrier or cognitive limitation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDM Tool	CDM Tool	participants will be randomized to completing the CDM tool

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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