Computerized Decision Aid (CDM RCT)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Randomized Clinical Trial of a Computerized Contraceptive Decision Aid|
- Percent of women using IUD, Implanon and injectable contraception [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Average decisional conflict score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Self-reported satisfaction with contraceptive counseling [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Self-reported continuation and satisfaction rate with contraceptive method [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: CDM Tool
participants will be randomized to completing the CDM tool
Other: 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
No Intervention: Control
Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479985
|Contact: Tessa E Madden, MD, MPHemail@example.com|
|Contact: Ragini Maddipati, MSWfirstname.lastname@example.org|
|Principal Investigator:||Tessa E Madden, MD, MPH||Washington University School of Medicine|