Computerized Contraceptive Decision Aid

Contraception Clinical Trial

— CDM RCT  

Official title:

Randomized Clinical Trial of a Computerized Contraceptive Decision Aid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479985
• Other study ID #: SFP5-8 -201112047
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: September 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: July 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Decision Making
• Evaluation
• Satisfaction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Society of Family Planning

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Pre-Visit and Post-Visit (same day)
Secondary	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)