Computerized Contraceptive Decision Aid

NCT ID: NCT01479985

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-07-31

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.

Conditions

Contraception; Decision Making; Satisfaction; Evaluation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

CDM Tool

participants will be randomized to completing the CDM tool

Group Type: EXPERIMENTAL

CDM Tool

Intervention Type: OTHER

Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers

Control

Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tessa E Madden, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Other Identifiers

SFP5-8 -201112047

Identifier Type: -

Identifier Source: org_study_id