Computerized Contraceptive Decision Aid (CDM RCT)

The Washington University

Status: Completed

Conditions: Decision Making; Contraception; Satisfaction; Evaluation

Treatments: Other: CDM Tool

Study type: Interventional

Funder types: Other

Identifiers

NCT01479985

SFP5-8 -201112047

Details and patient eligibility

About

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.

Full 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.

Enrollment: 253 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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253 participants in 2 patient groups

CDM Tool

Experimental group

Description:

participants will be randomized to completing the CDM tool

Treatment:

Other: CDM Tool

Control

No Intervention group

Description:

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