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Completed

NCT Number: NCT01479985

Computerized Contraceptive Decision Aid

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.

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Key information

Conditions

Contraception Behavior Decision Making Evaluation Personal Satisfaction Satisfaction

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CDM Tool

Other

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

Primary outcomes

  1. Decisional Conflict Scale Score

    Time frame: 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 outcomes

  1. Contraceptive Method Chosen

    Time frame: Post-visit (immediately after visit)

    Contraceptive method chosen at end of visit with healthcare provider as reported on the post-visit survey

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

Randomized Clinical Trial of a Computerized Contraceptive Decision Aid

Acronym: CDM RCT

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Nov 28, 2011
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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