Computerized Decision Aid (CDM RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01479985
Recruitment Status : Completed
First Posted : November 28, 2011
Last Update Posted : December 15, 2015
Society of Family Planning
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment
Contraception Decision Making Satisfaction Evaluation Other: CDM Tool

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Randomized Clinical Trial of a Computerized Contraceptive Decision Aid
Study Start Date : January 2014
Primary Completion Date : August 2014
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Percent of women using IUD, Implanon and injectable contraception [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Average decisional conflict score [ Time Frame: 6 months ]
  2. Self-reported satisfaction with contraceptive counseling [ Time Frame: 6 months ]
  3. Self-reported continuation and satisfaction rate with contraceptive method [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01479985

Sponsors and Collaborators
Washington University School of Medicine
Society of Family Planning
Principal Investigator: Tessa E Madden, MD, MPH Washington University School of Medicine

Responsible Party: Washington University School of Medicine Identifier: NCT01479985     History of Changes
Other Study ID Numbers: SFP5-8
First Posted: November 28, 2011    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015