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Computerized Decision Aid (CDM RCT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Washington University School of Medicine
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01479985
First received: November 17, 2011
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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 Intervention
Contraception
Decision Making
Satisfaction
Evaluation
Other: CDM Tool

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Randomized Clinical Trial of a Computerized Contraceptive Decision Aid

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Percent of women using IUD, Implanon and injectable contraception [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average decisional conflict score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Self-reported satisfaction with contraceptive counseling [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Self-reported continuation and satisfaction rate with contraceptive method [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 201
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479985

Contacts
Contact: Tessa E Madden, MD, MPH 314-747-6495 maddent@wudosis.wustl.edu
Contact: Ragini Maddipati, MSW 314-747-6418 maddipatir@wudosis.wustl.edu

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

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01479985     History of Changes
Other Study ID Numbers: SFP5-8
Study First Received: November 17, 2011
Last Updated: June 25, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014