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Computerized Decision Aid (CDM RCT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01479985
First Posted: November 28, 2011
Last Update Posted: October 12, 2017
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.
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Washington University School of Medicine
November 17, 2011
November 28, 2011
October 12, 2017
January 2014
August 2014   (Final data collection date for primary outcome measure)
Percent of women using IUD, Implanon and injectable contraception [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01479985 on ClinicalTrials.gov Archive Site
  • Average decisional conflict score [ Time Frame: 6 months ]
  • Self-reported satisfaction with contraceptive counseling [ Time Frame: 6 months ]
  • Self-reported continuation and satisfaction rate with contraceptive method [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
Computerized Decision Aid
Randomized Clinical Trial of a 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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Contraception
  • Decision Making
  • Satisfaction
  • Evaluation
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
  • Experimental: CDM Tool
    participants will be randomized to completing the CDM tool
    Intervention: Other: CDM Tool
  • No Intervention: Control
    Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
July 2015
August 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01479985
SFP5-8
No
Not Provided
Not Provided
Washington University School of Medicine
Washington University School of Medicine
Society of Family Planning
Principal Investigator: Tessa E Madden, MD, MPH Washington University School of Medicine
Washington University School of Medicine
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP