Computerized Contraceptive Decision Aid

NCT01479985 | Completed Results

• 1 other identifier: SFP5-8 -201112047
• Study Type: interventional
• Target: 253
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Contraception; Decision Making; Satisfaction; Evaluation

Outcome Measures

Primary Outcomes (1)

• Decisional Conflict Scale Score

  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.

  Pre-Visit and Post-Visit (same day)

Secondary Outcomes (1)

• Contraceptive Method Chosen

  Post-visit (immediately after visit)

Study Arms (2)

CDM Tool

EXPERIMENTAL

participants will be randomized to completing the CDM tool

Other: CDM Tool

Control

NO INTERVENTION

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

Interventions

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

CDM Tool

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Have had a hysterectomy, bilateral oophorectomy, have undergone female sterilization
• Unable to give informed consent secondary to language barrier or cognitive limitation

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Society of Family Planning: collaborator

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Tessa Madden, MD, MPH
• Organization: Washington University in St. Louis

maddent@wudosis.wustl.edu

314-747-6495

Study Officials

• Tessa E Madden, MD, MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 28, 2011
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: July 1, 2015
• Last Updated: September 29, 2020
• Results First Posted: November 2, 2018

Record last verified: 2020-09