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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00766207
Other study ID # R18HS017093-01
Secondary ID 1R18HS017093-01
Status Completed
Phase N/A
First received October 1, 2008
Last updated May 11, 2011
Start date October 2008
Est. completion date May 2011

Study information

Verified date May 2011
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study will use a factorial design randomized controlled trial to (1)compare multi-faceted decision support (intervention) to streamlined clinical alerts (control) and (2) evaluate whether collecting information about women's risk of pregnancy using a networked tablet computer (intervention) is superior to the way clinicians usually collect this information (control).

Over the course of 1 year, we will abstract data from the electronic medical record when study clinicians prescribe teratogenic medications, conduct phone interviews with women prescribed medications by participating clinicians, and survey participating clinicians about their satisfaction with the decision support they receive. We will use this data to confirm our hypotheses that clinicians in the intervention groups will (1) prescribe fewer teratogenic medications, (2) be more likely to prescribe contraception when a teratogenic medication is prescribed, (3) have more patients report satisfaction with the counseling they received, and (4) report more satisfaction with the decision support they received.


Recruitment information / eligibility

Status Completed
Enrollment 2593
Est. completion date May 2011
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Women aged 18-45 seen at a participating primary care clinic

Exclusion Criteria:

- Non-English speakers

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Intervention

Other:
Clinical decision support
multi-faceted decision support
stream-lined clinical alert
electronic notification that a medication is potentially teratogenic

Locations

Country Name City State
United States Partners in Health Delmont Pennsylvania
United States Partners in Health Level Green Pennsylvania
United States Partners in Health Murrysville Pennsylvania
United States General Internal Medicine Oakland (GIMO) Practice Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of women prescribed potentially teratogenic medications with documented use of contraception 1 year No
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