Electronic Notification of Teratogenic Risks (PREVENT)
Primary Purpose
Teratogens, Abnormalities, Drug-Induced, Contraception
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical decision support
stream-lined clinical alert
Sponsored by
About this trial
This is an interventional health services research trial for Teratogens focused on measuring Teratogens, Abnormalities, Drug-Induced, Contraception
Eligibility Criteria
Inclusion Criteria:
- Women aged 18-45 seen at a participating primary care clinic
Exclusion Criteria:
- Non-English speakers
Sites / Locations
- Partners in Health
- Partners in Health
- Partners in Health
- General Internal Medicine Oakland (GIMO) Practice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
multi-faceted decision support
control
Arm Description
Multi-faceted decision support
stream-lined clinical alert
Outcomes
Primary Outcome Measures
Proportion of women prescribed potentially teratogenic medications with documented use of contraception
Secondary Outcome Measures
Full Information
NCT ID
NCT00766207
First Posted
October 1, 2008
Last Updated
May 11, 2011
Sponsor
University of Pittsburgh
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT00766207
Brief Title
Electronic Notification of Teratogenic Risks
Acronym
PREVENT
Official Title
Preconception Risk Evaluation Via Electronic Medical Record Notification of Teratogenic Risks
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pittsburgh
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Teratogens, Abnormalities, Drug-Induced, Contraception
Keywords
Teratogens, Abnormalities, Drug-Induced, Contraception
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2593 (Actual)
8. Arms, Groups, and Interventions
Arm Title
multi-faceted decision support
Arm Type
Experimental
Arm Description
Multi-faceted decision support
Arm Title
control
Arm Type
Active Comparator
Arm Description
stream-lined clinical alert
Intervention Type
Other
Intervention Name(s)
Clinical decision support
Intervention Description
multi-faceted decision support
Intervention Type
Other
Intervention Name(s)
stream-lined clinical alert
Intervention Description
electronic notification that a medication is potentially teratogenic
Primary Outcome Measure Information:
Title
Proportion of women prescribed potentially teratogenic medications with documented use of contraception
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women aged 18-45 seen at a participating primary care clinic
Exclusion Criteria:
Non-English speakers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleanor B Schwarz, MD, MS
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Partners in Health
City
Delmont
State/Province
Pennsylvania
ZIP/Postal Code
15626
Country
United States
Facility Name
Partners in Health
City
Level Green
State/Province
Pennsylvania
ZIP/Postal Code
15085
Country
United States
Facility Name
Partners in Health
City
Murrysville
State/Province
Pennsylvania
ZIP/Postal Code
15085
Country
United States
Facility Name
General Internal Medicine Oakland (GIMO) Practice
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22297687
Citation
Schwarz EB, Parisi SM, Handler SM, Koren G, Cohen ED, Shevchik GJ, Fischer GS. Clinical decision support to promote safe prescribing to women of reproductive age: a cluster-randomized trial. J Gen Intern Med. 2012 Jul;27(7):831-8. doi: 10.1007/s11606-012-1991-y.
Results Reference
derived
Learn more about this trial
Electronic Notification of Teratogenic Risks
We'll reach out to this number within 24 hrs