Electronic Notification of Teratogenic Risks

NCT ID: NCT00766207

Last Updated: 2011-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2593 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Teratogens Abnormalities, Drug-Induced Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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multi-faceted decision support

Multi-faceted decision support

Group Type EXPERIMENTAL

Clinical decision support

Intervention Type OTHER

multi-faceted decision support

control

stream-lined clinical alert

Group Type ACTIVE_COMPARATOR

stream-lined clinical alert

Intervention Type OTHER

electronic notification that a medication is potentially teratogenic

Interventions

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Clinical decision support

multi-faceted decision support

Intervention Type OTHER

stream-lined clinical alert

electronic notification that a medication is potentially teratogenic

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Non-English speakers
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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University of Pittsburgh

Principal Investigators

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Eleanor B Schwarz, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Partners in Health

Delmont, Pennsylvania, United States

Site Status

Partners in Health

Level Green, Pennsylvania, United States

Site Status

Partners in Health

Murrysville, Pennsylvania, United States

Site Status

General Internal Medicine Oakland (GIMO) Practice

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22297687 (View on PubMed)

Other Identifiers

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1R18HS017093-01

Identifier Type: AHRQ

Identifier Source: secondary_id

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R18HS017093-01

Identifier Type: AHRQ

Identifier Source: org_study_id

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