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Clinical Trials/NCT01531088
NCT01531088CompletedNot Applicable

Enhancing the Detection and Management of Adverse Drug Events in the Nursing Home

University of Pittsburgh1 site in 1 country36 target enrollmentStarted: January 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
Adverse drug event detection

Study Overview

Brief Summary

Adverse drug events (ADEs) are the most clinically significant and costly medication-related problems in nursing homes (NH) and are associated with an estimated 93,000 deaths a year and as much as $4 billion of excess healthcare expenditures. Current ADE detection and management strategies that rely on pharmacist retrospective chart reviews (i.e., usual care) are inadequate. Active medication monitoring systems are recommended by many safety organizations as an alternative to detect and manage ADEs. These systems have been shown to be less expensive, faster, and identify ADEs not normally detected by clinicians in the hospital setting. The investigators developed and pilot-tested an active medication monitoring system for use in a single NH, where it was shown to detect ADEs with a high degree of accuracy and at a rate of nearly 2.5 times that of usual care. The long-term objective of our proposed research is to improve patient safety with respect to medications in NHs. The short-term objectives or specific aims of our proposed research are to determine if NH patients managed by physicians who receive active medication monitoring alerts have more ADEs detected, have a faster ADE management response time, and can result in more cost-savings from a societal perspective compared to usual care.

Detailed Description

To accomplish the aims outlined in our brief summary above, the investigators will conduct a cluster randomized controlled trial among up to 86 NH physicians working in one of 4 UPMC Health System nursing homes (NHs) in Southwestern Pennsylvania for a period of 12 months. Our hypotheses are that NH patients managed by physicians who receive active medication monitoring alerts will have more ADEs detected, will have a faster ADE management response time, and will result in cost-savings from a societal perspective compared to usual care. This application by an early stage investigator is responsive to PA-09-070 AHRQ Health Services Research Projects and several of its research portfolio priority areas (health information technology, patient safety, and value) by addressing how medication management systems can be used to improve the quality and safety of medication management, as well as improve healthcare decision making. This study represents the first large, well-controlled, comprehensive examination of an active medication monitoring system in the NH.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •All physicians participating in the study must be a credentialed attending physician at at least one of four UPMC Nursing Homes: UPMC Canterbury Place, UPMC Cranberry Place, UPMC Heritage Place, and/or UPMC Seneca Place.

Exclusion Criteria

  • •Physicians not credentialed as an attending physician at at least one of four UPMC Nursing Homes: UPMC Canterbury Place, UPMC Cranberry Place, UPMC Heritage Place, and/or UPMC Seneca Place.

Arms & Interventions

Usual care

No Intervention

Recommendations made by consultant pharmacists as part of their federally-mandated medication regimen review process

Active medication monitoring

Experimental

Active medication monitoring system providing consultant pharmacists with alerts representing potential adverse drug events

Intervention: Active medication monitoring (Behavioral)

Outcomes

Primary Outcomes

Adverse drug event detection

Time Frame: 12 months

Number of adverse events detected

Secondary Outcomes

  • Adverse drug event response time(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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