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

This study is currently recruiting participants.
Verified February 2012 by University of Pittsburgh
Sponsor:
Collaborator:
RAND
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01531088
First received: February 7, 2012
Last updated: February 9, 2012
Last verified: February 2012

February 7, 2012
February 9, 2012
January 2012
May 2013   (final data collection date for primary outcome measure)
Adverse drug event detection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Number of adverse events detected
Same as current
Complete list of historical versions of study NCT01531088 on ClinicalTrials.gov Archive Site
Adverse drug event response time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Response time to adverse drug event detection
Same as current
Not Provided
Not Provided
 
Enhancing the Detection and Management of Adverse Drug Events in Nursing Homes
Enhancing the Detection and Management of Adverse Drug Events in the Nursing Home

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Adverse Drug Event
Behavioral: Active medication monitoring
Active medication monitoring system providing consultant pharmacists with alerts representing potential adverse drug events.
  • No Intervention: Usual care
    Recommendations made by consultant pharmacists as part of their federally-mandated medication regimen review process
  • Experimental: Active medication monitoring
    Active medication monitoring system providing consultant pharmacists with alerts representing potential adverse drug events
    Intervention: Behavioral: Active medication monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
55
May 2014
May 2013   (final data collection date for primary outcome measure)

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.

Both
Not Provided
Yes
Contact: Steven M. Handler, MD, PhD, CMD 412-647-1452 handler@pitt.edu
United States
 
NCT01531088
0015923, AHRQ1R01HS018721
Yes
University of Pittsburgh
University of Pittsburgh
RAND
Principal Investigator: Steven M. Handler, MD, PhD, CMD University of Pittsburgh
University of Pittsburgh
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP