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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01531088
First Posted: February 10, 2012
Last Update Posted: January 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
RAND
Information provided by (Responsible Party):
University of Pittsburgh
  Purpose
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.

Condition Intervention
Adverse Drug Events Behavioral: Active medication monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Enhancing the Detection and Management of Adverse Drug Events in the Nursing Home

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Adverse drug event detection [ Time Frame: 12 months ]
    Number of adverse events detected


Secondary Outcome Measures:
  • Adverse drug event response time [ Time Frame: 12 months ]
    Response time to adverse drug event detection


Enrollment: 36
Study Start Date: January 2012
Study Completion Date: April 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: Active medication monitoring
Active medication monitoring system providing consultant pharmacists with alerts representing potential adverse drug events.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531088


Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15206-3701
Sponsors and Collaborators
University of Pittsburgh
RAND
Investigators
Principal Investigator: Steven M. Handler, MD, PhD, CMD University of Pittsburgh
  More Information

Publications:
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01531088     History of Changes
Other Study ID Numbers: 0015923
AHRQ1R01HS018721 ( Other Grant/Funding Number: AHRQ )
First Submitted: February 7, 2012
First Posted: February 10, 2012
Last Update Posted: January 5, 2016
Last Verified: January 2016

Keywords provided by University of Pittsburgh:
Nursing Home

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders


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