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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Pittsburgh.
Recruitment status was  Recruiting
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
  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 Event
Behavioral: Active medication monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    Number of adverse events detected


Secondary Outcome Measures:
  • Adverse drug event response time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Response time to adverse drug event detection


Estimated Enrollment: 55
Study Start Date: January 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2013 (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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531088

Contacts
Contact: Steven M. Handler, MD, PhD, CMD 412-647-1452 handler@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Steven M. Handler, MD, PhD, CMD    412-647-1452    handler@pitt.edu   
Contact: Mary C. Szczepaniak    412-648-6728    cleats@pitt.edu   
Principal Investigator: Steven M. Handler, MD, PhD, CMD         
Sponsors and Collaborators
University of Pittsburgh
RAND
Investigators
Principal Investigator: Steven M. Handler, MD, PhD, CMD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01531088     History of Changes
Other Study ID Numbers: 0015923, AHRQ1R01HS018721
Study First Received: February 7, 2012
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
nursing home

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

ClinicalTrials.gov processed this record on August 01, 2014