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.

Study Overview

• Status: Completed
• Conditions: Adverse Drug Events
• Intervention / Treatment: Behavioral: Active medication monitoring

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15206-3701
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse drug event detection	Number of adverse events detected	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse drug event response time	Response time to adverse drug event detection	12 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: RAND
• Investigators: Principal Investigator: Steven M. Handler, MD, PhD, CMD, University of Pittsburgh

Publications and helpful links

General Publications

• Handler SM, Kane-Gill SL, Kellum JA. Optimal and early detection of acute kidney injury requires effective clinical decision support systems. Nephrol Dial Transplant. 2014 Oct;29(10):1802-3. doi: 10.1093/ndt/gfu211. Epub 2014 Jun 9. No abstract available.
• Handler SM, Cheung PW, Culley CM, Perera S, Kane-Gill SL, Kellum JA, Marcum ZA. Determining the incidence of drug-associated acute kidney injury in nursing home residents. J Am Med Dir Assoc. 2014 Oct;15(10):719-24. doi: 10.1016/j.jamda.2014.03.014. Epub 2014 May 10.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: February 7, 2012
• First Submitted That Met QC Criteria: February 9, 2012
• First Posted (Estimate): February 10, 2012

Study Record Updates

• Last Update Posted (Estimate): January 5, 2016
• Last Update Submitted That Met QC Criteria: January 4, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Nursing Home
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 0015923; AHRQ1R01HS018721 (Other Grant/Funding Number: AHRQ)