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

Adverse Drug Events research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Adverse Drug Events

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Active medication monitoringActive medication monitoring system providing consultant pharmacists with alerts representing potential adverse drug events.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Completed

Start Date: January 2012

Completed Date: April 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Adverse drug event detection

Secondary Outcome: Adverse drug event response time

Study sponsors, principal investigator, and references

Principal Investigator: Steven M. Handler, MD, PhD, CMD

Lead Sponsor: University of Pittsburgh

Collaborator: RAND

More information:https://clinicaltrials.gov/show/NCT01531088

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.

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.

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