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

Adverse Drug Events Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531088
• Other study ID #: 0015923
• Secondary ID: AHRQ1R01HS018721
• Status: Completed
• Phase: N/A
• First received: February 7, 2012
• Last updated: January 4, 2016
• Start date: January 2012
• Est. completion date: April 2015

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Adverse Drug Events
• Drug-Related Side Effects and Adverse Reactions

Intervention

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

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	RAND

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse drug event detection	Number of adverse events detected	12 months	No
Secondary	Adverse drug event response time	Response time to adverse drug event detection	12 months	No