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

Primary Purpose

Adverse Drug Events

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active medication monitoring
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Adverse Drug Events focused on measuring Nursing Home

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Active medication monitoring

Arm Description

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

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

Outcomes

Primary Outcome Measures

Adverse drug event detection
Number of adverse events detected

Secondary Outcome Measures

Adverse drug event response time
Response time to adverse drug event detection

Full Information

First Posted
February 7, 2012
Last Updated
January 4, 2016
Sponsor
University of Pittsburgh
Collaborators
RAND
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1. Study Identification

Unique Protocol Identification Number
NCT01531088
Brief Title
Enhancing the Detection and Management of Adverse Drug Events in Nursing Homes
Official Title
Enhancing the Detection and Management of Adverse Drug Events in the Nursing Home
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
RAND

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Drug Events
Keywords
Nursing Home

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Recommendations made by consultant pharmacists as part of their federally-mandated medication regimen review process
Arm Title
Active medication monitoring
Arm Type
Experimental
Arm Description
Active medication monitoring system providing consultant pharmacists with alerts representing potential adverse drug events
Intervention Type
Behavioral
Intervention Name(s)
Active medication monitoring
Intervention Description
Active medication monitoring system providing consultant pharmacists with alerts representing potential adverse drug events.
Primary Outcome Measure Information:
Title
Adverse drug event detection
Description
Number of adverse events detected
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Adverse drug event response time
Description
Response time to adverse drug event detection
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven M. Handler, MD, PhD, CMD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206-3701
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24914088
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. No abstract available.
Results Reference
background
PubMed Identifier
24814042
Citation
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.
Results Reference
result

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

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