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Reducing Adverse Drug Events in the Nursing Home

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ClinicalTrials.gov Identifier: NCT00606606
Recruitment Status : Withdrawn (This is not a human subject's study. Protocol registered in error. This protocol studied nursing homes as a unit.)
First Posted : February 4, 2008
Last Update Posted : March 30, 2015
Sponsor:
Collaborators:
Baycrest Centre for Geriatric Care
Agency for Healthcare Research and Quality (AHRQ)
Information provided by:
University of Massachusetts, Worcester

Brief Summary:
Medications are the single most common form of treatment in the long-term care setting, and often represent the most efficacious (and cost-effective) therapeutic modality used in this clinical setting. However, the residents of nursing homes are at increased risk for experiencing adverse drug events. This risk is increased by the physiologic decline and pharmacologic changes that occur with aging, and also by the special clinical and social circumstances that characterize institutional long-term care. In a study funded by the National Institute on Aging (AG 14472), we have previously determined that adverse drug events are common and often preventable in the nursing home setting and that the more serious the adverse drug event, the more likely it is to be preventable. This study will test whether a computer-based clinical decision support system can lower the rate of adverse drug events (ADEs) and potential ADEs in the long-term care setting. The study design is a randomized trial based in the resident care units of two large long-term care facilities. Within each facility, half of the resident care units will be randomized to an intervention arm receiving the computer-based clinical decision support system which will display warnings, messages, and prompts based on resident and drug use characteristics; with over-rides by the prescriber required for some warnings. Rates of ADEs and potential ADEs will be tracked by the study's on-site clinical pharmacists prior to and during the intervention period. Rates will be compared between units receiving and not receiving the computer¬based clinical decision support system and to baseline, pre-intervention rates in the same units. We will track all project costs directly related to the development and installation of the computer-based clinical decision support system. We will also develop and test the sensitivity and specificity of a computerized adverse drug event monitor and assess the validity of a nursing home resident risk model developed in our prior study of adverse drug events in the nursing home setting.

Condition or disease Intervention/treatment Phase
Adverse Drug Events Other: Clinical Decision Support Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Reducing Adverse Drug Events in the Nursing Home
Study Start Date : July 2000
Actual Primary Completion Date : February 2005
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: I - Intervention units
nursing home units, provided HIT CDS intervention
Other: Clinical Decision Support
Other Name: CDS
No Intervention: C - control units
nursing home units, not provided the HIT CDS intervention



Primary Outcome Measures :
  1. adverse drug events [ Time Frame: March 2002 - February 2005 ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • prescriber at the study facilities

Exclusion Criteria:

  • not a prescriber at the study facilities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606606


Sponsors and Collaborators
University of Massachusetts, Worcester
Baycrest Centre for Geriatric Care
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Jerry H Gurwitz, MD Meyers Primary Care Institute

Responsible Party: Jerry Gurwitz, Executive Director, Meyers Primary Care Institute/University of Massachusetts Medical School
ClinicalTrials.gov Identifier: NCT00606606     History of Changes
Other Study ID Numbers: 3843
5R01HS010481 ( U.S. AHRQ Grant/Contract )
First Posted: February 4, 2008    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015

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