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Reducing Adverse Drug Events in the Nursing Home

NCT00606606 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-03-30

No results posted yet for this study

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.

Conditions

  • Adverse Drug Events

Interventions

OTHER

Clinical Decision Support

Sponsors & Collaborators

  • Baycrest Centre for Geriatric Care

    collaborator OTHER

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Jerry H Gurwitz, MD · Meyers Primary Care Institute

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-07-31
Primary Completion
2005-02-28
Completion
2006-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00606606 on ClinicalTrials.gov