Clinical Trial: Reducing Adverse Drug Events in the Nursing Home

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Reducing Adverse Drug Events in the Nursing Home

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 res

Detailed Summary:

This study was conducted in two large, academic long-term care facilities located in Connecticut and Ontario, Canada. The two facilities have a combined total of 1,229 beds. Patients residing in areas of the facilities related to short-term care (e.g., subacute care, hospital-level care, or rehabilitation) were not included in the study population.

Each of the facilities had an existing computerized provider order entry system without a computer-based clinical decision support system. At the time of the study, approximately 90% of new medication orders were entered using the system. All medication prescribing was performed by contracted staff; in one of the study facilities this included 27 physicians, nurse practitioners, and physicians' assistants. In the other facility, medication prescribing was performed by 10 physicians.

Across the two long-term care facilities, 26 resident care units, each with existing computer provider order entry, were randomized to having a clinical decision support system (intervention units) or not (control units). Bed size of the resident care units ranged from 20 to 60 beds. An effort was made to match the units according to bed size and general characteristics of the residents on the units. We block randomized within categories including: dementia units, units where mental health and behavioral problems were common among the residents, units where the residents had complex medical needs, and units where the residents had profound deficits in physical function.

On intervention units, prescribers ordering drugs were presented with alerts in the form of warning messages; these alerts were not displayed to prescribers when ordering medications for residents of control units. Although efforts were initially made to limit crossover of prescribers
Sponsor: University of Massachusetts, Worcester

Current Primary Outcome: adverse drug events [ Time Frame: March 2002 - February 2005 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Massachusetts, Worcester

Dates:
Date Received: January 11, 2008
Date Started: July 2000
Date Completion:
Last Updated: March 27, 2015
Last Verified: March 2015