Reducing Adverse Drug Events in the Nursing Home
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Purpose
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 | Intervention |
|---|---|
|
Adverse Drug Events |
Other: Clinical Decision Support |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Reducing Adverse Drug Events in the Nursing Home |
- adverse drug events [ Time Frame: March 2002 - February 2005 ] [ Designated as safety issue: Yes ]
| Enrollment: | 0 |
| Study Start Date: | July 2000 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- prescriber at the study facilities
Exclusion Criteria:
- not a prescriber at the study facilities
Contacts and Locations
More Information
No publications provided
| 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, 5 R01 HS010481 |
| Study First Received: | January 11, 2008 |
| Last Updated: | May 20, 2008 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Drug Toxicity Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 16, 2013