Reducing Adverse Drug Events in the Nursing Home

NCT00606606 | Withdrawn

• 2 other identifiers: 38435R01HS010481
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adverse Drug Events

Outcome Measures

Primary Outcomes (1)

• adverse drug events

  March 2002 - February 2005

Study Arms (2)

I - Intervention units

EXPERIMENTAL

nursing home units, provided HIT CDS intervention

Other: Clinical Decision Support

C - control units

NO INTERVENTION

nursing home units, not provided the HIT CDS intervention

Interventions

Clinical Decision Support OTHER

Also known as: CDS

I - Intervention units

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• prescriber at the study facilities

You may not qualify if:

• not a prescriber at the study facilities

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Baycrest Centre for Geriatric Care: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Jerry H Gurwitz, MD

  Meyers Primary Care Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: February 4, 2008
• Study Start: July 1, 2000
• Primary Completion: February 1, 2005
• Study Completion: June 1, 2006
• Last Updated: March 30, 2015

Record last verified: 2015-03