TREATMENT OF AGITATION IN THE NURSING HOME

NIH RePORTER · NIH · R01 · $160,317 · view on reporter.nih.gov ↗

Abstract

Agitation is a major problem for nursing home residents and for their caregivers. It is frequently treated with psychotropic drugs, although their efficacy for agitation has not been conclusive, and the drugs are associated with increased risks of adverse effects. The proposed study aims to explore the effectiveness of psychotropic drugs for the treatment of agitation in nursing home residents through a placebo-controlled, double-blind random assignment, parallel group, trial of withdrawal of medications. The effects of drug withdrawal on levels of agitation, on somatic adverse effects, and on neuropsychological functioning will be examined for three psychotropic drugs: haloperidol, thioridazine, and lorazepam. In addition, the study will explore the following questions: a) Is there a subgroup of residents who appear to benefit from psychotropic drugs? Are they characterized by use of a specific drug? or by type of agitation? or by other resident characteristics? b) Is functioning other than agitation affected by the withdrawal of psychotropic drug use? c) Does the response to withdrawal of these psychotropic drugs change over the course of tapering and withdrawal? Can the final outcome of discontinuation be predicted from an earlier assessment during the tapering phase? For each of the drugs, fifty residents receiving the drug will be randomly divided into two groups: those who continue their medication and those who will gradually receive placebo instead. Residents will be evaluated by nursing staff and by the research team at baseline, a week after beginning of withdrawal, and six weeks after administration of placebo. Drug levels in the blood and prolactin levels will also be assessed at these times. All staff and research personnel will be blind to the medication status until the end of the trial. Since recent OBRA regulations require nursing homes to increase monitoring of psychotropic drugs, and decrease their usage, there is an urgent need to study the impact of withdrawal of these drugs, and the conditions under which they may be effective. The proposed study will address some of these issues.

Key facts

NIH application ID
3122137
Project number
5R01AG010172-02
Recipient
HEBREW HOME OF GREATER WASHINGTON
SAM.gov UEI
RY46DLNQAN83
Principal Investigator
Jiska Cohen-Mansfield
Activity code
R01
Funding institute
NIH
Fiscal year
1993
Award amount
$160,317
Award type
5
Project period
1992-08-18 → 1996-07-31