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Deprescribing Antipsychotics in Long-Term Care

NCT02958800 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-11-21

No results posted yet for this study

Summary

Aggressive behaviours in long-term care (LTC) is a difficult health care issue to manage. One method that has been over-used is the prescription of antipsychotics for the behaviours and psychological symptoms of dementia (BPSD). This high prevalence of use is a recognized health care problem in Ontario and around the world; increased antipsychotics use is associated with increased falls and mortality. Existing strategies are educational in nature and are not systematic; the goal of this study is to develop a systematic algorithm to help LTC physicians deprescribe and taper antipsychotics safely and effectively.

The objectives of the study is to: 1) Develop a discontinuation algorithm for antipsychotics based on single patient open-label (SPOT) trial methodology (e.g. a variation of N-of-1 trials) with standardized outcome measures for LTC physicians; 2) To pilot a clinical pharmacist-led recruitment strategy; 3) To provide preliminary evidence to demonstrate that this algorithm could lead to deprescribing of anti-psychotic medications in LTC.

Conditions

Interventions

OTHER

Intervention

The intervention will be 12-weeks in duration consisting of four blocks resulting from a 1:1 randomization of two different three-week treatment courses of a patient's existing antipsychotic medication. For example, the intervention "ABAB" means that a participant would undergo three weeks of treatment A, followed by three weeks of treatment B, followed by three weeks of treatment A, and lastly three weeks of treatment B. Treatment A block is defined as a mutually agreed upon dose of a participant's antipsychotic medication that is different (i.e. lower) than their enrolment dose. Treatment B block is defined as a mutually agreed upon dose of a participant's antipsychotic medication that is different (i.e. lower) than their enrolment dose and the dose in Treatment A.

Sponsors & Collaborators

  • College of Family Physicians of Canada

    collaborator OTHER

  • MediSystem Pharmacy

    collaborator UNKNOWN

  • McMaster University

    lead OTHER

Principal Investigators

  • Henry YH Siu, MSc, MD · McMaster University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-01-31
Completion
2019-08-31

Countries

  • Canada

Study Locations

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Diseases
Companies

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 NCT02958800 on ClinicalTrials.gov