Deprescribing Antipsychotics in Long-Term Care

NCT02958800 | Completed

• 1 other identifier: CFPC-86796210
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Dementia; Behavior

Keywords

Deprescribing; Single patient open label trial; Long-term care

Outcome Measures

Primary Outcomes (1)

• Decision on antipsychotic dose at the end of the 12-week trial

  Frequency and description of clinical decisions resulting from the deprescribing trial. Clinical decisions that result from this trial may include, but are not limited to, starting a lower, tapered dose, remaining on the initial starting dose, discontinuing the dose altogether, and an increased dose.

  2 years

Secondary Outcomes (8)

• Evidence for implementation in Long-Term Care

  2 years

• Frequency of "as needed" doses used

  2 years

• Frequency of falls

  2 years

• Persistence of clinical decision

  2 years

• Evidence for implementation in Long-Term Care

  2 Years

Study Arms (1)

Intervention

EXPERIMENTAL

The intervention consists of assigning each participant to their own single patient open label trial consisting of a 1:1 randomized sequence of two pre-determined dose reductions of atypical antipsychotics for each participant in order to determine any behavioural issues that arise from atypical antipsychotic dose alteration.

Other: Intervention

Interventions

Intervention OTHER

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.

Also known as: Antipsychotic Atypical, Risperidone, Quetiapine, Olanzapine

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• LTC residents that have been on a stable antipsychotic dose \> 3 months (i.e. no changes in dose has been made during this time frame)
• Most recent RAI-MDS (Resident Assessment Instrument - Minimum Data Set) 2.0 quarterly assessment documents no change in tracked behaviours over the past 3 months while on the current on antipsychotic doses
• Power of Attorney for Healthcare (POA-HC) is locally present and able to consent
• POA-HC is proficient and can communicate fluently in English
• Chart indication for use of antipsychotic is not to manage a psychiatric condition (e.g. schizophrenia, bipolar disorder, active hallucinations and delusions)
• Currently being prescribed routine oral risperidone, olanzapine or quetiapine

You may not qualify if:

• Chart indication for use of antipsychotic for psychosis or other related mental health diagnoses
• POA-HC is not locally present or can not communicate fluently in English

Sponsors & Collaborators

• McMaster University: lead
• College of Family Physicians of Canada: collaborator
• MediSystem Pharmacy: collaborator

Study Sites (1)

Blackadar Continuing Care Centre

Dundas, Ontario, L9H 3B9, Canada

Location

MeSH Terms

Conditions

Dementia; Behavior

Interventions

Methods; Risperidone; Quetiapine Fumarate; Olanzapine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Study Officials

• Henry YH Siu, MSc, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 8, 2016
• Study Start: December 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: August 1, 2019
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

CA (1)