Clinical trial NCT02958800: Deprescribing Antipsychotics in Long-Term Care
Official title: Developing a Single Patient Open-label Trial Tapering Algorithm for Antipsychotics in Long-Term Care - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Behavior
Keywords: Deprescribing
Single patient open label trial
Long-term care
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: College of Family Physicians of Canada
name: MediSystem Pharmacy
First posted: 2016-11-08
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This pilot study will consist of enrolling long-term care (LTC) patients to a 12-week, single-patient, open-label, randomized multiple crossover trial consisting of 2 different treatment blocks (Block A, Block B) of 3 weeks duration each.

This study is targeting LTC residents in two Hamilton LTC facilities associated with MediSystem pharmacy. Once potential participants have been identified by the clinical pharmacist working at these two facilities, a invitation letter with a consent letter will be sent to the LTC resident's power of attorney for health care (POA-HC) describing the study and inviting them to complete the mail back the consent form. POA-HCs will be provided with contact information of the research assistant associated with the study in order to have any of their questions answered.

Once consent is received, the LTC patient will be assigned a randomized 1:1 treatment sequence of Block A (denoted by "A") and Block B (denoted by "B"). For example, Patient1 may be assigned the treatment sequence AABB, while Patient2 may be assigned the treatment sequence BAAB, and so on. The patient will then take a pre-determined dose, DOSE-A, of the antipsychotic that has been agreed upon between the physician and the POA-HC at time of enrolment during Block A. This pre-determined dose will be less than the current dose the LTC patient is taking at the time of enrolment. Similarly, the LTC patient will take DOSE-B, a second pre-determined dose of the antipsychotic that is different than the starting dose or DOSE-A, will be taken during Block B.

At the end of the 12-week study, LTC physicians will be given a report which describes and summarizes the outcome measures for each participating LTC patient. This report will be reviewed together with the POA-HC in order to make a clinical decision together on whether to continue using the antipsychotic medication, or whether a decreased or discontinued dose is more appropriate. After this decision, a six-month prospective chart review will be done to determine whether the clinical decision resulting from the 12-week study persisted. If a subsequent change does occur during this six-month prospective time period, the reason and rationale for the change will be recorded.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Decision on antipsychotic dose at the end of the 12-week trial
timeFrame: 2 years
Secondary outcomes:
measure: Evidence for implementation in Long-Term Care
timeFrame: 2 years
measure: Frequency of "as needed" doses used
timeFrame: 2 years
measure: Frequency of falls
timeFrame: 2 years
measure: Persistence of clinical decision
timeFrame: 2 years
measure: Evidence for implementation in Long-Term Care
timeFrame: 2 Years
measure: Evidence for implementation in Long-Term Care
timeFrame: 2 Years
measure: Evidence for implementation in Long-Term Care
timeFrame: 2 Years
measure: Evidence for implementation in Long-Term Care
timeFrame: 2 Years
Other outcomes:
Locations:
city: Dundas
country: Canada
facility: Blackadar Continuing Care Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: Henry YH Siu, MSc, MD
role: PRINCIPAL_INVESTIGATOR
References: