We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Deprescribing Antipsychotics in Long-Term Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02958800
Recruitment Status : Unknown
Verified March 2019 by McMaster University.
Recruitment status was:  Recruiting
First Posted : November 8, 2016
Last Update Posted : March 8, 2019
Sponsor:
Collaborators:
College of Family Physicians of Canada
MediSystem Pharmacy
Information provided by (Responsible Party):
McMaster University

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.


Condition or disease Intervention/treatment Phase
Dementia Behavior Other: Intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Developing a Single Patient Open-label Trial Tapering Algorithm for Antipsychotics in Long-Term Care - A Pilot Study
Actual Study Start Date : December 2016
Actual Primary Completion Date : January 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Clinical Trials

Arm Intervention/treatment
Experimental: Intervention
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

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.

Other Names:
  • Antipsychotic Atypical
  • Risperidone
  • Quetiapine
  • Olanzapine




Primary Outcome Measures :
  1. Decision on antipsychotic dose at the end of the 12-week trial [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. Evidence for implementation in Long-Term Care [ Time Frame: 2 years ]
    Rate of recruitment

  2. Frequency of "as needed" doses used [ Time Frame: 2 years ]
    The frequency of "as needed" (i.e. PRN) medications (e.g. benzodiazepines, antipsychotic, etc) used to manage behaviours. The frequency will be tracked throughout the 12 week trial and for six months after the participant has completed their trial.

  3. Frequency of falls [ Time Frame: 2 years ]
    The frequency of falls will be recorded during the 12 week trial, as well as for six months after the participant has completed the trial.

  4. Persistence of clinical decision [ Time Frame: 2 years ]
    The persistence of the clinical decision made regarding the dose of the antipsychotic by the long-term care physician and the power of attorney for personal care at six months after the participant has completed their trial.

  5. Evidence for implementation in Long-Term Care [ Time Frame: 2 Years ]
    Successful random sequence generation and allocation

  6. Evidence for implementation in Long-Term Care [ Time Frame: 2 Years ]
    Data collection from patient chart

  7. Evidence for implementation in Long-Term Care [ Time Frame: 2 Years ]
    Creation of participant summative behaviour reports

  8. Evidence for implementation in Long-Term Care [ Time Frame: 2 Years ]
    Feedback survey regarding acceptability of study rationale and procedures.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958800


Contacts
Layout table for location contacts
Contact: Henry Siu, MSc,MD,CCFP (COE) (905) 575-1300 siuh3@mcmaster.ca
Contact: Jenna Parascandalo 9055259140 ext 21232 parascaj@mcmaster.ca

Locations
Layout table for location information
Canada, Ontario
Blackadar Continuing Care Centre Recruiting
Dundas, Ontario, Canada, L9H 3B9
Contact: Henry Siu, MSc, MD, CCFP (COE)    (905) 575-1300    siuh3@mcmaster.ca   
Contact: Jenna Parascandalo    9055259140 ext 21232    parascaj@mcmaster.ca   
Sponsors and Collaborators
McMaster University
College of Family Physicians of Canada
MediSystem Pharmacy
Investigators
Layout table for investigator information
Principal Investigator: Henry YH Siu, MSc, MD McMaster University
Layout table for additonal information
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02958800    
Other Study ID Numbers: CFPC-86796210
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by McMaster University:
Deprescribing
Single patient open label trial
Long-term care
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Olanzapine
Risperidone
Quetiapine Fumarate
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents