DementiaNCT02958800
Deprescribing Antipsychotics in Long-Term Care
A study testing Intervention in people with Dementia and Behavior, run by McMaster University at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Single Patient Open-label Trial Tapering Algorithm for Antipsychotics in Long-Term Care - A Pilot Study
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.
Read the 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.
- Being tested
- Intervention
- Keywords
- Deprescribing, Single patient open label trial, Long-term care
- Medical subject headings
- Dementia, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Also called Antipsychotic Atypical, Risperidone, Quetiapine, Olanzapine
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (8)
Evidence for implementation in Long-Term Care
Rate of recruitment
Measured: 2 years
Frequency of "as needed" doses used
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.
Measured: 2 years
Frequency of falls
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.
Measured: 2 years
Persistence of clinical decision
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.
Measured: 2 years
Evidence for implementation in Long-Term Care
Successful random sequence generation and allocation
Measured: 2 Years
Evidence for implementation in Long-Term Care
Data collection from patient chart
Measured: 2 Years
Evidence for implementation in Long-Term Care
Creation of participant summative behaviour reports
Measured: 2 Years
Evidence for implementation in Long-Term Care
Feedback survey regarding acceptability of study rationale and procedures.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- College of Family Physicians of Canada, MediSystem Pharmacy
- Responsible party
- Sponsor
- Investigators
- Henry YH Siu, MSc, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958800
- Sponsor's protocol ID
- CFPC-86796210
- Status last verified
- Nov 2024
- First submitted
- 2 Nov 2016
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Single Patient Open-label Trial Tapering Algorithm for Antipsychotics in Long-Term Care - A Pilot Study
- ClinicalTrials.gov ID
- NCT02958800
- Acronym / sponsor ID
- CFPC-86796210
- Keywords
- Deprescribing, Single patient open label trial, Long-term care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- College of Family Physicians of Canada, MediSystem Pharmacy
- Study start
- Dec 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: InterventionThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionAlso: Antipsychotic Atypical, Risperidone, Quetiapine, OlanzapineThe 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 | Intervention |
Primary outcome
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.
8 secondary outcomes
Evidence for implementation in Long-Term Care
Time frame: 2 years
Frequency of "as needed" doses used
Time frame: 2 years
Frequency of falls
Time frame: 2 years
Persistence of clinical decision
Time frame: 2 years
Evidence for implementation in Long-Term Care
Time frame: 2 Years
Evidence for implementation in Long-Term Care
Time frame: 2 Years
Evidence for implementation in Long-Term Care
Time frame: 2 Years
Evidence for implementation in Long-Term Care
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry YH Siu, MSc, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Dementia and Behavior, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision on antipsychotic dose at the end of the 12-week trial (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.