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Optimizing Prescribing of Antipsychotics in Long-Term Care (OPAL)

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational
Sponsored by
Queen's University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Antipsychotic, Nursing home, Long-term care

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of dementia
  • Receiving an antipsychotic medication without a diagnosis of psychosis

Exclusion Criteria:

  • Diagnoses of schizophrenia, Huntington's disease
  • Presence of active hallucinations and/or delusions
  • Individuals at end of live or receiving palliative care

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Percentage of long-term care residents receiving any antipsychotic without a diagnosis of psychosis
    The proportion of long-term care residents receiving any antipsychotic without a diagnosis of psychosis is a quality indicator is used by the Canadian Institute for Health Information to determine potentially inappropriate antipsychotic use. The quality indicator is calculated using information routinely collected on Resident Assessment Index-Minimum Dataset (RAI-MDS) assessments by determining the number of individuals who received antipsychotics on one of more days in the 7 days preceding index (RAI-MDS item O4a ≥ 1). Individuals with schizophrenia, Huntington's disease, hallucinations, delusions, those with a limited life expectancy and those currently receiving palliative care are excluded from the numerator and denominator of this indicator.

    Secondary Outcome Measures

    Worsening of behavioral symptoms
    Proportion of residents who had one or more of the following behavioural symptoms: wandering, physically or verbally abusive, or socially inappropriate behaviours) present on their target RAI-MDS assessment than on their prior assessment.
    Use of physical restraints
    Proportion of residents in daily physical restraints as of the target RAI-MDS assessment.
    Depression: Proportion of residents whose mood from symptoms of depression worsened
    Proportion of residents whose mood from symptoms of depression worsened compared to the previous RAI-MDS assessment.
    Falls: Proportion of residents experiencing a fall in the 30 day
    Proportion of residents experiencing a fall in the 30 days preceding the RAI-MDS assessment.
    Pain: Proportion of residents who had pain
    Proportion of residents who had pain on their target RAI=MDS assessment.

    Full Information

    First Posted
    April 6, 2018
    Last Updated
    June 22, 2018
    Sponsor
    Queen's University
    Collaborators
    Canadian Consortium on Neurodegeneration in Aging, Canadian Frailty Network
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03557593
    Brief Title
    Optimizing Prescribing of Antipsychotics in Long-Term Care
    Acronym
    OPAL
    Official Title
    Optimizing Prescribing of Antipsychotics in Long-Term Care (OPAL): A Randomized Trial to Reduce Inappropriate Antipsychotic Prescribing in Long-Term Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    October 2017 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Queen's University
    Collaborators
    Canadian Consortium on Neurodegeneration in Aging, Canadian Frailty Network

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Inappropriate antipsychotic prescribing is a key quality indicator by which clinical outcomes might be monitored and improved in LTC. A multi component intervention to reduce inappropriate antipsychotic prescribing was evaluated in ten Canadian long-term care facilities.
    Detailed Description
    Increasing numbers of older adults are affected by dementia, and many will eventually reside in long-term care (LTC), where antipsychotic use is relatively common. Inappropriate antipsychotic prescribing is a key quality indicator by which clinical outcomes might be monitored and improved in LTC but limited evidence exists on the most effective strategies for reducing inappropriate antipsychotic use. The objective of the study was to evaluate a multicomponent approach to reduce inappropriate prescribing of antipsychotics in LTC. A prospective, randomized stepped-wedge, study design was used to evaluate the effect of the intervention in 10 LTC facilities in Canada. The intervention consisted of an educational in-service, provision of evidence-based tools to assess and monitor neuropsychiatric symptoms (NPS) and monthly interprofessional team meetings.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia
    Keywords
    Antipsychotic, Nursing home, Long-term care

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    Randomized, stepped-wedge cluster trial.
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Educational
    Intervention Description
    Multi component educational intervention in long-term care
    Primary Outcome Measure Information:
    Title
    Percentage of long-term care residents receiving any antipsychotic without a diagnosis of psychosis
    Description
    The proportion of long-term care residents receiving any antipsychotic without a diagnosis of psychosis is a quality indicator is used by the Canadian Institute for Health Information to determine potentially inappropriate antipsychotic use. The quality indicator is calculated using information routinely collected on Resident Assessment Index-Minimum Dataset (RAI-MDS) assessments by determining the number of individuals who received antipsychotics on one of more days in the 7 days preceding index (RAI-MDS item O4a ≥ 1). Individuals with schizophrenia, Huntington's disease, hallucinations, delusions, those with a limited life expectancy and those currently receiving palliative care are excluded from the numerator and denominator of this indicator.
    Time Frame
    12-months
    Secondary Outcome Measure Information:
    Title
    Worsening of behavioral symptoms
    Description
    Proportion of residents who had one or more of the following behavioural symptoms: wandering, physically or verbally abusive, or socially inappropriate behaviours) present on their target RAI-MDS assessment than on their prior assessment.
    Time Frame
    12-months
    Title
    Use of physical restraints
    Description
    Proportion of residents in daily physical restraints as of the target RAI-MDS assessment.
    Time Frame
    12-months
    Title
    Depression: Proportion of residents whose mood from symptoms of depression worsened
    Description
    Proportion of residents whose mood from symptoms of depression worsened compared to the previous RAI-MDS assessment.
    Time Frame
    12-months
    Title
    Falls: Proportion of residents experiencing a fall in the 30 day
    Description
    Proportion of residents experiencing a fall in the 30 days preceding the RAI-MDS assessment.
    Time Frame
    12-months
    Title
    Pain: Proportion of residents who had pain
    Description
    Proportion of residents who had pain on their target RAI=MDS assessment.
    Time Frame
    12-months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of dementia Receiving an antipsychotic medication without a diagnosis of psychosis Exclusion Criteria: Diagnoses of schizophrenia, Huntington's disease Presence of active hallucinations and/or delusions Individuals at end of live or receiving palliative care

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Optimizing Prescribing of Antipsychotics in Long-Term Care

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