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

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ClinicalTrials.gov Identifier: NCT03557593
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : June 26, 2018
Sponsor:
Collaborators:
Canadian Consortium on Neurodegeneration in Aging
Canadian Frailty Network
Information provided by (Responsible Party):
Dr. Dallas Seitz, Queen's University

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Randomized, stepped-wedge cluster trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimizing Prescribing of Antipsychotics in Long-Term Care (OPAL): A Randomized Trial to Reduce Inappropriate Antipsychotic Prescribing in Long-Term Care
Actual Study Start Date : January 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : December 2017

Intervention Details:
  • Other: Educational
    Multi component educational intervention in long-term care


Primary Outcome Measures :
  1. Percentage of long-term care residents receiving any antipsychotic without a diagnosis of psychosis [ Time Frame: 12-months ]
    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 :
  1. Worsening of behavioral symptoms [ Time Frame: 12-months ]
    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.

  2. Use of physical restraints [ Time Frame: 12-months ]
    Proportion of residents in daily physical restraints as of the target RAI-MDS assessment.

  3. Depression: Proportion of residents whose mood from symptoms of depression worsened [ Time Frame: 12-months ]
    Proportion of residents whose mood from symptoms of depression worsened compared to the previous RAI-MDS assessment.

  4. Falls: Proportion of residents experiencing a fall in the 30 day [ Time Frame: 12-months ]
    Proportion of residents experiencing a fall in the 30 days preceding the RAI-MDS assessment.

  5. Pain: Proportion of residents who had pain [ Time Frame: 12-months ]
    Proportion of residents who had pain on their target RAI=MDS assessment.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Dr. Dallas Seitz, Principal Investigator, Associate Professor, Dept. of Psychiatry, Queen's University, Queen's University
ClinicalTrials.gov Identifier: NCT03557593    
Other Study ID Numbers: 6017760
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Dallas Seitz, Queen's University:
Antipsychotic
Nursing home
Long-term care
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders