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Completed

NCT Number: NCT03557593

Optimizing Prescribing of Antipsychotics in Long-Term Care

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

educational

Other

Multi component educational intervention in long-term care

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • Canadian Consortium on Neurodegeneration in Aging
  • Canadian Frailty Network

Registry information

Official study title

Optimizing Prescribing of Antipsychotics in Long-Term Care (OPAL): A Randomized Trial to Reduce Inappropriate Antipsychotic Prescribing in Long-Term Care

Acronym: OPAL

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 15, 2018
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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