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

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

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Other: Educational

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12-months
Use of physical restraints	Proportion of residents in daily physical restraints as of the target RAI-MDS assessment.	12-months
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.	12-months
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.	12-months
Pain: Proportion of residents who had pain	Proportion of residents who had pain on their target RAI=MDS assessment.	12-months

Collaborators and Investigators

• Sponsor: Queen's University
• Collaborators: Canadian Frailty Network; Canadian Consortium on Neurodegeneration in Aging

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 22, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Antipsychotic; Nursing home; Long-term care
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 6017760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No