Optimizing Prescribing of Antipsychotics in Long-Term Care

Dementia Clinical Trial

— OPAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557593
• Other study ID #: 6017760
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2018
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Queen's University	Canadian Consortium on Neurodegeneration in Aging, Canadian Frailty Network

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Use of physical restraints	Proportion of residents in daily physical restraints as of the target RAI-MDS assessment.	12-months
Secondary	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
Secondary	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
Secondary	Pain: Proportion of residents who had pain	Proportion of residents who had pain on their target RAI=MDS assessment.	12-months