NCT03557593

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

1.8 years

First QC Date

April 6, 2018

Last Update Submit

June 22, 2018

Conditions

Keywords

AntipsychoticNursing homeLong-term care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Worsening of behavioral symptoms

    12-months

  • Use of physical restraints

    12-months

  • Depression: Proportion of residents whose mood from symptoms of depression worsened

    12-months

  • Falls: Proportion of residents experiencing a fall in the 30 day

    12-months

  • Pain: Proportion of residents who had pain

    12-months

Interventions

Multi component educational intervention in long-term care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Randomized, stepped-wedge cluster trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Associate Professor, Dept. of Psychiatry, Queen's University

Study Record Dates

First Submitted

April 6, 2018

First Posted

June 15, 2018

Study Start

January 1, 2016

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

June 26, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share