DementiaOPALNCT03557593
Optimizing Prescribing of Antipsychotics in Long-Term Care
A study testing Educational in people with Dementia, run by Queen's University.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Educational
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of dementia
- Receiving an antipsychotic medication without a diagnosis of psychosis
Who cannot join
- Diagnoses of schizophrenia, Huntington's disease
- Presence of active hallucinations and/or delusions
- Individuals at end of live or receiving palliative care
About this study
Official title: 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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Educational
- Keywords
- Antipsychotic, Nursing home, Long-term care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationalOther
Multi component educational intervention in long-term care
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-months
Secondary outcomes (5)
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.
Measured: 12-months
Use of physical restraints
Proportion of residents in daily physical restraints as of the target RAI-MDS assessment.
Measured: 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.
Measured: 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.
Measured: 12-months
Pain: Proportion of residents who had pain
Proportion of residents who had pain on their target RAI=MDS assessment.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study startJan 2016
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized, stepped-wedge cluster trial.
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Consortium on Neurodegeneration in Aging, Canadian Frailty Network
- Responsible party
- Principal investigator, Dr. Dallas Seitz, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557593
- Sponsor's protocol ID
- 6017760
- Acronym
- OPAL
- Status last verified
- Jun 2018
- First submitted
- 6 Apr 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Prescribing of Antipsychotics in Long-Term Care (OPAL): A Randomized Trial to Reduce Inappropriate Antipsychotic Prescribing in Long-Term Care
- ClinicalTrials.gov ID
- NCT03557593
- Acronym / sponsor ID
- OPAL / 6017760
- Conditions
- Dementia
- Keywords
- Antipsychotic, Nursing home, Long-term care
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Canadian Consortium on Neurodegeneration in Aging, Canadian Frailty Network
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Model description
- Randomized, stepped-wedge cluster trial.
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of dementia
- Receiving an antipsychotic medication without a diagnosis of psychosis
Key exclusion criteria (3 listed)
- Diagnoses of schizophrenia, Huntington's disease
- Presence of active hallucinations and/or delusions
- Individuals at end of live or receiving palliative care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationalMulti component educational intervention in long-term care | Other | – |
Primary outcome
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.
5 secondary outcomes
Worsening of behavioral symptoms
Time frame: 12-months
Use of physical restraints
Time frame: 12-months
Depression: Proportion of residents whose mood from symptoms of depression worsened
Time frame: 12-months
Falls: Proportion of residents experiencing a fall in the 30 day
Time frame: 12-months
Pain: Proportion of residents who had pain
Time frame: 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Educational in people with Dementia, run by Queen's University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of long-term care residents receiving any antipsychotic without a diagnosis of psychosis (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.