Pragmatic Cluster Trial for Nursing Home Antipsychotic Prescribing
- Conditions
- Adverse Effect of Other Antipsychotics and Neuroleptics
- Interventions
- Behavioral: Audit + FeedbackBehavioral: Audit + Feedback + Educational Outreach
- Registration Number
- NCT02604056
- Lead Sponsor
- Women's College Hospital
- Brief Summary
Two arm, pragmatic, cluster-randomized trial, with nursing homes allocated to the full, active intervention (featuring educational outreach offered to each prescriber and team members in the home) or standard quality improvement supports (including online audit and feedback reports for each prescriber in the home). The 'standard' quality improvement supports represent 'usual care' as these are to be launched province-wide; a concurrent control arm with no exposure to a quality improvement intervention is not feasible.
- Detailed Description
The Ministry of Health and Long-Term Care and Ontario Medical Association have initiated a project aiming to improve appropriateness of prescribing in long-term care facilities (aka nursing homes) through integrated educational supports for nursing home prescribers, inter-professional care teams, as well as residents and family members. The first focus of the project is appropriate prescribing of antipsychotic medications. Working with Health Quality Ontario, the policy makers have determined that all prescribers will have the opportunity to review practice reports detailing their prescribing performance for this class of medication (aka audit and feedback).
The primary question of this pragmatic, cluster-randomized trial is: What is the effect of adding educational outreach compared to the 'usual' quality improvement supports (i.e. audit and feedback) on prescribing of antipsychotic medications in long-term care?
Secondary questions include the following:
i. What is the effect of the intervention on acute care utilization (e.g., emergency room) rates? ii. What is the effect of the intervention on incidence of patient clinical outcomes and/or adverse effects associated with antipsychotic medications (e.g., falls, aggressive behaviours)? iii. What is the effect of the interventions on medications that might be used as alternatives to antipsychotic medications (e.g., benzodiazepines)? iv. What is the cost-benefit, focusing on prescribing outcomes?
Process evaluation questions include the following:
1. How and why do the interventions work as observed?
2. Was the intervention implemented as desired in nursing homes?
3. What were the contextual factors associated with implementation?
4. Do the interventions affect precursors of behaviour (e.g., motivation, capability)?
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Audit + Feedback + Educational Outreach Audit + Feedback 'Active/full' intervention (featuring Educational Outreach offered to each prescriber and team members in the home) Audit + Feedback Audit + Feedback 'Usual care' / standard quality improvement supports (including online Audit and Feedback reports for each prescriber in the home) Audit + Feedback + Educational Outreach Audit + Feedback + Educational Outreach 'Active/full' intervention (featuring Educational Outreach offered to each prescriber and team members in the home)
- Primary Outcome Measures
Name Time Method Antipsychotic dispensing 6 months post-intervention Number of days with antipsychotic prescriptions in the last week (count, range 0 - 7)
- Secondary Outcome Measures
Name Time Method Falls 3 and 6 months post-intervention Number of falls in the past month (count)
Benzodiazepine (or sedative) prescribing 3 and 6 months post-intervention Any prescription during the past month (dichotomous)
Anti-depressant prescribing 3 and 6 months post-intervention Any prescription during the past month (dichotomous)
Aggressive behaviour scale 3 and 6 months post-intervention Extent of aggressive behaviour (continuous variable, range 0-12)
Pain 3 and 6 months post-intervention Pain scale (continuous variable, range 0-3)
Mean Antipsychotic dose 3 and 6 months post-intervention Dose equivalent of antipsychotic dispensed in the past month (continuous)
Hospitalizations 3 months post-intervention Number of hospital visits visit during the previous 3 months (count)
Acetaminophen prescribing 3 and 6 months post-intervention Any prescription during the past month (dichotomous)
Depression 3 and 6 months post-intervention Depression rating scale (continuous variable, range 0-14)
Difficulty in performing activities 3 and 6 months post-intervention Activities of Daily Living long form scale (continuous variable, range 0-28)
Emergency Room visits 3 months post-intervention Number of ER visits during the previous 3 months (count)
Antipsychotic prescribing 3 and 6 months post-intervention Any antipsychotic prescription during the past month (dichotomous)