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Pragmatic Cluster Trial for Nursing Home Antipsychotic Prescribing

Ontario Appropriate Prescribing Demonstration Project: Pragmatic, Cluster-Randomized Clinical Trial to Reduce Antipsychotic Medication Prescribing in Long-Term Care Homes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02604056
Enrollment
60
Registered
2015-11-13
Start date
2015-09-30
Completion date
2017-04-30
Last updated
2018-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effect of Other Antipsychotics and Neuroleptics

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)?

Interventions

BEHAVIORALAudit + Feedback

Online Audit + Feedback practice reports detailing prescribing performance for this class of medication for each prescriber in the nursing home. (Details: http://www.hqontario.ca/Quality-Improvement/Practice-Reports/Primary-Care)

BEHAVIORALAudit + Feedback + Educational Outreach

The Educational Outreach program will be delivered by academic detailers, health professionals (often nurses or pharmacists) who have received specific intensive training to support prescribing providers in a particular environment, in this case long-term care homes, to make the best or appropriate clinical decisions as possible. It is defined as: an innovative method of service-oriented educational outreach for front-line clinicians. It combines the interactive, one-on-one communication approach of industry detailers with the evidence-based, non-commercial information of academia. The Educational Outreach will be delivered in addition to online Audit + Feedback practice reports, which detail prescribing performance for this class of medication for each prescriber in the nursing home.

Sponsors

Ontario Ministry of Health and Long Term Care
CollaboratorOTHER_GOV
Ontario Medical Association
CollaboratorOTHER
Health Quality Ontario
CollaboratorOTHER
Centre for Effective Practice
CollaboratorOTHER
Women's College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Nursing homes within pre-determined regions of Ontario that expressed an interest in the full intervention (the regions, or hubs, contain a wide variety of nursing home types within a reasonable travel distance \[i.e., \<100 km\]) * Nursing homes within the hubs in which the medical and administrative leads agree to and support the project

Exclusion criteria

* Nursing homes with a previous or ongoing involvement in externally supported quality improvement initiatives focusing on antipsychotic medications * Nursing homes without any prescribers caring for at least 10 residents routinely * Nursing homes with fewer than 30 residents

Design outcomes

Primary

MeasureTime frameDescription
Antipsychotic dispensing6 months post-interventionNumber of days with antipsychotic prescriptions in the last week (count, range 0 - 7)

Secondary

MeasureTime frameDescription
Difficulty in performing activities3 and 6 months post-interventionActivities of Daily Living long form scale (continuous variable, range 0-28)
Antipsychotic prescribing3 and 6 months post-interventionAny antipsychotic prescription during the past month (dichotomous)
Mean Antipsychotic dose3 and 6 months post-interventionDose equivalent of antipsychotic dispensed in the past month (continuous)
Benzodiazepine (or sedative) prescribing3 and 6 months post-interventionAny prescription during the past month (dichotomous)
Anti-depressant prescribing3 and 6 months post-interventionAny prescription during the past month (dichotomous)
Acetaminophen prescribing3 and 6 months post-interventionAny prescription during the past month (dichotomous)
Pain3 and 6 months post-interventionPain scale (continuous variable, range 0-3)
Depression3 and 6 months post-interventionDepression rating scale (continuous variable, range 0-14)
Falls3 and 6 months post-interventionNumber of falls in the past month (count)
Emergency Room visits3 months post-interventionNumber of ER visits during the previous 3 months (count)
Hospitalizations3 months post-interventionNumber of hospital visits visit during the previous 3 months (count)
Aggressive behaviour scale3 and 6 months post-interventionExtent of aggressive behaviour (continuous variable, range 0-12)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026