Clinical trial NCT02604056: Pragmatic Cluster Trial for Nursing Home Antipsychotic Prescribing
Official title: Ontario Appropriate Prescribing Demonstration Project: Pragmatic, Cluster-Randomized Clinical Trial to Reduce Antipsychotic Medication Prescribing in Long-Term Care Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Effect of Other Antipsychotics and Neuroleptics
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
name: Ontario Medical Association
name: Health Quality Ontario
name: Centre for Effective Practice
First posted: 2015-11-13
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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)?

Eligibility criteria: 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

Primary outcomes:
measure: Antipsychotic dispensing
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Antipsychotic prescribing
timeFrame: 3 and 6 months post-intervention
measure: Mean Antipsychotic dose
timeFrame: 3 and 6 months post-intervention
measure: Benzodiazepine (or sedative) prescribing
timeFrame: 3 and 6 months post-intervention
measure: Anti-depressant prescribing
timeFrame: 3 and 6 months post-intervention
measure: Acetaminophen prescribing
timeFrame: 3 and 6 months post-intervention
measure: Difficulty in performing activities
timeFrame: 3 and 6 months post-intervention
measure: Aggressive behaviour scale
timeFrame: 3 and 6 months post-intervention
measure: Pain
timeFrame: 3 and 6 months post-intervention
measure: Depression
timeFrame: 3 and 6 months post-intervention
measure: Falls
timeFrame: 3 and 6 months post-intervention
measure: Emergency Room visits
timeFrame: 3 months post-intervention
measure: Hospitalizations
timeFrame: 3 months post-intervention
Other outcomes:
Locations:
Study officials:
affiliation: Family Doctor and Research Scientist
name: Noah Ivers
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tadrous M, Fung K, Desveaux L, Gomes T, Taljaard M, Grimshaw JM, Bell CM, Ivers NM. Effect of Academic Detailing on Promoting Appropriate Prescribing of Antipsychotic Medication in Nursing Homes: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 May 1;3(5):e205724. doi: 10.1001/jamanetworkopen.2020.5724.
citation: Desveaux L, Saragosa M, Rogers J, Bevan L, Loshak H, Moser A, Feldman S, Regier L, Jeffs L, Ivers NM. Improving the appropriateness of antipsychotic prescribing in nursing homes: a mixed-methods process evaluation of an academic detailing intervention. Implement Sci. 2017 May 26;12(1):71. doi: 10.1186/s13012-017-0602-z.
citation: Desveaux L, Gomes T, Tadrous M, Jeffs L, Taljaard M, Rogers J, Bell CM, Ivers NM. Appropriate prescribing in nursing homes demonstration project (APDP) study protocol: pragmatic, cluster-randomized trial and mixed methods process evaluation of an Ontario policy-maker initiative to improve appropriate prescribing of antipsychotics. Implement Sci. 2016 Mar 29;11:45. doi: 10.1186/s13012-016-0410-x.