Pragmatic Cluster Trial for Nursing Home Antipsychotic Prescribing

Women's College Hospital

Status: Completed

Conditions: Adverse Effect of Other Antipsychotics and Neuroleptics

Treatments: Behavioral: Audit + Feedback + Educational Outreach; Behavioral: Audit + Feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT02604056

MOHLTCAPDP

Details and patient eligibility

About

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.

Full 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)?

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Audit + Feedback

Active Comparator group

Description:

'Usual care' / standard quality improvement supports (including online Audit and Feedback reports for each prescriber in the home)

Treatment:

Behavioral: Audit + Feedback

Audit + Feedback + Educational Outreach

Experimental group

Description:

'Active/full' intervention (featuring Educational Outreach offered to each prescriber and team members in the home)

Treatment:

Behavioral: Audit + Feedback + Educational Outreach

Behavioral: Audit + Feedback