Overview

This trial is active, not recruiting.

Condition adverse effect of other antipsychotics and neuroleptics
Treatments audit + feedback, audit + feedback + educational outreach
Sponsor Women's College Hospital
Collaborator Ontario Ministry of Health and Long Term Care
Start date September 2015
End date September 2017
Trial size 60 participants
Trial identifier NCT02604056, MOHLTCAPDP

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Active Comparator)
'Usual care' / standard quality improvement supports (including online Audit and Feedback reports for each prescriber in the home)
audit + 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)
(Experimental)
'Active/full' intervention (featuring Educational Outreach offered to each prescriber and team members in the home)
audit + 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)
audit + 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.

Primary Outcomes

Measure
Antipsychotic dispensing
time frame: 6 months post-intervention

Secondary Outcomes

Measure
Antipsychotic prescribing
time frame: 3 and 6 months post-intervention
Mean Antipsychotic dose
time frame: 3 and 6 months post-intervention
Benzodiazepine (or sedative) prescribing
time frame: 3 and 6 months post-intervention
Anti-depressant prescribing
time frame: 3 and 6 months post-intervention
Acetaminophen prescribing
time frame: 3 and 6 months post-intervention
Difficulty in performing activities
time frame: 3 and 6 months post-intervention
Aggressive behaviour scale
time frame: 3 and 6 months post-intervention
Pain
time frame: 3 and 6 months post-intervention
Depression
time frame: 3 and 6 months post-intervention
Falls
time frame: 3 and 6 months post-intervention
Emergency Room visits
time frame: 3 months post-intervention
Hospitalizations
time frame: 3 months post-intervention

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Ontario Appropriate Prescribing Demonstration Project: Pragmatic, Cluster-Randomized Clinical Trial to Reduce Antipsychotic Medication Prescribing in Long-Term Care Homes
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)?
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Women's College Hospital.