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

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.

Study Overview

• Status: Completed
• Conditions: Adverse Effect of Other Antipsychotics and Neuroleptics
• Intervention / Treatment: Behavioral: Audit + Feedback; Behavioral: Audit + Feedback + Educational Outreach

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)?

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Audit + Feedback; 'Usual care' / standard quality improvement supports (including online Audit and Feedback reports for each prescriber in the home)	Behavioral: 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: Audit + Feedback + Educational Outreach; 'Active/full' intervention (featuring Educational Outreach offered to each prescriber and team members in the home)	Behavioral: 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); Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antipsychotic dispensing	Number of days with antipsychotic prescriptions in the last week (count, range 0 - 7)	6 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antipsychotic prescribing	Any antipsychotic prescription during the past month (dichotomous)	3 and 6 months post-intervention
Mean Antipsychotic dose	Dose equivalent of antipsychotic dispensed in the past month (continuous)	3 and 6 months post-intervention
Benzodiazepine (or sedative) prescribing	Any prescription during the past month (dichotomous)	3 and 6 months post-intervention
Anti-depressant prescribing	Any prescription during the past month (dichotomous)	3 and 6 months post-intervention
Acetaminophen prescribing	Any prescription during the past month (dichotomous)	3 and 6 months post-intervention
Difficulty in performing activities	Activities of Daily Living long form scale (continuous variable, range 0-28)	3 and 6 months post-intervention
Aggressive behaviour scale	Extent of aggressive behaviour (continuous variable, range 0-12)	3 and 6 months post-intervention
Pain	Pain scale (continuous variable, range 0-3)	3 and 6 months post-intervention
Depression	Depression rating scale (continuous variable, range 0-14)	3 and 6 months post-intervention
Falls	Number of falls in the past month (count)	3 and 6 months post-intervention
Emergency Room visits	Number of ER visits during the previous 3 months (count)	3 months post-intervention
Hospitalizations	Number of hospital visits visit during the previous 3 months (count)	3 months post-intervention

Collaborators and Investigators

• Sponsor: Women's College Hospital
• Collaborators: Ontario Ministry of Health and Long Term Care; Ontario Medical Association; Health Quality Ontario; Centre for Effective Practice
• Investigators: Principal Investigator: Noah Ivers, Family Doctor and Research Scientist

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 11, 2015
• First Posted (Estimate): November 13, 2015

Study Record Updates

• Last Update Posted (Actual): March 23, 2018
• Last Update Submitted That Met QC Criteria: March 22, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: MOHLTCAPDP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No