Pragmatic Cluster Trial for Nursing Home Antipsychotic Prescribing

NCT02604056 | Completed

• 1 other identifier: MOHLTCAPDP
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adverse Effect of Other Antipsychotics and Neuroleptics

Outcome Measures

Primary Outcomes (1)

• Antipsychotic dispensing

  Number of days with antipsychotic prescriptions in the last week (count, range 0 - 7)

  6 months post-intervention

Secondary Outcomes (12)

• Antipsychotic prescribing

  3 and 6 months post-intervention

• Mean Antipsychotic dose

  3 and 6 months post-intervention

• Benzodiazepine (or sedative) prescribing

  3 and 6 months post-intervention

• Anti-depressant prescribing

  3 and 6 months post-intervention

• Acetaminophen prescribing

  3 and 6 months post-intervention

Study Arms (2)

Audit + Feedback

ACTIVE COMPARATOR

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

Behavioral: Audit + Feedback

Audit + Feedback + Educational Outreach

EXPERIMENTAL

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

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

Interventions

Audit + Feedback BEHAVIORAL

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; Audit + Feedback + Educational Outreach

Audit + Feedback + Educational Outreach BEHAVIORAL

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.

Audit + Feedback + Educational Outreach

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's College Hospital: lead
• Ontario Ministry of Health and Long Term Care: collaborator
• Ontario Medical Association: collaborator
• Health Quality Ontario: collaborator
• Centre for Effective Practice: collaborator

Related Publications (3)

• 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.

  PMID: 32453383 DERIVED

• 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.

  PMID: 28549480 DERIVED

• 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.

  PMID: 27026584 DERIVED

Study Officials

• Noah Ivers

  Family Doctor and Research Scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 13, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share