Pragmatic Factorial Cluster Trial of Framing and Comparators for Audit and Feedback

October 3, 2018 updated by: Noah Ivers, Women's College Hospital

Pragmatic Factorial Cluster Trial of Framing and Comparators for Audit and Feedback Aiming to Address High Risk Prescribing in Nursing Homes in Ontario

Health Quality Ontario (HQO) is the provincial advisor on quality in health care. HQO currently conducts audit and feedback as a key quality improvement strategy. For example, it offers physicians working in long-term care homes with access to practice reports detailing rates of high-risk prescribing in comparison with others in Ontario and suggested change ideas. Research shows that providing this kind of feedback can lead to improvements in care. However, the size of these improvements depends how the feedback is presented. For instance, prior research suggests that how the results are 'framed' and what sort of benchmark the recipient is compared to may each affect how the physician will respond. This factorial trial tests each of these aspects of feedback design in the context of practice reports that nursing home physicians have already signed up to receive quarterly.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

285

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5S1B2
        • Women's College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a physician licensed by the College of Physicians and Surgeons of Ontario (CPSO);
  • practice in at least one LTC facility in Ontario;.
  • have voluntarily signed up to receive an HQO practice report

Exclusion Criteria:

  • n/a

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1, Positive Framing
All metrics in the audit and feedback practice reports presented with 'positive' framing, where the proportion of patients safe from risk (i.e., appropriate/desirable prescribing behaviours) is described.
Experimental: Arm 2, Negative Framing
All metrics in the audit and feedback practice reports presented with 'negative' framing, where the proportion of patients at risk (i.e., due to inappropriate/undesirable prescribing behaviours) is described.
Experimental: Arm 3, Top Quartile Comparator
All metrics in the audit and feedback practice reports presented and the physician-recipient's performance is compared against the 75th percentile for performance by physicians working in nursing homes in the province for each metric.
Experimental: Arm 4, Average Comparator
All metrics in the audit and feedback practice reports presented and the physician-recipient's performance is compared against the average performance by physicians working in nursing homes in the province for each metric.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CNS-active medication prescribing
Time Frame: 6 months
monthly number of CNS-active medications per resident (antipsychotics, opioids, benzodiazepines or antidepressants (including TCAs and trazodone))
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Benzodiazepine (or z-drug) prescribing
Time Frame: 6 months
days supplied (continuous)
6 months
Benzodiazepine (or z-drug) rates
Time Frame: 6 months
monthly proportion
6 months
Antipsychotic rates
Time Frame: 6 months
monthly proportion
6 months
Antipsychotic prescribing
Time Frame: 6 months
days supplied (continuous)
6 months
Mean Antipsychotic dose
Time Frame: 6 months
Dose equivalent of antipsychotic dispensed (continuous)
6 months
Mean Benzodiazepine dose
Time Frame: 6 months
Dose equivalent of benzodiazepine dispensed (continuous)
6 months
3+ CNS-active medications
Time Frame: 6 months
monthly proportion supplied three or more meds from the following classes: antipsychotics, opioids, benzodiazepines, or antidepressants (including TCAs and trazodone).
6 months
Anti-depressant prescribing
Time Frame: 6 months
days supplied (continuous) - balance measure
6 months
Anti-acid prescribing
Time Frame: 6 months
days supplied (continuous) - tracer outcome
6 months
Statin prescribing
Time Frame: 6 months
days supplied (continuous) - tracer outcome
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Noah M Ivers, MD PhD CCFP, Women's College Hospital - University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2016

Primary Completion (Actual)

October 6, 2017

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

December 2, 2016

Study Record Updates

Last Update Posted (Actual)

October 5, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-0122-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Analyses of outcomes use routine administrative database holdings.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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