- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02979964
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
Conditions
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
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Ontario
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Toronto, Ontario, Canada, M5S1B2
- Women's College Hospital
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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.
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|
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.
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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
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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.
Sponsor
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
- Ivers NM, Sales A, Colquhoun H, Michie S, Foy R, Francis JJ, Grimshaw JM. No more 'business as usual' with audit and feedback interventions: towards an agenda for a reinvigorated intervention. Implement Sci. 2014 Jan 17;9:14. doi: 10.1186/1748-5908-9-14.
- Ivers N, Jamtvedt G, Flottorp S, Young JM, Odgaard-Jensen J, French SD, O'Brien MA, Johansen M, Grimshaw J, Oxman AD. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD000259. doi: 10.1002/14651858.CD000259.pub3.
- Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012 Apr 24;7:37. doi: 10.1186/1748-5908-7-37.
- Kiefe CI, Allison JJ, Williams OD, Person SD, Weaver MT, Weissman NW. Improving quality improvement using achievable benchmarks for physician feedback: a randomized controlled trial. JAMA. 2001 Jun 13;285(22):2871-9. doi: 10.1001/jama.285.22.2871.
- Akl EA, Oxman AD, Herrin J, Vist GE, Terrenato I, Sperati F, Costiniuk C, Blank D, Schunemann H. Framing of health information messages. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD006777. doi: 10.1002/14651858.CD006777.pub2.
- Kluger AN, Van Dijk D. Feedback, the various tasks of the doctor, and the feedforward alternative. Med Educ. 2010 Dec;44(12):1166-74. doi: 10.1111/j.1365-2923.2010.03849.x.
- Hibbard JH, Peters E, Slovic P, Finucane ML, Tusler M. Making health care quality reports easier to use. Jt Comm J Qual Improv. 2001 Nov;27(11):591-604. doi: 10.1016/s1070-3241(01)27051-5.
- Gould NJ, Lorencatto F, Stanworth SJ, Michie S, Prior ME, Glidewell L, Grimshaw JM, Francis JJ. Application of theory to enhance audit and feedback interventions to increase the uptake of evidence-based transfusion practice: an intervention development protocol. Implement Sci. 2014 Jul 29;9:92. doi: 10.1186/s13012-014-0092-1.
- Weissman NW, Allison JJ, Kiefe CI, Farmer RM, Weaver MT, Williams OD, Child IG, Pemberton JH, Brown KC, Baker CS. Achievable benchmarks of care: the ABCs of benchmarking. J Eval Clin Pract. 1999 Aug;5(3):269-81. doi: 10.1046/j.1365-2753.1999.00203.x.
- Li AC, Kannry JL, Kushniruk A, Chrimes D, McGinn TG, Edonyabo D, Mann DM. Integrating usability testing and think-aloud protocol analysis with "near-live" clinical simulations in evaluating clinical decision support. Int J Med Inform. 2012 Nov;81(11):761-72. doi: 10.1016/j.ijmedinf.2012.02.009. Epub 2012 Mar 27.
- Ivers NM, Desveaux L, Presseau J, Reis C, Witteman HO, Taljaard MK, McCleary N, Thavorn K, Grimshaw JM. Testing feedback message framing and comparators to address prescribing of high-risk medications in nursing homes: protocol for a pragmatic, factorial, cluster-randomized trial. Implement Sci. 2017 Jul 14;12(1):86. doi: 10.1186/s13012-017-0615-7.
Helpful Links
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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