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CompletedNCT02979964Updated Oct 5, 2018

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

An interventional study of Audit and Feedback in High-risk Prescribing in Nursing Homes, sponsored by Women's College Hospital. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2018-10-05.

Sponsored by Women's College Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
285
Allocation
Randomized
Sex
All
01

Study summary

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.

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Conditions studied

  • High-risk Prescribing in Nursing Homes
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In context

Lead sponsor

Women's College Hospital is the lead sponsor of 87 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • n/a
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
285 participants (actual)

Study arms

  • 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.

    Behavioral: Audit and Feedback

  • 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.

    Behavioral: Audit and Feedback

  • 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.

    Behavioral: Audit and Feedback

  • 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.

    Behavioral: Audit and Feedback

Interventions

  • BehavioralAudit and Feedback
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What researchers measure

Primary outcomes

  1. CNS-active medication prescribing

    monthly number of CNS-active medications per resident (antipsychotics, opioids, benzodiazepines or antidepressants (including TCAs and trazodone))

    Time frame: 6 months

Secondary outcomes

  1. Benzodiazepine (or z-drug) prescribing

    days supplied (continuous)

    Time frame: 6 months

  2. Benzodiazepine (or z-drug) rates

    monthly proportion

    Time frame: 6 months

  3. Antipsychotic rates

    monthly proportion

    Time frame: 6 months

  4. Antipsychotic prescribing

    days supplied (continuous)

    Time frame: 6 months

  5. Mean Antipsychotic dose

    Dose equivalent of antipsychotic dispensed (continuous)

    Time frame: 6 months

  6. Mean Benzodiazepine dose

    Dose equivalent of benzodiazepine dispensed (continuous)

    Time frame: 6 months

  7. 3+ CNS-active medications

    monthly proportion supplied three or more meds from the following classes: antipsychotics, opioids, benzodiazepines, or antidepressants (including TCAs and trazodone).

    Time frame: 6 months

  8. Anti-depressant prescribing

    days supplied (continuous) - balance measure

    Time frame: 6 months

  9. Anti-acid prescribing

    days supplied (continuous) - tracer outcome

    Time frame: 6 months

  10. Statin prescribing

    days supplied (continuous) - tracer outcome

    Time frame: 6 months

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Study locations

1 site
  • Women's College Hospital
    Toronto, Ontario M5S1B2, Canada
08

References and documents

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. PubMed 24438584 ↗
  • 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;2012(6):CD000259. doi: 10.1002/14651858.CD000259.pub3. PubMed 22696318 ↗
  • 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. PubMed 11401608 ↗
  • 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;2011(12):CD006777. doi: 10.1002/14651858.CD006777.pub2. PubMed 22161408 ↗
  • 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. PubMed 21091758 ↗
  • 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. PubMed 11708039 ↗
  • 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. PubMed 25070404 ↗
  • 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. PubMed 10461579 ↗
  • 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. PubMed 22456088 ↗
  • 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. PubMed 22530986 ↗
  • McCleary N, Desveaux L, Presseau J, Reis C, Witteman HO, Taljaard M, Linklater S, Thavorn K, Dobell G, Mulhall CL, Lam JMC, Grimshaw JM, Ivers NM. Engagement is a necessary condition to test audit and feedback design features: results of a pragmatic, factorial, cluster-randomized trial with an embedded process evaluation. Implement Sci. 2023 May 10;18(1):13. doi: 10.1186/s13012-023-01271-6. PubMed 37165413 ↗
  • 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. PubMed 28705208 ↗

Individual participant data

Plan to share: No — Analyses of outcomes use routine administrative database holdings.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2016 to primary completion in Oct 2017, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2016
First posted
Dec 2, 2016
StartActual
Dec 6, 2016
Primary completionActual
Oct 6, 2017
CompletionActual
Jul 2018
Last update
Oct 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02979964
Lead sponsor
Women's College Hospital
Collaborators
Health Quality Ontario
Responsible party
Noah Ivers (M.D., PhD, CCFP, Women's College Hospital) — Principal investigator
First posted
Dec 2, 2016
Start date
Dec 6, 2016
Primary completion
Oct 6, 2017
Completion
Jul 2018
Last update
Oct 5, 2018

Study contacts

Noah M Ivers, MD PhD CCFP
principal investigator · Women's College Hospital - University of Toronto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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