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

• ClinicalTrials.gov Identifier: NCT02979964
• Recruitment Status: Completed
• First Posted: December 2, 2016
• Last Update Posted: October 5, 2018
• Sponsor: Women's College Hospital
• Collaborator: Health Quality Ontario
• Information provided by (Responsible Party): Noah Ivers, Women's College Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
High-risk Prescribing in Nursing Homes	Behavioral: Audit and Feedback	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 285 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Pragmatic Factorial Cluster Trial of Framing and Comparators for Audit and Feedback Aiming to Address High Risk Prescribing in Nursing Homes in Ontario
• Actual Study Start Date: December 6, 2016
• Actual Primary Completion Date: October 6, 2017
• Actual Study Completion Date: July 2018

Arms and Interventions

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.	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

Outcome Measures

Primary Outcome Measures :

1. 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))

Secondary Outcome Measures :

1. Benzodiazepine (or z-drug) prescribing [ Time Frame: 6 months ]
   days supplied (continuous)
2. Benzodiazepine (or z-drug) rates [ Time Frame: 6 months ]
   monthly proportion
3. Antipsychotic rates [ Time Frame: 6 months ]
   monthly proportion
4. Antipsychotic prescribing [ Time Frame: 6 months ]
   days supplied (continuous)
5. Mean Antipsychotic dose [ Time Frame: 6 months ]
   Dose equivalent of antipsychotic dispensed (continuous)
6. Mean Benzodiazepine dose [ Time Frame: 6 months ]
   Dose equivalent of benzodiazepine dispensed (continuous)
7. 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).
8. Anti-depressant prescribing [ Time Frame: 6 months ]
   days supplied (continuous) - balance measure
9. Anti-acid prescribing [ Time Frame: 6 months ]
   days supplied (continuous) - tracer outcome
10. Statin prescribing [ Time Frame: 6 months ]
    days supplied (continuous) - tracer outcome

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

Women's College Hospital

Toronto, Ontario, Canada, M5S1B2

Sponsors and Collaborators

Women's College Hospital

Health Quality Ontario

Investigators

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

More Information

Additional Information:

Health Quality Ontario Long-Term Care Practice Report 

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Noah Ivers, M.D., PhD, CCFP, Women's College Hospital
• ClinicalTrials.gov Identifier: NCT02979964
• Other Study ID Numbers: 2016-0122-E
• First Posted: December 2, 2016
• Last Update Posted: October 5, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Analyses of outcomes use routine administrative database holdings.