High-risk Prescribing in Nursing Homes Clinical Trial
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
| NCT number | NCT02979964 |
| Other study ID # | 2016-0122-E |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 6, 2016 |
| Est. completion date | July 2018 |
| Verified date | October 2018 |
| Source | Women's College Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 285 |
| Est. completion date | July 2018 |
| Est. primary completion date | October 6, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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: |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Women's College Hospital | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Women's College Hospital | Health Quality Ontario |
Canada,
Akl EA, Oxman AD, Herrin J, Vist GE, Terrenato I, Sperati F, Costiniuk C, Blank D, Schünemann H. Framing of health information messages. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD006777. doi: 10.1002/14651858.CD006777.pub2. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CNS-active medication prescribing | monthly number of CNS-active medications per resident (antipsychotics, opioids, benzodiazepines or antidepressants (including TCAs and trazodone)) | 6 months | |
| Secondary | Benzodiazepine (or z-drug) prescribing | days supplied (continuous) | 6 months | |
| Secondary | Benzodiazepine (or z-drug) rates | monthly proportion | 6 months | |
| Secondary | Antipsychotic rates | monthly proportion | 6 months | |
| Secondary | Antipsychotic prescribing | days supplied (continuous) | 6 months | |
| Secondary | Mean Antipsychotic dose | Dose equivalent of antipsychotic dispensed (continuous) | 6 months | |
| Secondary | Mean Benzodiazepine dose | Dose equivalent of benzodiazepine dispensed (continuous) | 6 months | |
| Secondary | 3+ CNS-active medications | monthly proportion supplied three or more meds from the following classes: antipsychotics, opioids, benzodiazepines, or antidepressants (including TCAs and trazodone). | 6 months | |
| Secondary | Anti-depressant prescribing | days supplied (continuous) - balance measure | 6 months | |
| Secondary | Anti-acid prescribing | days supplied (continuous) - tracer outcome | 6 months | |
| Secondary | Statin prescribing | days supplied (continuous) - tracer outcome | 6 months |