High-risk Prescribing in Nursing HomesNCT02979964
Pragmatic Factorial Cluster Trial of Framing and Comparators for Audit and Feedback
A study testing Audit and Feedback in people with High-risk Prescribing in Nursing Homes, run by Women's College Hospital at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- High-risk Prescribing in Nursing Homes
- What is being tested?
- Audit and Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteCanada
- Study dates
- 6 Dec 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- High-risk Prescribing in Nursing Homes
- Being tested
- Audit and Feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audit and FeedbackBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1, Positive Framing | Experimental | 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. Receives: Behavioral: Audit and Feedback |
| Arm 2, Negative Framing | Experimental | 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. Receives: Behavioral: Audit and Feedback |
| Arm 3, Top Quartile Comparator | Experimental | 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. Receives: Behavioral: Audit and Feedback |
| Arm 4, Average Comparator | Experimental | 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. Receives: Behavioral: Audit and Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNS-active medication prescribing
monthly number of CNS-active medications per resident (antipsychotics, opioids, benzodiazepines or antidepressants (including TCAs and trazodone))
Measured: 6 months
Secondary outcomes (10)
Benzodiazepine (or z-drug) prescribing
days supplied (continuous)
Measured: 6 months
Benzodiazepine (or z-drug) rates
monthly proportion
Measured: 6 months
Antipsychotic rates
monthly proportion
Measured: 6 months
Antipsychotic prescribing
days supplied (continuous)
Measured: 6 months
Mean Antipsychotic dose
Dose equivalent of antipsychotic dispensed (continuous)
Measured: 6 months
Mean Benzodiazepine dose
Dose equivalent of benzodiazepine dispensed (continuous)
Measured: 6 months
3+ CNS-active medications
monthly proportion supplied three or more meds from the following classes: antipsychotics, opioids, benzodiazepines, or antidepressants (including TCAs and trazodone).
Measured: 6 months
Anti-depressant prescribing
days supplied (continuous) - balance measure
Measured: 6 months
Anti-acid prescribing
days supplied (continuous) - tracer outcome
Measured: 6 months
Statin prescribing
days supplied (continuous) - tracer outcome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start6 Dec 2016
- Primary completion6 Oct 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for High-risk Prescribing in Nursing HomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Health Quality Ontario
- Responsible party
- Principal investigator, Noah Ivers, Women's College Hospital
- Investigators
- Noah M Ivers, MD PhD CCFP, Principal investigator, Women's College Hospital - University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979964
- Sponsor's protocol ID
- 2016-0122-E
- Status last verified
- Oct 2018
- First submitted
- 29 Nov 2016
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Analyses of outcomes use routine administrative database holdings.
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 24438584Ivers 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 22696318Kiefe 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 11401608Akl 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 22161408Kluger 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 21091758Hibbard 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 11708039Gould 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 25070404Weissman 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 10461579Li 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 22456088Cane 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 22530986McCleary 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 37165413Ivers 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02979964
- Acronym / sponsor ID
- 2016-0122-E
- Conditions
- High-risk Prescribing in Nursing Homes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Health Quality Ontario
- Study start
- 6 Dec 2016 (actual)
- Primary completion
- 6 Oct 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1, Positive Framing | Experimental | Behavioral: Audit and FeedbackAll 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. |
| Arm 2, Negative Framing | Experimental | Behavioral: Audit and FeedbackAll 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. |
| Arm 3, Top Quartile Comparator | Experimental | Behavioral: Audit and FeedbackAll 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. |
| Arm 4, Average Comparator | Experimental | Behavioral: Audit and FeedbackAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audit and Feedback | Behavioural | Arm 1, Positive Framing, Arm 2, Negative Framing, Arm 3, Top Quartile Comparator, Arm 4, Average Comparator |
Primary outcome
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))
10 secondary outcomes
Benzodiazepine (or z-drug) prescribing
Time frame: 6 months
Benzodiazepine (or z-drug) rates
Time frame: 6 months
Antipsychotic rates
Time frame: 6 months
Antipsychotic prescribing
Time frame: 6 months
Mean Antipsychotic dose
Time frame: 6 months
Mean Benzodiazepine dose
Time frame: 6 months
3+ CNS-active medications
Time frame: 6 months
Anti-depressant prescribing
Time frame: 6 months
Anti-acid prescribing
Time frame: 6 months
Statin prescribing
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Background: PubMed 24438584Ivers 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.
- Background: PubMed 22696318Ivers 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.
- Background: PubMed 11401608Kiefe 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.
- Background: PubMed 22161408Akl 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.
- Background: PubMed 21091758Kluger 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.
- Background: PubMed 11708039Hibbard 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.
- Background: PubMed 25070404Gould 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.
- Background: PubMed 10461579Weissman 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.
- Background: PubMed 22456088Li 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.
- Background: PubMed 22530986Cane 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.
- Derived from this study: PubMed 37165413McCleary 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.
- Derived from this study: PubMed 28705208Ivers 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.
- Health Quality Ontario Long-Term Care Practice ReportLink provided by the sponsor.
- Individual participant dataSharing planned: No. Analyses of outcomes use routine administrative database holdings.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah M Ivers, MD PhD CCFP principal investigator
Women's College Hospital - University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audit and Feedback in people with High-risk Prescribing in Nursing Homes, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CNS-active medication prescribing (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02979964, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.