- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02979964
Pragmatic Factorial Cluster Trial of Framing and Comparators for Audit and Feedback
3. oktober 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
285
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ontario
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Toronto, Ontario, Canada, M5S1B2
- Women's College Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Eksperimentel: 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.
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Eksperimentel: 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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Eksperimentel: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
CNS-active medication prescribing
Tidsramme: 6 months
|
monthly number of CNS-active medications per resident (antipsychotics, opioids, benzodiazepines or antidepressants (including TCAs and trazodone))
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Benzodiazepine (or z-drug) prescribing
Tidsramme: 6 months
|
days supplied (continuous)
|
6 months
|
|
Benzodiazepine (or z-drug) rates
Tidsramme: 6 months
|
monthly proportion
|
6 months
|
|
Antipsychotic rates
Tidsramme: 6 months
|
monthly proportion
|
6 months
|
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Antipsychotic prescribing
Tidsramme: 6 months
|
days supplied (continuous)
|
6 months
|
|
Mean Antipsychotic dose
Tidsramme: 6 months
|
Dose equivalent of antipsychotic dispensed (continuous)
|
6 months
|
|
Mean Benzodiazepine dose
Tidsramme: 6 months
|
Dose equivalent of benzodiazepine dispensed (continuous)
|
6 months
|
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3+ CNS-active medications
Tidsramme: 6 months
|
monthly proportion supplied three or more meds from the following classes: antipsychotics, opioids, benzodiazepines, or antidepressants (including TCAs and trazodone).
|
6 months
|
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Anti-depressant prescribing
Tidsramme: 6 months
|
days supplied (continuous) - balance measure
|
6 months
|
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Anti-acid prescribing
Tidsramme: 6 months
|
days supplied (continuous) - tracer outcome
|
6 months
|
|
Statin prescribing
Tidsramme: 6 months
|
days supplied (continuous) - tracer outcome
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Noah M Ivers, MD PhD CCFP, Women's College Hospital - University of Toronto
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
6. december 2016
Primær færdiggørelse (Faktiske)
6. oktober 2017
Studieafslutning (Faktiske)
1. juli 2018
Datoer for studieregistrering
Først indsendt
29. november 2016
Først indsendt, der opfyldte QC-kriterier
29. november 2016
Først opslået (Skøn)
2. december 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. oktober 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. oktober 2018
Sidst verificeret
1. oktober 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2016-0122-E
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Analyses of outcomes use routine administrative database holdings.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .