<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02979964</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0122-E</org_study_id>
    <nct_id>NCT02979964</nct_id>
  </id_info>
  <brief_title>Pragmatic Factorial Cluster Trial of Framing and Comparators for Audit and Feedback</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Women's College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Health Quality Ontario</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Women's College Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Health Quality Ontario (HQO) is the provincial advisor on quality in health care. HQO&#xD;
      currently conducts audit and feedback as a key quality improvement strategy. For example, it&#xD;
      offers physicians working in long-term care homes with access to practice reports detailing&#xD;
      rates of high-risk prescribing in comparison with others in Ontario and suggested change&#xD;
      ideas. Research shows that providing this kind of feedback can lead to improvements in care.&#xD;
      However, the size of these improvements depends how the feedback is presented. For instance,&#xD;
      prior research suggests that how the results are 'framed' and what sort of benchmark the&#xD;
      recipient is compared to may each affect how the physician will respond. This factorial trial&#xD;
      tests each of these aspects of feedback design in the context of practice reports that&#xD;
      nursing home physicians have already signed up to receive quarterly.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2016</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">October 6, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CNS-active medication prescribing</measure>
    <time_frame>6 months</time_frame>
    <description>monthly number of CNS-active medications per resident (antipsychotics, opioids, benzodiazepines or antidepressants (including TCAs and trazodone))</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Benzodiazepine (or z-drug) prescribing</measure>
    <time_frame>6 months</time_frame>
    <description>days supplied (continuous)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Benzodiazepine (or z-drug) rates</measure>
    <time_frame>6 months</time_frame>
    <description>monthly proportion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antipsychotic rates</measure>
    <time_frame>6 months</time_frame>
    <description>monthly proportion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antipsychotic prescribing</measure>
    <time_frame>6 months</time_frame>
    <description>days supplied (continuous)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Antipsychotic dose</measure>
    <time_frame>6 months</time_frame>
    <description>Dose equivalent of antipsychotic dispensed (continuous)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Benzodiazepine dose</measure>
    <time_frame>6 months</time_frame>
    <description>Dose equivalent of benzodiazepine dispensed (continuous)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3+ CNS-active medications</measure>
    <time_frame>6 months</time_frame>
    <description>monthly proportion supplied three or more meds from the following classes: antipsychotics, opioids, benzodiazepines, or antidepressants (including TCAs and trazodone).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-depressant prescribing</measure>
    <time_frame>6 months</time_frame>
    <description>days supplied (continuous) - balance measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-acid prescribing</measure>
    <time_frame>6 months</time_frame>
    <description>days supplied (continuous) - tracer outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Statin prescribing</measure>
    <time_frame>6 months</time_frame>
    <description>days supplied (continuous) - tracer outcome</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">285</enrollment>
  <condition>High-risk Prescribing in Nursing Homes</condition>
  <arm_group>
    <arm_group_label>Arm 1, Positive Framing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2, Negative Framing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3, Top Quartile Comparator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 4, Average Comparator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Audit and Feedback</intervention_name>
    <arm_group_label>Arm 1, Positive Framing</arm_group_label>
    <arm_group_label>Arm 2, Negative Framing</arm_group_label>
    <arm_group_label>Arm 3, Top Quartile Comparator</arm_group_label>
    <arm_group_label>Arm 4, Average Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a physician licensed by the College of Physicians and Surgeons of Ontario (CPSO);&#xD;
&#xD;
          -  practice in at least one LTC facility in Ontario;.&#xD;
&#xD;
          -  have voluntarily signed up to receive an HQO practice report&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  n/a&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noah M Ivers, MD PhD CCFP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Women's College Hospital - University of Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Women's College Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S1B2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.hqontario.ca/Quality-Improvement/Practice-Reports/Long-Term-Care</url>
    <description>Health Quality Ontario Long-Term Care Practice Report</description>
  </link>
  <reference>
    <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.</citation>
    <PMID>24438584</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22696318</PMID>
  </reference>
  <reference>
    <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. doi: 10.1001/jama.285.22.2871.</citation>
    <PMID>11401608</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22161408</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21091758</PMID>
  </reference>
  <reference>
    <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. doi: 10.1016/s1070-3241(01)27051-5.</citation>
    <PMID>11708039</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25070404</PMID>
  </reference>
  <reference>
    <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. doi: 10.1046/j.1365-2753.1999.00203.x.</citation>
    <PMID>10461579</PMID>
  </reference>
  <reference>
    <citation>Li AC, Kannry JL, Kushniruk A, Chrimes D, McGinn TG, Edonyabo D, Mann DM. Integrating usability testing and think-aloud protocol analysis with &quot;near-live&quot; 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.</citation>
    <PMID>22456088</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22530986</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>October 3, 2018</last_update_submitted>
  <last_update_submitted_qc>October 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Women's College Hospital</investigator_affiliation>
    <investigator_full_name>Noah Ivers</investigator_full_name>
    <investigator_title>M.D., PhD, CCFP</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Analyses of outcomes use routine administrative database holdings.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02979964
org study id: 2016-0122-E
nct id: NCT02979964
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: CNS-active medication prescribing
time frame: 6 months
description: monthly number of CNS-active medications per resident (antipsychotics, opioids, benzodiazepines or antidepressants (including TCAs and trazodone))
measure: Benzodiazepine (or z-drug) prescribing
time frame: 6 months
description: days supplied (continuous)
measure: Benzodiazepine (or z-drug) rates
time frame: 6 months
description: monthly proportion
measure: Antipsychotic rates
time frame: 6 months
description: monthly proportion
measure: Antipsychotic prescribing
time frame: 6 months
description: days supplied (continuous)
measure: Mean Antipsychotic dose
time frame: 6 months
description: Dose equivalent of antipsychotic dispensed (continuous)
measure: Mean Benzodiazepine dose
time frame: 6 months
description: Dose equivalent of benzodiazepine dispensed (continuous)
measure: 3+ CNS-active medications
time frame: 6 months
description: monthly proportion supplied three or more meds from the following classes: antipsychotics, opioids, benzodiazepines, or antidepressants (including TCAs and trazodone).
measure: Anti-depressant prescribing
time frame: 6 months
description: days supplied (continuous) - balance measure
measure: Anti-acid prescribing
time frame: 6 months
description: days supplied (continuous) - tracer outcome
measure: Statin prescribing
time frame: 6 months
description: days supplied (continuous) - tracer outcome
arm group label: Arm 1, Positive Framing
arm group type: Experimental
description: 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.
arm group label: Arm 2, Negative Framing
arm group type: Experimental
description: 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.
arm group label: Arm 3, Top Quartile Comparator
arm group type: Experimental
description: 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.
arm group label: Arm 4, Average Comparator
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: Audit and Feedback
arm group label: Arm 1, Positive Framing
arm group label: Arm 2, Negative Framing
arm group label: Arm 3, Top Quartile Comparator
arm group label: Arm 4, Average Comparator
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Noah M Ivers, MD PhD CCFP
role: Principal Investigator
affiliation: Women's College Hospital - University of Toronto
facility: 
country: Canada
url: http://www.hqontario.ca/Quality-Improvement/Practice-Reports/Long-Term-Care
description: Health Quality Ontario Long-Term Care Practice Report
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.
PMID: 24438584
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.
PMID: 22696318
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. doi: 10.1001/jama.285.22.2871.
PMID: 11401608
citation: 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.
PMID: 22161408
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.
PMID: 21091758
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. doi: 10.1016/s1070-3241(01)27051-5.
PMID: 11708039
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.
PMID: 25070404
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. doi: 10.1046/j.1365-2753.1999.00203.x.
PMID: 10461579
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.
PMID: 22456088
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.
PMID: 22530986
responsible party type: Principal Investigator
investigator affiliation: Women's College Hospital
investigator full name: Noah Ivers
investigator title: M.D., PhD, CCFP
sharing ipd: No
ipd description: Analyses of outcomes use routine administrative database holdings.