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Feedback to Improve Rational Strategies of Antibiotic Initiation and Duration in Long Term Care (FIRST AID-LTC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03807466
Recruitment Status : Active, not recruiting
First Posted : January 17, 2019
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Ontario Agency for Health Protection and Promotion
Health Quality Ontario
Information provided by (Responsible Party):
Nick Daneman, Institute for Clinical Evaluative Sciences

Tracking Information
First Submitted Date  ICMJE January 15, 2019
First Posted Date  ICMJE January 17, 2019
Last Update Posted Date February 27, 2019
Actual Study Start Date  ICMJE May 15, 2017
Actual Primary Completion Date January 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • Antibiotic initiation [ Time Frame: 3 months ]
    Median % of patients initiated on an antibiotic
  • Antibiotic duration [ Time Frame: 3 months ]
    Median % of antibiotic treatments prolonged >7 days
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03807466 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
  • ER visit or hospitalization for infection [ Time Frame: 3 months ]
    The percentage of a LTC physicians' patients that experienced an ER visit or hospitalization due to a potential antibiotic-related harm, including: allergy, general medication adverse event, diarrhea, C. difficile infection, or infection with an antibiotic-resistant organism
  • ER visit or hospitalization for antibiotic harms [ Time Frame: 3 months ]
    To test for harms related to decreased antibiotic use by comparing the percentage of LTC physicians' patients that experience an infection-related ER visit or admission
  • Net Clinical impact [ Time Frame: 3 months ]
    Measure the net clinical impact of the intervention, by comparing all-cause ER visits and hospitalizations and mortality
  • Anti-psychotic use [ Time Frame: 3 months ]
    The percent reduction in anti-psychotic use
  • Benzodiazepine use [ Time Frame: 3 months ]
    The percent reduction in benzodiazepines
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • ER visit or hospitalization for infection [ Time Frame: 3 months ]
    The percentage of a LTC physicians' patients that experienced an ER visit or hospitalization due to a potential antibiotic-related harm, including: allergy, general medication adverse event, diarrhea, C. difficile infection, or infection with an antibiotic-resistant organism
  • ER visit or hospitalization for antibiotic harms [ Time Frame: 3 months ]
    To test for harms related to decreased antibiotic use, we will compare the percentage of LTC physicians' patients that experience an infection-related ER visit or admission
  • Net Clinical impact [ Time Frame: 3 months ]
    Measure the net clinical impact of the intervention, by comparing all-cause ER visits and hospitalizations and mortality
  • Anti-psychotic use [ Time Frame: 3 months ]
    The percent reduction in anti-psychotic use
  • Benzodiazepine use [ Time Frame: 3 months ]
    The percent reduction in benzodiazepines
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feedback to Improve Rational Strategies of Antibiotic Initiation and Duration in Long Term Care
Official Title  ICMJE Feedback to Improve Rational Strategies of Antibiotic Initiation and Duration in Long Term
Brief Summary There is a high rate of inappropriate antibiotic use in long-term care (LTC) facilities, with both unnecessary initiation and prolongation of treatments. Although there are challenges to rational antibiotic use in LTC, the variability in antibiotic initiation and use of prolonged treatment durations is driven by prescriber tendencies rather than resident characteristics. Audit-and-feedback is a well-established intervention to improve professional practices, and is ideally suited for use to improve antibiotic prescribing tendencies in LTC. The literature is saturated with trials indicating benefit of audit-and-feedback, but is in dire need of studies to identify methods to improve the impact of this technique. Health Quality Ontario (HQO), a key partner in the FIRST AID-LTC research program, is already providing audit-and-feedback for other inappropriate prescribing practices in LTC, and has identified antibiotic prescribing as a priority focus.
Detailed Description

Overarching Goals

The overarching goals of FIRST AID - LTC are two-fold:

  1. Improve rational antibiotic prescribing by physicians to minimize harms among LTC residents.
  2. Advance the science of audit-and-feedback to improve physician prescribing practices.

Specific Aims

To improve rational antibiotic prescribing in LTC:

  1. by decreasing unnecessary initiation of antibiotic treatments among Ontario LTC residents, as well as the variability in initiation rates across LTC prescribers.
  2. by decreasing unnecessary prolonged duration of antibiotic treatments among Ontario LTC residents, as well as the variability in prolonged duration treatment use across LTC prescribers.

To advance audit-and-feedback implementation science:

1. by evaluating whether a dynamic audit-and-feedback report highlighting antibiotic prescribing can lead to greater reductions in antibiotic use, than a static paginated report

Anticipated Contributions to Health-Related Knowledge

Although the literature is inundated with trials examining the impact of audit-and-feedback compared to usual care, there is a need for studies to improve audit-and-feedback delivery. FIRST AID-LTC will test optimal delivery and peer comparison techniques for audit-and-feedback. The knowledge learned can be extrapolated to antibiotic interventions in LTC in other provinces across Canada, as well more broadly to inappropriate medication prescribing practices in LTC.

Anticipated Contributions to Health Care, Health Systems and Health Outcomes

FIRST AID-LTC will lead to immediate reductions in excess antibiotic use in Ontario LTC facilities, which in turn should result in substantial reductions in direct drug costs, as well as downstream complications of allergy, organ toxicity, C. difficile infections and antimicrobial resistance. With easy transferability to other Canadian provinces, the improvements in cost-savings and patient outcomes could be massive in scope.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Assess two interventional parallel study models consisting of two intervention arms each
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
The team at Health Quality Ontario will be aware of the physicians' assignment to dynamic versus paginated reports so that they can send the correct audit-and-feedback document. However, the analytic team at ICES will be masked, and outcome data will be extracted by the analysis team from routinely collected administrative databases (Ontario drug benefits database).
Primary Purpose: Treatment
Condition  ICMJE
  • Antibiotic Initiation
  • Antibiotic Duration
Intervention  ICMJE
  • Behavioral: Dynamic/Interactive vs. Static/Paginated Report
    Evaluate whether a stand-alone interactive audit-and-feedback report highlighting antibiotic prescribing can lead to greater reductions in antibiotic use, than a report embedded in a broader static feedback system
  • Behavioral: LTC Physicians Enrolled vs. Not Enrolled in Reports
    Evaluate whether being provided an audit-and-feedback report (regardless of dynamic or static) can lead to greater reductions in antibiotic use, than those who do not receive either report
Study Arms  ICMJE
  • Active Comparator: Dynamic/Interactive Report
    LTC physician receives dynamic/interactive report only
    Intervention: Behavioral: Dynamic/Interactive vs. Static/Paginated Report
  • No Intervention: Static/Paginated Report
    LTC physician receives static/paginated report only
  • Active Comparator: LTC Physicians Enrolled in Reports

    All LTC physicians who receive a dynamic or paginated report

    [note: this is not part of randomization assignment, but a quasi-experimental study]

    Intervention: Behavioral: LTC Physicians Enrolled vs. Not Enrolled in Reports
  • No Intervention: LTC Physicians Not Enrolled in Reports

    All LTC physicians who do not receive a dynamic or paginated report

    [note: this is not part of randomization assignment, but a quasi-experimental study]

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 15, 2019)
356
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Actual Primary Completion Date January 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

To Identify an LTC Resident

Inclusion Criteria:

An individual having a minimum of 2 records on separate days within the quarter meeting any combination of the following criteria:

  • a record for a non-emergency long-term care inpatient services OR
  • an Ontario Drug Benefits record administered in long-term care

Index date = The analysis will be anchored on the most recent of either of the records above within a given quarter or their date of death (whichever date is earliest)

Exclusion Criteria:

  • Non-Ontario resident at index date
  • Invalid age (age<19 or age>115) at index date
  • Missing or invalid sex or date of birth at index date
  • Death date is >7 days before index date
  • If the individual does not live in a nursing home or home for the aged
  • Cannot be linked to a Most Responsible Physician (MRP) (see methodology below)

To Identify the Most Responsible Physician (MRP) Using Virtual Rostering

For each patient in the above resident cohort, the study team will retrieve all records from health care providers in the 6 month period preceding the index date (180 days), keeping only records from physicians who have a specialty of 1) general practice, 2) community medicine or 3) geriatrics.

Steps for MRP assignment:

Step 1) The study team will first select physicians with the highest count of records for the monthly management of a nursing home or home for the aged. This is completed for as many residents as possible.

Step 2) If there were no monthly management fee records as described above then the physician with highest count of non-emergency long-term care inpatient services records for each patient will be selected. This step is only applied to residents who could not be matched to a physician by Step 1. **Physician must have seen the patient one or more times in 90 days prior to and including index date to be considered MRP. This criteria is applied to ensure the physician has seen the resident within the reporting quarter.

Step 3) Some patients will virtually roster to physicians in Enrollment groups, some will virtually roster to physicians that are not in a group. For these, the study team will recode enrollment program type to 'NOR' (not otherwise rostered) - these are likely fee for service physicians.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03807466
Other Study ID Numbers  ICMJE 441-2017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nick Daneman, Institute for Clinical Evaluative Sciences
Study Sponsor  ICMJE Institute for Clinical Evaluative Sciences
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Ontario Agency for Health Protection and Promotion
  • Health Quality Ontario
Investigators  ICMJE
Principal Investigator: Nick Daneman, MD ICES
PRS Account Institute for Clinical Evaluative Sciences
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP