- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04187742
Feedback to Improve Rational Strategies of Antibiotic Initiation and Duration in Long Term Care (FIRST AID -LTC) - Phase 2 (FIRST AID-LTC)
Feedback to Improve Rational Strategies of Antibiotic Initiation and Duration in Long Term Care (Phase 2)
Study Overview
Status
Conditions
Detailed Description
The overarching goals of FIRST AID - LTC are two-fold:
- Improve rational antibiotic prescribing by physicians to minimize harms among LTC residents.
- Advance the science of audit-and-feedback to improve physician prescribing practices.
Specific Aims
To advance audit-and-feedback implementation science:
1. by determining whether social comparison incentives, personal maintenance of certification incentives, and informing physicians of their report opening status (i.e., never opened a report vs. opened at least one report), can lead to increased opening of the feedback report and greater reductions in antibiotic use than standard email messaging.
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M4N 3M5
- ICES
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 service 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 with 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 highest count of OHIP 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 the 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, we will recode enrollment program type to 'NOR' (not otherwise rostered) - these are likely fee for service physicians.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: LTC Physicians Receive Social Comparison Email
All LTC physicians who receive a social comparison email
|
Evaluate whether emails with social comparison incentives will encourage greater report opening by physicians leading to greater reductions in antibiotic use, than a standard email without social comparison incentives
|
No Intervention: LTC Physicians Do Not Receive Social Comparison Email
All LTC physicians who do not receive a social comparison email
|
|
Active Comparator: LTC Physicians Receive Maintenance Certification Email
All LTC physicians who receive a maintenance certification email
|
Evaluate whether emails with maintenance certification incentives will encourage greater report opening by physicians leading to greater reductions in antibiotic use, than a standard email without social comparison incentives
|
No Intervention: LTC Physicians Do Not Receive Maintenance Certification Email
All LTC physicians who do not receive a maintenance certification email
|
|
Active Comparator: LTC Physician Has (or has not) Opened Prior Report
LTC physicians who opened (or has not opened) at least one report receive an email informing them of their report opening status
|
Evaluate whether emails informing physicians of their report opening status (among those who have previously opened at least one report and those who have never opened a report) will encourage greater report opening by physicians leading to greater reductions in antibiotic use, than a standard email without report opening status information
|
No Intervention: LTC Physician Has (or has not) Opened Prior Report (Control)
LTC physicians who opened (or has not opened) at least one report receive a standard email without report opening status
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of report opening
Time Frame: 3 months
|
Percentage of physicians opening/accessing the report at least once in the 3 month interval following email send out
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 medicine adverse event, diarrhea, C. difficile infection, or infection with an antibiotic-resistant organism
|
3 months
|
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
|
3 months
|
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
|
3 months
|
Anti-psychotic use
Time Frame: 3 months
|
The percent reduction in anti-psychotic use
|
3 months
|
Benzodiazepine use
Time Frame: 3 months
|
The percent reduction in benzodiazepines
|
3 months
|
Antibiotic initiation
Time Frame: 3 months
|
Percentage of patients initiated on an antibiotic
|
3 months
|
Antibiotic duration
Time Frame: 3 months
|
Percentage of antibiotic treatments prolonged > 7 days
|
3 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 441-2017 (Phase 2)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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