Clinical trial NCT04187742: Feedback to Improve Rational Strategies of Antibiotic Initiation and Duration in Long Term Care (FIRST AID -LTC) - Phase 2
Official title: Feedback to Improve Rational Strategies of Antibiotic Initiation and Duration in Long Term Care (Phase 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antibiotic Initiation
Antibiotic Duration
Lead sponsor: Institute for Clinical Evaluative Sciences
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Ontario Agency for Health Protection and Promotion
name: Health Quality Ontario
First posted: 2019-12-05
Enrollment: 421
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assess three interventional parallel study models consisting of two intervention arms each
Primary purpose: TREATMENT

Brief summary: There is a high rate of inappropriate antibiotic use in 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: 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of report opening
timeFrame: 3 months
Secondary outcomes:
measure: ER visit or hospitalization for infection
timeFrame: 3 months
measure: ER visit or hospitalization for antibiotic harms
timeFrame: 3 months
measure: Net clinical impact
timeFrame: 3 months
measure: Anti-psychotic use
timeFrame: 3 months
measure: Benzodiazepine use
timeFrame: 3 months
measure: Antibiotic initiation
timeFrame: 3 months
measure: Antibiotic duration
timeFrame: 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: ICES
state: Ontario
Study officials:
affiliation: ICES
name: Nick Daneman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daneman N, Lee S, Bai H, Bell CM, Bronskill SE, Campitelli MA, Dobell G, Fu L, Garber G, Ivers N, Kumar M, Lam JMC, Langford B, Laur C, Morris AM, Mulhall CL, Pinto R, Saxena FE, Schwartz KL, Brown KA. Behavioral Nudges to Improve Audit and Feedback Report Opening Among Antibiotic Prescribers: A Randomized Controlled Trial. Open Forum Infect Dis. 2022 Mar 2;9(5):ofac111. doi: 10.1093/ofid/ofac111. eCollection 2022 May.