Feedback to Improve Rational Strategies of Antibiotic Initiation and Duration in Long Term Care (FIRST AID -LTC) - Phase 2

NCT ID: NCT04187742

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

421 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antibiotic Initiation Antibiotic Duration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Assess three interventional parallel study models consisting of two intervention arms each
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The team at Health Quality Ontario will be aware of the physicians' assignment to the different email interventions so that they can send the correct audit-and-feedback report email announcements. However, the analytic team at ICES will be masked, and outcome data will be extracted by the analysis team from routinely collected administrative databases and report opening metrics that cannot be linked back to the original intervention assignments.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LTC Physicians Receive Social Comparison Email

All LTC physicians who receive a social comparison email

Group Type ACTIVE_COMPARATOR

Social Comparison Email vs. Standard Email

Intervention Type BEHAVIORAL

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

LTC Physicians Do Not Receive Social Comparison Email

All LTC physicians who do not receive a social comparison email

Group Type NO_INTERVENTION

No interventions assigned to this group

LTC Physicians Receive Maintenance Certification Email

All LTC physicians who receive a maintenance certification email

Group Type ACTIVE_COMPARATOR

Maintenance Certification Email vs. Standard Email

Intervention Type BEHAVIORAL

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

LTC Physicians Do Not Receive Maintenance Certification Email

All LTC physicians who do not receive a maintenance certification email

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type ACTIVE_COMPARATOR

Report Opening Status Email vs. Standard Email (among previous report openers and non-openers)

Intervention Type BEHAVIORAL

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Social Comparison Email vs. Standard 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

Intervention Type BEHAVIORAL

Maintenance Certification Email vs. Standard 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

Intervention Type BEHAVIORAL

Report Opening Status Email vs. Standard Email (among previous report openers and non-openers)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Ontario Agency for Health Protection and Promotion

OTHER_GOV

Sponsor Role collaborator

Health Quality Ontario

OTHER

Sponsor Role collaborator

Institute for Clinical Evaluative Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nick Daneman

Adjunct Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nick Daneman, MD

Role: PRINCIPAL_INVESTIGATOR

ICES

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ICES

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35392461 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

441-2017 (Phase 2)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.