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

Feedback to Improve Rational Strategies of Antibiotic Initiation and Duration in Long Term

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.

Study Overview

• Status: Completed
• Conditions: Antibiotic Initiation; Antibiotic Duration
• Intervention / Treatment: Behavioral: Dynamic/Interactive vs. Static/Paginated Report; Behavioral: LTC Physicians Enrolled vs. Not Enrolled in Reports

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: Interventional
• Enrollment (Actual): 356
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • ICES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Dynamic/Interactive Report; LTC physician receives dynamic/interactive report only	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
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]	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
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]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic initiation	Median % of patients initiated on an antibiotic	3 months
Antibiotic duration	Median % of antibiotic treatments prolonged >7 days	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ER visit or hospitalization for antibiotic harms	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
Anti-psychotic use	The percent reduction in anti-psychotic use	3 months
Benzodiazepine use	The percent reduction in benzodiazepines	3 months
ER visit or hospitalization for infection	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	3 months
Net Clinical impact	Measure the net clinical impact of the intervention, by comparing all-cause ER visits and hospitalizations and mortality	3 months

Collaborators and Investigators

• Sponsor: Institute for Clinical Evaluative Sciences
• Collaborators: Canadian Institutes of Health Research (CIHR); Ontario Agency for Health Protection and Promotion; Health Quality Ontario

Publications and helpful links

General Publications

• Daneman N, Lee SM, Bai H, Bell CM, Bronskill SE, Campitelli MA, Dobell G, Fu L, Garber G, Ivers N, Lam JMC, Langford BJ, Laur C, Morris A, Mulhall C, Pinto R, Saxena FE, Schwartz KL, Brown KA. Population-Wide Peer Comparison Audit and Feedback to Reduce Antibiotic Initiation and Duration in Long-Term Care Facilities with Embedded Randomized Controlled Trial. Clin Infect Dis. 2021 Sep 15;73(6):e1296-e1304. doi: 10.1093/cid/ciab256.
• Laur C, Sribaskaran T, Simeoni M, Desveaux L, Daneman N, Mulhall C, Lam J, Ivers NM. Improving antibiotic initiation and duration prescribing among nursing home physicians using an audit and feedback intervention: a theory-informed qualitative analysis. BMJ Open Qual. 2021 Feb;10(1):e001088. doi: 10.1136/bmjoq-2020-001088.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2017
• Primary Completion (ACTUAL): April 30, 2020
• Study Completion (ACTUAL): March 31, 2021

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (ACTUAL): January 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 441-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No