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

NCT04187742 | Completed DMC

• 1 other identifier: 441-2017 (Phase 2)
• Study Type: interventional
• Target: 421
• Locations: 1 country
• Sites: 1

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.

Conditions

Antibiotic Initiation; Antibiotic Duration

Outcome Measures

Primary Outcomes (1)

• Rate of report opening

  Percentage of physicians opening/accessing the report at least once in the 3 month interval following email send out

  3 months

Secondary Outcomes (7)

• ER visit or hospitalization for infection

  3 months

• ER visit or hospitalization for antibiotic harms

  3 months

• Net clinical impact

  3 months

• Anti-psychotic use

  3 months

• Benzodiazepine use

  3 months

Study Arms (6)

LTC Physicians Receive Social Comparison Email

ACTIVE COMPARATOR

All LTC physicians who receive a social comparison email

Behavioral: Social Comparison Email vs. Standard Email

LTC Physicians Do Not Receive Social Comparison Email

NO INTERVENTION

All LTC physicians who do not receive a social comparison email

LTC Physicians Receive Maintenance Certification Email

ACTIVE COMPARATOR

All LTC physicians who receive a maintenance certification email

Behavioral: Maintenance Certification Email vs. Standard Email

LTC Physicians Do Not Receive Maintenance Certification Email

NO INTERVENTION

All LTC physicians who do not receive a maintenance certification email

LTC Physician Has (or has not) Opened Prior Report

ACTIVE COMPARATOR

LTC physicians who opened (or has not opened) at least one report receive an email informing them of their report opening status

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

LTC Physician Has (or has not) Opened Prior Report (Control)

NO INTERVENTION

LTC physicians who opened (or has not opened) at least one report receive a standard email without report opening status

Interventions

Social Comparison Email vs. Standard Email 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 Receive Social Comparison Email

Maintenance Certification Email vs. Standard Email 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 Receive Maintenance Certification Email

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

ICES

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• 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.

  PMID: 35392461 DERIVED

Study Officials

• Nick Daneman, MD

  ICES

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Scientist

Model Details: Assess three interventional parallel study models consisting of two intervention arms each

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: May 15, 2017
• Primary Completion: September 30, 2021
• Study Completion: March 31, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)