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

NCT03807466 | Completed DMC

• 1 other identifier: 441-2017
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Antibiotic Initiation; Antibiotic Duration

Outcome Measures

Primary Outcomes (2)

• Antibiotic initiation

  Median % of patients initiated on an antibiotic

  3 months

• Antibiotic duration

  Median % of antibiotic treatments prolonged \>7 days

  3 months

Secondary Outcomes (5)

• 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 (4)

Dynamic/Interactive Report

ACTIVE COMPARATOR

LTC physician receives dynamic/interactive report only

Behavioral: Dynamic/Interactive vs. Static/Paginated Report

Static/Paginated Report

NO INTERVENTION

LTC physician receives static/paginated report only

LTC Physicians Enrolled in Reports

ACTIVE COMPARATOR

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

LTC Physicians Not Enrolled in Reports

NO INTERVENTION

All LTC physicians who do not receive a dynamic or paginated report \[note: this is not part of randomization assignment, but a quasi-experimental study\]

Interventions

Dynamic/Interactive vs. Static/Paginated Report BEHAVIORAL

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

Dynamic/Interactive Report

LTC Physicians Enrolled vs. Not Enrolled in Reports BEHAVIORAL

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

LTC Physicians Enrolled in Reports

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 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)

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 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.

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 (2)

• 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.

  PMID: 33754632 DERIVED

• 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.

  PMID: 33547157 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 dynamic versus paginated reports so that they can send the correct audit-and-feedback document. However, the analytic team at ICES will be masked, and outcome data will be extracted by the analysis team from routinely collected administrative databases (Ontario drug benefits database).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Scientist

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

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 17, 2019
• Study Start: May 15, 2017
• Primary Completion: April 30, 2020
• Study Completion: March 31, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)