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

NCT ID: NCT03807466

Last Updated: 2021-08-25

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Antibiotic Initiation Antibiotic Duration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Assess two 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 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).

Study Groups

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Dynamic/Interactive Report

LTC physician receives dynamic/interactive report only

Group Type ACTIVE_COMPARATOR

Dynamic/Interactive vs. Static/Paginated Report

Intervention Type 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

Static/Paginated Report

LTC physician receives static/paginated report only

Group Type NO_INTERVENTION

No interventions assigned to this group

LTC Physicians Enrolled in Reports

All LTC physicians who receive a dynamic or paginated report

\[note: this is not part of randomization assignment, but a quasi-experimental study\]

Group Type ACTIVE_COMPARATOR

LTC Physicians Enrolled vs. Not Enrolled in Reports

Intervention Type 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 Not Enrolled in Reports

All LTC physicians who do not receive a dynamic or paginated report

\[note: this is not part of randomization assignment, but a quasi-experimental study\]

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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

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Nick Daneman

Adjunct Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nick Daneman, MD

Role: PRINCIPAL_INVESTIGATOR

ICES

Locations

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ICES

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 33754632 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33547157 (View on PubMed)

Other Identifiers

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441-2017

Identifier Type: -

Identifier Source: org_study_id

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