Do Fair Comparisons or Harms Data Increase Responsiveness to Feedback About Antibiotic Prescribing: 2x2 Factorial Trial

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

5107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2023-01-01

Brief Summary

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

Antibiotic overuse is common and antibiotic prescribing contributes to rising rates of antimicrobial resistance. Primary care physicians prescribe the majority of all antibiotics and there is large inter-physician variability in prescribing that cannot be explained by differences in patient populations.

Peer comparison audit and feedback (A\&F) can act as an effective behavioural intervention to reduce unnecessary antibiotic use. The range of effects seen in prior A\&F trials could be attributed, at least in part, to differences in the way the feedback interventions were designed. In fall 2018, the investigators conducted an audit and feedback trial of mailed letters to 3500 family physicians in Ontario who prescribe the highest volume of antibiotics \[NCT03776383\]. While effective, family physicians questioned the credibility of the report in terms of its ability to fairly account for their practice size and population.

In Ontario, A\&F is routinely offered to primary care providers from a variety of sources. Ontario Health - an agency created by the Government of Ontario - provides A\&F via email to physicians who voluntarily sign up for their "MyPractice" reports. These are multi-topic reports with aggregated (physician-level) data. As of November 2021, the MyPractice reports for family physicians will include data on antibiotic prescribing. To date, less than half of Ontario family physicians have signed up for the MyPractice reports from Ontario Health.

For this study, the investigators will conduct a trial to investigate the effect of A\&F in family physicians not already receiving A\&F through a MyPractice: Primary Care report. Physicians who do not already receive antibiotic prescribing feedback through a MyPractice report will receive personalized antibiotic prescribing feedback through a letter mailed out from PHO. This large-scale evaluation provides an opportunity to evaluate not only whether A\&F using such data is helpful in the post-covid context, but how best to design the A\&F intervention and to explore why we observed (or not) changes in antibiotic prescribing.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reducing Inappropriate Antibiotic Prescribing by Primary Care Clinicians

NCT01099943

Increased Drug Resistance Infectious Diseases

COMPLETED NA

Improving Antibiotic Prescribing for Pediatric Respiratory Infections by Family Physicians With Peer Comparison

NCT04588376

Upper Respiratory Infection Acute Bacterial Sinusitis Acute Otitis Media

COMPLETED NA

Improving Safe Antibiotic Prescribing in Telehealth

NCT05138874

Acute Respiratory Infection Telehealth

COMPLETED NA

Antimicrobial Stewardship for Primary Care Pediatricians

NCT01806103

Acute Sinusitis Streptococcal Pharyngitis Pneumonia +1 more

COMPLETED NA

Implementation of Academic Detailing Interventions on Prescribing of Antimicrobial Drugs in Primary Health Care

NCT05090475

Upper Respiratory Tract Infections Acute Respiratory Tract Infection Viral Infection

COMPLETED NA

Detailed Description

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

This study will examine ways to optimize the effects of A\&F for antibiotic prescribing in primary care. This study will aim to answer the following questions:

1. Do patients of family physicians receiving A\&F about antibiotic prescribing receive fewer antibiotics compared to patients of family physicians that do not receive A\&F?
2. Does the effects of A\&F vary with the following design features? i) case-mix adjusted (or simple) peer comparators to represent a target for the prescribing quality indicators ii) emphasis (or not) on antibiotic-associated harms in addition to messages that focus on lack of benefit

This trial will include family physicians who did not opt-in to receive MyPractice: Primary Care report from Ontario Health. Physicians will be randomized to the control group or intervention group. Physicians in the intervention group will receive a personalized antibiotic prescribing feedback letter that will include personalized data regarding total antibiotic prescribing per 1000 patient visits and proportion of antibiotic prescriptions provided for a duration of \>7 days. The letter will also contain two experimental factors: 1: Simple vs complex peer comparators; and 2) Emphasis or not on antibiotic harms. For the complex (adjusted) comparator, recipients will be compared only to top-performing 'like-peers' - the group of physicians with similar complexity and numbers of patients. For the harms vs no harms factor, physicians will be either provided with information that focuses on lack of benefit for certain conditions (no harms), or with information that emphasizes the potential harms caused by unnecessary use of antibiotics. The feedback letters will be mailed to each physicians' primary practice address, along with a viral prescription pad developed by Choosing Wisely Canada.

One month after the initial intervention, intervention participants will be invited to complete a process evaluation survey to determine why or why not the intervention worked and how individual factors can affect physician motivation, willingness, and ability to engage in new practices. Intervention participants will also be invited to take part in a process evaluation interview.

Conditions

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

Infection

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2x2 Pragmatic Factorial Randomized Control Trial

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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

Intervention Group: Harms Emphasis - Simple Comparator

Physicians in this group will receive a personalized antibiotic prescribing feedback letter which contains a simple comparator to represent a target or benchmark for antibiotic prescribing. For the simple comparator, we will rank the antibiotic prescribing outcomes for all Ontario family physicians and use the lowest quartile as the benchmark. The letter will also include information on both lack of benefit and potential harms caused by unnecessary use of antibiotics. Physicians will also receive a paper-copy viral prescription pad and will receive the intervention letter again 1-month post initial dissemination.

Group Type EXPERIMENTAL

Audit and Feedback (A&F)

Intervention Type BEHAVIORAL

In this protocol, we propose comparing 2 intervention design elements in a multifactorial design. Specifically, we will evaluate:

i) an emphasis on antibiotic-associated harms in comparison to messages that focus on lack of benefit; ii) simple versus adjusted peer comparators to represent a target for the prescribing quality indicators

We will also investigate the effects of the inclusion of materials developed by Choosing Wisely Canada (CWC) - namely the viral prescription pad - to help physicians act upon the feedback to reduce their prescribing

Intervention Group: Harms Emphasis - Complex Comparator

Physicians in this group will receive a personalized antibiotic prescribing feedback letter which contains a complex (adjusted) comparator to represent a target or benchmark for antibiotic prescribing. For the complex comparator, recipients will be compared only to top-performing 'like-peers' - the group of physicians with similar complexity and numbers of patients. We will adjust the prescribing indicators for patient sex, number of patients \>85 years, rurality, continuity of care score, proportion of emergency room practice, proportion nursing home practice, neighborhood income quintile of patients, and rates of common patient comorbidities. The letter will also include information on both lack of benefit and potential harms caused by unnecessary use of antibiotics. Physicians will also receive a paper-copy viral prescription pad and will receive the intervention letter again 1-month later.

Group Type EXPERIMENTAL

Audit and Feedback (A&F)

Intervention Type BEHAVIORAL

In this protocol, we propose comparing 2 intervention design elements in a multifactorial design. Specifically, we will evaluate:

i) an emphasis on antibiotic-associated harms in comparison to messages that focus on lack of benefit; ii) simple versus adjusted peer comparators to represent a target for the prescribing quality indicators

We will also investigate the effects of the inclusion of materials developed by Choosing Wisely Canada (CWC) - namely the viral prescription pad - to help physicians act upon the feedback to reduce their prescribing

Intervention Group: No Harms Emphasis - Simple Comparator

Physicians in this group will receive a personalized antibiotic prescribing feedback letter which contains a simple comparator to represent a target or benchmark for antibiotic prescribing. For the simple comparator we will rank the antibiotic prescribing outcomes for all Ontario family physicians and use the lowest quartile as the benchmark. The letter will also include information on lack of benefit of unnecessary use of antibiotics. Physicians will also receive a paper-copy viral prescription pad and will receive the intervention letter again 1-month post initial dissemination.

Group Type EXPERIMENTAL

Audit and Feedback (A&F)

Intervention Type BEHAVIORAL

In this protocol, we propose comparing 2 intervention design elements in a multifactorial design. Specifically, we will evaluate:

i) an emphasis on antibiotic-associated harms in comparison to messages that focus on lack of benefit; ii) simple versus adjusted peer comparators to represent a target for the prescribing quality indicators

We will also investigate the effects of the inclusion of materials developed by Choosing Wisely Canada (CWC) - namely the viral prescription pad - to help physicians act upon the feedback to reduce their prescribing

Intervention Group: No Harms Emphasis - Complex Comparator

Physicians in this group will receive a personalized antibiotic prescribing feedback letter which contains a complex (adjusted) comparator to represent a target or benchmark for antibiotic prescribing. For the complex comparator, recipients will be compared only to top-performing 'like-peers' - the group of physicians with similar complexity and numbers of patients. We will adjust the prescribing indicators for patient sex, number of patients \>85 years, rurality, continuity of care score, proportion of emergency room practice, proportion nursing home practice, neighborhood income quintile of patients, and rates of common patient comorbidities. The letter will also include information on lack of benefit of unnecessary use of antibiotics. Physicians will also receive a paper-copy viral prescription pad and will receive the intervention letter again 1-month later.

Group Type EXPERIMENTAL

Audit and Feedback (A&F)

Intervention Type BEHAVIORAL

In this protocol, we propose comparing 2 intervention design elements in a multifactorial design. Specifically, we will evaluate:

i) an emphasis on antibiotic-associated harms in comparison to messages that focus on lack of benefit; ii) simple versus adjusted peer comparators to represent a target for the prescribing quality indicators

We will also investigate the effects of the inclusion of materials developed by Choosing Wisely Canada (CWC) - namely the viral prescription pad - to help physicians act upon the feedback to reduce their prescribing

Control Group

Participants in this group will not receive a personalized antibiotic prescribing feedback letter and they will not receive a viral prescription pad.

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.

Audit and Feedback (A&F)

In this protocol, we propose comparing 2 intervention design elements in a multifactorial design. Specifically, we will evaluate:

i) an emphasis on antibiotic-associated harms in comparison to messages that focus on lack of benefit; ii) simple versus adjusted peer comparators to represent a target for the prescribing quality indicators

We will also investigate the effects of the inclusion of materials developed by Choosing Wisely Canada (CWC) - namely the viral prescription pad - to help physicians act upon the feedback to reduce their prescribing

Intervention Type BEHAVIORAL

Eligibility Criteria

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

Inclusion Criteria

Family physicians with an active practice who prescribe antibiotics in Ontario to patients aged 65 or older.

Family physicians who did not sign up by September 2021 to receive the MyPractice report

Exclusion Criteria

\<100 unique patient visits in the most recent year or two of the three prior years for patients 65 years of age or older;

\<10 antibiotic prescriptions to patients 65+ in the most recent year or two of the three prior years; or

previously opted out of antibiotic prescribing letters from PHO (n= 15)

Eligible Sex

ALL

Accepts Healthy Volunteers

No