Diagnosis Mandate and Feedback for Antimicrobial Resistance

Recruiting at 2 trial locations

Overseen By Yubraj Acharya, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Disqualifiers: Pregnant, Cognitively impaired, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to prescribe antibiotics by training junior doctors to think carefully before prescribing, which helps combat antibiotic resistance (when germs stop responding to drugs). The trial includes a behavioral intervention with a refresher course on antibiotic resistance, requiring doctors to list a diagnosis when prescribing, and providing feedback on their prescribing habits. Patients visiting outpatient clinics in participating hospitals may join this study. As an unphased trial, it offers patients the chance to contribute to important research that could enhance antibiotic prescribing practices and fight resistance.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this behavioral intervention is safe?

Past research has shown promise in reducing antibiotic use through programs aimed at changing behavior. Specifically, 35.7% of these studies reported a significant decrease in antibiotic use following such programs. This suggests they can effectively change habits without causing harm. The current trial employs a behavioral approach, avoiding new drugs or medical procedures that might have risky side effects. Instead, it focuses on educating and providing feedback to doctors. This method is generally safe, as it doesn't pose direct physical risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Diagnosis Mandate and Feedback" intervention because it tackles antimicrobial resistance with a fresh approach. Unlike traditional methods that focus on developing new antibiotics, this intervention emphasizes changing clinician behavior through a combination of refresher training, mandatory diagnosis protocols, and personalized feedback. This approach aims to optimize antibiotic use and curb resistance by ensuring that healthcare providers are better informed and more accountable in their prescribing habits. By targeting the root of the problem—overprescription and misuse—the intervention has the potential to make a significant impact on controlling antimicrobial resistance.

What evidence suggests that this behavioral intervention is effective for reducing antibiotic overprescription?

Research has shown that certain methods can change how people use antibiotics. In this trial, participants will receive a behavioral intervention called "Diagnosis Mandate and Feedback," which includes Refresher Training on antimicrobial resistance, a Diagnosis Mandate, and Individualized Feedback. Studies have found that these methods lead to a better understanding and less misuse of antibiotics. For example, a review found that training and feedback greatly improve knowledge about correct antibiotic use. Other studies show that these approaches reduce antibiotic prescriptions by changing attitudes and behaviors. Overall, these strategies are promising for encouraging responsible antibiotic use and tackling antimicrobial resistance, which occurs when germs become resistant to drugs designed to kill them. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for physicians aged 18+ working in outpatient clinics at participating hospitals, and their patients aged 18+ who seek care there. It aims to optimize antibiotic prescriptions to combat antimicrobial resistance.

Inclusion Criteria

I am over 18 and have visited an outpatient clinic at a participating hospital.

I am over 18 and work at an outpatient clinic in a participating hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Intervention Data Collection

Data collected from patients before the intervention to establish baseline antibiotics prescription rates

1-3 months

Intervention

Implementation of the behavioral intervention including Refresher Training on AMR, Diagnosis Mandate, and Individualized Feedback

Varies by hospital

Post-Intervention Data Collection

Data collected from patients after the intervention to assess changes in antibiotics prescription rates

3-5 months

Follow-up

Participants are monitored for changes in prescription behavior and effectiveness of the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Intervention

Trial Overview The study tests a behavioral intervention where junior doctors must note the diagnosis when prescribing antibiotics and receive feedback on their prescription rates. The impact across gender and caste will be examined.

How Is the Trial Designed?

Group I: Diagnosis Mandate and Feedback Experimental Treatment 1 Intervention

The intervention will consist of three components: (a) a Refresher Training on antimicrobial resistance, (b) a Diagnosis Mandate, and (c) an Individualized Feedback.

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8248115/

Behavioural interventions to address rational use ... All studies included in the review reported positive effects of the interventions through either increased knowledge around antibiotic use or reductions in ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949916X24000343

Antimicrobial resistance: Impacts, challenges, and future ... The rise of MDR diminished the number of available effective antibiotics and resulted in the withdrawal of pharmaceutical companies from antibiotic research.

3. academic.oup.com academic.oup.com/jac/article/73/6/1464/4937884

Effectiveness of interventions to improve the public's ... Seventeen studies demonstrated a significant effect on changing knowledge, attitudes or the public's antimicrobial stewardship behaviours.

4. cdc.gov cdc.gov/antibiotic-use/hcp/data-research/stewardship-report.html

Antibiotic Use and Stewardship in the United States, 2024 ... CDC tracks antibiotic use and stewardship implementation data to evaluate progress and improve health care quality by identifying opportunities for improving ...

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-17766-w

Assessment of global antimicrobial resistance campaigns ... This review provides some evidence that campaigns can significantly improve outcome measures relating to AMR and antibiotic usage.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11953028/

Evaluation of antimicrobial resistance surveillance data ... Our review of 21 included studies emphasized the significance of utilizing AMR surveillance data to enhance clinical care.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10166487/

Behavior-change interventions to improve antimicrobial ... Amongst the 15 of 42 studies (35.7%) that found a statistically significant (p value <0.05) pre- to post-intervention decrease in AMU; the average decrease in ...