E-PAUse: Encouraging Proper Antibiotic Use in Outpatient Setting (E-PAUse)

Specific Aim 1: To determine the knowledge, attitude, and practice (KAP) of PHCC physicians regarding appropriate prescription of antibiotics in the outpatient setting.

Hypothesis 1a: PHCC physicians will have adequate theoretical knowledge regarding use of antibiotics for upper respiratory tract infections.

Hypothesis 1b: Despite adequate theoretical knowledge, fear of complications of untreated infection and patient demand and expectations will drive inappropriate antibiotic prescription for upper respiratory tract infections

Specific Aim 2: To test the effectiveness of a comprehensive multi-component intervention in a cluster randomized trial upon rate of antibiotics prescription for upper respiratory tract infections in individuals aged > 2 years presenting to primary care by PHCC physicians Hypothesis 2: Compared with a single intervention, a comprehensive multi-component intervention package will be associated with a significant reduction in inappropriate antibiotic prescription.

Investigators will conduct this study in the Primary Healthcare Center (PHCC) setting in Qatar. Investigators will identify four large PHCCs from the existing active centers. The study has 2 parts. Part 1 corresponds to specific aim 1 and comprises of a KAP survey which will be carried out in all four PHCCs and will include all physicians. Part 2 corresponds to specific aim 2 and is a cluster randomized clinical trial in which Investigators will randomize the four PHCCs into two groups.

First group (2 PHCCs) will receive training in appropriate documentation of infections and antibiotics prescription and will continue to provide usual care. Second group (2 PHCCs) will receive the comprehensive multi-component intervention, which consists of four elements:

1. Option for deferred prescription fulfilment;
2. Education of staff regarding appropriate uses of antibiotics,
3. algorithm-driven decision support tool,
4. Feedback on individual and group performance.

Study Overview

• Status: Recruiting
• Conditions: Drug Use
• Intervention / Treatment: Behavioral: comprehensive multi-component interventions

Detailed Description

As above.

• Study Type: Interventional
• Enrollment (Estimated): 600000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adeel A. Butt, MBBS, MS; Phone Number: +97433311228; Email: aabutt@hamad.qa

Study Locations

• Qatar
  • Doha, Qatar
    • Recruiting
    • PHCC
    • Contact: Adeel A. Butt, MBBS,MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients >2 years old presenting to any of the selected PHCCs (rationale: signs and symptoms of bacterial infection in very young children are more non-specific and empiric antibiotics are often indicated due to serious consequences of unrecognized and untreated bacterial infections)

• Presenting with acute (<1 week of symptoms) upper respiratory tract infection (URTI) like illness including

  • common cold/acute rhinitis/nasopharyngitis
  • laryngitis/laryngotracheitis
  • Acute bronchitis
  • acute otitis media
  • influenza (confirmed or influenza-like illness)
  • pharyngitis/tonsillitis
  • acute sinusitis

Exclusion Criteria:

• Known immune compromised status, e.g., cystic fibrosis, cancer, organ transplant recipient.
• On immune suppressive therapy for any duration (e.g., steroids, disease modifying antirheumatic agents; cancer chemotherapy, anti-rejection drugs, etc.) in one year prior to presentation
• Known or diagnosed bacterial cause of infection.
• Severe systemic illness requiring referral to the emergency department or hospitalization within 24 hours of presentation
• Known or suspected chronic obstructive pulmonary disease. Asplenic patients (anatomic or functional)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control groups with single intervention; The control groups will each receive a single intervention which will be selected at random.	Behavioral: comprehensive multi-component interventions; It is a combination of educational and behavioral interventions. 4 PHCCs will be randomized to 2 groups: 2 PHCCs will receive single intervention and 2 PHCCs will receive all 4 interventions.
Experimental: Experimental group with 4 interventions; 2 Primary Health Care Centers (PHCCs) will receive the comprehensive multi-component intervention, which consists of four elements: Option for deferred prescription fulfilment.; Education of staff regarding appropriate uses of antibiotics.; algorithm-driven decision support tool.; Feedback on individual and group performance. The training will be repeated at monthly intervals over the 6-month intervention period.	Behavioral: comprehensive multi-component interventions; It is a combination of educational and behavioral interventions. 4 PHCCs will be randomized to 2 groups: 2 PHCCs will receive single intervention and 2 PHCCs will receive all 4 interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of antibiotics courses prescribed for URTIs	For each recorded diagnosis of URTI, investigators will count the number of persons who received an antibiotic prescription. All prescriptions regardless of drug, dose, route of administration and duration will be counted. Only one prescription per 30-day period will be counted to exclude those with ongoing, evolving, or unresolved infection.	36 months
Proportion of antibiotics prescription dispensed for an inappropriate use	For each antibiotic prescription written for a URTI diagnosis, investigators will determine the appropriateness of antibiotics based on our previously published criteria.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of hospitalization in 28 days after the PHCC visit	Number of hospitalizations within 28 days of the index visit	36 months
Rates of ED visits in 28 days after the PHCC visit	Number of ED visits within 28 days of the index visit	36 months

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation
• Collaborators: Primary Health Care Corporation, Qatar
• Investigators: Principal Investigator: Adeel A. Butt, MBBS, MS, Hamad medical corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Prescription rate; Antibiotics
• Other Study ID Numbers: MRC-01-23-076

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No