E-PAUse: Encouraging Proper Antibiotic Use in Outpatient Setting

NCT06135376 | Active Not Recruiting DMC

• 1 other identifier: MRC-01-23-076
• Study Type: interventional
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Use

Keywords

Prescription rate; Antibiotics;

Outcome Measures

Primary Outcomes (2)

• 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.

  Primary Analysis 11 months; Final analysis 24 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.

  Total 11 months for primary analysis; Follow-up up to 36 months

Secondary Outcomes (2)

• Rates of hospitalization in 28 days after the PHCC visit

  Total 11 months for primary analysis; Follow-up up to 36 months

• Rates of ED visits in 28 days after the PHCC visit

  Total 11 months for primary analysis;

Study Arms (2)

Control groups with single intervention

ACTIVE COMPARATOR

The control groups will each receive a single intervention which will be selected at random.

Behavioral: comprehensive multi-component interventions

Experimental group with 4 interventions

EXPERIMENTAL

2 Primary Health Care Centers (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. The training will be repeated at monthly intervals over the 6-month intervention period.

Behavioral: comprehensive multi-component interventions

Interventions

comprehensive multi-component interventions BEHAVIORAL

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.

Control groups with single intervention; Experimental group with 4 interventions

Eligibility Criteria

• Age: 2 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hamad Medical Corporation: lead
• Primary Health Care Corporation, Qatar: collaborator

Study Sites (1)

PHCC

Doha, Qatar

Location

Related Publications (1)

• Butt AA, Shams S, Jabeen A, Al-Nuaimi AA, Krishnan JI, Malik AB, Saleem S, Abdulaziz MH, Seyam NI, Aziz K, Kandil D, Thomas AG, Nafady-Hego H, Lone MI, Al Ajmi J, Bhutta ZA, AlSulaiti N, Hussein WES, Semaan S, Al-Abdulla SA, Al-Kuwari MG, Abou-Samra AB. A prospective cluster randomized trial of an interventions bundle to reduce inappropriate antibiotic use for upper respiratory tract infections in the outpatient setting. BMC Infect Dis. 2025 Jul 1;25(1):818. doi: 10.1186/s12879-025-11210-z.

  PMID: 40597774 DERIVED

Study Officials

• Adeel A. Butt, MBBS, MS

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant in Infectious Disease

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 18, 2023
• Study Start: December 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: April 30, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-04

Locations

QA (1)