E-PAUse: Encouraging Proper Antibiotic Use in Outpatient Setting

Hamad Medical Corporation (HMC)

Status: Active, not recruiting

Conditions: Drug Use

Treatments: Behavioral: comprehensive multi-component interventions

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06135376

MRC-01-23-076

Details and patient eligibility

About

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.

Full description

As above.

Enrollment: 100,000 estimated patients

Sex: All

Ages: 2 to 120 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100,000 participants in 2 patient groups

Control groups with single intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: comprehensive multi-component interventions

Experimental group with 4 interventions

Experimental group

Description:

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.

Treatment:

Behavioral: comprehensive multi-component interventions