Clinical trial NCT06135376: E-PAUse: Encouraging Proper Antibiotic Use in Outpatient Setting
Official title: E-PAUse: Encouraging Proper Antibiotic Use in Outpatient Setting
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Drug Use
Keywords: Prescription rate; Antibiotics;
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Primary Health Care Corporation, Qatar
First posted: 2023-11-18
Enrollment: 100000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.

Detailed description: As above.

Eligibility criteria: 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)

Primary outcomes:
measure: Total number of antibiotics courses prescribed for URTIs
timeFrame: Primary Analysis 11 months; Final analysis 24 months
measure: Proportion of antibiotics prescription dispensed for an inappropriate use
timeFrame: Total 11 months for primary analysis; Follow-up up to 36 months
Secondary outcomes:
measure: Rates of hospitalization in 28 days after the PHCC visit
timeFrame: Total 11 months for primary analysis; Follow-up up to 36 months
measure: Rates of ED visits in 28 days after the PHCC visit
timeFrame: Total 11 months for primary analysis;
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: PHCC
Study officials:
affiliation: Hamad Medical Corporation
name: Adeel A. Butt, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References: