Clinical trial NCT06568432: Effect of CRP and SAA Point-of-care Testing on Antibiotic Prescribing for Acute Respiratory-tract Infections
Official title: Effect of C-reactive Protein and Serum Amyloid a Point-of-care Testing on Antibiotic Prescribing for Acute Respiratory-tract Infections At Village Clinics in China: a Study Protocol for a Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Antibiotic Prescribing for Acute Respiratory-tract Infections
Keywords: point-of-care testing
acute respiratory-tract infections
primary care facilities
Antibiotic prescription
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2024-08-23
Enrollment: 19424
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In parallel arm design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention. After randomization each subject stays in their assigned treatment arm for the duration of the study.

Subjects receive the same treatment throughout the trial. The results are then compared.
Primary purpose: TREATMENT

Brief summary: The study was a practical, cluster-randomized controlled trial to evaluate the impact of CRP and SAA point-of-care testing (CRP\&SAA POCT) on antibiotic prescribing in patients with acute respiratory-tract infections (ARI) at primary care facilities in rural China.

Detailed description: The study was a practical, cluster-randomized controlled trial to evaluate the impact of CRP and SAA point-of-care testing (CRP\&SAA POCT) on antibiotic prescribing in patients with acute respiratory-tract infections (ARI) at primary care facilities in rural China. The study includes two arms, in which CRP\&SAA POCT will be provided in 20 village clinics in the intervention arm. Additional physician training on the use of CRP\&SAA POCT (including centralized training, distribution of physician training manuals, and desk reminders) and patient education sheets (to help patients understand the help of CRP\&SAA POCT in guiding their care) will also be provided；The control arm will not receive any intervention and will serve as the control (usual care). The primary outcome is the proportion of patients who are diagnosed with ARIs and prescribed antibiotics during their initial visit (defined as no prescription record at the current institution within the preceding 14 days) in both study arms.

Eligibility criteria: Eligibility criteria for clusters Village clinics with an annual outpatient volume exceeding 2000, an average of 10 or more patients per week presenting with ARIs, and licensed prescribers are considered eligible for selection for the intervention. Annual outpatient prescriptions and average weekly visits for ARIs will be verified by obtaining prescription data from all village clinics for the previous year, as documented in the information section of the local health board.

Eligibility criteria for participants The target population of this study included (1) patients of all ages diagnosed by a village doctor with ARIs (including upper and lower respiratory infections); and (2) patients who present with ≥1 acute respiratory symptoms (including cough, rhinitis (sneezing, nasal congestion or runny nose), sore throat, shortness of breath, wheezing or abnormal auscultation). Patients with non-respiratory diseases or those with severe clinical symptoms requiring referral to a higher-level institution are excluded from the target population.

Primary outcomes:
measure: The primary outcome is the proportion of patients who are diagnosed with ARIs and prescribed antibiotics during their initial visit (defined as no prescription record at the current institution within the preceding 14 days) in both study arms.
timeFrame: between the start of intervention and 6 months of follow-up
Secondary outcomes:
measure: The proportion of multiple antibiotic prescriptions in the intervention and control arms.
timeFrame: between the start of intervention and 6 months of follow-up
measure: The intravenously injected antibiotic prescription rate
timeFrame: between the start of intervention and 6 months of follow-up
measure: The proportion containing any Traditional Chinese Medicines.
timeFrame: between the start of intervention and 6 months of follow-up
measure: The mean cost of an ARI prescription
timeFrame: between the start of intervention and 6 months of follow-up
measure: The mean cost of a consultation
timeFrame: between the start of intervention and 6 months of follow-up
Other outcomes:
Locations:
city: Xiantao
country: China
facility: 40 Village Clinics
state: Hubei
Study officials:
References: