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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 35,108
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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.
Exclusion Criteria
- Not provided
Arms & Interventions
Control group
The control group will not have any intervention, as the control (usual care)
Intervention group
CRP&SAA POCT will be provided in 20 village clinics in the intervention group and additional physician training on the use of CRP&SAA POCT will be provided (including centralized and unified training, distribution of physician training manuals and desk reminders)
Intervention: CRP+SAA POCT (Device)
Outcomes
Primary Outcomes
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.
Time Frame: between the start of intervention and 6 months of follow-up
This outcome serves as the primary indicator, reflecting the overall impact of a comprehensive intervention based on CRP\&SAA POCT in guiding antibiotic use for patients with ARIs. Since most self-limiting ARIs are caused by viral infections that do not require antibiotic treatment, the decline in antibiotic prescribing rates suggests that village doctors are prescribing antibiotics more judiciously. The selection of this outcome is both feasible and reliable within the context of village clinics in China. This is due to the transition of prescriptions from traditional paper documents to electronic storage, which allows for the proper preservation of prescription records, thereby ensuring data integrity and traceability.
Secondary Outcomes
- The proportion of multiple antibiotic prescriptions in the intervention and control arms.(between the start of intervention and 6 months of follow-up)
- The intravenously injected antibiotic prescription rate(between the start of intervention and 6 months of follow-up)
- The proportion containing any Traditional Chinese Medicines.(between the start of intervention and 6 months of follow-up)
- The mean cost of an ARI prescription(between the start of intervention and 6 months of follow-up)
- The mean cost of a consultation(between the start of intervention and 6 months of follow-up)
Investigators
Xiaoxv Yin, PhD
Professor and Head of Social Medicne and Health Management Department
Huazhong University of Science and Technology