Respiratory Infections in Children
Conditions
Keywords
Community health workers, C-reactive protein
Brief summary
This is a stepped wedge, cluster randomized study of a clinical algorithm that includes point-of-care C-reactive protein testing to inform antibiotic treatment decisions by village health workers for children presenting with acute respiratory illness in the Bugoye sub-county of the Kasese District in southwestern Uganda. The purpose of this study is to assess the impact of the algorithm on antibiotic use.
Interventions
OTHERSTAR Sick Child Job Aid
The STAR Sick Child Job Aid is a modified ICCM protocol that includes the addition of a point-of-care C-reactive protein (CRP) test to inform antibiotic treatment decisions for children presenting with febrile acute respiratory illness who do not have any danger signs. If CRP ≥ 40 mg/L, the village health worker (VHW) will dispense amoxicillin per local guidelines. If CRP \< 40 mg/L, the VHW will advise symptomatic care alone including acetaminophen for fever and additional fluids to maintain hydration.
Sponsors
Thrasher Research Fund
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Stepped wedge, cluster randomized trial with 5 clusters or treatment sequences of 3 villages each. Villages are first stratified by altitude, proximity to the local health center, and size (based on approximate number of children seen by the village health workers per year) into one of three strata: (1) low altitude, proximal, large, (2) low altitude, mid-distance, medium, (3) high altitude, distal, small. One village is then randomly selected from each strata for each of the 5 clusters. All clusters start in the control condition and one cluster crosses over from control to intervention each month.
Eligibility
Sex/Gender
ALL
Age
2 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* Age 2 months-5 years * Evaluated by a study VHW in one of the participating villages in Bugoye sub-county for acute respiratory illness defined as the following: fever (documented (temperature \> 38°C) or subjective fever in the last seven days) AND fast breathing (respiratory rate \> 30) OR cough
Exclusion criteria
* Age \> 5 years or \< 2 months at time of presentation * Guardian not present to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibiotic prescriptions at baseline visit | Baseline visit | Proportion of children prescribed antibiotics by the village health worker at the baseline visit in the control as compared to the intervention condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unexpected visits | Between baseline visit and Day 7 follow-up assessment | Proportion of children brought to the village health worker during the seven-day follow-up period for persistent or worsening symptoms by their caregiver in the control as compared to the intervention condition. |
| Perceived improvement per caregiver | Day 7 | Proportion of caregivers who perceive that their child has clinically improved at the Day 7 follow-up assessment in the control as compared to the intervention condition. |
| Persistent fever | Day 7 | Proportion of children who have persistence of subjective or documented fever at the Day 7 follow-up assessment in the control as compared to the intervention condition. |
| Clinical Failure (Composite Outcome) | Between baseline visit and Day 7 follow-up assessment | Proportion of children with one or more of the following outcomes in the control as compared to the intervention condition: persistence of fever at Day 7, development of danger signs as defined by local Integrated Community Care Management guidelines at any time during the seven-day follow-up period, need for hospitalization at any time during follow-up period, or death at any time during follow-up period. |
| Hospitalization | Between Day 1 and Day 7 | Proportion of children who require inpatient admission to a health facility during the seven-day follow-up period in the control as compared to intervention periods. |
| Death | Between Day 1 and Day 7 | Proportion of children who die during the seven-day follow-up period in the control as compared to intervention periods. |
| Antibiotic prescriptions during study follow-up | Between baseline visit and Day 7 follow-up assessment | Proportion of children prescribed antibiotics by any provider either at the baseline visit or during the seven-day follow-up period in the control as compared to the intervention condition. |
| Development of danger signs | Between Day 1 and Day 7 | Proportion of children who develop danger signs (as defined by local Integrated Community Care Management guidelines) during the seven-day follow-up period in the control as compared to intervention conditions. |
Countries
Uganda
Outcome results
None listed