A digital health algorithm to guide antibiotic prescription in pediatric outpatient care: a cluster randomized controlled trial

Abstract

Excessive antibiotic use and antimicrobial resistance are major global public health threats. We developed ePOCT+, a digital clinical decision support algorithm in combination with C-reactive protein test, hemoglobin test, pulse oximeter and mentorship, to guide health-care providers in managing acutely sick children under 15 years old. To evaluate the impact of ePOCT+ compared to usual care, we conducted a cluster randomized controlled trial in Tanzanian primary care facilities. Over 11 months, 23,593 consultations were included from 20 ePOCT+ health facilities and 20,713 from 20 usual care facilities. The use of ePOCT+ in intervention facilities resulted in a reduction in the coprimary outcome of antibiotic prescription compared to usual care (23.2% versus 70.1%, adjusted difference −46.4%, 95% confidence interval (CI) −57.6 to −35.2). The coprimary outcome of day 7 clinical failure was noninferior in ePOCT+ facilities compared to usual care facilities (adjusted relative risk 0.97, 95% CI 0.85 to 1.10). There was no difference in the secondary safety outcomes of death and nonreferred secondary hospitalizations by day 7. Using ePOCT+ could help address the urgent problem of antimicrobial resistance by safely reducing antibiotic prescribing. Clinicaltrials.gov Identifier: NCT05144763

Quality of care when using a digital clinical decision support algorithm to manage sick children at primary care health facilities in Tanzania: a cross-sectional cluster randomized controlled trial (DYNAMIC study)

“…The study also revealed a two-fold reduction in antibiotic prescriptions (adjusted relative risk 0.5, 95% CI 0.4 to 0.7), and 50% improvement in the appropriate use of antibiotics in health facilities using ePOCT+ (adjusted relative risk 1.5 (95% CI 1.2 to 1.8), critical findings given the global concern for bacterial antimicrobial resistance [47]. Similar reductions were found in the parent trial using the intention-to-treat results over the full 11 month trial period (adjusted relative risk 0.6 (95% CI 0.5 to 0.6),[24] and in the same 5-week period as the present trial (adjusted relative risk 0.4, 95% CI 0.2 to 0.7). However, the documented antibiotic prescription as observed by external clinical researchers was slightly higher than what was documented by the health providers in ePOCT+ (intervention health facilities) and the eCRF (control health facilities), suggesting that some health providers may under report antibiotic prescription in ePOCT+ and the eCRF.…”

“…Initially, antibiotic prescription was considered a co-primary outcome alongside the current primary outcome (proportion of 14 major IMCI symptoms and signs), but was later reclassified as a secondary outcome. We made this change to focus the analysis on quality of care, given that antibiotic prescription was already the primary outcome of the large longitudinal cluster randomized trial [24].…”

“…An external clinical researcher observed a sample of consultations from health facilities from both study arms documenting adherence of health care providers to quality-of-care indicators. The study was a planned ancillary study within a larger cluster randomized trial that was conducted between 1 December 2021 and 31 October 2022 using a sample of the clusters [24]. A cluster design was chosen since the intervention was targeted at the health facility and healthcare provider.…”