Electronic decision support and diarrhoeal disease guideline adherence (mHDM): a cluster randomised controlled trial

Abstract

Background: Acute diarrhoeal disease management often requires rehydration alone without antibiotics. However, non-indicated antibiotics are frequently ordered and this is an important driver of antimicrobial resistance. The mHealth Diarrhoea Management (mHDM) trial aimed to establish whether electronic decision support improves rehydration and antibiotic guideline adherence in resource-limited settings.

Methods: A cluster randomised controlled trial was done at ten district hospitals in Bangladesh. Inclusion criteria were patients aged 2 months or older with uncomplicated acute diarrhoea. Admission orders were observed without intervention in the pre-intervention period, followed by randomisation to electronic (rehydration calculator) or paper formatted WHO guidelines for the intervention period. The primary outcome was rate of intravenous fluid ordered as a binary variable. Generalised linear mixed-effect models, accounting for hospital clustering, served as the analytical framework; the analysis was intention to treat. The trial is registered with ClinicalTrials.gov (NCT03154229) and is completed.

Findings: From March 11 to Sept 10, 2018, 4975 patients (75·6%) of 6577 screened patients were enrolled. The intervention effect for the primary outcome showed no significant differences in rates of intravenous fluids ordered as a function of decision-support type. Intravenous fluid orders decreased by 0·9 percentage points for paper electronic decision support and 4·2 percentage points for electronic decision support, with a 4·2-point difference between decision-support types in the intervention period (paper 98·7% [95% CI 91·8-99·8] vs electronic 94·5% [72·2-99·1]; p_interaction=0·31). Adverse events such as complications and mortality events were uncommon and could not be statistically estimated.

Interpretation: Although intravenous fluid orders did not change, electronic decision support was associated with increases in the volume of intravenous fluid ordered and decreases in antibiotics ordered, which are consistent with WHO guidelines.

Funding: US National Institutes of Health.

Figure 1:. Trial profile

*Younger than 18 years.

Figure 2:. Effect of the intervention on the secondary outcome of the volume of intravenous fluid ordered

Distribution of weight-adjusted intravenous fluid volume for all ages by dehydration status: no, some, severe (see appendix 1 p 27). *Significant analysis (p<0·05).

Figure 3:. Effect of the intervention on the secondary outcome of antibiotics ordered

(A) Non-indicated antibiotic orders defined as antibiotics ordered for patients with an objective classification of no dehydration and non-bloody watery stools. (B) Comparison of specific antibiotic orders and decision-support type. Error bars are 95% CIs. Difference in difference rates shown above the bars are percentage-point differences. *Significant difference (p<0·05).