Ashraful I Khan1, Jasmine A Mack2, M Salimuzzaman3, Mazharul I Zion1, Hasnat Sujon3, Robyn L Ball4, Stace Maples5, Md Mahbubur Rashid1, Mohammod J Chisti6, Shafiqul A Sarker6, Debashish Biswas1, Raduan Hossin1, Kevin L Bardosh7, Yasmin A Begum1, Azimuddin Ahmed1, Dane Pieri8, Farhana Haque9, Mahmudur Rahman10, Adam C Levine11, Firdausi Qadri1, Meerjady S Flora3, Matthew J Gurka2, Eric J Nelson12. 1. Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh. 2. Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, FL, USA. 3. Institute of Epidemiology, Disease Control and Research, Ministry of Health and Family Welfare, Government of Bangladesh, Dhaka, Bangladesh. 4. Quantitative Sciences Unit, Department of Medicine, Stanford University, Stanford, CA, USA. 5. Geospatial Center, Stanford University Libraries, Stanford, CA, USA. 6. Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh. 7. Department of Anthropology, University of Florida, Gainesville, FL, USA; Department of Environmental and Occupational Health Sciences, School of Public Health, University of Washington, Seattle, WA, USA. 8. Independent Technology Developer, San Francisco, CA, USA. 9. Institute of Epidemiology, Disease Control and Research, Ministry of Health and Family Welfare, Government of Bangladesh, Dhaka, Bangladesh; Institute for Global Health, University College London, London, UK. 10. Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh; Institute of Epidemiology, Disease Control and Research, Ministry of Health and Family Welfare, Government of Bangladesh, Dhaka, Bangladesh. 11. Department of Emergency Medicine, Brown University, Providence, RI, USA. 12. Department of Pediatrics, University of Florida, Gainesville, FL, USA; Department of Environmental and Global Health, University of Florida, Gainesville, FL, USA; Emerging Pathogens Institute, University of Florida, Gainesville, FL, USA; Department of Pediatrics, Stanford University School of Medicine, Stanford University, Stanford, CA, USA. Electronic address: USAeric.nelson@ufl.edu.
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]; pinteraction=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.
RCT Entities:
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]; pinteraction=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.
Authors: Debasish Saha; Mohammad M Karim; Wasif A Khan; Sabeena Ahmed; Mohammed A Salam; Michael L Bennish Journal: N Engl J Med Date: 2006-06-08 Impact factor: 91.245
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