Evaluation of a mHealth Platform for Diarrheal Disease Decision-support

University of Florida

Status: Completed

Conditions: Diarrhea

Treatments: Other: Pre-Assessment of practices; Other: Paper-based decision-support; Other: Smartphone-based decision-support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03154229

TW010182 [Pending] (Other Grant/Funding Number)

1DP5OD019893 (U.S. NIH Grant/Contract)

IRB201601762 - N

Details and patient eligibility

About

The study hypothesis is that clinical decision-support on a smartphone for the management of diarrheal disease will improve the assessment of dehydration, reduce IV fluid usage, and increase guideline adherence for the use of zinc and antibiotics. To test this hypothesis we will conduct a cluster randomized controlled trial in the diarrhea wards of 10 hospitals in Bangladesh. A 6-week pre-intervention period will establish a baseline at all sites, and in the intervention, hospitals will be randomized to use a paper versus smartphone adaptation of the WHO guidelines by the admitting physician. Inclusion criteria are patients 2 months and older that have uncomplicated acute diarrheal disease; estimated enrollment is 7893 patients. The primary outcome measure is use of IV fluids. This project may have broad impact that will include opportunities to provide improved decision-support for the assessment of dehydration, decreased use intravenous fluids and more prudent use of antibiotics.

Full description

Technology is making possible new approaches to overcome old public health challenges. Cellular networks are now ubiquitous in resource-poor settings and offer new opportunities for high-yield interventions for both chronic and acute diseases. We are specifically interested in developing mHealth solutions for diarrheal disease for two reasons. The first reason is that diarrheal disease globally remains the second leading cause of death for children less than 5 years of age. Barriers to combat this problem include poor adherence to guidelines for rehydrating children and outbreaks often outpace current epidemiological tools. The second reason is that diarrheal diseases in a setting like Bangladesh, including cholera outbreaks, are a model system to develop and test mHealth solutions that can be adapted to more complex chronic and acute diseases in Bangladesh and globally.

In partnership with the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b; primary collaborator) and the Institute of Epidemiology, Disease Control, Research (IEDCR) within the Ministry of Health and Family Welfare in Bangladesh, we propose to compare a paper-based versus a smartphone-based decision-support tool in a cluster randomized controlled trial (cRCT) to determine the impact of the method of decision-support on the use of IV fluids (primary outcome) and indicated medications (secondary outcomes). The smartphone tool is an adaptation of the paper-based World Health Organization guidelines, and is called the 'Rehydration Calculator.' The cRCT will be conducted collaboratively between the icddr,b and government hospitals (N=10) in Bangladesh over 4.5 months per site. A 6-week pre-intervention period will establish a baseline at all sites, and in the intervention, hospitals will be randomized to use the paper versus smartphone tool by the admitting physician. Inclusion criteria are patients 2 months and older that have uncomplicated acute diarrheal disease; estimated enrollment is 7893 patients. Standard of care will be practiced at all sites, with the exception of the decision-support tool(s) in the interventional period. The primary outcome measure is use of IV fluids. This project may have broad impact that will include opportunities to provide improved decision-support for the assessment of dehydration, decrease intravenous fluid use and improve antibiotic stewardship.

Enrollment: 4,975 patients

Sex: All

Ages: 2+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute uncomplicated diarrhea (less than 7 days with at least 3 loose stools in the last 24 hours)
• Age greater than or equal to two months.

Exclusion criteria

• No diarrhea
• Complicated diarrheal disease (e.g. e.g. sepsis, meningitis, convulsions, electrolyte imbalance, myocardial infarction, respiratory failure, chronic kidney disease, severe malnutrition by clinical measures and mid-upper arm circumference (<11.5cm for >= 6 mo to less than 5 years; <11.0 cm for >= 2mo to <6 mo))

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,975 participants in 2 patient groups

Paper-based decision-support

Active Comparator group

Description:

Prior to starting the study, 10 hospitals will be made into 5 pairs. The paper versus smartphone intervention will be randomized to one member of each pair. The study arm will consist of a pre-interventional (6 weeks) followed by an interventional period (12 weeks); this arms will use paper-based decision support at the 5 hospitals designated.

Treatment:

Other: Pre-Assessment of practices

Other: Paper-based decision-support

Smartphone-based decision-support

Active Comparator group

Description:

Prior to starting the study, 10 hospitals will be made into 5 pairs. The paper versus smartphone intervention will be randomized to one member of each pair. The study arm will consist of a pre-interventional (6 weeks) followed by an interventional period (12 weeks); this arms will use smartphon-based decision support at the 5 hospitals designated.

Treatment:

Other: Pre-Assessment of practices

Other: Smartphone-based decision-support