The Acceptability and Impact of Diarrheal Etiology Prediction (DEP) Algorithm

NCT04602676 | Completed DMC

• 1 other identifier: IRB_00135830
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a randomized crossover study, where clinicians will be randomized to periods where they will use a rehydration calculator application with or without the Diarrheal Etiology Prediction (DEP) algorithm. The crossover will include a washout period to reduce carryover effect. The study will be conducted over a 9-week period. The Investigators will use a random number generator to randomize clinicians to DEP (use of the etiology calculator) or control arm (use of a previously-tested rehydration calculator) within site for the first 4 weeks. After the first 4 weeks, there will be 1-week washout period without decision support, after which each clinician will cross-over to the other arm for the next 4 weeks. The Investigators will enroll diarrhea-treating clinicians who treat children presenting with acute diarrhea at sites in Bangladesh and Mali. Utah investigators will only analyze de-identified data provided by our collaborators in Bangladesh and Mali.

Conditions

Diarrhea Infectious; Algorithms; Decision Support Systems, Clinical; Clinical Decision-Making

Keywords

Diarrhea; Treatment Algorithm

Outcome Measures

Primary Outcomes (1)

• Proportion of antibiotic prescriptions given to patients with diarrhea

  9 weeks

Secondary Outcomes (2)

• Proportion of patients with resolution of diarrheal symptoms at 10-days after enrollment

  10 days

• Clinician satisfaction towards use of the DEP as assessed by pre- and post-study questionnaires.

  9 weeks

Study Arms (2)

Diarrheal Assessment with DEP, then diarrheal assessment

EXPERIMENTAL

Participants will go through a 4 week period where clinicians will use a rehydration calculator application with the DEP algorithm. After a washout period of 1 week, they will go through a 4 week period where clinicians will use a rehydration calculator application.

Diagnostic Test: Rehydration calculator application with DEP algorithm; Diagnostic Test: Rehydration calculator application

Diarrheal Assessment, then Diarrheal assessment with DEP

EXPERIMENTAL

Participants will go through a 4 week period where clinicians will use a rehydration calculator. After a washout period of 1 week, they will go through a 4 week period where clinicians will use a rehydration calculator application with the DEP algorithm.

Diagnostic Test: Rehydration calculator application with DEP algorithm; Diagnostic Test: Rehydration calculator application

Interventions

Rehydration calculator application with DEP algorithm DIAGNOSTIC_TEST

4 week period where clinicians will use a rehydration calculator application with the DEP algorithm followed by a 1 week washout period.

Diarrheal Assessment with DEP, then diarrheal assessment; Diarrheal Assessment, then Diarrheal assessment with DEP

Rehydration calculator application DIAGNOSTIC_TEST

4 week period where clinicians will use a rehydration calculator application without the DEP algorithm followed by a 1 week washout period.

Diarrheal Assessment with DEP, then diarrheal assessment; Diarrheal Assessment, then Diarrheal assessment with DEP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician providing acute care for children with diarrhea at study hospitals
• Available to answer survey questionnaire

You may not qualify if:

• Planning to leave the study site prior to completion of the research
• Inability to read

Sponsors & Collaborators

• University of Utah: lead

Study Sites (2)

Enteric and Respiratory Infections Unit, Infectious Diseases Division, icddr,b

Dhaka, Bangladesh

Location

Centre pour le Développement des Vaccins

Bamako, Mali

Location

Related Publications (1)

• Nelson EJ, Khan AI, Keita AM, Brintz BJ, Keita Y, Sanogo D, Islam MT, Khan ZH, Rashid MM, Nasrin D, Watt MH, Ahmed SM, Haaland B, Pavia AT, Levine AC, Chao DL, Kotloff KL, Qadri F, Sow SO, Leung DT. Improving Antibiotic Stewardship for Diarrheal Disease With Probability-Based Electronic Clinical Decision Support: A Randomized Crossover Trial. JAMA Pediatr. 2022 Oct 1;176(10):973-979. doi: 10.1001/jamapediatrics.2022.2535.

  PMID: 36036920 DERIVED

MeSH Terms

Conditions

Dysentery; Diarrhea

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Leung, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 26, 2020
• Study Start: November 18, 2020
• Primary Completion: March 5, 2021
• Study Completion: March 5, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1); BA (1)