Video Discharge Instructions for Pediatric Gastroenteritis in an Emergency Department

NCT04463355 | Completed

• 1 other identifier: GEA01
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

Video discharge instructions (VDI) have been suggested as a useful strategy to improve discharge instructions in pediatric emergency units. The goal of this study is to evaluate if the addition of VDI to usual verbal information improved the comprehension of information provided to caregivers of patients who consult for acute gastroenteritis (AGE). An open-label, parallel, randomized trial was designed, enrolling patients who consult for AGE. First, caregivers answer a written test concerning AGE characteristics and management. They are randomly allocated to a control group, which receives verbal discharge instructions, or to an intervention group, which additionally receives video discharge instructions. After discharge, caregivers are contacted by telephone and answer the same test. Main outcome measure is difference between test scores in the first and the second tests, secondary endpoints are how many caregivers score 5/5 on the second test, as well as rate of return visits and caregivers satisfaction with the information received.

Conditions

Acute Gastroenteritis

Keywords

discharge instructions; video; acute gastroenteritis; pediatric emergency department

Outcome Measures

Primary Outcomes (1)

• Change in test score

  We calculated the difference between the score obtained in the initial test and the score obteined in the follow-up test and compared between groups. Scores are based on a 5-question test, minimum score is 0 points and maximum score (best score) is 5 points

  From 3 days to 10 days after first emergency care visit

Secondary Outcomes (3)

• Number of caregivers getting a total score of 5 points

  From 3 days to 10 days after first emergency care visit

• Rate of return visits

  72 hours from from the first emergency care visit

• Satisfaction score with the information received

  From 3 days to 10 days after first emergency care visit

Study Arms (2)

Control group: usual verbal instructions

NO INTERVENTION

In this group, caregivers receive, after completing the test and prior to discharge, the usual verbal information and recommendations about AGE following the guidelines of the Spanish Society of Pediatric Emergencies. The instructions are always given by one of the main investigators to provide homogeneity in the information

Intervention group: video discharge instructions

EXPERIMENTAL

Additionally to the verbal information, patients are shown a short 2-minute video providing the same information about AGE that would be given by verbal information.

Behavioral: Video discharge instructions

Interventions

Video discharge instructions BEHAVIORAL

Short video (2 minutes) including information about clinical features, management and follow up of pediatric patients with acute gastroenteritis

Intervention group: video discharge instructions

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients who met ESPGHAN criteria for AGE: decreased stool consistency and/or increased evacuation frequency during a period \<7 days, associated or not to fever or vomiting.
• Patients accompanied by a usual caregiver.

You may not qualify if:

• Patients with severe dehydration
• Patients with chronic comorbidities needing special instructions (i.e. neurologic, respiratory or cardiologic)
• Patients whose caregivers were not able to communicate in Spanish
• Patients who were admitted for hospitalization.

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, 28009, Spain

Location

Study Officials

• Gonzalo Solís, M.D.

  Hospital General Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Gonzalo Solís García, Principal Investigator

Model Details: Open-label, parallel trial with a control group and an intervention group.

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 9, 2020
• Study Start: June 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: June 1, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available as soon as published. It will be available for 20 years (year 2040)
• Access Criteria: Investigators with research accepted by a research ethics committee conducting research in this area.

Locations

ES (1)