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Video Discharge Instructions for Pediatric Gastroenteritis in an Emergency Department

Primary Purpose

Acute Gastroenteritis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Video discharge instructions
Sponsored by
Hospital General Universitario Gregorio Marañon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Gastroenteritis focused on measuring discharge instructions, video, acute gastroenteritis, pediatric emergency department

Eligibility Criteria

1 Month - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hospital General Universitario Gregorio Marañón

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group: usual verbal instructions

Intervention group: video discharge instructions

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of caregivers getting a total score of 5 points
We measured how many caregivers got a 5-score (perfect) in the follow up test after interventions, and compared between groups
Rate of return visits
We asked caregivers whether they had returned to emergency care or to pediatric outpatient clinics for the same problem after the first visit.
Satisfaction score with the information received
We asked caregivers to give a score between 1 and 10 (1 very unsatisfied, 10 very satisfied) regarding how useful they felt that the information given to them had been.

Full Information

First Posted
June 23, 2020
Last Updated
July 7, 2020
Sponsor
Hospital General Universitario Gregorio Marañon
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1. Study Identification

Unique Protocol Identification Number
NCT04463355
Brief Title
Video Discharge Instructions for Pediatric Gastroenteritis in an Emergency Department
Official Title
Video Discharge Instructions for Pediatric Gastroenteritis in an Emergency Department: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Gregorio Marañon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Video discharge instructions (VDI) have been suggested as a useful strategy to improve discharge instructions in pediatric emergency units. This study is designed to evaluate if the addition of VDI to usual verbal information improves the comprehension of the information provided to caregivers of patients who consult in pediatric emergency department for acute gastroenteritis (AGE). Secondary objectives are evaluating if video instructions improve satisfaction with the information received and decrease return visits. The study is an open-label, parallel, randomized trial which takes place between June 2019 and June 2020 in the pediatric emergency department of a third-level Spanish hospital which receives 58000 emergencies annually. Up to 3 eligible patients are enrolled every shift when one of the main investigators is present. Simple, 1:1 randomization is performed using R software. Patients are randomly assigned to a group by opening sequentially numbered paper envelopes which contain the group in which the patient will be allocated, ensuring thus allocation concealment. Written informed consent is provided before trial enrollment. Interventions The trial is developed in three steps: an initial written test, an information phase and a second follow-up test after discharge. After enrollment, all patients fill-in a written test before discharge, which consists of 5 questions about AGE, 1 point per correct answer. Enrolled subjects are randomly assigned to the control or intervention group. In the first group of subjects (control 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. In the second group (intervention group) patients are shown a short 2-minute video providing the same information about AGE, in addition to verbal instructions. In both groups, instructions are given by one of the main investigators in order to provide homogeneous and consistent information. Both sets of instructions explicitly include the information that had been previously asked in the test. All patients additionally receive a discharge report which includes instructions concerning aftercare treatment. After discharge, all caregivers are contacted by telephone and asked the same 5 questions from the initial test. The questionnaire has to be completed by the same caregiver as in the previous test. This test also includes questions about subsequent visits to either emergency units or outpatient pediatric clinics and satisfaction with the information. The first telephonic contact is established 72 hours after discharge, and if unable to contact, repeated every 1-2 days up to a total of 5 days before excluding them and considering them as lost in follow-up. Statistical Analysis The sample size was calculated to provide a statistical power of 80% at an alpha level of 5% to detect a two-tailed difference of 0.5 points between the two groups. It was calculated that with an estimated loss rate of 15% of patients between randomization and follow-up test, assuming a 1-point variance in test results based on previous studies, this statistical power would be reached by enrolling 75 patients in each group. All randomized patients who complete both tests are included in the primary-end point analysis as part of the group in which they were randomized, following intention-to-treat principle. The differences in test points and satisfaction between groups are analyzed using Student's T-test, and the differences in proportions are analyzed using Chi-square test. Statistical significance is set at p<0.05. Analysis are performed using Rv3.6.1 and SPSS.25 statistical softwares.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastroenteritis
Keywords
discharge instructions, video, acute gastroenteritis, pediatric emergency department

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open-label, parallel trial with a control group and an intervention group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group: usual verbal instructions
Arm Type
No Intervention
Arm Description
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
Arm Title
Intervention group: video discharge instructions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Video discharge instructions
Intervention Description
Short video (2 minutes) including information about clinical features, management and follow up of pediatric patients with acute gastroenteritis
Primary Outcome Measure Information:
Title
Change in test score
Description
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
Time Frame
From 3 days to 10 days after first emergency care visit
Secondary Outcome Measure Information:
Title
Number of caregivers getting a total score of 5 points
Description
We measured how many caregivers got a 5-score (perfect) in the follow up test after interventions, and compared between groups
Time Frame
From 3 days to 10 days after first emergency care visit
Title
Rate of return visits
Description
We asked caregivers whether they had returned to emergency care or to pediatric outpatient clinics for the same problem after the first visit.
Time Frame
72 hours from from the first emergency care visit
Title
Satisfaction score with the information received
Description
We asked caregivers to give a score between 1 and 10 (1 very unsatisfied, 10 very satisfied) regarding how useful they felt that the information given to them had been.
Time Frame
From 3 days to 10 days after first emergency care visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gonzalo Solís, M.D.
Organizational Affiliation
Hospital General Universitario Gregorio Marañón
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD are available under request.
IPD Sharing Time Frame
Data will be available as soon as published. It will be available for 20 years (year 2040)
IPD Sharing Access Criteria
Investigators with research accepted by a research ethics committee conducting research in this area.

Learn more about this trial

Video Discharge Instructions for Pediatric Gastroenteritis in an Emergency Department

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