Video Discharge Instructions for Pediatric Gastroenteritis in an Emergency Department
Condition: Acute Gastroenteritis
MeSH terms: Gastroenteritis; Emergencies
Study type: Interventional

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.
    

Intervention name(s): Video discharge instructions
Intervention type(s): Behavioral
Intervention description(s): Short video (2 minutes) including information about clinical features, management and follow up of pediatric patients with acute gastroenteritis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-label, parallel trial with a control group and an intervention group.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: discharge instructions; video; acute gastroenteritis; pediatric emergency department