Video Discharge Instructions for Pediatric Gastroenteritis in an Emergency Department: a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Change in test score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in test score
时间窗: From 3 days to 10 days after first emergency care visit
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
次要结局
- 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)
- Number of caregivers getting a total score of 5 points(From 3 days to 10 days after first emergency care visit)
研究者
Gonzalo Solis Garcia
Dr. Gonzalo Solís García, Principal Investigator
Hospital General Universitario Gregorio Marañon