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临床试验/NCT03234777
NCT03234777已完成不适用

Evaluating a Knowledge Translation Tool for Parents: A Pilot Randomized Trial

University of Alberta1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2017年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Decision Regret Scale

研究概览

简要总结

Diarrhea and vomiting in children is a common reason to visit the emergency department. There has been a lot of research on how best to treat children with diarrhea and vomiting who visit the emergency department; however, the care children receive varies by healthcare provider and across hospitals. Additionally, there are things parents can do at home to help manage childhood diarrhea and vomiting and potentially avoid a trip to the emergency department. This shows an urgent need for knowledge translation, that is, efforts to align research knowledge and healthcare practice. Actively involving parents in healthcare decisions has the potential to bridge this gap; however, there is little research on the best ways to communicate complex health information to parents of sick kids. In 2013, a national needs assessment was conducted with parents seeking care for their kids in general emergency departments (trekk.ca). This survey showed that 39% of parents looked for information about their child's health prior to coming to the emergency department and that 44% of these parents looked for this information on the internet. This means that the development and evaluation of digital tools to give parents timely and effective child health information has the potential to reduce unnecessary emergency department visits, empower parents in health decision-making, and ultimately improve child health outcomes. In this project, parents will be actively involved in the evaluation of a digital tool, a whiteboard animation video, designed to communicate the best research evidence on the treatment and management of vomiting and diarrhea in children. In this pilot trial, parents in two emergency departments will be randomized to view the video or a sham video, and then provide quantitative and qualitative data on the potential effectiveness of the video, the perceived benefit and value of the knowledge translation intervention for pediatric vomiting and diarrhea, the feasibility of using iPads and an electronic data collection platform to conduct research with this population, the time required to complete data collection, and parents' willingness to participate in future, similar research.

详细描述

STUDY PURPOSE: The purpose of this pilot randomized trial is to use quantitative and qualitative approaches to achieve the following objectives in the four key pilot trial domains:

  1. Scientific domain objectives:

1.a.) To determine the potential effectiveness of a digital knowledge translation tool for parents/caregivers about pediatric acute gastroenteritis (AGE). KT tools are intended to impact end-user experience, including increasing knowledge, influencing healthcare decision making, and use of healthcare resources/services. Comprehension and retention of health information is a key component of the patient experience, a determinant of care instruction follow-through, and the cornerstone of health literacy; therefore, parental knowledge over time will be assessed. In addition to comprehension, educational materials may also influence health decision making; therefore, parental decision regret over time will be assessed to examine this impact in light of the decision to bring their child to the ED for care. Additionally, minimal clinically important differences (MCIDs) will be identified for both knowledge and decision regret outcome measures. Finally, healthcare utilization post-ED visit will be explored as a potential future outcome.

  1. b.) To understand the perceived benefit and value of KT tools for parents/caregivers of a child with pediatric AGE, including important components that enhance knowledge and decision making.
  2. Process domain objectives:

2.a.) To examine the feasibility of using an electronic, web-based platform for intervention delivery and data collection with this population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Parent or caregiver of a child 16 years old or younger
  • •Child is presenting to the ED with vomiting and diarrhea
  • •Parent is fluent in English
  • •Parent is willing to be contacted for follow-up data collection

排除标准

  • •Child has significant chronic gastrointestinal problem or inflammatory bowel disease (i.e., Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis, chronic constipation)
  • •Child is taking immunosuppressive therapy or known history of immunodeficiency
  • •Child has undergone oral or gastrointestinal surgery within the preceding 7 days
  • •Child has had a prior visit to ED for vomiting and diarrhea within the preceding 14 days

研究组 & 干预措施

Regular video

Sham Comparator

3 minute video on hand washing for infection control

干预措施: Regular video (Behavioral)

Whiteboard animation video

Experimental

3 minute video on treatment, management of pediatric acute gastroenteritis

干预措施: Whiteboard animation video (Behavioral)

结局指标

主要结局

Decision Regret Scale

时间窗: 0-14 days (x3)

Measure 2 (quantitative) of potential effectiveness of the knowledge translation intervention

knowledge questionnaire

时间窗: 0-14 days (x3)

Measure 1 (quantitative) of potential effectiveness of the knowledge translation intervention

Health care utilization

时间窗: 4-14 days

Measure 3 (quantitative) of potential effectiveness of the knowledge translation intervention

Perceived benefit and value of the knowledge translation intervention for pediatric AGE

时间窗: 0-14 days (x2) and qualitative interview (experimental group only) after post-intervention 2 questionnaire

Measure 4 (qualitative) of potential effectiveness of the knowledge translation intervention

次要结局

  • Recruitment rate(3 months)
  • Time (days) to complete follow-up questionnaire post-discharge(0-14 days)
  • Consent rate(3 months)
  • Time (minutes) to complete study forms(0-14 days)
  • Number of technical problems with electronic platform during study period(3 months)
  • Data completion rate(3 months)
  • Number of technical problems as well as lost, stolen or damaged equipment during study period(3 months)
  • Willingness to participate in future similar research(Assessed during qualitative interview after post-intervention 2 questionnaire)
  • Satisfaction with electronic platform(Assessed during qualitative interview (experimental group only) after post-intervention 2 questionnaire)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lauren Albrecht

PhD Student

University of Alberta

研究点 (1)

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