Albrecht Lauren, Scott Shannon D, Hartling Lisa
1Department of Pediatrics, University of Alberta, Edmonton Clinic Health Academy, 11405 87 Avenue, Edmonton, Alberta T6G 1C9 Canada.
2Faculty of Nursing, University of Alberta, 3rd floor Edmonton Clinic Health Academy, 11405 87 Avenue, Edmonton, Alberta T6G 1C9 Canada.
Pilot Feasibility Stud. 2018 Aug 2;4:131. doi: 10.1186/s40814-018-0318-0. eCollection 2018.
Pediatric acute gastroenteritis (AGE) is a common childhood illness with substantial health, family, and system impacts. Connecting parents to evidence-based patient education is key to effective decision-making and therapeutic management of AGE. Digital knowledge translation (KT) tools offer a promising approach to communicate complex health information to parents; therefore, we developed a whiteboard animation video for parents about AGE. To optimize future effectiveness evaluation of this video, the purpose of this pilot study is to assess feasibility of effectiveness outcomes and specific trial methods in four key trial domains.
A single-site, parallel-arm, pilot randomized trial will be conducted. The trial will employ quantitative and qualitative methods to evaluate feasibility objectives in key scientific, process, management, and resource domains. Parents seeking care for a child with AGE in the emergency department (ED) over a 6-month period will be randomized to receive the whiteboard animation video or a sham control video. Quantitative data will be collected electronically in the ED and at home (4-10 days post-ED visit). Qualitative data will be collected via semi-structured interviews with experimental condition participants after quantitative data collection. Data will be collected to perform a sample size calculation for a full-scale trial. Scientific outcomes will include parental knowledge, decision regret, and health utilization, and estimation for these outcomes will use confidence intervals (CI) of different widths to illustrate strength of preliminary evidence. CIs will be presented alongside minimum clinically important differences (MCIDs) calculated using two methods: (1) data driven and (2) patient perspective. Descriptive statistics will be calculated to describe process, management, and resource domain outcomes. Qualitative thematic analysis will be conducted to describe additional process, management, and resource outcomes in the experimental group. Analyses will be performed using intention-to-treat.
This pilot randomized trial will inform the design and conduct of a full-scale, effectiveness trial by gathering key data in four domains: scientific, process, management, and resource. These results will impact the emerging field of KT efforts targeting health consumers and advance the science on the best mode of patient education for acute childhood illnesses.
clinicaltrails.gov registration number NCT03234777. Registered 31 July 2017.
小儿急性胃肠炎（AGE）是一种常见的儿童疾病，对健康、家庭和医疗系统均有重大影响。让家长获得基于证据的患者教育是AGE有效决策和治疗管理的关键。数字知识转化（KT）工具为向家长传达复杂的健康信息提供了一种很有前景的方法；因此，我们为家长制作了一部关于AGE的白板动画视频。为了优化该视频未来的效果评估，本试点研究的目的是评估四个关键试验领域中效果指标及特定试验方法的可行性。
将开展一项单中心、平行组、试点随机试验。该试验将采用定量和定性方法来评估关键科学、流程、管理和资源领域的可行性目标。在6个月内到急诊科（ED）为患AGE的孩子寻求治疗的家长将被随机分组，分别接受白板动画视频或虚假对照视频。定量数据将在急诊科和家中（急诊就诊后4 - 10天）通过电子方式收集。定性数据将在定量数据收集后，通过对参与实验条件的参与者进行半结构化访谈来收集。将收集数据以进行大规模试验的样本量计算。科学指标将包括家长知识、决策遗憾和医疗利用情况，对这些指标的估计将使用不同宽度的置信区间（CI）来说明初步证据的强度。CI将与使用两种方法计算的最小临床重要差异（MCID）一起呈现：（1）数据驱动法和（2）患者视角法。将计算描述性统计量以描述流程、管理和资源领域的指标。将进行定性主题分析以描述实验组中其他的流程、管理和资源指标。分析将采用意向性分析。
这项试点随机试验将通过在科学、流程、管理和资源四个领域收集关键数据，为全面的效果试验设计和实施提供信息。这些结果将影响针对健康消费者的KT工作这一新兴领域，并推动关于儿童急性疾病最佳患者教育模式的科学发展。
clinicaltrails.gov注册号NCT03234777。于2017年7月31日注册。
