Evaluating Patient-Entered Electronic Health Data as a Strategy to Improve Quality of Care in a Diabetes Clinic: Protocol for a Randomized Controlled Trial.

内容摘要

Quality care for pediatric type 1 diabetes (T1D) requires frequent, multidisciplinary visits. Technological and clinical innovation have led to changes in T1D management, resulting in increasing data exchange required during these visits. Capturing comprehensive personal health and diabetes-related information discretely and integrating it into the clinical workflow is critical for optimal T1D care but is time-consuming. Time spent on data transfer often results in less time for holistic care and can lead to unmet needs for patients, families, and health care providers, as well as increased time pressures in clinic. To address this, the Children's Hospital of Eastern Ontario developed a caregiver proxy-reported questionnaire distributed via the MyChart patient portal, allowing families to input care information ahead of visits with the aim of dedicating more clinic time to personalized care. The launch of this tool, which integrates caregiver-entered information into the physician's documentation workflow, brings the opportunity to systematically evaluate its impact on care quality and efficiency, with potential implications for broader adoption. Our objective is to evaluate the impact of a caregiver proxy-reported, electronic health record-integrated preclinic questionnaire (MyChart questionnaire) on the quality of care in a pediatric diabetes clinic, through measurement of its impact on caregiver-perceived quality of care compared to the standard of care using 2 validated measures of care quality. We also aim to explore the impact of the intervention on glycemic control and visit efficiency. We conducted a single-center, parallel-group randomized controlled trial designed for 222 children with T1D. Participants were randomly allocated in a 1:1 ratio to either the intervention (MyChart questionnaire) or standard care. Our primary outcome is caregiver-perceived quality of care, as measured by the Patient's Evaluation of the Quality of Diabetes Care at 8 months, administered with caregivers serving as proxy respondents for patients. Secondary outcomes are the Patient's Evaluation of the Quality of Diabetes Care at 4 months and Perceived Quality of Medical Care at 4 and 8 months. Tertiary outcomes include glycemic control and physician-reported visit efficiency at 4 and 8 months. Analysis of covariance models will be used to assess changes between baseline and postintervention outcomes across treatment groups. Recruitment for this study began in April 2023 and was completed in February 2024, with a total of 139 participants enrolled. Data collection has concluded, and the first results are expected in the spring of 2026. This study is the first randomized trial to assess the impact of a caregiver proxy-reported, electronic health record-integrated, preclinic questionnaire distributed via a patient portal on caregiver-perceived quality of care in a pediatric care setting. The results will guide changes in health service infrastructure and delivery to enhance comprehensive data capture and improve care quality within and beyond pediatric T1D.