RESUMO
BACKGROUND: There is growing evidence that digital patient-reported outcome (PRO) questionnaires and PRO-based decision support tools may help improve the active engagement of people with diabetes in self-care, thereby improving the quality of care. However, many barriers still exist for the real-world effectiveness and implementation of such PRO tools in routine care. Furthermore, limited research has evaluated the acceptability, feasibility, and benefits of such tools across different health care settings. OBJECTIVE: This study aims to evaluate the acceptability, feasibility, and perceived benefits of the Danish digital PRO diabetes tool in different health care settings in Denmark and to determine the factors affecting its implementation. Furthermore, the study evaluates the psychometric characteristics of the Danish PRO Diabetes Questionnaire and the validity of the scoring algorithms for dialogue support. The objective of this study is to guide the ongoing optimization of the PRO diabetes tool, its implementation, and the design of future randomized controlled effectiveness studies. METHODS: We designed a multicenter, mixed methods, single-arm acceptability-feasibility implementation study protocol to contribute to the real-world pilot test of a new digital PRO diabetes tool in routine diabetes care. The use of the tool involves two main steps. First, the people with diabetes will complete a digital PRO Diabetes Questionnaire in the days before a routine diabetes visit. Second, the health care professional (HCP) will use a digital PRO tool to review the PRO results together with the people with diabetes during the visit. The PRO diabetes tool is designed to encourage and support people to take an active role for the people with diabetes in their own care and to expedite the delivery of person-centered, collaborative, and coordinated care. RESULTS: A multicenter pilot study protocol and psychometrically designed digital data collection tools for evaluation were developed and deployed as part of a national evaluation of a new digital PRO diabetes intervention. A total of 598 people with diabetes and 34 HCPs completed the study protocol by April 1, 2021. CONCLUSIONS: A large-scale, mixed methods, multicenter study for evaluating the use of the nationally developed PRO Diabetes Questionnaire in routine care across all health care sectors in Denmark by using the RE-AIM (Reach, Efficacy, Adoption, Implementation and Maintenance) model as a framework has been designed and is ongoing. This study is expected to provide new important and detailed information about the real-world acceptability, perceived relevance, and benefits of the PRO diabetes tool among a large heterogeneous population of people with diabetes in Denmark and HCPs in different care settings. The results will be used to further improve the PRO tool, design implementation facilitation support strategies, and design future controlled effectiveness studies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/28391.
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INTRODUCTION: Collaborative goal setting and action-planning are key elements of self-management support for people with type 2 diabetes mellitus (T2DM), however little is known regarding action plan quality or correlation of quality in primary T2DM care. METHODS: T2DM patients from 12 primary care sites participated in either: Connection to Health (CTH; 6 practices), consisting of a health survey followed by collaborative action planning, or Enhanced Engagement CTH (EE-CTH; 6 practices), including additional training in relationship building promoting patient engagement. Action plan quality was rated using an adapted version of the Goal-Setting Evaluation Tool for Diabetes (GET-D) (dual coding of 20%, inter-rater reliability [IRR] >80%). Associations with patient characteristics were examined using generalized linear mixed models adjusting for clustering by clinic and intervention arm. RESULTS: With a mean score ± standard deviation (SD) of 14.62 ± 3.87 on a 0 to 20 scale (n = 725), overall action plan quality was moderate-high. Higher health literacy (ß = 1.184, 95% CI, 0.326-2.041; P = .007), and having no social risks (ß = 0.416; 95% CI, 0.062-0.770; P = .021) were associated with higher action plan quality, whereas sex, age, language, education level, depression, stress, and health distress were unrelated to quality (P value not significant). Higher quality was associated with greater patient confidence in the plan (ß = 0.050; 95% CI, 0.016-0.084, P = .004). CONCLUSIONS: Although there was a considerable difference in action plan quality ratings, ratings did not systematically differ based on most patient demographic or mental health measures. Results suggest that action planning should be tailored to health literacy and social risks. Further research should examine associations between quality and longer-term clinical outcomes.
