Abstract
BackgroundThere 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.ObjectiveThis 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.MethodsWe 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.ResultsA 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.ConclusionsA 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
Highlights
BackgroundPatient-reported outcome (PRO) questionnaires and patient-reported outcome (PRO)-based digital decision support tools, referred to as PRO tools, may help improve the quality of life and multiple person-centered aspects of quality of care for those with diabetes when appropriately designed for use in routine practice [1,2,3]
PRO tools may facilitate the active engagement of people with diabetes in caring for themselves on their own through improved self-insight and disease insight [8,9,10]; better preparation before visits, thereby benefiting the quality of the visit [11]; focus on the person with diabetes’ individual needs and priorities [1]; detection of symptoms and underlying conditions requiring treatment [12,13,14,15]; assessment of symptom severity [16], prioritization of topics to discuss at the care visit [17]; monitoring of side effects [18,19] and treatment response; provision of treatment decision support [18]; and the creation of data allowing ongoing quality monitoring, benchmarking, and care improvement [20]
Evidence shows that designing digital PRO tools that are acceptable, feasible, and effective among the majority of the population and successfully implementing them in diverse routine care settings are difficult tasks, owing to a variety of barriers to and challenges for both people with diabetes and health care professional (HCP) [21,22,23,24]
Summary
Patient-reported outcome (PRO) questionnaires and PRO-based digital decision support tools, referred to as PRO tools, may help improve the quality of life and multiple person-centered aspects of quality of care for those with diabetes when appropriately designed for use in routine practice [1,2,3]. Evidence shows that designing digital PRO tools that are acceptable, feasible, and effective among the majority of the population and successfully implementing them in diverse routine care settings are difficult tasks, owing to a variety of barriers to and challenges for both people with diabetes and HCPs [21,22,23,24]. 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. Limited research has evaluated the acceptability, feasibility, and benefits of such tools across different health care settings
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