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 (PWD) in their own care and improve the quality of care. However, many barriers exist for the implementation and real-world effectiveness of such PRO tools in routine care, and limited research has evaluated their acceptability, feasibility, and benefits across different healthcare settings.
OBJECTIVE
This pilot study aims to evaluate the acceptability, feasibility, and perceived benefits of the Danish digital PRO diabetes tool in different healthcare settings in Denmark and factors affecting implementation. Furthermore, the study will evaluate the psychometric characteristics of the Danish PRO diabetes questionnaire and the validity of the scoring algorithms for dialogue support. The purpose of the study is to guide ongoing optimization of the PRO diabetes tool, implementation, and design of future randomized controlled effectiveness studies.
METHODS
A multi-center, mixed-method, single-arm pilot acceptability-feasibility implementation study protocol was designed 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. In the first step, the PWD completes a digital PRO diabetes questionnaire in the days prior to a routine diabetes visit covering multiple topics such as psychological well-being, social support, daily life with diabetes, self-management symptoms, medicine experience, and personal priorities. In the second step, the health care professional (HCP) uses a digital PRO tool to review the PRO results together with PWD during the visit. The PRO diabetes tool is designed to facilitate an active role for the PWD in his/her own care and facilitate delivery of person-centered, collaborative, and coordinated care.
The aim is to recruit a minimum of 500 PWD and 30 HCPs (nurses, physicians, dietitians, and physiotherapists) with multiple sites representing municipality-based diabetes rehabilitation and education services, specialized outpatient hospital-based diabetes care and primary practice respectively. Both qualitative and quantitative data are collected and used for mixed-method analysis using the RE-AIM (Reach, Efficacy, Adoption, Implementation and Maintenance) framework. PWD complete Likert-scale evaluation questionnaires after self-completing the PRO questionnaire and after their diabetes visit, and a subset take part in structured interviews for 30-45 minutes after their visit. HCPs complete evaluation questionnaires and free-text forms after each diabetes visit and take part in semi-structured 4-5 hour workshops evaluating their experience with PRO. Each site completes center evaluation forms regarding resources and organization as well as approaches to PRO and person-centered care. Mixed-method evaluative and exploratory analyses will be used to characterize primary outcomes. Qualitative and quantitative analyses will be applied to examine associations between the use and impacts of PRO and individual, HCP, and center factors.
RESULTS
A multi-center pilot study protocol and digital data collection tools for evaluation were developed and deployed as part of a national evaluation of a new digital PRO diabetes intervention
CONCLUSIONS
A large-scale mixed-method multi-center study to evaluate the use of the nationally developed PRO diabetes questionnaire in routine care across all health care sectors in Denmark using the RE-AIM model as framework has been designed and is ongoing. More than 550 people with diabetes and 31 health professionals have completed the study at this time.
The study is expected to provide new important and detailed information the real-world acceptability and perceived relevance and benefits of the PRO diabetes tool among a large heterogenous population of people with diabetes in Denmark and HCP in different care settings. The results will be used to further improve the PRO tool, design implementation facilitation support strategies and future effectiveness research.
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