There is a lack of knowledge showing the real-life effects of person-centered type 2 diabetes (T2DM) Management programs offered in a municipal setting. The aim of this study is to determine the effectiveness of individualized T2DM management programs for patients with T2DM in a municipal setting on HbA1c and blood pressure (BP). Based on a person-centered and differentiated approach, the intervention consists of education, physical training, cooking classes and/or individual consultations. Methods: The study was conducted during 2018 to 2021 with citizens referred consecutively for T2DM management programs. A total of 308 patients were included. Of these 308, 172, and 131 completed questionaries and physiological measurements at baseline, at end of the program and at 6 months follow-up, respectively. All physiological data was collected by selected health care professionals trained in standard operations procedures. Results: Respondents consist of 60% men, age range primarily from 55-79, 57% have a short education level. At baseline mean HbA1c was 58.5 mmol/mol (IQR: 48.0-64.0). At end of the program, a statistically significant decrease of −6.5 mmol/mol (95% CI: −9.0; −4.1, p<0.001) was observed. At 6 months follow-up this decrease was unchanged as it was showing a decrease of −5.8 mmol/mol (95% CI: −8.8; −2.8, p<0.001) compared to baseline. At baseline mean systolic and diastolic BP was 147.5 mmHg (IQR: 134.2-158.0) and 86.2 mmHg (IQR: 79.6-93.3), respectively. At end of the program and at 6 months follow-up a significant decrease of −10.7mmHg (95% CI: −15.0; −6.3, p<0.001) and −11.8 mmHg (95% CI: −16.4; −7, 2, p<0.001), respectively, was observed for systolic BP when compared to baseline. Conclusion: Person-centered T2DM management programs in a large municipal setting significantly reduce HbA1c and BP on long and short term. These results may be caused by person-centered care and a holistic approach. Disclosure L.A.Helgstrand: None. A.D.Hvidberg: None. C.Glümer: None.

Impaired mental health among patients with type 2-diabetes (T2DM) constitutes a major challenge as it has negative influence on T2DM self-management, HbA1c and complications. Inclusion of mental health issues in municipal rehabilitation is important as patients need to cope both physical, practical, and mental aspects of a life with T2DM. The aim of this study was to assess whether T2DM management program influences mental health including diabetes distress and overall wellbeing. Methods: During 2018-2021, all patients referred for T2DM management programs were invited to the study. Included patients completed a series of validated questionnaires including WHO-5, PAID-1 and PAID-5 at baseline, at end of the program and at 6 months follow-up. A total of 131 completed all three questionnaires and were included in the study. Based on a person-centered and differentiated approach to diabetes management programs, the intervention consists of teaching, physical training, cooking and/or individual conversations. Results: The study population consist of 60% men, age range primarily from 55-79, 57% have a short education level. At baseline, mean WHO-5 score was 61.6 points (IQR: 48.0-80.0). At end of rehabilitation a statistically significant increase of 4.6 points (95%CI: 1.1-7.8, p=0.003) was observed. At 6 months follow-up the WHO-5 score was leveled and unchanged when compared to baseline. According to PAID-5, 47% of included patients had diabetes distress at baseline. This was reduced to 30% and 26% at end of the program and at 6 months follow-up, respectively. Conclusion: T2DM management programs has a positive effect on mental health including general well-being and diabetes distress. Nonetheless there is still room for improvement which is why we have now initiated a project in collaboration with a research institute, aiming to improve identification of individuals and develop interventions targeting patients with moderate to high degrees of diabetes distress. Disclosure C.Glümer: None. A.D.Hvidberg: None. L.A.Helgstrand: None.

Introduction: A national value-based health care project, VBHC-PRO-DIA, was initiated in 2017 to develop and evaluate a scalable solution for value based diabetes care in Denmark. Our project was undertaken in partnership and alignment with a national PRO diabetes program. We present the study design for this national project. Materials and Methods: A participatory multi-stakeholder research design process 2017-2020 with systematic involvement of > 70 PWD using interviews, workshops, clinical & qualitative research: 1) A minimal patient-important diabetes outcome domain set (VBHC structure) . 2) A unified PRO diabetes “logic model” for how to use PRO to drive health value. 3) A national psychometric PRO Diabetes Questionnaire & Decision-Algorithm. 4) A VBHC-PRO IT Tool for seamless use of outcome data in routine diabetes care. 5) A multi-center real-world PRO pilot study of public health potential (RE-AIM) . 6) Implementation planning, data-driven VBHC model design and effectiveness study. Results: National PRO Model: PWD fills out PRO before visit. PRO is used in-visit for collaborative, focused, whole-person care. A multi-dimensional PRO questionnaire (36-70 items) covering: General health/wellbeing, daily life with diabetes, diabetes distress, self-care, BG regulation, symptoms, access to care, personal goals and priorities. Real-world 10-site PRO study : Interim data: > 460 PWD/ 30 HCPs showed high acceptability and experience of benefits related to active engagement of PWD and person-centred diabetes care quality. Disclosure N.Ejskjaer: None. P.H.Kjaer: None. D.B.Berthelsen: None. S.H.Kaplan: n/a. P.O.Jakobsen: None. C.Glümer: n/a. S.E.Skovlund: Consultant; Roche Diabetes Care.

Aim: To assess health care professionals’ (HCP) perceptions of feasibility, acceptability, and impacts of a new digital patient-reported outcome (PRO) dialogue tool in routine diabetes care. Methods: A single-arm implementation study (MPRODIA) evaluating use of a PRO tool by 33 HCP in routine multi-sector diabetes care. Intervention: Persons with diabetes (PWD) filled out a digital questionnaire about health, well-being and self-care 1-8 days prior to the visit and their HCP used a PRO dialogue dashboard in the visit to facilitate a collaborative, person-centered dialogue. Primary outcome in this sub study was HCP responses to a clinical end-of-study Likert-Scale and Free-Text evaluation survey. Quantitative and explanatory qualitative data analyses were done with SPSS 25.0/Nvivo 12. Results: 33 HCP at 7 unique sites used PRO in 474 diabetes visits and completed the end-of-study survey. 80% were diabetes specialized, 67% saw>10 PWD/week, 33% had <10 years of care experience. HCP confidence in use of PRO improved in pre-post analysis (3,8 (SD=.9) to 4,4 (SD=.7), range 1-5, p<0.05). 97% were confident in their ability to use PRO well (interpret and use PRO insights). 52% became more positive (3% more negative) towards the PRO tool overall over time. 85% reported improved work satisfaction (due to better preparation and dialogue), 0% worse satisfaction. 33% felt visits were less stressful, 21% felt it was somewhat more stressful with PRO (due to time constraints). All HCP indicated the desire to continue PRO use (9,0(SD=1,2), range 1-10) and recommend it to others (9,0(SD=1,4), range 1-10). 64% found it essential that HCP are trained in use of PRO prior to implementation. Conclusions: HCP in both municipality and hospital settings found a new digital PRO diabetes tool to be highly acceptable and value-adding by improving the active participation of PWD and the delivery of quality person-centered care. Disclosure S. E. Skovlund: None. D. M. Hessler: Consultant; Self; Eli Lilly and Company. S. H. Kaplan: None. N. Ejskjaer: None. C. Glümer: None. S. H. Nielsen: None. D. B. Berthelsen: None. H. Perrild: n/a. N. C. Balk-møller: None. L. Nørgaard: None. L. Troelsen: None. A. Pietraszek: None. Funding Danish Health Data Authority

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.

Aim: To develop a protocol and set of purpose-built psychometric PRO evaluation questionnaires for a national multi-sector study to evaluate feasibility, acceptability, validity, barriers, facilitators and perceived value of the National Danish PRO diabetes intervention (PRO diabetes questionnaire and dialogue tool) in Denmark. Methods: The protocol was designed through a participatory process with People With Diabetes (PWD), multi-disciplinary representatives of diabetes centres and municipality diabetes rehabilitation centres from 3 regions of Denmark. Hypotheses and assessment tools were guided by formative qualitative research. The intervention involved that PWD fill out the PROM prior to their visit and the Health Care Professional (HCP) uses a PRO IT dialogue tool to collaboratively evaluate needs and plan care. Results: The pragmatic mixed-methods study protocol involved hypothesis testing and exploratory research: 1) PRO-DIA-READY Scales for Clinic and HCP PRO-Diabetes Readiness (incl. structural/process indicators of person-centred care). 2) 6-item PRO-EVAL-P Scale completed by PWD after the PROM. 3) 8-item PROCON-EVAL-HCP and 13-item PROCON-EVAL-PWD scales completed by HCPs and PWD after the visit, 4) Clinician rating scales of PROM validity 5) Semi-structured interview/group workshop guides for PWD, Caregivers (CG), multi-disciplinary HCPs, and administrators based on RE-AIM: Reach, Effectiveness, Adoption, Implementation and Maintenance, 6) HCP/PWD Follow-Up Impact Questionnaires (incl. active participation, person-centred care, care utilisation and outcomes). Newly designed evaluation scales were analyzed psychometrically. Conclusions: A protocol and new psychometric assessment tools for evaluation of validity, readiness, acceptability and impact of PRO in diabetes care were developed and successfully applied in large scale in Denmark. The new tools are available for comparative PRO research studies. Disclosure S.E. Skovlund: None. L. Boel: None. N.C. Balk-Møller: None. P.M. Højholt: None. D.B. Berthelsen: None. C. Glümer: None. H. Perrild: None. D.M. Hessler: Consultant; Self; Eli Lilly and Company. S.H. kaplan: None. P.O. Jakobsen: None. N. Ejskjaer: None. Funding Danish Health Data Board

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.