Integrated care for older multimorbid heart failure patients: protocol for the ESCAPE randomized trial and cohort study.

ESCAPE: Evaluation of a patient-centred biopsychosocial blended collaborative care pathway for the treatment of multimorbid elderly patients. THERAPEUTIC AREA: Healthcare interventions for the management of older patients with multiple morbidities. AIMS: Multi-morbidity treatment is an increasing challenge for healthcare systems in ageing societies. This comprehensive cohort study with embedded randomized controlled trial tests an integrated biopsychosocial care model for multimorbid elderly patients. HYPOTHESIS: A holistic, patient-centred pro-active 9-month intervention based on the blended collaborative care (BCC) approach and enhanced by information and communication technologies can improve health-related quality of life (HRQoL) and disease outcomes as compared with usual care at 9 months. METHODS: Across six European countries, ESCAPE is recruiting patients with heart failure, mental distress/disorder plus ≥2 medical co-morbidities into an observational cohort study. Within the cohort study, 300 patients will be included in a randomized controlled assessor-blinded two-arm parallel group interventional clinical trial (RCT). In the intervention, trained care managers (CMs) regularly support patients and informal carers in managing their multiple health problems. Supervised by a clinical specialist team, CMs remotely support patients in implementing the treatment plan-customized to the patients' individual needs and preferences-into their daily lives and liaise with patients' healthcare providers. An eHealth platform with an integrated patient registry guides the intervention and helps to empower patients and informal carers. HRQoL measured with the EQ-5D-5L as primary endpoint, and secondary outcomes, that is, medical and patient-reported outcomes, healthcare costs, cost-effectiveness, and informal carer burden, will be assessed at 9 and ≥18 months. CONCLUSIONS: If proven effective, the ESCAPE BCC intervention can be implemented in routine care for older patients with multiple morbidities across the participating countries and beyond.

Study protocol for a multicenter randomized controlled trial of personalized exercise therapy and self-management support for people with multimorbidity: The MOBILIZE study.

Background: Despite the great individual and societal burden associated with multimorbidity, little is known about how to effectively manage it. Objective: The aim of this multicenter randomized controlled trial (RCT) is to investigate the 12-month effects of a personalized exercise therapy and self-management support program in addition to usual care in people with multimorbidity. Design: This is a protocol for a pragmatic, parallel-group (1:1 ratio), superiority RCT conducted at five intervention sites (two hospitals, a private practice physiotherapy clinic and two municipal rehabilitation centers) in Region Zealand, Denmark. A total of 228 persons with multimorbidity aged 18 years or older, will be randomly allocated to one of two groups. Both groups will receive usual care, defined as routine care for multimorbidity at the discretion of the treating doctor, while the intervention group will also participate in a 12-week exercise therapy and self-management support program tailored to people with multimorbidity at one of the intervention sites. The primary outcome will be the between-group difference in change in EQ-5D-5L from baseline to the follow-up at 12 months. Secondary outcomes include objectively-measured physical function and physical activity, inflammatory markers, disease and treatment burden, anxiety, depression, stress, sleep, pain and other self-reported parameters. In parallel with the RCT, an observational cohort will follow persons aged ≥18 years with multimorbidity not adhering to all eligibility criteria, as well as people fulfilling all eligibility criteria, but unwilling to participate in the RCT. This study was approved by the Regional Committee on Health Research Ethics for Region Zealand (SJ-857) and results will be communicated in scientific papers, at relevant conferences and to a broader audience. Discussion: Exercise therapy and self-management support is safe and effective in people with single conditions. However, it is still unclear whether this holds true for individuals with multimorbidity. This pragmatic, multicenter RCT will provide high-quality evidence on the benefits and harms of exercise therapy and self-management support and, if the results support it, lead to the development of a plan for implementation in clinical practice.

Real life evaluation of sodium-glucose cotransporter 2 inhibition in type 1 diabetes and the risk of diabetic ketoacidosis.

BACKGROUND: The indication for treatment of type 1 diabetes(T1D) with the sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin has been withdrawn in Europe likely because of concern for diabetic ketoacidosis (DKA). We calculated the incidence of DKA in people with T1D treated with SGLT2i in Denmark. METHODS: Clinical data from adults with T1D in Denmark were collected from nine outpatient clinics. Electronic health records made the search for DKA accurate. RESULTS: From a population of 10.500 we observed 134 people treated with SGLT2i over a total period of 222 patient-years. Of those 72% were female, mean age (SD) was 51.4 (13.6) years and median duration of treatment (median, IQR) with an SGLT2i were 12.0 (6.0-29.0) months. The incidence of DKA was zero%. CONCLUSION: In 134 people with T1D treated with SGLT2i we found that none of the participants developed DKA during the treatment.

Interventions involving own treatment choice for people living with coexisting severe mental illness and type 1 or 2 diabetes: A scoping review.

AIM: The objective of this scoping review was to summarize, understand and provide an overview of the empirical literature on interventions involving own treatment choice for people with coexisting diabetes (type 1 and 2) and severe mental illness (SMI). METHODS: This scoping review undertook a systematic literature assessment. Searches were performed in MEDLINE, Embase, PsycINFO, Web of Science, CINAHL, the Cochrane Library and grey literature (OpenGrey, Google Scholar and Danish Health and Medicine Authority databases). Publications from 2000 to July 2020 were of interest. Studies were included if they involved the users' own choice of treatment. INCLUDED STUDIES: RCT, intervention, cohort and case-based studies. RESULTS: A total of 4320 articles were screened, of which nine were included. The review identified eight studies from the United States and one from Canada testing different interventions for people with SMI and diabetes (one diabetes education program, five randomized controlled trials, one retrospective cohort study, one naturalistic intervention program and one case vignette). The interventions described in the nine articles involved service users, the majority incorporated individualized healthcare plans, and all interventions were based on multidisciplinary teamwork. CONCLUSIONS: Research in the area is limited. Care management interventions tend to focus on a single condition, paradoxically excluding SMI during enrolment. Interventions aimed at people with both conditions often prioritize one condition treatment leading to an unbalanced care.

Monitoring patients with acute dyspnoea with a serial focused ultrasound of the heart and the lungs (MODUS): a protocol for a multicentre, randomised, open-label, pragmatic and controlled trial.

INTRODUCTION: Among patients admitted to an emergency department, dyspnoea is one of the most common symptoms. Patients with dyspnoea have high mortality and morbidity. Therefore, novel methods to monitor the patients are warranted. The aim is to investigate whether therapy guided by monitoring patients with acute dyspnoea with serial ultrasound examinations of the heart and the lungs together with standard care can change the severity of dyspnoea compared with treatment guided by standard monitoring alone. METHODS AND ANALYSIS: The study will be conducted as a multicentre, randomised, pragmatic, open-label and controlled trial where patients admitted with acute dyspnoea to an emergency ward will be randomised into a standard care group and a serial ultrasound group with 103 patients in each. All patients will be examined with an ultrasound of the heart and the lungs upfront. In addition, the patients in the serial ultrasound group will be examined with an ultrasound of the heart and lungs two more times to guide further therapy during the admittance. The primary outcome is a change in dyspnoea on a verbal scale. After discharge, the patients are followed for 1 year to assess the number of readmissions, death and length of hospital stay. ETHICS AND DISSEMINATION: The trial is conducted in accordance with the Declaration of Helsinki and approved by The Regional Committee on Health Research Ethics for Region Zealand, Denmark (identifier SJ-744). Data handling agreement with participating centres has been made (identifier REG-056-2019). The General Data Protection Regulation and the Danish Data Protection Act will be respected. The results of the trial will be reported in peer-reviewed scientific journals regardless of the outcomes. TRIAL REGISTRATION NUMBER: NCT04091334.