Heart Rehabilitation for All (HeRTA): Protocol for a feasibility study and pilot randomized trial.

INTRODUCTION: Today, 50% of people with cardiac disease do not participate in rehabilitation. The HeRTA-study aims to develop and test a sustainable rehabilitation model supporting vulnerable patients in participating in rehabilitation and long-term physical activity. METHODS: A feasibility study with a non-blinded pilot randomized trial was developed in collaboration with partners and cardiac patients to test a multi-component rehabilitation intervention across hospital, municipality, and civil society. The study runs from January 2020 to December 2024. Eligibility criteria for participants: a) diagnosed with either ischemic heart disease, persistent atrial fibrillation, heart failure, or have had cardiac valve surgery, b) residents in Hvidovre Hospitals uptake area, c) cognitively functional, d) physically able to participate in rehabilitation. Patient recruitment will be located at Hvidovre Hospital, Capital Region of Denmark, data collection at Hvidovre Hospital, Rehabilitation Center Albertslund, the Danish Heart Association, and in two municipalities (Hvidovre and Brøndby). Patients in the control group have access to usual care at the hospital: rehabilitation-needs-assessment, patient education, and physical training. After or instead of hospital rehabilitation, the patient can be referred to municipal rehabilitation with patient education, and a total of 12 weeks of physical training across sectors. Patients in the intervention group will in addition to usual care, have access to an information book about cardiac disease, patient supporters from the Danish Heart Association, Information materials to inform employers about the employees' rehabilitation participation, a rehabilitation goal setting plan, a support café for relatives, and follow-up phone calls from physiotherapists 1 and 3 months after rehabilitation to support physical activities. Patients with vulnerabilities will additionally receive patient education conducted in small groups, pro-active counselling by a cardiac nurse, psychologist, or social worker, paid transportation to rehabilitation, and paid membership in a sports association. Patients are computer block-randomized so patients with vulnerability are distributed evenly in the two study arms by stratifying on a) a cut-off score of ≥ 5 in the Tilburg Frailty Indicator questionnaire and/or b) need of language translator support. A power calculation, based on an estimated 20% difference in participation proportion between groups, 80% power, a type 1 error of 5% (two-tailed), results in 91 participants in each study arm. The primary outcome: rehabilitation participation (attending ≥ two activities: patient education, smoking cessation, dietary counseling, and physical training) and reaching at least 50% attendance. Secondary outcomes: health-related quality of life, coping strategies, level of physical activities, and sustainability regarding participation in active communities after rehabilitation. The study is registered at ClinicalTrials.gov (NCT05104658). RESULTS: Differences between changes in outcomes between groups will be analyzed according to the intention-to-treat principle. Sensitivity analysis and analysis of the effect of the combined activities will be made. A process evaluation will clarify the implementation of the model, the partnership, and patients' experiences. CONCLUSION: Cross-sectoral collaborations between hospitals, municipalities, and organizations in civil society may lead to sustainable and affordable long-term physical activities for persons with chronic illness. The results can lead to improve cross-sectoral collaborations in other locations and patient groups.

Protocol for a cluster-randomized non-inferiority trial of the effect of direct access to publicly subsidized physiotherapy for adults with musculoskeletal pain.

BACKGROUND: In the Danish healthcare system, direct access to physiotherapy is an option, but public subsidy for treatment requires referral from a general practitioner. To relieve general practice of unnecessary consultations and provide patients with easier access to relevant treatment, direct access to publicly subsidized physiotherapy has been suggested. METHODS: Direct access to subsidized physiotherapy will be evaluated in a controlled design and has a duration of one year. Physiotherapy clinics invite eligible patients to participate in the evaluation. Participants complete questionnaires at baseline and six weeks and six months after baseline. Physical health status (ShortForm-12v2) is the primary outcome. In addition, the evaluation will assess the use of services in general practice, physiotherapy, specialists in private practice and hospitals and referrals to diagnostic imaging. A process evaluation will assess the attitude to and implementation of direct access to subsidized physiotherapy through the experiences and attitudes of local general practitioners, secretaries and physiotherapists in participating clinics. DISCUSSION: This intervention may affect the point of entry to health care services. For the intervention group the physiotherapists assume responsibility in symptom assessment. During recruitment registration of red flags in physiotherapy is closely monitored. The results of the study may be used to assess if direct access to subsidized physiotherapy is a way to relieve the workload in general practice while maintaining or improving patient level outcomes. TRIAL REGISTRATION: The project was reported to The Committee on Health Research Ethics of the Capital Region of Denmark with protocol number J.nr.: H-19074802. The Committee assessed the project as not registrable and therefore can be implemented without further permission. This trial has been registered at the Danish Data Protection Agency (J.nr.: P-2019-672). The trial has been registered at ClinicalTrials.gov (identifiers: NCT04900480).

Design of a tailored and integrated violence prevention program in psychiatric wards and prisons.

BACKGROUND: Violence and threats of violence against personnel at psychiatric wards as well as in the prison service is a major work environment problem. To date results from interventions to prevent violence and threats in these sectors have been inconclusive or of small effect. One of the reasons may be that violence and threats of violence occur as a consequence of a complex interaction between employee-level and management-level factors. OBJECTIVE: To design a tailored and theory-based intervention program directed at violence prevention in psychiatric wards and prisons that integrates the employee-level and management-level, and development of an evaluation design building on the Context, Process, and Outcome Evaluation Model. METHODS: The study follows a stepped-wedged design with 16 work units entering the intervention in four groups with differing start dates from September 2017 to January 2019. The context and process evaluation includes: calculating the implementation degree; mapping of contextual factors; interviews with unit-leaders and employees before and after the intervention. The outcome evaluation includes performing multi-level statistical analysis on data from a three-monthly questionnaire to employees at the participating workplaces. RESULTS: The first results will be available in 2020. CONCLUSIONS: The comprehensive evaluation of the intervention will give insight into the processes and effects of the intervention.