Background Stroke affects many aspects of life in stroke survivors and their family, and returning home after hospital discharge is a key step for the patient and his or her relatives. Patients and caregivers report a significant need for advice and information during this transition period. Our hypothesis is that, through a comprehensive, individualised and flexible support for patients and their caregivers, a patient-centred post-stroke hospital/home transition programme, combining an Internet information platform and telephone follow-up by a case manager, could improve patients’ level of participation and quality of life. Methods An open parallel-group randomized trial will be conducted in two centres in France. We will recruit 170 adult patients who have had a first confirmed stroke, and were directly discharged home from the stroke unit with a modified Rankin score ≤3. Intervention content will be defined using a user-centred approach involving patients, caregivers, health-care professionals and social workers. Patients randomized to the intervention group will receive telephonic support by a trained case manager and access to an interactive Internet information platform during the 12 months following their return home. Patients randomized to the control group will receive usual care. The primary outcome is patient participation, measured by the “participation” dimension score of the Stroke Impact Scale 6 months after discharge. Secondary outcomes will include, for patients, quality of life, activation, care consumption, as well as physical, mental and social outcomes; and for caregivers, quality of life and burden. Patients will be contacted within one week after discharge, at 6 and 12 months for the outcomes collection. A process evaluation alongside the study is planned. Discussion Our patient-centred programme will empower patients and their carers, through individualised and progressive follow-up, to find their way around the range of available healthcare and social services, to better understand them and to use them more effectively. The action of a centralised case manager by telephone and the online platform will make it possible to disseminate this intervention to a large number of patients, over a wide area and even in cases of geographical isolation. Trial registration: ClinicalTrials NCT03956160, Posted: May-2019 and Update: September-2021.
IntroductionThe prognosis of first episode psychosis (FEP), which is a severe disorder, can be notably impaired by patients’ disengagement from healthcare providers. Coordinated specialty care with case management is now considered as the gold standard in this population, but there are still challenges for engagement with subsequent functional impairments. Youth-friendly and patient-centred clinical approaches are sought to improve engagement in patients with FEP. Mobile applications are widely used by young people, including patients with FEP, and can increase the youth friendliness of clinical tools. We hypothesise that a co-designed mobile application used during case management can improve functioning in patients with FEP as compared with usual case management practices.Methods and analysisA mobile case management application for planning and monitoring individualised care objectives will be co-designed with patients, caregivers and health professionals in a recovery-oriented approach. The application will be compared with usual case management practices in a multicentre, two-arm and parallel groups clinical trial. Patients will be recruited by specialised FEP teams. Impact on functioning will be assessed using the Personal and Social Performance Scale; the variation between baseline and 12 months in each group (control and active) will be the primary outcome.Ethics and disseminationThis study has been approved by the Inserm Institutional Review Board IRB00003888 (Comité d’évaluation éthique de l’INSERM, reference number 20-647). The results of the study will be published in a peer-reviewed journal and presented at national and international conferences. We will also communicate the results to patients and family representatives’ associations. An optimised version of the application will be then disseminated through the French FEP network (Transition Network).Trial registration numberClinicalTrials.gov: NCT04657380
Background Implementing practices adapted to patient health literacy (HL) is a promising avenue for improving their outcomes in the context of cardiovascular diseases (CVD). The health communication skills of healthcare professionals (HCPs) and the quality of information provided are essential for low-HL patients. We aimed to explore HCP knowledge about HL, patients’ and HCPs’ views on current practices regarding low-HL patients, and facilitators and barriers to adapting communication to patients’ HL level, in order to prepare the implementation of a complex intervention dedicated to improve CVD management for low-HL patients. Methods We conducted face-to-face semi-structured interviews with HCPs practicing in cardiology units and patients hospitalized for CVD. The study design and analysis were based on the Theory of Planned Behavior for HCPs and on the framework of Health Literacy and Health Action for patients. Deductive and inductive thematic analysis were used. Barriers and facilitators were structured into an Ishikawa fishbone diagram and implementation strategies were selected to address resulting themes from the Expert Recommendations for Implementing Change (ERIC). Results Fifteen patients and 14 HCPs were interviewed. HCPs had partial knowledge of HL dimensions. Perceptions of HCPs and patients were not congruent regarding HCP-patient interactions and information provided by hospital and community HCPs. HCPs perceived they lacked validated tools and skills, and declared they adapted spontaneously their communication when interacting with low-HL patients. Patients expressed unmet needs regarding communication during hospital discharge and at return to home. Conclusion To implement HL-tailored practices in this setting, our results suggest that several implementation strategies will be valuable at individual (engaging patients and their family), interactional (educating and training of HCPs about HL), and organizational levels (creating a multidisciplinary HCP interest group dedicated to HL). Trial registration ClinicalTrials.gov, (NCT number) NCT03949309, May 10, 2019.
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