Co-design and evaluation of a patient-centred transition programme for stroke patients, combining case management and access to an internet information platform: study protocol for a randomized controlled trial - NAVISTROKE.

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.

Development of a patient-centered transition program for stroke survivors and their informal caregivers, combining case-management and access to an online information platform: A user-centered design approach.

Background: During the hospital-to-home transition, stroke survivors and their caregivers face a significant lack of support and information which impacts their psychosocial recovery. We aimed to co-design a program combining individual support by a trained case-manager (dedicated professional providing individual support) and an online information platform to address needs of stroke survivors and caregivers. Methods: A two-step methodology was used. The first step followed a "user-centered design" approach during four workshops with stroke survivors, caregivers, and healthcare professionals to develop the platform and define the case-manager profile. The second step was a usability test of the platform following a Think Aloud method with patients and caregivers. The workshops and interviews were analyzed following a qualitative thematic analysis. The analysis of Think Aloud interviews was based on User Experience Honeycomb framework by Morville. Results: Eight participants attended the workshops: two patients, two caregivers, three nurses, and a general practitioner. Activities, training, and skills of the case-manager were defined according to stroke survivors and caregivers needs. Name, graphics, navigation, and content of the platform were developed with the participants, a developer and a graphic designer. The usability of the platform was tested with 5 patients and 5 caregivers. The Think Aloud confirmed satisfaction with graphics and content but a need for improvement regarding the navigability. An update of the platform was conducted in order to answer the needs expressed by participants. Conclusion: We developed, with a participatory approach, a patient-centered transition program, which will be evaluated in a randomized controlled trial.

Evaluating the impact of a standardised intervention for announcing decisions of withholding and withdrawing life-sustaining treatments on the stress of relatives in emergency departments (DISCUSS): protocol for a stepped-wedge randomised controlled trial.

INTRODUCTION: The decisions of withholding or withdrawing life-sustaining treatments are difficult to make in the context of emergency departments (EDs) because most patients are unable to communicate. Relatives are thus asked to participate in the decision-making process, although they are unprepared to face such situations. We therefore aimed to develop a standardised intervention for announcing decisions of withholding or withdrawing life-sustaining treatments in EDs and assess the efficacy of the intervention on the stress of relatives. METHODS AND ANALYSIS: The DISCUSS trial is a multicentre stepped-wedge cluster randomised study and will be conducted at nine EDs in France. A standardised intervention based on human simulation will be codesigned with partner families and implemented at three levels: the relatives, the healthcare professionals (HCP) and the EDs. The intervention will be compared with a control based on treatment as usual. A total of 538 families are planned to be included: 269 in the intervention group and 269 in the control group. The primary endpoint will be the symptoms of post-traumatic stress disorder (PTSD) at 90 days. The secondary endpoints will be symptoms of PTSD at 7 and 30 days, diagnosis of PTSD at 90 days and anxiety and depression scores at 7, 30 and 90 days. Satisfaction regarding the training, the assertiveness in communication and real-life stress of HCPs will be measured at 90 days. ETHICS AND DISSEMINATION: This study was approved by the ethics committee Est III from Nancy and the French national data protection authority. All relatives and HCPs will be informed regarding the study objectives and data confidentiality. Written informed consent will be obtained from participants, as required by French law for this study type. The results from this study will be disseminated at conferences and in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT06071078.