Screening and care for emotional and cognitive problems after stroke: A prospective mixed-methods process evaluation of a cluster-randomized controlled trial

BACKGROUND: Emotional and cognitive problems are prevalent after stroke. We developed an intervention including screening for emotional and cognitive problems, screening for participation restrictions, self-management support including education and, if needed, referral to rehabilitation services. This intervention was delivered through a nurse-led outpatient consultation at six weeks after stroke. Its effectiveness was examined in a patient-blinded, cluster-randomized controlled trial and its feasibility in a process evaluation. This process evaluation aims to (1) assess the reach, dose and fidelity of the intervention, (2) evaluate barriers and facilitators to implementation and (3) explore experiences from the perspective of healthcare providers. METHODS: A mixed-methods study was conducted. Specialized nurses offering the intervention completed registration forms to evaluate the reach, dose and fidelity of the intervention. The Barriers and Facilitators Instrument (BFAI) was used to evaluate barriers and facilitators. Furthermore, the specialized nurses participated in a group interview to explore experiences in delivering the intervention. Group interviews were analysed using inductive thematic analysis. RESULTS: In total, 262 of 264 patients (99.2%) attended the intervention. In 233 patients (88.9%), all screening instruments were completed. The BFAI demonstrated that the intervention was feasible and was not considered time-consuming or hindered by contextual factors. Barriers to deliver the intervention were limited to patient characteristics. During group interviews, specialized nurses reported that the intervention significantly overlapped with care as usual prior to start of the trial, yet indicated that the intervention provided a more profound understanding of post-stroke sequelae. CONCLUSIONS: The implementation of a nurse-led intervention, comprising screening and care for emotional and cognitive problems after stroke, was generally well executed and deemed feasible. If this intervention proves to be clinically and/or cost-effective in our upcoming primary analyses, we will advocate to incorporate it in daily clinical practice and to adhere to the implementation strategy as presented in this process evaluation. TRIAL REGISTRATION: This study was registered at 25 September 2018 in the Netherlands Trial Register (NL7295).