JMIR Publications

ABSTRACT

Background Around one-third of all patients with schizophrenia are classified as "treatment-resistant". Across the globe, there is under-treatment with clozapine and other effective treatment options for people with treatment-resistant schizophrenia (TRS). In this respect, it appears that regular healthcare models do not optimally fit this particular patient group. The Collaborative Care model (CC) has proven to be effective for patients with severe mental illness, both in primary care and in specialized mental healthcare facilities. The key principles of the CC model is that both patients and informal caregivers are part of the treatment team, that a structured treatment plan is put in place with planned evaluations by the team, and that the treatment approach is both multidisciplinary in nature and uses evidence-based interventions. We have developed a tailored CC-program for patients with TRS (CC-TRS). In this paper, we provide an overview of the research design for a potential study that seeks to gain insight into both the process of implementation and the preliminary effects of CC-TRS. Moreover, we will aim to gain insight into the experiences of professionals, patients and informal caregivers with the program. Methods The study will be underpinned by a multiple case-study design (N = 20) that utilizes a mixed-methods approach. These case studies will focus on one Early Intervention in Psychosis Team (EIT) and two Flexible Assertive Community treatment (FACT) teams in the Netherlands. Data will be collected from patients’ records as well as through questionnaires, individual interviews and focus groups. We began the process of recruiting patients in October 2020. Discussion The research design is discussed in line with the aims of the study, which are framed within the process of developing and testing innovative interventions. The limitations in clinical practice as well as their specific consequences for this study are explained. Trial registration AsPredicted (#62738), pre-registration titled 'Collaborative care for patients with treatment-resistant schizophrenia', registered 13 April 2021. https://aspredicted.org/gk958.pdf.