Towards community-based and recovery-oriented care for severe mental disorders in Southern and Eastern Europe: Aims and design of a multi-country implementation and evaluation study (RECOVER-E)

Background: Substantial strides have been made around the world in reforming mental health systems by shifting away from institutional care towards community-based services. Despite an extensive evidence base on what constitutes effective care for people with severe mental ill-health, many people in Europe do not have access to optimal mental health care. In an effort to consolidate previous efforts to improve community mental health care and support the complex transition from hospital-based to community-based care delivery, the RECOVER-E (LaRge-scalE implementation of COmmunity based mental health care for people with seVere and Enduring mental ill health in EuRopE) project aims to implement and evaluate multidisciplinary community mental health teams in five countries in Central and Eastern Europe. This paper provides a brief overview of the RECOVER-E project and its methods. Methods: Five implementation sites were selected (Sofia, Bulgaria; Zagreb, Croatia; Skopje, North Macedonia; Kotor, Montenegro; Siret-Suceava, Romania) where hospital-based mental health services are available (care as usual, CAU) for patients with severe mental disorders (severe depression, bipolar disorder, schizophrenia). The intervention consists of the introduction of a new service delivery model in each site, consisting of community-based recovery-oriented care delivered by trained multidisciplinary community mental health teams (including a peer worker with lived experience of a severe mental disorder). The implementation outcomes of the teams and the effect of the team's approach on patient and service utilisation outcomes will be evaluated using a mix of research methods. The study includes five planned hybrid implementation-effectiveness trials (1 per site) with patient-level randomization (n = 180, with patients randomised to either care as usual or intervention condition). Effectiveness is evaluated using a pragmatic non-blinded design with patients randomised into two parallel groups: receiving new community-based care or receiving usual care in the form of institutional, hospital-based mental health care. Trial-based health economic evaluation will be conducted; implementation outcomes will be evaluated, with data aligned with dimensions from the RE-AIM framework. Pathways to sustaining project results will be developed through policy dialogue sessions, which will be carried out in each country and through ongoing policy engagement activities at the European level. Discussion: The RECOVER-E project has been developed and conducted to demonstrate the impact of implementing an evidence-based service delivery model for people with severe mental illness in different contexts in middle-income countries in Central and Eastern Europe. It is expected that the results will contribute to the growing evidence-base on the health and economic benefits of recovery-oriented and community-based service models for health systems in transition. Trial registration Each trial was registered before participant enrolment in the clinicaltrials.gov database: Site - Croatia, Zagreb (Trial Reg. No. NCT03862209); Montenegro, Kotor (Trial Reg. No. NCT03837340); Romania, Suceava (Trial Reg. No. NCT03884933); Macedonia, Skopje (Trial Reg. No. NCT03892473); Bulgaria, Sofia (Trial Reg. No. NCT03922425)