Clinical trial NCT03884933: Large Scale Implementation of Community Based Mental Health Care for People With Severe and Enduring Mental Ill Health in Europe
Official title: Large Scale Implementation of Community Based Mental Health Care for People With Severe and Enduring Mental Ill Health in Europe
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Disorders, Severe
Lead sponsor: Liga Romana pentru Sanatate Mintala
Sponsor class: OTHER
Collaborators: name: Psychiatric Hospital for Chronic Patients Siret, Suceava, Romania
First posted: 2019-03-21
Enrollment: 180
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: RECOVER-E's main purpose is to ensure well-functioning community mental health teams in five countries in Europe; these teams will serve as the central node for the coordination and provision of care for people with severe mental illness (SMI). At present, specialist teams providing comprehensive, evidence-based mental health care are not available or functional in many countries in Eastern Europe, and the care pathways and evidence-based treatment protocols for community-based and recovery-oriented mental healthcare have not been defined or tailored to local situations and therefore, are not being implemented. This project aims to implement and study community-based initiatives to narrow this gap. These efforts will emphasize the development of human resource capacity and care pathways that can be distilled in a comprehensive pathway to scale for regional and national decision-makers for potential project expansion and replication after the project period.

Detailed description: AIMS / OBJECTIVES The overall aim of Recover-E is to contribute to the implementation of a community-based service delivery model in five implementation sites in low and middle-income countries and vulnerable populations in high-income countries in Europe to improve the level of functioning, quality of life, and mental health outcomes for people with severe and enduring mental ill health (schizophrenia, bipolar disorder, depression).

RECOVER-E's specific project objectives are to:

* design, implement and evaluate recovery-oriented care for people with severe mental illness in community settings by recognizing the value of experiential knowledge through including peer experts as members of the community mental health teams
* identify intervention and program elements, as well as contextual factors, which enhance sustainable implementation of community-based mental healthcare for people with severe mental illness
* establish a peer-to-peer capacity building partnership in community mental health, by linking a European expert panel with key stakeholders in five implementation sites (policy makers, service managers, service providers, users, and carers) to co-create community health services for people with SMI
* develop evidence-based care pathways and treatment protocols and transition to scale for regional and national decision-makers, for continued implementation and scale up after the project's life span

Eligibility criteria: Inclusion Criteria:The target population for inclusion in the study are consenting adults (ages 18-65 years) with severe mental illness (SMI), defined based on Deslespaul's conceptualisation of SMI:

1. meets criteria for (and presence of) bipolar disorder, severe major depression, schizophrenia, schizophreniform, and schizoaffective disorder according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10). The person should require care and treatment and not be in symptomatic remission;
2. has severe limitations in social and community functioning;
3. problems are not transient in nature; the problems are systematic and long-term, and potentially chronic, intermitted, and/or recurrent;
4. coordinated care provided by care networks or multidisciplinary teams is needed to deliver treatment
5. Patients with prevalence of suicidal behaviours (including suicide attempts)

Exclusion criteria are:

1. Patients under the age of 18
2. Patients with dementia or Alzheimer's disease
3. Patients for whom treatment is legally prescribed (in forensic psychiatry), however if they are discharged from the forensic ward, and still in need of treatment they can be included

Primary outcomes:
measure: The primary outcome is global (personal and social) functioning, measured with the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0).
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Siret
country: Romania
facility: Spitalul de Psihiatrie Cronici Siret
state: Suceava
Study officials:
References:
citation: Roth C, Wensing M, Kuzman MR, Bjedov S, Medved S, Istvanovic A, Grbic DS, Simetin IP, Tomcuk A, Dedovic J, Djurisic T, Nica RI, Rotaru T, Novotni A, Bajraktarov S, Milutinovic M, Nakov V, Zarkov Z, Dinolova R, Walters BH, Shields-Zeeman L, Petrea I. Experiences of healthcare staff providing community-based mental healthcare as a multidisciplinary community mental health team in Central and Eastern Europe findings from the RECOVER-E project: an observational intervention study. BMC Psychiatry. 2021 Oct 24;21(1):525. doi: 10.1186/s12888-021-03542-2.
citation: Wijnen BFM, Smit F, Uhernik AI, Istvanovic A, Dedovic J, Dinolova R, Nica R, Velickovski R, Wensing M, Petrea I, Shields-Zeeman L. Sustainability of Community-Based Specialized Mental Health Services in Five European Countries: Protocol for Five Randomized Controlled Trial-Based Health-Economic Evaluations Embedded in the RECOVER-E Program. JMIR Res Protoc. 2020 Jun 1;9(6):e17454. doi: 10.2196/17454.