Large Scale Implementation of Community Based Mental Health Care for People With Severe and Enduring Mental Ill Health in Europe

Mental Disorders, Severe Clinical Trial

— RECOVER-E  

Official title:

Large Scale Implementation of Community Based Mental Health Care for People With Severe and Enduring Mental Ill Health in Europe

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03884933
• Other study ID #: 779362
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2019
• Source: Liga Romana pentru Sanatate Mintala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: December 31, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Mental Disorders, Severe
• Psychotic Disorders

Intervention

Other:
• Mobile team community mental health services
The intervention focuses on changing mental health care systems to be able to provide community-based mental health care for people with severe mental illness. This will be done through the development and implementation of multidisciplinary community mental health teams (CMHTs) in each of the implementation sites, consisting of at least one nurse, psychiatrist, psychologist, social worker, and peer worker (person with lived experience of a severe mental illness). The structure and delivery method of the community mental health teams is part of an evidence-based service delivery model providing flexible, assertive community mental health teams providing integrated services to people with severe mental illness (SMI) in order to structurally attain their recovery goals, as well as timely and appropriate care in the event of a crisis.

Locations

Country	Name	City	State
Romania	Spitalul de Psihiatrie Cronici Siret	Siret	Suceava

Sponsors (2)

Lead Sponsor	Collaborator
Liga Romana pentru Sanatate Mintala	Psychiatric Hospital for Chronic Patients Siret, Suceava, Romania

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is global (personal and social) functioning, measured with the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0).	The WHODAS 2.0 is a generic measure designed to measure functioning and disability as well as health-related quality of life based on the Internal Classification of Functioning (ICF) framework. The WHODAS 2.0 will be used as a continuous outcome in the clinical trial evaluation. The scale comes in 12- and 36-item versions. The 36-item version captures the level of functioning in six domains of life: Domain 1: Cognition - understanding and communicating Domain 2: Mobility - moving and getting around Domain 3: Self-care - attending to one's hygiene, dressing, eating and staying alone Domain 4: Getting along - interacting with other people Domain 5: Life activities - domestic responsibilities, leisure, work and school Domain 6: Participation - joining in community activities, participating in society; The 12-item version helps to assess overall (global) functioning only. Therefore, it is planned to use the 36-itme self-report version of the WHODAS 2.0.	18 months