Clinical trial NCT03862209: Community-based Mental Health Care for People With Severe and Enduring Mental Ill Health (RECOVER-E) Croatia
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: Severe Mental Disorder
Schizophrenia
Bipolar Disorder
Severe Depression
Keywords: Community implementation
Community engagement
patient centerednessP
Implementation science
Co-creation
Iterative learning processes
Lead sponsor: Klinički Bolnički Centar Zagreb
Sponsor class: OTHER
Collaborators: name: Stichting Trimbos-Instituut
First posted: 2019-03-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two study groups both consisting of patients with SMI (severe mental illness). One group will be receiving care as usual, which in the actual setting means mostly medical treatment, without home care and assertive treatment through community based outreach teams. Another, intervention group, will be receiving assertive treatment care, with mobile assertive teams, consisting of at least three team members.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To contribute to improving the level of functioning and quality of life and mental health outcomes for people with severe and enduring mental ill health (SMI) (schizophrenia, bipolar disorder, depression) by adapting and up scaling the implementation of a community-based service delivery model in Croatia.

Detailed description: For nearly 900 million people living in Europe, mental disorders constitute the most significant yet most neglected public health problem: depression affects an estimated 30.3 million Europeans, and psychotic disorders 5 million Europeans. People with severe and enduring mental ill health want the same things out of life as other citizens but are often placed in a vulnerable position and are hence afforded less opportunities to attain their goals and thus experience a lower quality of life, and have a lower life expectancy compared to the general population. For many countries that have undergone mental health services reform or have health systems in transition, efforts to make such comprehensive community-based mental health services available resulted in short-lived outcomes or are still to demonstrate substantial impact. RECOVER-E's aims to ensure well-functioning community mental health teams in 5 countries in Europe (Macedonia, Romania, Bulgaria, Croatia, and Montenegro), which will serve as the central node for coordination and provision of care for people with SMI. Our project narrows the implementation gap by going beyond infrastructure changes and pursuing 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 uptake after the project's life span. RECOVER-E will: 1) Develop evidence based care pathways and treatment protocols for transition to scale for regional and national decision makers in 5 implementation sites; 2) Establish a peer to peer capacity building partnership in community mental health by linking a European expert panel with key stakeholders in 5 implementation sites to co-create community mental health services for people with SMI) 3) Evaluate intervention elements that will enhance sustainable adoption and implementation of community-based mental health care for people with SMI, by carrying out implementation research.

Eligibility criteria: Inclusion Criteria:

Adults (ages 18-65), current service users, with severe and enduring mental ill-health, which, for clinical purposes, typically relates to diagnostic categories of bipolar disorder, severe depression, or schizophrenia. We use the following definition for SMI:

* Presence of a psychiatric disorder that requires care and treatment (so, they are NOT in symptom remission)
* Has severe limitations in social and community functioning (i.e. they are not in functional remission)
* These problems are not transient (e.g. temporary, one-off) in nature (They are systematic and long-term)
* Coordinated care provided by care networks or teams is needed to implement the treatment plan

Exclusion Criteria:

Exclusion criteria at the patient level includes patients who do not consent to their data being collected who are part of the intervention or control conditions, those who are under the age of 18 at the start of the study.

Primary outcomes:
measure: Changes in daily functioning
timeFrame: baseline, 12 months, 18 months
Secondary outcomes:
measure: Change in health-related quality of life
timeFrame: baseline, 12 months, 18 months
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: KBC Zagreb
Study officials:
affiliation: Department of Psychiatry
name: Martina Rojnić Kuzman, A/Prof.
role: STUDY_CHAIR
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.
citation: Shields-Zeeman L, Petrea I, Smit F, Walters BH, Dedovic J, Kuzman MR, Nakov V, Nica R, Novotni A, Roth C, Tomcuk A, Wijnen BFM, Wensing M. 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). Int J Ment Health Syst. 2020 Apr 22;14:30. doi: 10.1186/s13033-020-00361-y. eCollection 2020.