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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Dec 13, 2019
Date Accepted: Mar 21, 2020

The final, peer-reviewed published version of this preprint can be found here:

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

Wijnen BF, 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;9(6):e17454

DOI: 10.2196/17454

PMID: 32476658

PMCID: 7296406

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Sustainability of community-based specialised mental health services in five European countries: Protocol for five RCT-based health-economic evaluations embedded in the RECOVER-E programme

  • Ben F.M. Wijnen; 
  • Filip Smit; 
  • Ana Ivičević Uhernik; 
  • Ana Istvanovic; 
  • Jovo Dedovic; 
  • Roumyana Dinolova; 
  • Raluca Nica; 
  • Robert Velickovski; 
  • Michel Wensing; 
  • Ionela Petrea; 
  • Laura Shields-Zeeman

ABSTRACT

Background:

Community-based recovery-oriented mental health services for people with severe mental disorders have not been fully implemented in Bulgaria, Croatia, Macedonia, Montenegro and Romania. The Recover-E project facilitates the implementation of specialised mental health care delivered by setting up, implementing their services and evaluating multidisciplinary community mental health teams. The outcomes of the Recover-E project are assessed in a trial-based outcome evaluation in each of the participating countries with a health-economic evaluation linked to these trials.

Objective:

The aim of this protocol paper is to describe the methodology that will be used for the health-economic evaluation alongside the trials.

Methods:

Implementation sites have been selected in each of the five countries where hospital-based mental health services are available (care as usual, CAU) for patients with severe mental disorders (severe depression, bipolar disorder, schizophrenia and other psychotic disorders). The newly implemented healthcare system will be community-based recovery-oriented care (CMHT). In each site, 180 consenting patients will be randomised to either CAU or CMHT. Patient-level outcomes are personal and social functioning and quality adjusted life years (QALYs). Data on the participants’ healthcare use will be collected and corresponding healthcare costs will be computed. This enables evaluation of healthcare costs of CMHT vis-à-vis/compared to CAU and these costs can be related to patient-level outcomes (functioning, QALY gains) in the health-economic evaluation. The results of the outcome evaluations will be reported for each of the five countries apart, and the five trials will be pooled for multi-level analysis on the combined dataset.

Results:

NA

Conclusions:

Results of the health economic evaluation of Recover-E 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. Clinical Trial: The five trial have been registered separately for every site: 1) NCT03922425 (Bulgaria); 2) NCT03862209 (Croatia); 3) NCT03892473 (Macedonia); 4) NCT03837340 (Montenegro); 5) NCT03884933 (Romania).


 Citation

Please cite as:

Wijnen BF, 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;9(6):e17454

DOI: 10.2196/17454

PMID: 32476658

PMCID: 7296406

Per the author's request the PDF is not available.