ENGLISH translation : Psychosocial Rehabilitation Research - REHABase Cohort

The trajectories and profiles of the patients in rehabilitation are varied and complex. In order to improve the quality of care, it is important to understand the evolution of the people receiving rehabilitation support, so that we can improve the methods of care available to them, respond to their needs and facilitate their recovery. It is in this context that the Resource Centre for Psychosocial Rehabilitation and Cognitive Remediation (CRR) has developed the REHABase project under the direction of Professor Nicolas Franck.

Until now, the study of the effects of psychosocial rehabilitation on people impacted by a range of severe mental health disorders (eg. bipolarity, schizophrenia, autistic spectrum disorders, severe personality disorders, etc.) across a large cohort of service users, has not been carried out in France. This is crucial in order to gather aggregate data, giving a broad overview of the efficacy of different support mechanisms and treatments.

Other « cohort studies » do exist, but they are based on the long-term treatment of specific mental health conditions and how they evolve. The REHABase cohort is made up of service-users coming from 8 psychosocial rehabilitation centres spread across France (6 referral centres and 2 outreach centres) (see map below). The aim of this study is not to exclusively monitor people affected by a specific diagnosis, but to consider the impact of psychosocial rehabilitative support across a wide cross-section of service-users, using a functional and trans-nosographic approach. A large range of sociodemographic, clinical, and functional data will be collected and stored in a database over the course of 15 years. In November 2018, there were 1900 registered users in this database.


Map of rehabilitation centres participating in the REHABase cohort in January 2019


History

Created in 2015, the CRR contributes to the development of new methods of diagnosis, evaluation, and care for people with mental health issues.

One of the CRR’s core missions is to support research through the development of a secure computerised database, facilitating specific research projects and/or public health studies. These projects conducted by various health practitioners aim to improve the quality of the care provided, and to assess the efficacy of the programmes offered in the field of psychosocial rehabilitation.

In June 2015, AuRA’s 3 referral centres (SUR-CL3R in Lyon, C3R in Grenoble, and REHALISE in St Etienne) developed the tools and standardised the procedures required to create the REHABase database. These three centres started collecting data from the cohort in January 2016. In November 2017, 2 new reference centres joined the project (C2RP in Bordeaux and C2RL in Limoges; CReATIV, in Poitiers, participates in the project in connection with C2RL). In September 2018, the reference centre in Clermont-Ferrand also joined the project, as did the nearby centre in Roanne.


Objective

REHABase has three main objectives :
1. Compilation of data: Listing the profiles of people seeking psychosocial rehabilitative support, including details pertaining to their identity, pathology and treatment, in turn facilitating the creation of a rich database.
2. Studying rehabilitation trajectories: analysing the evolving trajectories of people receiving care to better understand the processes of change and to respond effectively to the demands and needs of the service-users.
3.To determine the impact of rehabilitation in terms of social and professional integration: to measure the integration rates during rehabilitative treatment.

The pool of data generated will enable large-scale statistical studies to be carried out in order to: :

  • better understand the profiles of the service-users
  • to improve the quality of care
  • to improve the knowledge and visibility of strategies and tools used in psychosocial rehabilitation for people experiencing severe psychiatric disorders within the scientific community

The systematisation of data collection and the involvement of a variety of teams of clinicians and researchers from different disciplines are key to the positive dynamics of this project.

Their involvement facilitates the development of a national research network aimed at improving knowledge and the quality of rehabilitation care. This will ultimately contribute to improving the quality of life of people experiencing severe mental health issues.

Care plan

To encourage recovery, rehabilitative care must be designed around the patients’ needs. Therefore, the initial assessment is crucial in the construction of a care plan that respects their specific needs and will enable their rehabilitation.

1. Initial assessment

The initial assessment is multidisciplinary, and accounts for the person’s daily routine, lifestyle, level of independence, goals and desires etc.

This initial assessment consists of a medical interview, a review of their day-to-day life and a neuropsychological assessment. All of this data is entered into the REHABase database.

Once the individualised care plan has been drawn up, the service-user can either continue his or her journey within the service or be redirected to another facility if the appropriate treatments are not provided at the centre, in which case his or her exit from the process is recorded in REHABase.

2. Rehabilitative care

If the support set out in the individualised care plan can be facilitated in the reference centre, the service-user undertakes their rehabilitative care there.

Data relating to care is then collected, such as the type of treatment, dates and hourly volume. Several types of support can be provided simultaneously or at staggered intervals. A follow-up evaluation is systematically carried out one year after the initial assessment. Once the course of treatment at the reference centre has been completed, a final assessment is carried out.

Data collection process

Database

The specificity of the database is the multidisciplinary nature of the professionals involved in the care of service-users and therefore the input of varied data. As the data comes from different sources, it was necessary to opt for a centralised database, hosted on a secure server and administered by a service provider approved in the administration of biomedical data.
The OpenClinica platform was chosen as the input interface, which is accessible via a simple web browser. It is secure, specialised, and compatible with compliance of good clinical practice. This open source application is characterised by its adaptability and can be easily customised according to data entry and processing needs. The data is anonymised as the list of contacts is stored locally at each reference centre in a secure file controlled by the structure’s IT department.  



Each reference centre records its own data. The data is then shared (i.e. accessible to all research project leaders who are members of the CRR) after validation by the clinical research officer. The data is extracted and analysed by the biostatistician under the supervision of the project leaders.

Ethics and confidentiality

This is an observational study of current rehabilitative treatments, which has been submitted to the relevant authorities - CCTIRS (Consultative Committee on Information Processing in Health Research) and CNIL (National commission of Information and Freedom).

The collection of medical data in the CRR database, intended to be used in support of biomedical research, was authorised by the CCTIRS on 29/03/2016 (#16.060bis). The method of anonymisation of the data, proposed in order to ensure the confidentiality of its collection, exchange and analysis, was validated by the CNIL in the form of a "Declaration of Conformity to the MR003 Reference Methodology" (#2035126 of 14/02/2017), and a notification of authorisation (#DR-2017-268 of 04/09/2017).

Before any data entry takes palce, the psychiatrist, during the first appointment, must ask for the patient’s consent to participate in the research and no data entry is possible without this consent. Patients are informed that they are free to stop their participation and request the deletion of their data at any time.

Organisation

The project’s coordinating team is part of the CRR, based at Le Vinatier hospital in Lyon.

The CRR team is multidisciplinary and includes two psychiatrists, two neuropsychologists, two clinical research associates, a biostatistician, a secretary, a peer health mediator, a librarian-webmaster and a communications officer.

The CRR’s missions in terms of research are :

  • to support the reference centres and ensure the smooth running of data entry for the REHABase cohort (user support, IT problems, regulatory aspects, etc.),
  • to guarantee the consistency and quality of the data,
  • to guide the reference centres in the collection of their own data,
  • extract and analyse data at the centre, on a national level,
  • to coordinate meetings,
  • to help build research dynamics within multidisciplinary teams,
  • organise the communication of results