Effectiveness of internet-based platform to improve self management in schizophrenia: A cluster-randomized controlled trial

Main objectives of this study are to determine whether: - The use of an internet-based platform: Personal Control in Rehabilitation (PCR) results in: 1) patients experiencing more opportunities for self management, 2) better quality of life and 3) less care consumption - Whether PCR is implemented as meant and how its use is experienced by patients and their formal and informal caregivers. One large institution for protected living (RIBW) with more than 1100 inhabitants including more than 400 patients with schizophrenia living 250 separate locations will participate in the present longitudinal study. A cluster-randomized controlled trial design is used with measurements before the introduction of PCR and one year later. The questionnaire is completed by 76 patients and their formal and informal caregivers. Patients also complete a shortened questionnaire about self management and quality of life at 6 months. The introduction of PCR will be followed with a process and an effect evaluation. In the process evaluation a sample of patients, managers, formal and informal caregivers will be interviewed before the intervention and six and twelve months later to investigate whether PCR is implemented as meant and how its use is experienced. In the effect evaluation it will be studied whether the aims of the study will be obtained. Patients, formal and informal caregivers complete a questionnaire and data of the EPD and the use of PCR are gathered. PCR consists of an open portal and three protected, personalized portals for; 1) persons with schizophrenia, 2) their relatives/informal caregivers and 3) formal caregivers. The content and the usability of PCR is developed in close cooperation with patients and their formal and informal caregivers. Patients and caregivers can collect reliable information, cooperate, communicate and follow the course of treatment. In PCR several innovations are joined together: interventions regarding self management for patients (like shared decision making, screen to screen communication and the possibility to look into their personal signal and treatment plan), evidence based care programs for caregivers (from the multidisciplinary guideline), and interventions for improved cooperation between patients and their formal and informal caregivers (like shared decision making). It is expected that the number of long term face to face contacts with caregivers will decrease and short digital contacts will increase by the use of PCR, the number of crisis interventions and (re)admissions will decrease resulting in an overall reduction of 15% of the time spend by caregivers PCR is developed to support caregivers and patients in: - (shared) decision making about care and treatment - monitoring the course of disease and its treatment, and the course of rehabilitation and recovery - improving quality and continuity of care for people with schizophrenia. Main outcome variables are: self management, quality of life, social functioning of patients and Cost-utility of PCR, the number of long and short term contacts between caregivers and patients and the number (re)admissions, crisis interventions and no-shows. To reach a clinically relevant increase of 10% in our primary outcome measure, the Empowerment questionnaire (mean: 3.56, SD: 0.53), with a power of 0.8 and an alpha of 0.05 in an independent ANCOVA the required number of patients would be 38 in each of the two groups. This number is feasible since about 400 patients the RIBW fulfil the inclusion criteria and anticipating an attrition rate of 50%. The cost-utility of PCR versus usual care for schizophrenic patients will be evaluated. All health care use during the study period will be monitored using the electronic patient files of the Protected Living Institution participating. Quality of life will be monitored using EQ-5D. All health care use will be valued using a societal perspective. The cost-utility ratio will be estimated by dividing differences in total costs between intervention and care as usual group by differences in QALY's. TIME SCHEDULE 01-03-2012: Start of the project (making an inventory of current care, treatment and software used at the institution; testing elements of the PCR; implementing PCR, recruitment and training of patients, formal and informal caregivers to use PCR. 01-08/11-2012: Baseline measurement, start of the intervention (PCR), interviews with formal and informal caregivers, managers and patients, completion of the questionnaire by patients, formal and informal caregivers, measurement of clinical and care-related data for the process evaluation;. 01-02/05-2014: Completion of a short intermediate questionnaire by patients. 01-08/11-2014: First comprehensive follow-up measurement 01-03-2014: End of the project