Cost effectiveness and budgetary impact of the Boston University approach to Psychiatric Rehabilitation for societal participation in people with severe mental illness: a randomised controlled trial protocol

BACKGROUND People with Severe Mental Illness (SMI) frequently experience problems with regard to societal participation (i.e. work, education and daily activities outside the home), and require professional support in this area. The Boston University approach to Psychiatric Rehabilitation (BPR) is a comprehensive methodology that can offer this type of support. To date, several Randomised Controlled Trials (RCT's) investigating the effectiveness of BPR have yielded positive outcomes with regard to societal participation. However, information about the cost-effectiveness and budgetary impact of the methodology, which may be important for broader dissemination of the approach, is lacking. BPR may be more cost effective than Care As Usual (CAU) because an increase in participation and independence may reduce the costs to society. Therefore, the aim of this study is to investigate, from a societal perspective, the cost-effectiveness of BPR for people with SMI who wish to increase their societal participation. In addition, the budget impact of implementing BPR in the Dutch healthcare setting will be assessed by means of a budget impact analysis (BIA) after completion of the trial. METHODS In a multisite RCT, 225 adults (18-64 years of age) with SMI will be randomly allocated to the experimental (BPR) or the control condition (CAU). Additionally, a pilot study will be conducted with a group of 25 patients with severe and enduring eating disorders. All participants will be offered support aimed at personal rehabilitation goals, and will be monitored over a period of a year. Outcomes will be measured at baseline, and at 6 and 12 months after enrolment. Based on trial results, further analyses will be performed to assess cost-effectiveness and the budgetary impact of implementation scenarios. DISCUSSION The trial results will provide insight into the cost-effectiveness of BPR in supporting people with SMI who would like to increase their level of societal participation. These results can be used to make decisions about further implementation of the method. Also, assessing budgetary impact will facilitate policymaking. The large sample size, geographic coverage and heterogeneity of the study group will ensure reliable generalisation of the study results. TRIAL REGISTRATION Current Controlled Trials: ISRCTN88987322. Registered 13 May 2014.