Abstract Background: Cardiovascular disease is the leading cause of the estimated 11–25 years reduced life expectancy for persons with serious mental illness (SMI). This excess cardiovascular mortality is primarily attributable to obesity, diabetes, hypertension, and dyslipidaemia. Obesity is associated with a sedentary lifestyle, limited physical activity and an unhealthy diet. Lifestyle interventions for persons with SMI seem promising in reducing weight and cardiovascular risk. The aim of this study is to evaluate the effectiveness and cost-effectiveness of a lifestyle intervention among persons with SMI in an outpatient treatment setting. Methods: The Serious Mental Illness Lifestyle Evaluation (SMILE) study is a cluster-randomized controlled trial including an economic evaluation in approximately 18 Flexible Assertive Community Treatment (FACT) teams in the Netherlands. The intervention aims at a healthy diet and increased physical activity. Randomisation takes place at the level of participating FACT-teams. We aim to include 260 outpatients with SMI and a body mass index of 27 or higher who will either receive the lifestyle intervention or usual care. The intervention will last 12 months and consists of weekly 2-h group meetings delivered over the first 6 months. The next 6 months will include monthly group meetings, supplemented with regular individual contacts. Primary outcome is weight loss. Secondary outcomes are metabolic parameters (waist circumference, lipids, blood pressure, glucose), quality of life and health related self-efficacy. Costs will be measured from a societal perspective and include costs of the lifestyle program, health care utilization, medication and lost productivity. Measurements will be performed at baseline and 3, 6 and 12 months. Discussion: The SMILE intervention for persons with SMI will provide important information on the effectiveness, cost-effectiveness, feasibility and delivery of a group-based lifestyle intervention in a Dutch outpatient treatment setting. Trial registration: Dutch Trial Registration NL6660, registration date: 16 November 2017.
Background: Impaired upper extremity function due to muscle paresis or paralysis has a major impact on independent living and quality of life (QoL). Assistive technology (AT) for upper extremity function (i.e. dynamic arm supports and robotic arms) can increase a client’s independence. Previous studies revealed that clients often use AT not to their full potential, due to suboptimal provision of these devices in usual care. Objective: To optimize the process of providing AT for impaired upper extremity function and to evaluate its (cost-)effectiveness compared with care as usual. Methods: Development of a protocol to guide the AT provision process in an optimized way according to generic Dutch guidelines; a quasi-experimental study with non-randomized, consecutive inclusion of a control group (n = 48) receiving care as usual and of an intervention group (optimized provision process) (n = 48); and a cost-effectiveness and cost-utility analysis from societal perspective will be performed. The primary outcome is clients’ satisfaction with the AT and related services, measured with the Quebec User Evaluation of Satisfaction with AT (Dutch version; D-QUEST). Secondary outcomes comprise complaints of the upper extremity, restrictions in activities, QoL, medical consumption and societal cost. Measurements are taken at baseline and at 3, 6 and 9 months follow-up.
Background: The purpose of this study was to investigate the cost-effectiveness and budget impact of the Boston University Approach to Psychiatric Rehabilitation (BPR) compared to an active control condition (ACC) to increase the social participation (in competitive employment, unpaid work, education, and meaningful daily activities) of individuals with severe mental illnesses (SMIs). ACC can be described as treatment as usual but with an active component, namely the explicit assignment of providing support with rehabilitation goals in the area of social participation. Method: In a randomized clinical trial with 188 individuals with SMIs, BPR (n = 98) was compared to ACC (n=90). Costs were assessed with the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P). Outcome measures for the cost-effectiveness analysis were incremental cost per Quality Adjusted Life Year (QALY) and incremental cost per proportional change in social participation. Budget Impact was investigated using four implementation scenarios and two costing variants. Results: Total costs per participant at 12-month follow-up were e 12,886 in BPR and e 12,012 in ACC, a non-significant difference. There were no differences with regard to social participation or QALYs. Therefore, BPR was not cost-effective compared to ACC. Types of expenditure with the highest costs were in order of magnitude: supported and sheltered housing, inpatient care, outpatient care, and organized activities. Estimated budget impact of wide BPR implementation ranged from cost savings to e190 million, depending on assumptions regarding uptake. There were no differences between the two costing variants meaning that from a health insurer perspective, there would be no additional costs if BPR was implemented on a wider scale in mental health care institutions. Conclusions: This was the first study to investigate BPR cost-effectiveness and budget impact. The results showed that BPR was not cost-effective compared to ACC. When interpreting the results, one must keep in mind that the cost-effectiveness of BPR was investigated in the area of social participation, while BPR was designed to offer support in all rehabilitation areas. Therefore, more studies are needed before definite conclusions can be drawn on the cost-effectiveness of the method as a whole.
