Group medical appointments for neuromuscular patients
07 / 2008 - onbekend
To compare group medical appointment as a novel approach in care for chronic neuromuscular patients with conventional outpatient visits, in terms of health outcomes and costs.In the absence of definitive cures for chronic neuromuscular diseases, the improvement of quality of life, patient- and partner satisfaction with care, and functional capacity become key objectives of care. It is increasingly recognised that these objectives may be realized through greater self-efficacy. Self-efficacy refers to a patient s confidence in his or her ability to perform a task or specific behaviour or to change a specific cognitive state successfully (Bandura, 1997). Self-efficacy has been shown to be modifiable, and to be instrumental in translating educational and supportive interventions into improved health outcomes (Marks et al, 2005). The main research question of this project is whether group visits are more cost-effective than conventional one-to-one outpatient visits, resulting in better health outcomes (quality of life, patient- and partner satisfaction with care, functional activities) through greater self-efficacy while making more efficient use of one of the most scarce resources in health care: time. Objective(s) / research question(s):To compare group medical appointments (group visits) with conventional one to one appointments for patients with a chronic neuromuscular disease in terms of health outcome and costs. Group medical appointments are 2-hour physician appointments in the company of other patients with the same neuromuscular disease..study design:A randomised, prospective, controlled study. .study population(s)/ datasets:Patients with a specific chronic neuromuscular disease (myotonic dystrophy, facioscapulohumeral dystrophy, etc, see "plan van aanpak") and their partners. .intervention:Group medical appointments (group visits) with 10 patients and their partners during a 2 hour session at the outpatient clinic of the department of neurology. .outcome measures:Primary: quality of life; Secondary: self-efficacy, patient- and partner satisfaction with care, functional activities, service utilization and costs..sample size calculation/data analysis: On the basis of the literature (Blumenfeld et al, 2003; Bjorner et al, 2007) group visits are expected to lead to a clinically relevant improvement in quality of life (5 points on SF-36) compared to 1-to-1 visits. Based on a standard deviation of 12 (Ware et al 1993) at least 92 patients are needed in each group (alpha = 0.05, beta = 0.2, two-sided test). Taking into account non-evaluable patients, to adjust for imbalances and to be able to do subgroup analysis on age, sex, gender and severity (Rankin scale) 135 patients will be enrolled in each group (Bonferroni correction). In the control group, these patients will be seen on a 1-to-1 basis as usual. In the intervention group, these patients will be seen in group visits, comprising 6-10 patients and 6-10 partners.A mixed model ANOVA will be used to test differences between intervention and control patients with quality of life score as dependent variable, and study arm and any inbalance at baseline as independent variable..economic evaluation: Utilization of services will be measured in each participating patient. Unit cost prices will be used in accordance with national guidelines (Oostenbrink et al, 2004). An incremental cost-effectiveness analysis will be conducted from a societal perspective, relating differences in costs to difference in health outcome, as measured by the Euroqol-5D, an instrument to evaluate different health states..time schedule: Preparation of the trial: 3 months; enrollment and follow up of patients: 21 months; data analysis and reporting: 12 months.