Department of Medical Decision Making, Leiden University Medical Centre, P,O, Box 9600, 2300, RC, Leiden, the Netherlands.
Implement Sci. 2012 Nov 21;7:113. doi: 10.1186/1748-5908-7-113.
Internet-based self-management (IBSM) support cost-effectively improves asthma control, asthma related quality of life, number of symptom-free days, and lung function in patients with mild to moderate persistent asthma. The current challenge is to implement IBSM in clinical practice.
METHODS/DESIGN: This study is a three-arm cluster randomized trial with a cluster pre-randomisation design and 12 months follow-up per practice comparing the following three IBSM implementation strategies: minimum strategy (MS): dissemination of the IBSM program; intermediate strategy (IS): MS + start-up support for professionals (i.e., support in selection of the appropriate population and training of professionals); and extended strategy (ES): IS + additional training and ongoing support for professionals. Because the implementation strategies (interventions) are primarily targeted at general practices, randomisation will occur at practice level.In this study, we aim to evaluate 14 primary care practices per strategy in the Leiden-The Hague region, involving 140 patients per arm. Patients aged 18 to 50 years, with a physician diagnosis of asthma, prescription of inhaled corticosteroids, and/or montelukast for ≥3 months in the previous year are eligible to participate. Primary outcome measures are the proportion of referred patients that participate in IBSM, and the proportion of patients that have clinically relevant improvement in the asthma-related quality of life. The secondary effect measures are clinical outcomes (asthma control, lung function, usage of airway treatment, and presence of exacerbations); self-management related outcomes (health education impact, medication adherence, and illness perceptions); and patient utilities. Process measures are the proportion of practices that participate in IBSM and adherence of professionals to implementation strategies. Cost-effective measurements are medical costs and healthcare consumption. Follow-up is six months per patient.
This study provides insight in the amount of support that is required by general practices for cost-effective implementation of IBSM. Additionally, design and results can be beneficial for implementation of other self-management initiatives in clinical practice.
the Netherlands National Trial Register NTR2970.
基于互联网的自我管理（IBSM）支持可在经济有效地改善轻度至中度持续性哮喘患者的哮喘控制、哮喘相关生活质量、无症状天数和肺功能。当前的挑战是将 IBSM 应用于临床实践。
方法/设计：这是一项三臂集群随机试验，采用集群预随机设计，每个实践的随访时间为 12 个月，比较以下三种 IBSM 实施策略：最小策略（MS）：传播 IBSM 计划；中间策略（IS）：MS+专业人员启动支持（即，选择合适人群和培训专业人员的支持）；和扩展策略（ES）：IS+专业人员的额外培训和持续支持。由于实施策略（干预措施）主要针对全科医生，因此将在实践层面进行随机分组。在这项研究中，我们旨在莱顿-海牙地区评估每种策略下的 14 个初级保健实践，每个臂下招募 140 名患者。年龄在 18 至 50 岁之间、有医生诊断的哮喘、在过去一年中至少使用了 3 个月的吸入皮质激素和/或孟鲁司特的患者有资格参加。主要结果测量指标是参与 IBSM 的转诊患者比例和哮喘相关生活质量有临床显著改善的患者比例。次要效果测量指标是临床结果（哮喘控制、肺功能、气道治疗的使用和加重的发生）；自我管理相关结果（健康教育效果、药物依从性和疾病认知）；和患者效用。过程测量指标是参与 IBSM 的实践比例和专业人员对实施策略的依从性。成本效益测量指标是医疗费用和医疗保健消费。每位患者的随访时间为 6 个月。
本研究提供了关于一般实践需要多少支持才能实现 IBSM 的成本效益的见解。此外，设计和结果可以为临床实践中其他自我管理计划的实施提供有益的参考。
荷兰国家试验注册 NTR2970。
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