PORTALS: design of an innovative approach to anticoagulation management through eHealth.

BACKGROUND: For the monitoring of International Normalized Ratio (INR) values, venous thromboembolism (VTE) and atrial fibrillation (AF) patients can visit anticoagulation clinics, laboratories, or physicians for venous puncture. Point-of-care testing (POCT) made it possible for patients to monitor INR themselves (self-monitoring) and even self-adjust their medication dosage (self-dosage). Both skills are accepted as forms of self-management. eHealth applications can improve this self-management, resulting in better clinical outcomes. METHODS: Our study, called PORTALS, aims at identifying the optimal implementation strategy of training to improve self-management and explore factors that enhance good self-management skills. In addition, the relationship between the implementation strategy of training, clinical outcomes, and individual characteristics will be investigated. Of the 247 recruited participants, 110 chose to continue with regular care. 137 patients have been randomly divided in subgroups and compared using a parallel cohort design: one group will be trained and educated by e-learning, and the other group will receive face-to-face group training. DISCUSSION: More insight in factors that enhance good self-management will help to improve clinical outcomes and patient satisfaction on anticoagulation therapy. Our study will provide practical insights and knowledge of eHealth in daily practice and of the importance of education on the adoption of self-management. We expect the self-management program including training to help patients to better manage their own INR values and medication use, thereby increasing health status and diminishing thromboembolic events and hospitalisation. TRIAL REGISTRATION: The Netherlands National Trial Register, number NTR3947 .

e-Vita: design of an innovative approach to COPD disease management in primary care through eHealth application.

BACKGROUND: COPD is a highly complex disease to manage as patients show great variation in symptoms and limitations in daily life. In the last decade self-management support of COPD has been introduced as an effective method to improve quality and efficiency of care, and to reduce healthcare costs. Despite the urge to change the organisation of health care and the potential of eHealth to support this, large-scale implementation in daily practice remains behind, especially in the Netherlands. METHODS/DESIGN: We designed a multilevel study, called e-Vita, to investigate different organisational implementation methods of a self-management web portal to support and empower patients with COPD in three different primary care settings. Using a parallel cohort design, the clinical effects of the web portal will be assessed using an interrupted times series (ITS) study design and measured according to changes in health status with the Clinical COPD Questionnaire (CCQ). The different implementations and net benefits of self-management through eHealth on clinical outcomes will be evaluated from human, organisational, and technical perspectives. DISCUSSION: To our knowledge this is the first study to combine different study designs that enable simultaneous investigation of clinical effects, as well as effects of different organisational implementation methods whilst controlling for confounding effects of the organisational characteristics. We hypothesize that an implementation with higher levels of personal assistance, and integrated in an existing care program will result in increased use of and satisfaction with the platform, thereby increasing health status and diminishing exacerbation and hospitalisation. TRIAL REGISTRATION: NTR4098 (31-07-2013).

e-Vita: design of an innovative approach to COPD disease management in primary care through eHealth application.

BACKGROUND: COPD is a highly complex disease to manage as patients show great variation in symptoms and limitations in daily life. In the last decade self-management support of COPD has been introduced as an effective method to improve quality and efficiency of care, and to reduce healthcare costs. Despite the urge to change the organisation of health care and the potential of eHealth to support this, large-scale implementation in daily practice remains behind, especially in the Netherlands. METHODS/DESIGN: We designed a multilevel study, called e-Vita, to investigate different organisational implementation methods of a self-management web portal to support and empower patients with COPD in three different primary care settings. Using a parallel cohort design, the clinical effects of the web portal will be assessed using an interrupted times series (ITS) study design and measured according to changes in health status with the Clinical COPD Questionnaire (CCQ). The different implementations and net benefits of self-management through eHealth on clinical outcomes will be evaluated from human, organisational, and technical perspectives. DISCUSSION: To our knowledge this is the first study to combine different study designs that enable simultaneous investigation of clinical effects, as well as effects of different organisational implementation methods whilst controlling for confounding effects of the organisational characteristics. We hypothesize that an implementation with higher levels of personal assistance, and integrated in an existing care program will result in increased use of and satisfaction with the platform, thereby increasing health status and diminishing exacerbation and hospitalisation. TRIAL REGISTRATION NUMBER: NTR4098 (31-07-2013).