van Dijk-de Vries Anneke, van Bokhoven Marloes A, Terluin Berend, van der Weijden Trudy, van Eijk Jacques Th M
BMC Fam Pract. 2013 Jun 7;14:77. doi: 10.1186/1471-2296-14-77.
Psychosocial problems are more prevalent among patients with chronic diseases than among the general population. They may lead to a downward spiral of poor adherence, deterioration of the condition and decline in daily functioning. In addition to medical management, systematic attention to emotional and role management tasks during routine chronic care seems mandatory. We intend to integrate an existing nurse-led minimal psychological intervention to support patients' self-management, which appeared to be effective and cost-effective, in routine care by primary care nurses, so we adjusted it to fit the host setting. The resulting Self-Management Support (SMS) programme involves early detection of patients with emotional distress and problems of daily functioning, as well as self-management support through problem solving and reattribution techniques. Strategies to embed SMS in daily practice include training and booster sessions for practice nurses as well as organisational and financial arrangements. This study aims to simultaneously evaluate the implementation process and effects of SMS in routine care, using a hybrid effectiveness-implementation design.
METHODS/DESIGN: Registration data, questionnaires and interviews will be used to explore the facilitators, barriers and costs regarding successful implementation of SMS. The effects of SMS will be evaluated in a pragmatic cluster-randomised controlled trial with a baseline measurement and follow-up measurements after 4 and 12 months. The population will consist of 46 practice nurses and their type 2 diabetes patients (N = 460; 10 per practice nurse). The practice nurses will be randomly assigned to the intervention or control group. Practice nurses of the intervention group will receive SMS training. Patients for the intervention and control groups will be recruited by a researcher-led self-administered screening procedure to decide which patients of those scheduled for routine consultation are likely to be detected by the practice nurses as eligible for the self-management support. Primary outcome measure is patients' daily functioning. Secondary measures include emotional well-being, participation, autonomy and control over the disease.
Our hybrid study design is complicated by the detection method used by the practice nurses. This method is an implementation issue in itself that has consequences for the realisation and power of the effect evaluation.
Current Controlled Trials, NTR2764.
与普通人群相比，心理社会问题在慢性病患者中更为普遍。这些问题可能导致依从性差、病情恶化和日常功能下降的恶性循环。除了医疗管理外，在常规慢性病护理期间系统关注情绪和角色管理任务似乎是必要的。我们打算将现有的由护士主导的最小心理干预措施整合到初级护理护士的常规护理中，以支持患者的自我管理，该干预措施似乎有效且具有成本效益，因此我们对其进行了调整以适应所在环境。由此产生的自我管理支持（SMS）计划包括早期发现有情绪困扰和日常功能问题的患者，以及通过问题解决和重新归因技术提供自我管理支持。将SMS融入日常实践的策略包括为执业护士提供培训和强化课程，以及组织和财务安排。本研究旨在使用混合有效性-实施设计同时评估SMS在常规护理中的实施过程和效果。
方法/设计：将使用注册数据、问卷调查和访谈来探讨成功实施SMS的促进因素、障碍和成本。将在一项实用的整群随机对照试验中评估SMS的效果，该试验包括基线测量以及4个月和12个月后的随访测量。研究对象将包括46名执业护士及其2型糖尿病患者（N = 460；每位执业护士10名患者）。执业护士将被随机分配到干预组或对照组。干预组的执业护士将接受SMS培训。干预组和对照组的患者将通过研究人员主导的自我管理筛查程序招募，以确定那些安排进行常规咨询的患者中哪些可能被执业护士检测为有资格获得自我管理支持。主要结局指标是患者的日常功能。次要指标包括情绪健康、参与度、自主性和对疾病的控制。
我们的混合研究设计因执业护士使用的检测方法而变得复杂。这种方法本身就是一个实施问题，会对效果评估的实现和效力产生影响。
当前受控试验，NTR2764。
