ObjectiveTo evaluate the effectiveness of biopsychosocial Self-Management Support (SMS) delivered by practice nurses in routine diabetes care.DesignA pragmatic cluster-randomised controlled trial within a hybrid effectiveness-implementation study design. Practice nurses were cluster-randomised.SettingA regional care group in the Netherlands consisting of 77 family practices. The study involved practice nurses (n=40) providing care to approximately 4000 patients with diabetes.ParticipantsPatients with type 2 diabetes (n=264) selected by a self-administered questionnaire aimed at measuring emotional distress and diabetes-related reduced daily functioning.InterventionPractice nurses in the intervention arm (n=19) were trained to integrate SMS into their routine consultations. SMS included detection of patients with emotional distress and reduced daily functioning, and supporting them when needed through problem solving and reattribution techniques. Practice nurses in the control arm (n=21) provided usual care.Main outcome measuresThe primary outcome measure was a dichotomised score on a Visual Analogue Scale that measured the perceived effect of diabetes on daily functioning. Secondary measures included patients’ diabetes-related distress, quality of life, autonomy and participation, self-efficacy, self-management and glycaemic control. Outcomes were measured at baseline and at 4-month and 12-month follow-ups.ResultsOnly 16 of the 117 patients in the intervention arm (14%) who were found eligible by the posted research-driven screening questionnaire were detected by their practice nurses. Extra consultations for the self-management support were delivered to only 11 study participants. In the control arm, 147 patients received usual care. Multilevel analyses showed no significant differences in outcomes between the intervention and control arms.ConclusionsSMS in its present form was not effective. The research-driven screening to select trial participants appeared to be inconsistent with nurse-led detection in routine practice. Adequate follow-up moments need to be built in to overcome barriers resulting from tension between the implementation and effectiveness parts of hybrid studies.Trial registration numberCurrent Controlled Trials NTR2764.

BackgroundChronically ill patients often experience psychosocial problems in everyday life. A biopsychosocial approach is considered to be essential in chronic care. In Dutch primary health care the current biomedically oriented clinical practice may conflict with the biopsychosocial approach. This study is aimed to explore the views of Dutch stakeholders on achieving a biopsychosocial approach to the care of patients with chronic diseases.MethodsIn a qualitative explorative study design, we held semi-structured interviews with stakeholders, face-to-face or by telephone. Data were analysed using content analysis. Thirty representatives of Dutch patients with chronic illnesses, primary care professionals, policy makers, health inspectorate, health insurers, educational institutes and researchers were interviewed.ResultsStakeholders were aware that a systematic biopsychosocial care approach is lacking in current practice. Opportunities for effective change are multidimensional. Achieving a biopsychosocial approach to care relates to active patient participation, the training of professionals, high-quality guidelines, protocols and tools, integrated primary care, research and financial issues.ConclusionsAlthough the principles and importance of the biopsychosocial model have been recognized, the provision of care that starts from the medical, emotional or social needs of individual patients does not fit in easily with the current Dutch health care system. All parties involved need to make a commitment to realize the ideal of biopsychosocial chronic care. Together they need to equip health professionals with skills to understand patients' multifaceted needs and to reward integrated biopsychosocial care. Patients need to be empowered to be active partners in their own care.

Active participation of stakeholders in health research practice is important to generate societal impact of outcomes, as innovations will more likely be implemented and disseminated in clinical practice. To foster a co-creative process, numerous frameworks and tools are available. As they originate from different professions, it is not evident that health researchers are aware of these tools, or able to select and use them in a meaningful way. This article describes the bottom-up development process of a compass and presents the final outcome. This Co-creation Impact Compass combines a well-known business model with tools from design thinking that promote active participation by all relevant stakeholders. It aims to support healthcare researchers to select helpful and valid co-creation tools for the right purpose and at the right moment. Using the Co-creation Impact Compass might increase the researchers' understanding of the value of co-creation, and it provides help to engage stakeholders in all phases of a research project.

BackgroundPsychosocial 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/DesignRegistration 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.DiscussionOur 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.Trial registrationCurrent Controlled Trials, NTR2764

Patients see primary care nurses primarily as specialists regarding the biomedical management of diabetes. Although patients seemed to support the ideal of integrated care, they did not expect a discussion about psychosocial problems in diabetes consultations. The incorporation of systematic detection of patients with psychosocial problems in diabetes care requires endeavours to make patients acquainted with the new role of the nurse.