The proposed study focuses on the much-needed translation of evidence-based diabetes care in real world settings . It focuses on patient empowerment and patient-centred shared goal setting, which are considered priority areas for further research. It builds upon previous behavioural and implementation research which identified elements, such as proactive surveillance, patient involvement in setting realistic treatment goals and strategies, outcomes-related processes, and use of clinical information systems to improve the quality of care, as some of the key characteristics of effective diabetes management. There is growing evidence that active patient involvement improves diabetes care but the focus has been mostly on dietary and glucose regulation issues. Little attention has been given to involving patients in the overall treatment decision-making process.
Several complex, multifaceted implementation strategies have shown to improve diabetes care in experimental settings but they are seldom replicated or sustained in daily practice [4, 20, 72]. Healthcare providers have many competing demands, and especially small healthcare organisations have few resources for conducting complex interventions . Despite positive attitudes that healthcare providers and patients express regarding shared goal-setting and decision-making, they appear to have difficulties to translate these intentions into practice [15, 42, 45]. Simple tools that can help to structure and prioritise treatment goals and plans are needed. The PORTDA-diab developed in this study can be characterised as a minimal-intensity strategy that requires little extra time to conduct in a normal practice setting. Strategies that can prepare patients better for a consultation on disease management have the potential of being very cost-effective.
The decision aid is developed building on existing knowledge and following most of the recommendations for high quality decision aids . To the best of our knowledge, there have been no rigorous studies evaluating the effects of patient-oriented treatment decision aids that deal with multiple treatment goals and plans for individual patients. Recently, two newly developed decision aids dealing with multifactorial cardiovascular treatment have been pilot tested, showing acceptability and feasibility of using such decision aids in primary care settings [27, 28].
The outcome measures in our study have been chosen to provide detailed information on the process and outcomes of the intervention. Changes in patients’ empowerment and perceptions will be measured with structured questionnaires. Data on actual management and clinical outcomes will be assessed up to 6 months after the intervention allowing for delayed actions. The study is not designed or powered to assess any long-term outcomes regarding morbidity or mortality. By inclusion of the predicted absolute coronary heart disease risk as secondary outcome measure, however, we will be able to draw conclusions on potential benefits on long-term outcomes.
There is scarce information on how positive and negative effects of patient-oriented decision aids may differ for different patients [18, 73]. Diabetes patients will typically differ in the severity and duration of their disease, the number of co-morbid conditions, and the number of medications they need. Patients may also differ in experiencing negative feelings when confronted with personal risk information. Some patients have trouble with the quantitative scoring of risk and the clinical focus on numerical treatment goals instead of functional goals [8, 15, 17, 42, 57, 58, 74]. Patients can furthermore differ in their preferences and abilities to participate in treatment decision-making [8, 58, 74], and in their information needs. This study aims to include a heterogeneous group of patients with type 2 diabetes. By examining interaction effects of the intervention in relation to inter-individual differences, the study can provide insights into the utility and feasibility of using this type of decision support in various patient populations. The population is, however, restricted on specific clinical characteristics, such as age at diagnosis (≤65 years), and on cognitive and reading abilities.
The study will specifically address two matters of interest, which can contribute to the further development of interactive (web-based) programs for the management of chronic diseases . Many computer and web-based decision aids are being developed but there are concerns that not all patients may be able to use such systems. This study will provide information on differential effects of using a paper-based as compared to a computer-based decision aid, looking particularly at patient demographics, such as age, gender, educational level, and socioeconomic status. There are also questions regarding reframing messages about benefits of treatment to the perspective of the patient [57, 76]. Most patient decision aids formulate outcomes in terms of major clinical endpoints, such as the risk of dying or - in case of cardiovascular risk management - the risk of getting a myocardial infarction. This study will assess what the effects can be of giving additional information on other outcomes that some patients might consider of more importance.
A possible limitation of our study may be selection bias of participating practices. They may represent a group that is more open to shared decision-making. Since this study aims to develop and pilot an innovative strategy, we feel this is not a major drawback. Furthermore, the short duration of the intervention may limit the potential of the decision aid. Although the intervention allows for a follow-up consultation, it is possible that repeated use of the decision aid can enhance its effect. We will be able to use the results from the process evaluation to make adjustments or recommendations for further implementation of treatment decision aids in practice. If this aid is found to be helpful, it can be implemented and tested on a larger scale. The approach can also be translated to other areas of chronic disease management where patients are confronted with multiple treatment goals and plans.