No more than 10-15% of type 2 diabetes mellitus (T2DM) patients achieve all treatment goals regarding glycaemic control, lipids and blood pressure. Shared decision making (SDM) should increase that... Show moreNo more than 10-15% of type 2 diabetes mellitus (T2DM) patients achieve all treatment goals regarding glycaemic control, lipids and blood pressure. Shared decision making (SDM) should increase that percentage; however, not all support decision tools are appropriate. Because the ADDITION-Europe study demonstrated two (almost) equally effective treatments but with slightly different intensities, it may be a good starting point to discuss with the patients their diabetes treatment, taking into account both the intensity of treatment, clinical factors and patients' preferences. We aim to evaluate whether such an approach increases the proportion of patients that achieve all three treatment goals.|In a cluster-randomised trial including 40 general practices, that participated until 2009 in the ADDITION Study, 150 T2DM patients 60-80 years, known with T2DM for 8-15 years, will be included. Practices are randomised a second time, i.e. intervention practices in the ADDITION study could be control practices in the current study and vice versa. For the GPs from the intervention group a 2-hour training in SDM was developed as well as a decision support tool to be used during the consultation. GPs plan the first visit with the patients to decide on the intensity of the treatment, personalised targets and the priorities of treatment. The control group will continue with the treatment they were allocated to in the ADDITION study.|24 months. The primary outcome is the proportion of patients who achieve all three treatment goals. Secondary outcomes are the proportion of patients who achieve five treatment goals (HbA1c, blood pressure, total cholesterol, body weight, not smoking), evaluation of the SDM process (SDM-Q9 and CPS), satisfaction with the treatment (DTSQ), wellbeing and quality of life (W-BQ12, ADD QoL-19), health status (SF-36, EQ-5D) and coping (DCMQ). The proportions of achieved treatment goals will be compared between both groups. For the secondary outcomes mixed models will be used. The Medical Research Ethics Committee of the University Medical Centre Utrecht has approved the study protocol (Protocol number: 11-153).|This trial will provide evidence whether an intervention with a multi-faceted decision support tool increases the proportion of achieved personalised goals in type 2 diabetes patients.|NCT02285881, November 4, 2014. Show less
Ouden, H. den; Vos, R.C.; Reidsma, C.; Rutten, G.E.H.M. 2015
No more than 10-15% of type 2 diabetes mellitus (T2DM) patients achieve all treatment goals regarding glycaemic control, lipids and blood pressure. Shared decision making (SDM) should increase that... Show moreNo more than 10-15% of type 2 diabetes mellitus (T2DM) patients achieve all treatment goals regarding glycaemic control, lipids and blood pressure. Shared decision making (SDM) should increase that percentage; however, not all support decision tools are appropriate. Because the ADDITION-Europe study demonstrated two (almost) equally effective treatments but with slightly different intensities, it may be a good starting point to discuss with the patients their diabetes treatment, taking into account both the intensity of treatment, clinical factors and patients' preferences. We aim to evaluate whether such an approach increases the proportion of patients that achieve all three treatment goals.|In a cluster-randomised trial including 40 general practices, that participated until 2009 in the ADDITION Study, 150 T2DM patients 60-80 years, known with T2DM for 8-15 years, will be included. Practices are randomised a second time, i.e. intervention practices in the ADDITION study could be control practices in the current study and vice versa. For the GPs from the intervention group a 2-hour training in SDM was developed as well as a decision support tool to be used during the consultation. GPs plan the first visit with the patients to decide on the intensity of the treatment, personalised targets and the priorities of treatment. The control group will continue with the treatment they were allocated to in the ADDITION study.|24 months. The primary outcome is the proportion of patients who achieve all three treatment goals. Secondary outcomes are the proportion of patients who achieve five treatment goals (HbA1c, blood pressure, total cholesterol, body weight, not smoking), evaluation of the SDM process (SDM-Q9 and CPS), satisfaction with the treatment (DTSQ), wellbeing and quality of life (W-BQ12, ADD QoL-19), health status (SF-36, EQ-5D) and coping (DCMQ). The proportions of achieved treatment goals will be compared between both groups. For the secondary outcomes mixed models will be used. The Medical Research Ethics Committee of the University Medical Centre Utrecht has approved the study protocol (Protocol number: 11-153).|This trial will provide evidence whether an intervention with a multi-faceted decision support tool increases the proportion of achieved personalised goals in type 2 diabetes patients.|NCT02285881, November 4, 2014. Show less
Dungen, C. van den; Hoeymans, N.; Akker, M. van den; Biermans, M.C.J.; K. van boven; Joosten, J.H.K.; ... ; Oers, J.A.M. van 2014
BACKGROUND The introduction of efficacious physical activity interventions in primary health care is a complex process. Understanding factors influencing the process can enhance the development of... Show moreBACKGROUND The introduction of efficacious physical activity interventions in primary health care is a complex process. Understanding factors influencing the process can enhance the development of effective introduction strategies. This Delphi study aimed to identify factors most relevant for the adoption, implementation, and continuation of physical activity interventions in primary health care by examining experts' opinions on the importance and changeability of factors previously identified as potentially relevant for the process. METHODS In the first round, 44 experts scored factors on their importance for each stage of the introduction process, as well as on their changeability. In the second round, the same experts received a questionnaire containing a reduced list of factors, based on the first-round results. They were asked to indicate their top-10 most important factors for each stage, and to re-rate factors' changeability. Thirty-seven experts completed this round. RESULTS Most important factors could be identified for each stage. Some factors were found important for a specific stage, e.g., the presence of intervention champions within the organization (adoption), provider knowledge (implementation), and the intervention's sustainability (continuation), while others were perceived important for all stages, i.e., the intervention's financial feasibility, the intervention's accessibility to the target group, and time to deliver the intervention. The majority of most important factors was perceived changeable. However, for some factors no consensus could be reached regarding their changeability. CONCLUSIONS This study identified general and stage-specific factors relevant for the introduction of physical activity interventions in primary health care. It emphasizes the importance of taking these factors into account when designing introduction strategies, and of giving special attention to the distinct stages of the process. Due to lack of consensus on the changeability of most important factors, the extent to which these factors can be influenced by introduction strategies remains unclear. Show less
