Clinical trial NCT02285881: Shared Decision Making Between Patients and GPs in the Treatment of Type 2 Diabetes in Primary Care.
Official title: Shared Decision Making in Type 2 Diabetes With a Support Decision Tool That Takes Into Account Patient Preferences, Clinical Factors and the Intensity of Treatment: Design of a Cluster Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes treatment
personalized medicine
shared decision making
goal setting
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 153
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Less than 20% of type 2 diabetes mellitus (T2DM) patients in different healthcare settings achieve all treatment goals to prevent cardiometabolic disease. A more personalised approach with shared decision making should increase that percentage. 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. The aim of the study was to evaluate whether such an approach increases the proportion of treatment goals that T2DM patients achieve.

Methods: In a cluster-randomised trial in 40 primary care 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 shared decision making (SDM) was developed as well as a decision support tool to use during the consultation. These 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 (treatment-as-before). Follow-up: 24 months. The primary outcome is the proportion of patients who achieve all three treatment goals (HbA1c, blood pressure, total cholesterol) at 24 months. 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), 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 groups by estimating the relative risk of meeting the treatment targets. For the secondary outcomes mixed models will be used.

Discussion: To achieve optimal diabetes care with a higher proportion of achieved individualised treatment goals, the SDM approach including a multi-faceted decision support tool might be useful. An intervention with such a support decision tool is designed.

Detailed description: See brief summary

Eligibility criteria: Inclusion Criteria:

* Two more or less comparable categories of patients are eligible: 1. if diagnosed with T2DM in 2002-2004 by screening, aged between 50-70 years at that time and having participated in the ADDITION-study that ended in 2009; 2. treated for their T2DM in a practice that participated in the ADDITION study, between 60 and 80 years in 2012-2014 and with a T2DM duration between 8 to 15 years.

Exclusion Criteria:

* Patients will be excluded if they have a history of alcoholism, drug abuse, psychosis, personality disorder or another emotional, psychological or intellectual problem that is likely to invalidate informed consent, or limit the ability of the individual to comply with the protocol requirements and patients with a limited life expectancy.

Primary outcomes:
measure: The between groups difference in the proportion of patients which achieve the treatment goals for HbA1c, blood pressure, and total cholesterol
timeFrame: after 12 months
Secondary outcomes:
measure: The difference between groups in the proportion of patients which achieved the five treatment goals for HbA1c, blood pressure, total cholesterol, body weight, and smoking.
timeFrame: after 24 months
measure: Characteristics of success for the SDM process in the patients in the intervention group.
timeFrame: after 24 months
measure: The difference in health related Quality of Life between both groups at 24 months as measured with the Audit of Diabetes Dependent Quality of Life and the European Quality of Life questionnaire.
timeFrame: after 24 months
measure: The difference in health status between both groups at 24 months as measured with the Short Form-36.
timeFrame: after 24 months
measure: The difference in well-being between baseline and 24 months within and between both groups as measured with the Well-Being Questionnaire.
timeFrame: after 24 months
measure: The difference in wellbeing between baseline and 24 months within and between both groups as measured with the Well-Being Questionnaire.
timeFrame: after 24 months
measure: The difference in coping style between baseline and 24 months within and between both groups as measured with the Diabetes Coping Measurement Questionnaire.
timeFrame: after 24 months
Other outcomes:
measure: Process evaluation of the shared decision making ability of the general practitioners by using the Shared Decision Making Questionnaire.
timeFrame: at 24 months
Locations:
city: Utrecht
country: Netherlands
facility: Julius Centre for Health Sciences and Primary Care
Study officials:
affiliation: Julius Centre
name: Guy EH Rutten, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Griffin SJ, Borch-Johnsen K, Davies MJ, Khunti K, Rutten GE, Sandbaek A, Sharp SJ, Simmons RK, van den Donk M, Wareham NJ, Lauritzen T. Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial. Lancet. 2011 Jul 9;378(9786):156-67. doi: 10.1016/S0140-6736(11)60698-3. Epub 2011 Jun 24.
citation: Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012 Jun;35(6):1364-79. doi: 10.2337/dc12-0413. Epub 2012 Apr 19. No abstract available.
citation: Stiggelbout AM, Van der Weijden T, De Wit MP, Frosch D, Legare F, Montori VM, Trevena L, Elwyn G. Shared decision making: really putting patients at the centre of healthcare. BMJ. 2012 Jan 27;344:e256. doi: 10.1136/bmj.e256.
citation: Wilkinson MJ, Nathan AG, Huang ES. Personalized decision support in type 2 diabetes mellitus: current evidence and future directions. Curr Diab Rep. 2013 Apr;13(2):205-12. doi: 10.1007/s11892-012-0348-6.
citation: den Ouden H, Vos RC, Reidsma C, Rutten GE. Shared decision making in type 2 diabetes with a support decision tool that takes into account clinical factors, the intensity of treatment and patient preferences: design of a cluster randomised (OPTIMAL) trial. BMC Fam Pract. 2015 Feb 27;16:27. doi: 10.1186/s12875-015-0230-0.