Ignite Creation Date:
2024-05-06 @ 3:24 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02285881
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2014-09-05
Brief Title:
Shared Decision Making Between Patients and GPs in the Treatment of Type 2 Diabetes in Primary Care
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None