PMID- 25887759
OWN - NLM
STAT- MEDLINE
DCOM- 20160210
LR  - 20240322
IS  - 1471-2296 (Electronic)
IS  - 1471-2296 (Linking)
VI  - 16
DP  - 2015 Feb 27
TI  - 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.
PG  - 27
LID - 10.1186/s12875-015-0230-0 [doi]
LID - 27
AB  - BACKGROUND: 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 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. METHODS: 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. FOLLOW-UP: 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). 
      DISCUSSION: 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. TRIAL REGISTRATION: NCT02285881, 
      November 4, 2014.
FAU - den Ouden, Henk
AU  - den Ouden H
AD  - Julius Centre for Health Sciences and Primary Care, University Medical Centre 
      Utrecht, Str. 6.131, PO Box 85500, 3508 GA, Utrecht, The Netherlands. 
      H.denOuden@umcutrecht.nl.
FAU - Vos, Rimke C
AU  - Vos RC
AD  - Julius Centre for Health Sciences and Primary Care, University Medical Centre 
      Utrecht, Str. 6.131, PO Box 85500, 3508 GA, Utrecht, The Netherlands. 
      R.C.Vos-3@umcutrecht.nl.
FAU - Reidsma, Carla
AU  - Reidsma C
AD  - Julius Centre for Health Sciences and Primary Care, University Medical Centre 
      Utrecht, Str. 6.131, PO Box 85500, 3508 GA, Utrecht, The Netherlands. 
      Carlareidsma@hotmail.com.
FAU - Rutten, Guy E H M
AU  - Rutten GE
AD  - Julius Centre for Health Sciences and Primary Care, University Medical Centre 
      Utrecht, Str. 6.131, PO Box 85500, 3508 GA, Utrecht, The Netherlands. 
      G.E.H.M.Rutten@umcutrecht.nl.
LA  - eng
SI  - ClinicalTrials.gov/NCT02285881
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150227
PL  - England
TA  - BMC Fam Pract
JT  - BMC family practice
JID - 100967792
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - *Decision Making
MH  - *Decision Support Systems, Clinical
MH  - Diabetes Mellitus, Type 2/*therapy
MH  - Disease Management
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Quality of Life
MH  - Research Design
MH  - Surveys and Questionnaires
PMC - PMC4369865
EDAT- 2015/04/19 06:00
MHDA- 2016/02/11 06:00
PMCR- 2015/02/27
CRDT- 2015/04/19 06:00
PHST- 2015/01/03 00:00 [received]
PHST- 2015/01/23 00:00 [accepted]
PHST- 2015/04/19 06:00 [entrez]
PHST- 2015/04/19 06:00 [pubmed]
PHST- 2016/02/11 06:00 [medline]
PHST- 2015/02/27 00:00 [pmc-release]
AID - 10.1186/s12875-015-0230-0 [pii]
AID - 230 [pii]
AID - 10.1186/s12875-015-0230-0 [doi]
PST - epublish
SO  - BMC Fam Pract. 2015 Feb 27;16:27. doi: 10.1186/s12875-015-0230-0.