RCT Regarding SDM Online Training and Face-to-face SDM Training
NCT ID: NCT02674360
Last Updated: 2019-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
161 participants
INTERVENTIONAL
2016-05-31
2019-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study therefore aims to examine the effectiveness of different disseminations strategies (individualized face-to-face context-based SDM individual training vs. web-based SDM online training) compared to a control group without any training. It will be analyzed which improvements in medical SDM competence can be accomplished by the different SDM trainings. Further the effects of the training on SDM knowledge, quality of the doctor-patient interaction and SDM self-efficacy expectation will be evaluated.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Trial Comparing Approaches to Shared Decision Making Skills Training for Clinicians
NCT02871739
CSDM: A Trial to Improve Communication and Shared Decision Making Using a Web-Based Tool
NCT02955563
Development of a Web-Based Interactive Patient Decision Aid for the Treatment of Acute Low Back Pain and Depression
NCT00525811
Focus on Values to Stimulate Shared Decisions
NCT03905369
Evaluation of a Decision Aid About Life-sustaining Therapies
NCT04034979
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Face-to-Face SDM Training
The intervention consists of a SDM training for oncologists, which is conducted in the form of an individualized, context-based SDM individual face-to-face training at the workplace of the participants (intervention group II). During training, the oncologists are guided to use decision aids for breast and colon cancer patients in their consultations, which were developed and evaluated in a previous project. The SDM training has the same duration (one session à 120 minutes) in both intervention groups. Doctors in the intervention group receive decision aids for breast cancer and colorectal cancer patients during training. The training contents are based on an already developed, evaluated and published SDM manual. The individual training works on the coaching principle.
SDM Training
Control Group
The Control Group receives no SDM Training. All participants of the Control Group will be offered to participate in the SDM Online Training after T2.
No interventions assigned to this group
SDM Online Training
The intervention consists of a SDM training for oncologists, which is conducted in the form of a web-based SDM online Training (intervention group I). During training, the oncologists are guided to use decision aids for breast and colon cancer patients in their consultations, which were developed and evaluated in a previous project. The SDM training has the same duration (one session à 120 minutes) in both intervention groups. Doctors in the intervention group receive decision aids for breast cancer and colorectal cancer patients during training. The training contents are based on an already developed, evaluated and published SDM manual. The SDM online training works on the modeling principle.
SDM Training
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SDM Training
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Internet access
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universitätsklinikum Hamburg-Eppendorf
OTHER
University Hospital Heidelberg
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Kathrin Gschwendtner
Prinicipal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christiane Bieber, PD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Heidelberg
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
University Hospital Hamburg-Eppendorf
Hamburg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Janz NK, Wren PA, Copeland LA, Lowery JC, Goldfarb SL, Wilkins EG. Patient-physician concordance: preferences, perceptions, and factors influencing the breast cancer surgical decision. J Clin Oncol. 2004 Aug 1;22(15):3091-8. doi: 10.1200/JCO.2004.09.069.
Melbourne E, Sinclair K, Durand MA, Legare F, Elwyn G. Developing a dyadic OPTION scale to measure perceptions of shared decision making. Patient Educ Couns. 2010 Feb;78(2):177-83. doi: 10.1016/j.pec.2009.07.009. Epub 2009 Aug 3.
Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
Scholl I, Kriston L, Dirmaier J, Buchholz A, Harter M. Development and psychometric properties of the Shared Decision Making Questionnaire--physician version (SDM-Q-Doc). Patient Educ Couns. 2012 Aug;88(2):284-90. doi: 10.1016/j.pec.2012.03.005. Epub 2012 Apr 3.
Bieber C, Muller KG, Nicolai J, Hartmann M, Eich W. How does your doctor talk with you? Preliminary validation of a brief patient self-report questionnaire on the quality of physician-patient interaction. J Clin Psychol Med Settings. 2010 Jun;17(2):125-36. doi: 10.1007/s10880-010-9189-0.
Elwyn G, Edwards A, Wensing M, Hood K, Atwell C, Grol R. Shared decision making: developing the OPTION scale for measuring patient involvement. Qual Saf Health Care. 2003 Apr;12(2):93-9. doi: 10.1136/qhc.12.2.93.
Elwyn G, Hutchings H, Edwards A, Rapport F, Wensing M, Cheung WY, Grol R. The OPTION scale: measuring the extent that clinicians involve patients in decision-making tasks. Health Expect. 2005 Mar;8(1):34-42. doi: 10.1111/j.1369-7625.2004.00311.x.
Goss C, Fontanesi S, Mazzi MA, Del Piccolo L, Rimondini M, Elwyn G, Zimmermann C. Shared decision making: the reliability of the OPTION scale in Italy. Patient Educ Couns. 2007 Jun;66(3):296-302. doi: 10.1016/j.pec.2007.01.002. Epub 2007 Apr 11.
Muller N, Gschwendtner KM, Dwinger S, Bergelt C, Eich W, Harter M, Bieber C. Study protocol of a randomized controlled trial on two new dissemination strategies for a brief, shared-decision-making (SDM) training for oncologists: web-based interactive SDM online-training versus individualized context-based SDM face-to-face training. Trials. 2019 Jan 7;20(1):18. doi: 10.1186/s13063-018-3112-7.
Related Links
Access external resources that provide additional context or updates about the study.
Study Homepage
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DKH109956, DKH110010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.