Shared Decision Making in Graves Disease - Graves Disease (GD) Choice
The investigators' decision aid for patients with GD, GD Choice, will be the result of a user-centered participatory action research involving) synthesis of the best available evidence from the literature and real-world registry experience, ii) input and involvement of patients, clinicians and other stakeholders, iii) direct observation of encounters and iv) extensive field-testing. The goal is to create a decision aid that will be rigorously evidence-based, clear and complete, able to be used by clinicians with minimal training time, while satisfying extant standards for rigorous high-quality shared decision making tools.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Shared Decision Making in Graves Disease - Graves Disease (GD) Choice|
- Decisional Quality (Knowledge, Decisional Conflict, Satisfaction) of 100 participants [ Time Frame: up to 2 weeks post-visit ] [ Designated as safety issue: No ]Outcome measure to be assessed through post-visit surveys.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Decision Aid
Observation of clinical encounter using the decision aid, via video, audio or written notes.
Other: Decision Aid
Paper based decision aid will be utilized to facilitate treatment option conversation between clinician and patient.
No Intervention: Usual Care
Observations in clinical encounters, either video, audio, or observational notes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02107794
|Contact: Juan P Brito Campana, MBBSfirstname.lastname@example.org|
|Contact: Sara Dickemail@example.com|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Juan P Brito Campana, MBBS 507-284-4080 Brito.Juan@mayo.edu|
|Contact: Sara Dick 507-538-3254 firstname.lastname@example.org|
|Sub-Investigator: Juan P Brito Campana, MBBS|
|Principal Investigator: Victor M Montori, M.D.|
|Principal Investigator:||Victor M Montori, M.D.||Mayo Clinic|