Shared Decision Making in Graves Disease - Graves Disease (GD) Choice
1 other identifier
interventional
93
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 24, 2014
CompletedFirst Posted
Study publicly available on registry
April 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedApril 7, 2015
April 1, 2015
2.3 years
March 24, 2014
April 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decisional Quality (Knowledge, Decisional Conflict, Satisfaction) of 100 participants
Outcome measure to be assessed through post-visit surveys.
up to 2 weeks post-visit
Study Arms (2)
Decision Aid
ACTIVE COMPARATORObservation of clinical encounter using the decision aid, via video, audio or written notes.
Usual Care
NO INTERVENTIONObservations in clinical encounters, either video, audio, or observational notes.
Interventions
Paper based decision aid will be utilized to facilitate treatment option conversation between clinician and patient.
Eligibility Criteria
You may qualify if:
- Adults ≥ 18 years
- Diagnosis of Graves Disease
- Appointment with endocrinologist to discuss treatment options for Graves Disease
You may not qualify if:
- Major barriers to participate in shared decision making or to providing informed consent (i.e. dementia, severe hearing or visual impairment)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
Brito JP, Castaneda-Guarderas A, Gionfriddo MR, Ospina NS, Maraka S, Dean DS, Castro MR, Fatourechi V, Gharib H, Stan MN, Branda ME, Bahn RS, Montori VM. Development and Pilot Testing of an Encounter Tool for Shared Decision Making About the Treatment of Graves' Disease. Thyroid. 2015 Nov;25(11):1191-8. doi: 10.1089/thy.2015.0277. Epub 2015 Oct 15.
PMID: 26413979DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victor M Montori, M.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
March 24, 2014
First Posted
April 8, 2014
Study Start
December 1, 2012
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
April 7, 2015
Record last verified: 2015-04