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Shared Decision Making in Graves Disease - Graves Disease (GD) Choice

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ClinicalTrials.gov Identifier: NCT02107794
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Victor Montori, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Graves' Disease Thyroid Disease Hyperthyroidism Other: Decision Aid Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Shared Decision Making in Graves Disease - Graves Disease (GD) Choice
Study Start Date : December 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Other Name: DA
No Intervention: Usual Care
Observations in clinical encounters, either video, audio, or observational notes.



Primary Outcome Measures :
  1. Decisional Quality (Knowledge, Decisional Conflict, Satisfaction) of 100 participants [ Time Frame: up to 2 weeks post-visit ]
    Outcome measure to be assessed through post-visit surveys.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ≥ 18 years
  • Diagnosis of Graves Disease
  • Appointment with endocrinologist to discuss treatment options for Graves Disease

Exclusion Criteria:

  • Major barriers to participate in shared decision making or to providing informed consent (i.e. dementia, severe hearing or visual impairment)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107794


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Victor M Montori, M.D. Mayo Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Victor Montori, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02107794     History of Changes
Other Study ID Numbers: 12-007708
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by Victor Montori, Mayo Clinic:
Grave's
Disease
Thyroid
Hyperthyroidism
Thyroidectomy
Radioactive
Iodine
Antithyroid
Shared
Decision
Making
Aid
Evidence
Based
Endocrinology
Mayo
Clinic

Additional relevant MeSH terms:
Graves Disease
Thyroid Diseases
Hyperthyroidism
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases