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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Victor Montori, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02107794
First received: March 24, 2014
Last updated: April 6, 2015
Last verified: April 2015
  Purpose

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 Intervention
Graves' Disease
Thyroid Disease
Hyperthyroidism
Other: Decision Aid

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Enrollment: 93
Study Start Date: December 2012
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • DA
  • Decision Aid
No Intervention: Usual Care
Observations in clinical encounters, either video, audio, or observational notes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Victor Montori, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02107794     History of Changes
Other Study ID Numbers: 12-007708
Study First Received: March 24, 2014
Last Updated: April 6, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Hyperthyroidism
Thyroid Diseases
Autoimmune Diseases
Endocrine System Diseases
Exophthalmos
Eye Diseases
Goiter
Immune System Diseases
Orbital Diseases

ClinicalTrials.gov processed this record on April 23, 2015