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

Hyperthyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107794
• Other study ID #: 12-007708
• Status: Completed
• Phase: N/A
• First received: March 24, 2014
• Last updated: April 6, 2015
• Start date: December 2012
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Graves Disease
• Graves' Disease
• Hyperthyroidism
• Thyroid Disease
• Thyroid Diseases

Intervention

Other:
• Decision Aid
Paper based decision aid will be utilized to facilitate treatment option conversation between clinician and patient.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional Quality (Knowledge, Decisional Conflict, Satisfaction) of 100 participants	Outcome measure to be assessed through post-visit surveys.	up to 2 weeks post-visit	No