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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02107794

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Dec 1, 2012

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

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 Names: DA
No Intervention: Usual Care Observations in clinical encounters, either video, audio, or observational notes.

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 Names:

No Intervention: Usual Care

Observations in clinical encounters, either video, audio, or observational notes.

Outcome Measures

Primary Outcome Measures

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