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

NCT ID: NCT02107794

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-04-30

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.

Conditions

Graves' Disease; Thyroid Disease; Hyperthyroidism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Decision Aid

Observation of clinical encounter using the decision aid, via video, audio or written notes.

Group Type: ACTIVE_COMPARATOR

Decision Aid

Intervention Type: OTHER

Paper based decision aid will be utilized to facilitate treatment option conversation between clinician and patient.

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Decision Aid

Paper based decision aid will be utilized to facilitate treatment option conversation between clinician and patient.

Intervention Type: OTHER

Other Intervention Names

DA

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Victor Montori

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victor M Montori, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26413979 (View on PubMed)

Other Identifiers

12-007708

Identifier Type: -

Identifier Source: org_study_id