Recruiting

Thyroid Hormone

Sponsor:

University of Michigan

Code:

NCT06629272

Conditions

Hypothyroidism

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

D-THIO (Deprescribing Thyroid Hormone In Older Adults)

Enhanced usual care

Study Details

Brief summary:

The proposed study focuses on testing a novel adapted evidence-based multilevel intervention, Deprescribing Thyroid Hormone In Older Adults (D-THIO), to support thyroid hormone deprescribing (dose de-escalation and/or discontinuation) in older adults with thyroid hormone overtreatment and/or misuse and reduce patient harm. Findings from this study will lay the groundwork for broad implementation of D-THIO and serve as a model for deprescribing inappropriate medications for other endocrine conditions and conditions with biochemical monitoring.

Conditions

Hypothyroidism

Study ID

NCT06629272

Start date

Dec 2, 2024

Status verified date

Sep, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Patient Eligibility:

Inclusion Criteria:

1. age 65 years and older
2. on thyroid hormone therapy and have a serum Thyroid-stimulating hormone (TSH) <0.5 mIU/L or are on thyroid hormone therapy for an inappropriate indication
3. English speaking
4. without cognitive impairment

Exclusion Criteria:

1\) Patients with a diagnosis of thyroid cancer, secondary hypothyroidism, history of total thyroidectomy or hospitalization in the past 3 months will be excluded.

Provider eligibility:

Inclusion: Primary care physicians, endocrinologists, geriatricians, and Advanced Practice Providers (APPs) who practice at University of Michigan, Henry Ford Health System or University of California San Fransico (UCSF) and who prescribe thyroid hormone for eligible patients identified above will be eligible for study participation.

Exclusion: Providers who don't prescribe thyroid hormone.

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: D-THIO (Deprescribing Thyroid Hormone In Older Adults)

D-THIO is an innovative adapted multilevel intervention.

Providers in the intervention arm will receive: 1) an introductory letter, and 2) the D-THIO pharmaceutical opinion via EMR-compatible correspondence.

After randomization of their treating providers, patients in the intervention arm will receive a study packet including: 1) introductory letter, and 2) the D-THIO patient brochure (educational EMPOWER brochure).

active comparator: Enhanced usual care

This arm will receive enhanced usual care.

Providers in the control arm will receive: 1) an introductory letter signed by the PI and site-PIs, and 2) the ATA hypothyroidism pocket card via EMR.

Patients in the control arm will receive a study packet including: 1) introductory letter, and 2) the ATA patient brochure.

Interventions

D-THIO (Deprescribing Thyroid Hormone In Older Adults)

D-THIO consists of evidence-based pharmaceutical opinion letters to providers advising deprescribing for their patients 65 years and older with thyroid hormone overtreatment/misuse and EMPOWER ("Eliminating Medications through Patient Ownership of End Results") brochures to their patients.

Enhanced usual care

American Thyroid Association \[ATA\] provider guidelines, ATA patient brochure

Primary outcome measure

  • Thyroid hormone deprescribing by providers [ Time Frame: 6 months post-enrollment ]

Central Contacts and Locations

Central contacts

Brittany Gay

734-763-8608bbartol@umich.edu

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Zoe Cheng

628-977-9851Zoe.Cheng@ucsf.edu

Principal Investigator:

Jennifer Perkins, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Brittany Gay

734-763-8608bbartol@umich.edu

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Araceli Ambers

313-916-3906AAMBERS1@hfhs.org

Principal Investigator:

Arti Bhan, MD

More Information

Sponsor

University of Michigan

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • thyroid hormone overtreatment and misuse
  • older adults
  • deprescribing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-09-04.