Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing

Part of paid clinical trials in San Francisco, California.

Sponsor
University of Michigan
Study ID
NCT06629272
Status
Recruiting
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Conditions

  • Hypothyroidism

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • D-THIO (Deprescribing Thyroid Hormone In Older Adults) — BEHAVIORAL
    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 — BEHAVIORAL
    American Thyroid Association \[ATA\] provider guidelines, ATA patient brochure

Study Details

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.

Key Dates

Start date
Dec 2, 2024
Status verified
Feb 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143
Zoe Cheng
[email protected]
628-977-9851
Jennifer Perkins, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Brittany Gay
[email protected]
734-763-8608
Henry Ford Health SystemDetroitMichigan48202
Araceli Ambers
[email protected]
313-916-3906
Arti Bhan, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California San Francisco· San Francisco, CAUniversity of Michigan· Ann Arbor, MIHenry Ford Health System· Detroit, MI

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