Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing
2 other identifiers
interventional
900
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2024
CompletedFirst Posted
Study publicly available on registry
October 8, 2024
CompletedStudy Start
First participant enrolled
December 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
February 13, 2026
February 1, 2026
4.3 years
October 4, 2024
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Thyroid hormone deprescribing by providers
Assessed by proportion of patients who had any thyroid hormone dose de-escalation and/or thyroid hormone discontinuation. Thyroid hormone deprescribing is defined as thyroid hormone dose de-escalation and/or discontinuation and will be assessed via Electronic Medical Record (EMR).
6 months post-enrollment
Secondary Outcomes (8)
Reduction of thyroid hormone overtreatment, measured as proportion of patients who had their TSH normalized.
6 months post-enrollment
Provider-reported knowledge
6-12 months post-enrollment
Provider-reported intent to deprescribe
6-12 months post-enrollment
Provider-reported self-efficacy
6-12 months post-enrollment
Patient-reported discussion of deprescribing with provider
3-6 months post-enrollment
- +3 more secondary outcomes
Study Arms (2)
D-THIO (Deprescribing Thyroid Hormone In Older Adults)
EXPERIMENTALD-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).
Enhanced usual care
ACTIVE COMPARATORThis 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 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.
American Thyroid Association \[ATA\] provider guidelines, ATA patient brochure
Eligibility Criteria
You may qualify if:
- age 65 years and older
- 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
- English speaking
- without cognitive impairment
You may not qualify if:
- \) 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:
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Institute on Aging (NIA)collaborator
Study Sites (3)
University of California San Francisco
San Francisco, California, 94143, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Papaleontiou
University of Michigan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Because the intervention is educational in nature, blinding is not possible. But, to preserve a certain level of blinding and protect against bias, the study will be presented as a "medication optimization study" and consenting patient participants will be informed that their medication profiles will be transmitted to the research team within the following months and that they will receive a customized brochure at some point during the next year that may contain recommendations for change which they can discuss with their prescribing provider. For providers, blinding will be achieved by presenting the same study timeline. Providers will be aware that they will receive a customized letter with thyroid hormone optimization recommendations and that their patients will receive an intervention at some point during the following year, and remain blinded to group allocation throughout the course of the study.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Internal Medicine and Research Associate Professor at the Institute of Gerontology
Study Record Dates
First Submitted
October 4, 2024
First Posted
October 8, 2024
Study Start
December 2, 2024
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- For 5 years following publication
- Access Criteria
- Researchers
The researchers will make the de-identified data available to researchers upon reasonable request via email to the study PI at the conclusion of the study.