NCT06629272

Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The proposed study is the first multi-site trial to evaluate a novel evidence-based adapted multilevel intervention, D-THIO (Deprescribing Thyroid Hormone In Older Adults), consisting of evidence-based pharmaceutical opinion to providers, education brochures to patients and facilitated by clinical champions, to support thyroid hormone deprescribing in older adults. We will conduct a type 1 hybrid effectiveness-implementation trial of D-THIO vs. enhanced usual care (American Thyroid Association \[ATA\] provider abbreviated guidelines, ATA patient brochure) at 3 sites (University of Michigan, Henry Ford, University of California San Francisco) in 150 providers (primary care, endocrinologists, geriatricians, advance practice providers) and 750 of their patients 65 years and older who are overtreated with thyroid hormone. We will randomize 1:1 at the provider level within each site. The aims of the study are: 1) to assess the effectiveness of D-THIO on thyroid hormone deprescribing by providers and on reducing overtreatment and misuse with thyroid hormone via EMR, 2) to assess the effectiveness of D-THIO on provider and patient knowledge and attitudes regarding thyroid hormone deprescribing via surveys, and 3) to identify factors related to the implementation of D-THIO across diverse general care settings via post-trial interviews with key stakeholders. We changed the provider survey from 6 months post enrollment to 6-12 months, due to lower than anticipated enrollment, we wanted to be able to expand the window of time for which we could enroll associated patients with providers who agreed to participate.

Conditions

• Hypothyroidism

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	Enhanced usual care	American Thyroid Association \[ATA\] provider guidelines, ATA patient brochure

Timeline

• Start date: 2024-12-02
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2024-10-08
• Last updated: 2026-02-13

Locations

3 sites across 1 country: United States