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NCT06629272NARecruiting

Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing

University of Michigan

Start Date

12/2/2024

Completion Date

4/1/2029

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.

Eligibility Criteria

Age Range: 65 years to No maximum

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.

Interventions

BEHAVIORAL

D-THIO (Deprescribing Thyroid Hormone In Older Adults)

BEHAVIORAL

Enhanced usual care

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Conditions

Hypothyroidism

Locations

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