Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing

University of Michigan

Status: Enrolling

Conditions: Hypothyroidism

Treatments: Behavioral: Enhanced usual care; Behavioral: D-THIO (Deprescribing Thyroid Hormone In Older Adults)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06629272

HUM00231965

1R01AG079833-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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900 participants in 2 patient groups

D-THIO (Deprescribing Thyroid Hormone In Older Adults)

Experimental group

Description:

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).

Treatment:

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

Enhanced usual care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced usual care