Clinical trial NCT06629272: Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing
Official title: Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypothyroidism
Keywords: thyroid hormone overtreatment and misuse
older adults
deprescribing
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-10-08
Enrollment: 900
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Thyroid hormone deprescribing by providers
timeFrame: 6 months post-enrollment
Secondary outcomes:
measure: Reduction of thyroid hormone overtreatment, measured as proportion of patients who had their TSH normalized.
timeFrame: 6 months post-enrollment
measure: Provider-reported knowledge
timeFrame: 6 months post-enrollment
measure: Provider-reported intent to deprescribe
timeFrame: 6 months post-enrollment
measure: Provider-reported self-efficacy
timeFrame: 6 months post-enrollment
measure: Patient-reported discussion of deprescribing with provider
timeFrame: 3-6 months post-enrollment
measure: Patient-reported knowledge
timeFrame: 3-6 months post-enrollment
measure: Patient-reported attitudes towards deprescribing
timeFrame: 3-6 months post-enrollment
measure: Patient-reported beliefs about medicines
timeFrame: 3-6 months post-enrollment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Maria Papaleontiou
role: PRINCIPAL_INVESTIGATOR
References: