Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: D-THIO (Deprescribing Thyroid Hormone In Older Adults), Enhanced usual care.
- Who it may be relevant to
- Registry conditions: Hypothyroidism. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Thyroid hormone deprescribing by providers [Time frame: 6 months post-enrollment]
Secondary outcome measures (8)
- Reduction of thyroid hormone overtreatment, measured as proportion of patients who had their TSH normalized. [Time frame: 6 months post-enrollment]
- Provider-reported knowledge [Time frame: 6-12 months post-enrollment]
- Provider-reported intent to deprescribe [Time frame: 6-12 months post-enrollment]
- Provider-reported self-efficacy [Time frame: 6-12 months post-enrollment]
- Patient-reported discussion of deprescribing with provider [Time frame: 3-6 months post-enrollment]
- Patient-reported knowledge [Time frame: 3-6 months post-enrollment]
- Patient-reported attitudes towards deprescribing [Time frame: 3-6 months post-enrollment]
- Patient-reported beliefs about medicines [Time frame: 3-6 months post-enrollment]
Eligibility criteria
Patient Eligibility:
Inclusion criteria
- 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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
United States · 3 centers
- University of California San Francisco — San Francisco
- University of Michigan — Ann Arbor
- Henry Ford Health System — Detroit
Identifiers
NCT: NCT06629272 · HUM00231965 · 1R01AG079833-01A1