Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое Enhanced usual care
  American Thyroid Association \[ATA\] provider guidelines, ATA patient brochure

Первичные конечные точки

• Thyroid hormone deprescribing by providers [Срок оценки: 6 months post-enrollment]

Вторичные конечные точки (8)

• Reduction of thyroid hormone overtreatment, measured as proportion of patients who had their TSH normalized. [Срок оценки: 6 months post-enrollment]
• Provider-reported knowledge [Срок оценки: 6-12 months post-enrollment]
• Provider-reported intent to deprescribe [Срок оценки: 6-12 months post-enrollment]
• Provider-reported self-efficacy [Срок оценки: 6-12 months post-enrollment]
• Patient-reported discussion of deprescribing with provider [Срок оценки: 3-6 months post-enrollment]
• Patient-reported knowledge [Срок оценки: 3-6 months post-enrollment]
• Patient-reported attitudes towards deprescribing [Срок оценки: 3-6 months post-enrollment]
• Patient-reported beliefs about medicines [Срок оценки: 3-6 months post-enrollment]

Критерии участия

Patient Eligibility:

Критерии включения

• 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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 3 центра

• University of California San Francisco — San Francisco
• University of Michigan — Ann Arbor
• Henry Ford Health System — Detroit

Идентификаторы

NCT: NCT06629272 · HUM00231965 · 1R01AG079833-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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