Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing
概览
- 阶段
- 不适用
- 干预措施
- D-THIO (Deprescribing Thyroid Hormone In Older Adults)
- 疾病 / 适应症
- Hypothyroidism
- 发起方
- University of Michigan
- 入组人数
- 900
- 试验地点
- 3
- 主要终点
- Thyroid hormone deprescribing by providers
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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.
研究者
Maria Papaleontiou
Associate Professor of Internal Medicine and Research Associate Professor at the Institute of Gerontology
University of Michigan
入排标准
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
D-THIO (Deprescribing Thyroid Hormone In Older Adults)
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).
干预措施: D-THIO (Deprescribing Thyroid Hormone In Older Adults)
Enhanced usual care
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.
干预措施: Enhanced usual care
结局指标
主要结局
Thyroid hormone deprescribing by providers
时间窗: 6 months post-enrollment
Assessed by proportion of patients who had any thyroid hormone dose de-escalation and/or thyroid hormone discontinuation. Thyroid hormone deprescribing is defined as thyroid hormone dose de-escalation and/or discontinuation and will be assessed via Electronic Medical Record (EMR).
次要结局
- Reduction of thyroid hormone overtreatment, measured as proportion of patients who had their TSH normalized.(6 months post-enrollment)
- Patient-reported discussion of deprescribing with provider(3-6 months post-enrollment)
- Patient-reported knowledge(3-6 months post-enrollment)
- Patient-reported attitudes towards deprescribing(3-6 months post-enrollment)
- Patient-reported beliefs about medicines(3-6 months post-enrollment)
- Provider-reported knowledge(6-12 months post-enrollment)
- Provider-reported intent to deprescribe(6-12 months post-enrollment)
- Provider-reported self-efficacy(6-12 months post-enrollment)