Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing
Purpose
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.
Condition
- Hypothyroidism
Eligibility
- Eligible Ages
- Over 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- ) 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Care Provider)
- Masking Description
- Because the intervention is educational in nature, blinding is not possible. But, to preserve a certain level of blinding and protect against bias, the study will be presented as a "medication optimization study" and consenting patient participants will be informed that their medication profiles will be transmitted to the research team within the following months and that they will receive a customized brochure at some point during the next year that may contain recommendations for change which they can discuss with their prescribing provider. For providers, blinding will be achieved by presenting the same study timeline. Providers will be aware that they will receive a customized letter with thyroid hormone optimization recommendations and that their patients will receive an intervention at some point during the following year, and remain blinded to group allocation throughout the course of the study.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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). |
|
|
Active Comparator 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. |
|
Recruiting Locations
San Francisco, California 94143
Ann Arbor, Michigan 48109
Detroit, Michigan 48202
More Details
- NCT ID
- NCT06629272
- Status
- Recruiting
- Sponsor
- University of Michigan
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.