HypothyroidismNCT06629272
Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing
A study testing D-THIO (Deprescribing Thyroid Hormone In Older Adults) in people with Hypothyroidism, run by University of Michigan at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- D-THIO (Deprescribing Thyroid Hormone In Older Adults)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Dec 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Brittany Gay, 734-763-8608, bbartol@umich.edu
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Araceli Ambers, 313-916-3906, AAMBERS1@hfhs.org
Arti Bhan, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Zoe Cheng, 628-977-9851, Zoe.Cheng@ucsf.edu
Jennifer Perkins, MD
About this study
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.
Read the 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.
- Conditions
- Hypothyroidism
- Being tested
- D-THIO (Deprescribing Thyroid Hormone In Older Adults), Enhanced usual care
- Keywords
- thyroid hormone overtreatment and misuse, older adults, deprescribing
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-THIO (Deprescribing Thyroid Hormone In Older Adults)Behavioural
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.
Enhanced usual careBehavioural
American Thyroid Association [ATA] provider guidelines, ATA patient brochure
| Study group | Role | What they receive |
|---|---|---|
| D-THIO (Deprescribing Thyroid Hormone In Older Adults) | Experimental | 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). Receives: Behavioral: D-THIO (Deprescribing Thyroid Hormone In Older Adults) |
| Enhanced usual care | Active comparator | 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. Receives: Behavioral: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid hormone deprescribing by providers
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).
Measured: 6 months post-enrollment
Secondary outcomes (8)
Reduction of thyroid hormone overtreatment, measured as proportion of patients who had their TSH normalized.
Reduction in thyroid hormone overtreatment will be measured via EMR based on serum TSH in the normal range (=>0.5-6 mIU/L). We will assess TSH as a continuous variable and as a categorical variable (<0.5, 0.5-6, >6 mIU/L) to also delineate unintended TSH above the upper limit of normal.
Measured: 6 months post-enrollment
Provider-reported knowledge
Assessed via surveys by provider report and defined as the composite score obtained from 4 items with response categories ranging from low to high (5-point Likert scale; 1: low to 5: high); higher scores indicate increased knowledge.
Measured: 6-12 months post-enrollment
Provider-reported intent to deprescribe
Assessed via surveys by provider report (single item) with response categories ranging from low to high (5-point Likert scale; 1: very unlikely to 5: very likely).
Measured: 6-12 months post-enrollment
Provider-reported self-efficacy
Assessed via provider surveys using the 9-item validated deprescribing self-efficacy survey designed to gain a better understanding of how providers rate their self-efficacy in deprescribing medications in their older adult patients (scale 0-100; higher scores indicate higher self-efficacy).
Measured: 6-12 months post-enrollment
Patient-reported discussion of deprescribing with provider
Assessed via patient surveys by patient report and analyzed as a binary variable (yes/no).
Measured: 3-6 months post-enrollment
Patient-reported knowledge
Assessed by patient surveys and will be defined as the percentage of correct answers (range 0-100%) from four questions regarding thyroid hormone therapy in older adults (true/false), where higher percentages indicate increased knowledge.
Measured: 3-6 months post-enrollment
Patient-reported attitudes towards deprescribing
Assessed via patient surveys using the validated 22-item Revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire [subscales: perceived burden of medication taking, concerns about stopping the medication, belief in appropriateness of medication use (harms / benefits), level of involvement / knowledge of medications] and global questions. Questions pertaining to the burden, concerns about stopping, involvement in treatment, and global questions are scored such that a higher total score indicates a greater burden, concern, involvement, or agreement with global questions (5= strongly agree, 4= agree, 3= unsure, 2=disagree, 1= strongly disagree). Questions regarding the appropriateness factor were scored in reverse. In that case, a higher score indicates participants' belief in the appropriateness of their medications.
Measured: 3-6 months post-enrollment
Patient-reported beliefs about medicines
Assessed via patient surveys using the validated 18-item Beliefs about Medicines Questionnaire (BMQ), with each item scored on a 5-point Likert scale (5= strongly agree, 4= agree, 3= unsure, 2=disagree, 1= strongly disagree). The BMQ is divided into BMQ-General (sub-scales: overuse and harm) and BMQ-Specific (subscales: necessity and concerns). Higher scores in the BMQ-General subscales indicate an overall negative perception of medications. Higher scores in the BMQ-Specific necessity subscale are indicative of a patient's need to adhere to medication to maintain health, while higher scores in the BMQ-Specific concerns subscale represent the notion that adverse reactions are potentially harmful when taking medication on a regular basis.
Measured: 3-6 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start2 Dec 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Maria Papaleontiou, University of Michigan
- Investigators
- Maria Papaleontiou, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629272
- Sponsor's protocol ID
- HUM00231965
- Other IDs
- 1R01AG079833-01A1
- Status last verified
- Sep 2026
- First submitted
- 4 Oct 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The researchers will make the de-identified data available to researchers upon reasonable request via email to the study PI at the conclusion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing
- ClinicalTrials.gov ID
- NCT06629272
- Acronym / sponsor ID
- HUM00231965
- Conditions
- Hypothyroidism
- Keywords
- thyroid hormone overtreatment and misuse, older adults, deprescribing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-THIO (Deprescribing Thyroid Hormone In Older Adults) | Experimental | Behavioral: 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). |
| Enhanced usual care | Active comparator | Behavioral: Enhanced usual careThis 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 1) Patients with a diagnosis of thyroid cancer, secondary hypothyroidism, history of total thyroidectomy or hospitalization in the past 3 months will be excluded.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | D-THIO (Deprescribing Thyroid Hormone In Older Adults) |
| Enhanced usual careAmerican Thyroid Association [ATA] provider guidelines, ATA patient brochure | Behavioural | Enhanced usual care |
Primary outcome
Thyroid hormone deprescribing by providers
Time frame: 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).
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Yes. The researchers will make the de-identified data available to researchers upon reasonable request via email to the study PI at the conclusion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Papaleontiou principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-THIO (Deprescribing Thyroid Hormone In Older Adults) in people with Hypothyroidism, run by University of Michigan at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brittany Gay (734-763-8608, bbartol@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid hormone deprescribing by providers (time frame: 6 months post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.