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Hormone Therapy

Deprescribing Thyroid Hormone for Hypothyroidism

N/A

Recruiting

Led By Maria Papaleontiou

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients aged 65 years and older

Patients on thyroid hormone therapy with a serum Thyroid-stimulating hormone (TSH) <0.5 mIU/L or on thyroid hormone therapy for an inappropriate indication

Must not have

Patients with secondary hypothyroidism

Providers who do not prescribe thyroid hormone.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-6 months post-enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new method called D-THIO to help older adults safely reduce their thyroid hormone medication when they are taking too much. The goal is to prevent harm to patients. If

Who is the study for?

This trial is for older adults who are being overtreated with thyroid hormone or using it inappropriately. The goal is to safely reduce or stop their medication to prevent harm.

What is being tested?

The study tests D-THIO, a strategy to help doctors and patients lower or stop unnecessary thyroid hormone use, compared with the usual care practices.

What are the potential side effects?

Since this trial involves reducing medication, side effects may include symptoms of low thyroid levels like fatigue, weight gain, and cold sensitivity if the dose is lowered too much.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

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I am on thyroid hormone therapy with low TSH or for a reason not typically recommended.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition where my thyroid doesn't produce enough hormones due to a pituitary issue.

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My doctor does not prescribe thyroid hormone treatments.

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I have been diagnosed with thyroid cancer.

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I have had my entire thyroid removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-6 months post-enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-6 months post-enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-6 months post-enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Thyroid hormone deprescribing by providers

Secondary study objectives

Patient-reported attitudes towards deprescribing

Patient-reported beliefs about medicines

Patient-reported discussion of deprescribing with provider

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: D-THIO (Deprescribing Thyroid Hormone In Older Adults)Experimental Treatment1 Intervention

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).

Group II: Enhanced usual careActive Control1 Intervention

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.

0 / 6Eligibility criteria met