Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing
ConditionHypothyroidism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
D-THIO (Deprescribing Thyroid Hormone In Older Adults)
BehavioralD-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 care
BehavioralAmerican Thyroid Association \[ATA\] provider guidelines, ATA patient brochure
Treatment groups
900 Participants
are divided into 2 treatment groupsGroup A: D-THIO (Deprescribing Thyroid Hormone In Older Adults)Experimental treatment 1 intervention
Group B: Enhanced usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
6 months post-enrollmentSecondary outcomes
1
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.
Time frame
6 months post-enrollment2
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.
Time frame
6-12 months post-enrollment3
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).
Time frame
6-12 months post-enrollment4
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).
Time frame
6-12 months post-enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov