Hypothyroidism
Conditions
Keywords
thyroid hormone overtreatment and misuse, older adults, deprescribing
Brief 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 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.
Interventions
BEHAVIORALD-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.
BEHAVIORALEnhanced usual care
American Thyroid Association \[ATA\] provider guidelines, ATA patient brochure
Sponsors
University of Michigan
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Eligibility: Inclusion Criteria: 1. 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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thyroid hormone deprescribing by providers | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of thyroid hormone overtreatment, measured as proportion of patients who had their TSH normalized. | 6 months post-enrollment | 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. |
| Provider-reported knowledge | 6-12 months post-enrollment | 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. |
| Provider-reported intent to deprescribe | 6-12 months post-enrollment | 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). |
| Provider-reported self-efficacy | 6-12 months post-enrollment | 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). |
| Patient-reported discussion of deprescribing with provider | 3-6 months post-enrollment | Assessed via patient surveys by patient report and analyzed as a binary variable (yes/no). |
| Patient-reported knowledge | 3-6 months post-enrollment | 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. |
| Patient-reported attitudes towards deprescribing | 3-6 months post-enrollment | 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. |
| Patient-reported beliefs about medicines | 3-6 months post-enrollment | 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. |
Countries
United States
Contacts
CONTACTBrittany Gay
PRINCIPAL_INVESTIGATORMaria Papaleontiou
University of Michigan
Outcome results
None listed