Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629272
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor discontinuation in older adults with thyroid hormone overtreatment andor 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None