Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562881
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism
Status:
RECRUITING
Status Verified Date:
2024-10
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 goal of this study is to address surgical health equity in historically marginalized participants with primary hyperparathyroidism PHPT The main questions that this study aims to answer are how does patient navigation impact
The proportion of PHPT participants undergo parathyroidectomy
The proportion of PHPT participants who complete surgical consultation
Time to surgical consultation
Time to surgery
The proportion of PHPT participants undergo parathyroidectomy
The proportion of PHPT participants who complete surgical consultation
Time to surgical consultation
Time to surgery
Detailed Description:
Patients historically marginalized in Medicine are at increased risk of delayed care and undertreatment of PHPT which can result in end-organ damage and reduced quality of life due to fatigue brain fog pain and other constitutional symptoms due to imbalances in calcium levels It can be easily treated with a highly curative cost-effective and low risk surgery but less than 40 of patients who qualify for surgery undergo treatment Patients from historically marginalized populations such as blackHispanicAsian race underinsurance and older age are disproportionately impacted by lower rates of surgery and longer delays to surgery
This pragmatic pilot trial aims to address surgical health equity in historically marginalized patients with PHPT by assessing the impact of navigation specifically direct outreach and appointment scheduling on conversion of surgical referral to consultation and conversion of surgical consultation to treatment in two dimensions timeliness and clinical outcomes Participants will be randomized to receive or not receive scheduling navigation at time of recruitment with a crossover design at 3 months for those who do not receive scheduling navigation at time of recruitment and have yet to complete surgical consultation
This pragmatic pilot trial aims to address surgical health equity in historically marginalized patients with PHPT by assessing the impact of navigation specifically direct outreach and appointment scheduling on conversion of surgical referral to consultation and conversion of surgical consultation to treatment in two dimensions timeliness and clinical outcomes Participants will be randomized to receive or not receive scheduling navigation at time of recruitment with a crossover design at 3 months for those who do not receive scheduling navigation at time of recruitment and have yet to complete surgical consultation
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