Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism

NCT ID: NCT06562881

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2026-12-30

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?

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 black/Hispanic/Asian 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.

Conditions

Hyperparathyroidism, Primary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Scheduling Navigation

Participants will be assigned to a scheduler.

Group Type: EXPERIMENTAL

Scheduling Navigation

Intervention Type: OTHER

Participants will be connected to a scheduler to schedule a surgical consultation visit at time of recruitment. Participation does not guarantee or require surgery.

Without Scheduling Navigation

Participants will not be assigned to a scheduler.

Group Type: ACTIVE_COMPARATOR

Without Scheduling Navigation

Intervention Type: OTHER

Patients will work with clinic staff in the usual fashion for their treatment for primary hyperparathyroidism. They will not be connected directly to a scheduler to help schedule a surgical consultation visit at time of recruitment. With our crossover design, if patients have not yet received surgical consultation after 3 months, they will be called and connected with a scheduler at that time. Participation does not guarantee or require surgery.

Interventions

Scheduling Navigation

Participants will be connected to a scheduler to schedule a surgical consultation visit at time of recruitment. Participation does not guarantee or require surgery.

Intervention Type: OTHER

Without Scheduling Navigation

Patients will work with clinic staff in the usual fashion for their treatment for primary hyperparathyroidism. They will not be connected directly to a scheduler to help schedule a surgical consultation visit at time of recruitment. With our crossover design, if patients have not yet received surgical consultation after 3 months, they will be called and connected with a scheduler at that time. Participation does not guarantee or require surgery.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosed with PHPT and not yet had parathyroidectomy who meet criteria for surgical treatment of PHPT (osteoporosis, fragility fracture, or evidence of vertebral compression fracture on spine imaging, renal involvement [renal stone, silent nephrolithiasis on renal imaging, nephrocalcinosis, hypercalciuria (24-hour urine calcium level 400 mg/dL) with increased stone risk, or impaired renal function (glomerular filtration rate 60 mL/min)], calcium 1 mg/dL above upper limit of normal, age less than 50)
• Qualify as a member of a racial or ethnic minority group (Black, Hispanic, Asian and Pacific Islander, Native American), lower socioeconomic neighborhoods (by zipcode), socially vulnerable (social determinants of health indicating financial strain, social vulnerability index in the top quartile 75%+ by zip code), or with underinsurance (Medicaid, Medicare, dual eligible, uninsured)

Exclusion Criteria

• Prior Parathyroidectomy
• End-stage Renal Disease
• Renal Transplant
• Vitamin D Deficiency
• Metastatic Disease
• Familial Hypocalciuric Hypercalcemia
• No Indication for Surgery
• Unable/Unwilling to provide consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American College of Surgeons

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Rachel Kelz

Executive Vice Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Kelz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jasmine Hwang, MD

Role: CONTACT

Jasmine.Hwang@pennmedicine.upenn.edu

(267) 251-2835

Rachel Kelz, MD

Role: CONTACT

Rachel.Kelz@pennmedicine.upenn.edu

(215) 662-2030

Facility Contacts

Jasmine Hwang, MD

Role: primary

Jasmine.Hwang@pennmedicine.upenn.edu

(267) 251-2835

Other Identifiers

855141

Identifier Type: -

Identifier Source: org_study_id