Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism

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?

Study Overview

• Status: Recruiting
• Conditions: Hyperparathyroidism, Primary
• Intervention / Treatment: Other: Scheduling Navigation; Other: Without Scheduling Navigation

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.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jasmine Hwang, MD; Phone Number: (267) 251-2835; Email: Jasmine.Hwang@pennmedicine.upenn.edu
• Study Contact Backup: Name: Rachel Kelz, MD; Phone Number: (215) 662-2030; Email: Rachel.Kelz@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Principal Investigator: Rachel Kelz, MD
      • Contact: Jasmine Hwang, MD; Phone Number: (267) 251-2835; Email: Jasmine.Hwang@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scheduling Navigation; Participants will be assigned to a scheduler.	Other: 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.
Active Comparator: Without Scheduling Navigation; Participants will not be assigned to a scheduler.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parathyroidectomy Surgical Outcome	The primary outcome will be the proportion of patients who undergo parathyroidectomy	Within 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of Consultation	Proportion of participants who complete surgical consultation	Through study completion, an average of 1 year after time of recruitment or surgery
Time to Consultation	Time from participant referral to scheduling and completion of surgical consultation consultation	Through study completion, an average of 1 year after time of recruitment or surgery
Time to Surgery	Time from participant referral to surgery	Through study completion, an average of 1 year after time of recruitment or surgery
Complications related to hyperparathyroidism	New, worsening, or recurrent end organ disease (osteoporosis, kidney stone, renal impairment, mental health disorders or cognitive function (requiring hospitalization or loss of independence), pancreatitis)	Assessed at 6 and 12 months after recruitment or surgery in all groups
Parathyroidectomy complications	Complications rates of the following: Bleeding/hematoma Hypocalcemia Surgical site infection Voice dysfunction Tracheostomy	Assessed at 6 and 12 months after recruitment or surgery in all groups
Persistent hyperparathyroidism	Rate of persistent disease, based on pattern of calcium and parathyroid hormone levels postoperatively	Assessed at 6 and 12 months after recruitment or surgery in all groups
Recurrent hyperparathyroidism	Rate of recurrent disease, based on pattern of calcium and parathyroid hormone levels postoperatively)	Assessed at 6 and 12 months after recruitment or surgery in all groups
Surgical parathyroid re-exploration	Rate of re-exploration for hyperparathyroidism	Assessed at 6 and 12 months after recruitment or surgery in all groups

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: American College of Surgeons
• Investigators: Principal Investigator: Rachel Kelz, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Parathyroidectomy; Barriers and Challenges to Surgical Health Equity
• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary
• Other Study ID Numbers: 855141

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No