Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism

NCT06562881 | Recruiting

• 1 other identifier: 855141
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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?

Conditions

Hyperparathyroidism, Primary

Keywords

Parathyroidectomy; Barriers and Challenges to Surgical Health Equity

Outcome Measures

Primary Outcomes (1)

• Parathyroidectomy Surgical Outcome

  The primary outcome will be the proportion of patients who undergo parathyroidectomy

  Within 12 months

Secondary Outcomes (8)

• Completion of Consultation

  Through study completion, an average of 1 year after time of recruitment or surgery

• Time to Consultation

  Through study completion, an average of 1 year after time of recruitment or surgery

• Time to Surgery

  Through study completion, an average of 1 year after time of recruitment or surgery

• Complications related to hyperparathyroidism

  Assessed at 6 and 12 months after recruitment or surgery in all groups

• Parathyroidectomy complications

  Assessed at 6 and 12 months after recruitment or surgery in all groups

Study Arms (2)

Scheduling Navigation

EXPERIMENTAL

Participants will be assigned to a scheduler.

Other: Scheduling Navigation

Without Scheduling Navigation

ACTIVE COMPARATOR

Participants will not be assigned to a scheduler.

Other: Without Scheduling Navigation

Interventions

Without Scheduling Navigation 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.

Without Scheduling Navigation

Scheduling Navigation 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.

Scheduling Navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• American College of Surgeons: collaborator
• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Rachel Kelz, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasmine Hwang, MD

CONTACT

(267) 251-2835; Jasmine.Hwang@pennmedicine.upenn.edu

Rachel Kelz, MD

CONTACT

(215) 662-2030; Rachel.Kelz@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Vice Chair

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 20, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (1)