Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism

University of Pennsylvania

Status: Enrolling

Conditions: Hyperparathyroidism, Primary

Treatments: Other: Without Scheduling Navigation; Other: Scheduling Navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT06562881

855141

Details and patient eligibility

About

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?

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

76 participants in 2 patient groups

Scheduling Navigation

Experimental group

Description:

Participants will be assigned to a scheduler.

Treatment:

Other: Scheduling Navigation

Without Scheduling Navigation

Active Comparator group

Description:

Participants will not be assigned to a scheduler.

Treatment:

Other: Without Scheduling Navigation