Improving surgical access for patients with primary hyperparathyroidism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance surgical health equity for historically marginalized patients diagnosed with primary hyperparathyroidism (PHPT) by implementing patient navigation strategies. It investigates how these navigation efforts, including direct outreach and appointment scheduling, affect the rates of surgical consultations and surgeries among participants. The study will randomize participants to receive or not receive navigation support, with a crossover design allowing those initially not receiving navigation to access it after three months. The focus is on improving timely access to parathyroidectomy, a curative and low-risk surgery for PHPT.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital of the University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Rachel Kelz, MD — University of Pennsylvania
• Study coordinator: Jasmine Hwang, MD
• Email: Jasmine.Hwang@pennmedicine.upenn.edu
• Phone: (267) 251-2835

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.