Improving surgical access for patients with primary hyperparathyroidism
Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism
This study is testing if helping patients with primary hyperparathyroidism get better support and guidance can improve their chances of getting timely surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06562881 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with primary hyperparathyroidism who belong to racial or ethnic minority groups and meet specific clinical criteria for surgical treatment.
Not a fit: Patients who have previously undergone parathyroidectomy or have end-stage renal disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase the rates of surgical treatment for marginalized patients with primary hyperparathyroidism, improving their quality of life.
How similar studies have performed: Other studies have shown success in using patient navigation to improve access to surgical care, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.