Recruiting

Patient Navigation

Sponsor:

University of Pennsylvania

Code:

NCT06562881

Conditions

Hyperparathyroidism, Primary

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Scheduling Navigation

Without Scheduling Navigation

Study Details

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

Study ID

NCT06562881

Start date

Oct 1, 2026

Status verified date

Aug, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Scheduling Navigation

Participants will be assigned to a scheduler.

active comparator: Without Scheduling Navigation

Participants will not be assigned to a scheduler.

Interventions

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.

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.

Primary outcome measure

  • Parathyroidectomy Surgical Outcome [ Time Frame: Within 12 months ]

Central Contacts and Locations

Central contacts

Jasmine Hwang, MD

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

Rachel Kelz, MD

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

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Jasmine Hwang, MD

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

Principal Investigator:

Rachel Kelz, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Parathyroidectomy
  • Barriers and Challenges to Surgical Health Equity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-08-27.