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NCT Number: NCT06562881

Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism

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?

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Jasmine Hwang, MD

CONTACT

[email protected]

(267) 251-2835

Rachel Kelz, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Parathyroidectomy Surgical Outcome

    Time frame: Within 12 months

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

Secondary outcomes

  1. Completion of Consultation

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

    Proportion of participants who complete surgical consultation

  2. Time to Consultation

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

    Time from participant referral to scheduling and completion of surgical consultation consultation

  3. Time to Surgery

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

    Time from participant referral to surgery

  4. Complications related to hyperparathyroidism

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

    New, worsening, or recurrent end organ disease (osteoporosis, kidney stone, renal impairment, mental health disorders or cognitive function (requiring hospitalization or loss of independence), pancreatitis)

  5. Parathyroidectomy complications

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

    Complications rates of the following:

    Bleeding/hematoma Hypocalcemia Surgical site infection Voice dysfunction Tracheostomy

  6. Persistent hyperparathyroidism

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

    Rate of persistent disease, based on pattern of calcium and parathyroid hormone levels postoperatively

  7. Recurrent hyperparathyroidism

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

    Rate of recurrent disease, based on pattern of calcium and parathyroid hormone levels postoperatively)

  8. Surgical parathyroid re-exploration

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

    Rate of re-exploration for hyperparathyroidism

Study contacts

Contact information is provided by the study sponsor or research team.

Jasmine Hwang, MD

CONTACT

[email protected]

(267) 251-2835

Rachel Kelz, MD

CONTACT

[email protected]

(215) 662-2030

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • American College of Surgeons

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2024
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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