Clinical trial NCT06562881: Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism
Official title: Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperparathyroidism, Primary
Keywords: Parathyroidectomy
Barriers and Challenges to Surgical Health Equity
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: American College of Surgeons
First posted: 2024-08-20
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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?

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Parathyroidectomy Surgical Outcome
timeFrame: Within 12 months
Secondary outcomes:
measure: Completion of Consultation
timeFrame: Through study completion, an average of 1 year after time of recruitment or surgery
measure: Time to Consultation
timeFrame: Through study completion, an average of 1 year after time of recruitment or surgery
measure: Time to Surgery
timeFrame: Through study completion, an average of 1 year after time of recruitment or surgery
measure: Complications related to hyperparathyroidism
timeFrame: Assessed at 6 and 12 months after recruitment or surgery in all groups
measure: Parathyroidectomy complications
timeFrame: Assessed at 6 and 12 months after recruitment or surgery in all groups
measure: Persistent hyperparathyroidism
timeFrame: Assessed at 6 and 12 months after recruitment or surgery in all groups
measure: Recurrent hyperparathyroidism
timeFrame: Assessed at 6 and 12 months after recruitment or surgery in all groups
measure: Surgical parathyroid re-exploration
timeFrame: Assessed at 6 and 12 months after recruitment or surgery in all groups
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Rachel Kelz, MD
role: PRINCIPAL_INVESTIGATOR
References: