Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism

Overview

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.

Interventions

• Other 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.
• Other 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 measures

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

Secondary outcome measures (8)

• Completion of Consultation [Time frame: Through study completion, an average of 1 year after time of recruitment or surgery]
• Time to Consultation [Time frame: Through study completion, an average of 1 year after time of recruitment or surgery]
• Time to Surgery [Time frame: Through study completion, an average of 1 year after time of recruitment or surgery]
• Complications related to hyperparathyroidism [Time frame: Assessed at 6 and 12 months after recruitment or surgery in all groups]
• Parathyroidectomy complications [Time frame: Assessed at 6 and 12 months after recruitment or surgery in all groups]
• Persistent hyperparathyroidism [Time frame: Assessed at 6 and 12 months after recruitment or surgery in all groups]
• Recurrent hyperparathyroidism [Time frame: Assessed at 6 and 12 months after recruitment or surgery in all groups]
• Surgical parathyroid re-exploration [Time frame: Assessed at 6 and 12 months after recruitment or surgery in all groups]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Hospital of the University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT06562881 · 855141

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗