Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism

University of Pennsylvania76 enrolled

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?

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Hyperparathyroidism, Primary

Interventions

Scheduling NavigationOTHER

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 NavigationOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Parathyroidectomy Surgical Outcome

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

Time frame: Within 12 months

Secondary Outcomes

Completion of Consultation

Proportion of participants who complete surgical consultation

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

Time to Consultation

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

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

Time to Surgery

Time from participant referral to surgery

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

Complications related to hyperparathyroidism

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)

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

Parathyroidectomy complications

Complications rates of the following: Bleeding/hematoma Hypocalcemia Surgical site infection Voice dysfunction Tracheostomy

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

Persistent hyperparathyroidism

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

Central Contacts

Jasmine Hwang, MD

CONTACT

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

Rachel Kelz, MD

CONTACT

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

Data from ClinicalTrials.gov

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