An interventional study of Scheduling Navigation and Without Scheduling Navigation in Hyperparathyroidism, Primary, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Supportive care
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:
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.
104 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.
This study's planned enrollment of 76 is above the median of 68 across 60 interventional studies indexed under Hyperparathyroidism, Primary.
Browse Hyperparathyroidism, Primary studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be assigned to a scheduler.
Other: Scheduling Navigation
Participants will not be assigned to a scheduler.
Other: Without 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.
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.
Parathyroidectomy Surgical Outcome
The primary outcome will be the proportion of patients who undergo parathyroidectomy
Time frame: Within 12 months
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
Time frame: Assessed at 6 and 12 months after recruitment or surgery in all groups
Recurrent hyperparathyroidism
Rate of recurrent disease, based on pattern of calcium and parathyroid hormone levels postoperatively)
Time frame: Assessed at 6 and 12 months after recruitment or surgery in all groups
Surgical parathyroid re-exploration
Rate of re-exploration for hyperparathyroidism
Time frame: Assessed at 6 and 12 months after recruitment or surgery in all groups
Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.
Of 20 interventional studies with no phase under Hyperparathyroidism, Primary, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 84. This study's planned 2 months is below that.
How these figures are worked out, and which studies are left out of them.
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