Hyperparathyroidism, PrimaryNCT06562881
Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism
A study testing Scheduling Navigation and Without Scheduling Navigation in people with Hyperparathyroidism, Primary, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperparathyroidism, Primary
- What is being tested?
- Scheduling Navigation and Without Scheduling Navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jasmine Hwang, MD, (267) 251-2835, Jasmine.Hwang@pennmedicine.upenn.edu
Rachel Kelz, MD
About this study
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?
Read the 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.
- Conditions
- Hyperparathyroidism, Primary
- Being tested
- Scheduling Navigation, Without Scheduling Navigation
- Keywords
- Parathyroidectomy, Barriers and Challenges to Surgical Health Equity
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Scheduling Navigation | Experimental | Participants will be assigned to a scheduler. Receives: Other: Scheduling Navigation |
| Without Scheduling Navigation | Active comparator | Participants will not be assigned to a scheduler. Receives: Other: Without Scheduling Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parathyroidectomy Surgical Outcome
The primary outcome will be the proportion of patients who undergo parathyroidectomy
Measured: Within 12 months
Secondary outcomes (8)
Completion of Consultation
Proportion of participants who complete surgical consultation
Measured: 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
Measured: Through study completion, an average of 1 year after time of recruitment or surgery
Time to Surgery
Time from participant referral to surgery
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: Assessed at 6 and 12 months after recruitment or surgery in all groups
Surgical parathyroid re-exploration
Rate of re-exploration for hyperparathyroidism
Measured: Assessed at 6 and 12 months after recruitment or surgery in all groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Oct 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperparathyroidism, PrimaryStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Surgeons
- Responsible party
- Principal investigator, Rachel Kelz, University of Pennsylvania
- Investigators
- Rachel Kelz, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562881
- Sponsor's protocol ID
- 855141
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT06562881
- Acronym / sponsor ID
- 855141
- Conditions
- Hyperparathyroidism, Primary
- Keywords
- Parathyroidectomy, Barriers and Challenges to Surgical Health Equity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- American College of Surgeons
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scheduling Navigation | Experimental | Other: Scheduling NavigationParticipants will be assigned to a scheduler. |
| Without Scheduling Navigation | Active comparator | Other: Without Scheduling NavigationParticipants will not be assigned to a scheduler. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (8 listed)
- Prior Parathyroidectomy
- End-stage Renal Disease
- Renal Transplant
- Vitamin D Deficiency
- Metastatic Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scheduling NavigationParticipants will be connected to a scheduler to schedule a surgical consultation visit at time of recruitment. Participation does not guarantee or require surgery. | Other | Scheduling Navigation |
| Without Scheduling NavigationPatients 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. | Other | Without Scheduling Navigation |
Primary outcome
Parathyroidectomy Surgical Outcome
Time frame: Within 12 months
The primary outcome will be the proportion of patients who undergo parathyroidectomy
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Kelz, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scheduling Navigation and Without Scheduling Navigation in people with Hyperparathyroidism, Primary, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasmine Hwang, MD ((267) 251-2835, Jasmine.Hwang@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parathyroidectomy Surgical Outcome (time frame: Within 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.