Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism
ConditionHyperparathyroidism, Primary
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Prior Parathyroidectomy
End-stage Renal Disease
Renal Transplant
Vitamin D Deficiency
Trial design
Design model
Parallel
Treatments tested in this trial
Scheduling Navigation
Other interventionParticipants 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 Navigation
Other interventionPatients 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.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Scheduling NavigationExperimental treatment 1 intervention
Group B: Without Scheduling NavigationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Parathyroidectomy Surgical Outcome
The primary outcome will be the proportion of patients who undergo parathyroidectomy
Time frame
Within 12 monthsSecondary outcomes
1
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 surgery2
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 surgery3
Time to Surgery
Time from participant referral to surgery
Time frame
Through study completion, an average of 1 year after time of recruitment or surgery4
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 groupsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
American College of Surgeons
Collaborator
Source ClinicalTrials.gov