Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
NCT Number: NCT06562881
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?
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Within 12 months
The primary outcome will be the proportion of patients who undergo parathyroidectomy
Time frame: Through study completion, an average of 1 year after time of recruitment or surgery
Proportion of participants who complete surgical consultation
Time frame: Through study completion, an average of 1 year after time of recruitment or surgery
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 from participant referral to surgery
Time frame: Assessed at 6 and 12 months after recruitment or surgery in all groups
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
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
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
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
Rate of re-exploration for hyperparathyroidism
Contact information is provided by the study sponsor or research team.
Jasmine Hwang, MD
CONTACT
Rachel Kelz, MD
CONTACT
University of Pennsylvania
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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