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| Name | Class |
|---|---|
| American College of Surgeons | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scheduling Navigation | Experimental | Participants will be assigned to a scheduler. |
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| Without Scheduling Navigation | Active Comparator | Participants will not be assigned to a scheduler. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scheduling Navigation | Other | Participants will be connected to a scheduler to schedule a surgical consultation visit at time of recruitment. Participation does not guarantee or require surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Parathyroidectomy Surgical Outcome | The primary outcome will be the proportion of patients who undergo parathyroidectomy | Within 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of Consultation | Proportion of participants who complete surgical consultation | Through study completion, an average of 1 year after time of recruitment or surgery |
| Time to Consultation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jasmine Hwang, MD | Contact | (267) 251-2835 | Jasmine.Hwang@pennmedicine.upenn.edu | |
| Rachel Kelz, MD | Contact | (215) 662-2030 | Rachel.Kelz@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rachel Kelz, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D049950 | Hyperparathyroidism, Primary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| Without Scheduling Navigation | Other | 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 from participant referral to scheduling and completion of surgical consultation consultation
| Through study completion, an average of 1 year after time of recruitment or surgery |
| Time to Surgery | Time from participant referral to surgery | 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) | 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 | 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 | 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) | Assessed at 6 and 12 months after recruitment or surgery in all groups |
| Surgical parathyroid re-exploration | Rate of re-exploration for hyperparathyroidism | Assessed at 6 and 12 months after recruitment or surgery in all groups |