Patient Navigation for Primary Hyperparathyroidism

Overseen By Rachel Kelz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Prior parathyroidectomy, End-stage renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether assisting patients in scheduling medical appointments can improve access to surgery for those with primary hyperparathyroidism (PHPT), a condition where the parathyroid glands produce excess hormone, leading to issues like weak bones and kidney problems. Researchers aim to determine if a scheduler, known as Scheduling Navigation, helps more people reach their surgical consultations and surgeries more quickly. Participants will either receive help from a scheduler or manage their appointments independently. Individuals with PHPT who qualify for surgery and belong to racial or ethnic minority groups or face financial challenges may be well-suited for this study. As an unphased trial, this study offers participants the chance to contribute to research that could enhance healthcare access for others facing similar challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this patient navigation method is safe for participants with primary hyperparathyroidism?

Research has shown that scheduling assistance for primary hyperparathyroidism (PHPT) is safe and well-received. This approach helps patients navigate the healthcare system, ensuring timely care. No reports of serious side effects have emerged from the scheduling assistance itself.

Similar studies have demonstrated that data-driven referrals for surgery yield positive results without increasing negative effects. Patients referred to higher-quality facilities for surgery experienced fewer serious complications and improved overall care.

Although scheduling assistance is a different method, these findings suggest that helping patients with their treatment can be safe and beneficial. Currently, no evidence indicates that scheduling assistance itself causes harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for scheduling navigation in patients with primary hyperparathyroidism because it explores a novel approach to patient care. Unlike the traditional focus on medical or surgical interventions, this trial emphasizes the role of guided scheduling to enhance treatment adherence and efficiency. By assigning participants a scheduler, the trial aims to streamline the often complex process of managing appointments and follow-ups, potentially leading to better health outcomes and more personalized patient experiences. This innovative method could significantly improve the overall management of the condition by reducing patient stress and optimizing healthcare resources.

What evidence suggests that scheduling navigation is effective for improving surgical outcomes in primary hyperparathyroidism?

Studies have shown that helping patients navigate the healthcare system can improve their health outcomes. For individuals with primary hyperparathyroidism (PHPT), timely surgery is crucial as it can alleviate symptoms and prevent complications. This trial will compare two groups: one receiving Scheduling Navigation support and another without it. Research suggests that organized support, such as assistance with scheduling appointments, increases the likelihood of patients seeing a surgeon and undergoing necessary surgery. This support can expedite treatment, which is vital for managing PHPT. Although specific data on navigation for PHPT is limited, the overall benefits of patient navigation in enhancing healthcare access and adherence to treatment plans are well-documented. ^{5 6 7 8 9}

Who Is on the Research Team?

Rachel Kelz, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for individuals with primary hyperparathyroidism, particularly those from historically marginalized communities. The study aims to improve their access to surgery. Specific eligibility criteria are not provided, but typically include a confirmed diagnosis and being within a certain age range.

Inclusion Criteria

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)

I have PHPT and need surgery due to bone, kidney issues, high calcium, or being under 50.

Exclusion Criteria

I have had surgery to remove my parathyroid glands.

Vitamin D Deficiency

My kidneys are in the final stage of failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recruitment and Randomization

Participants are recruited and randomized to receive or not receive scheduling navigation

3 months

Consultation and Treatment

Participants undergo surgical consultation and potentially parathyroidectomy

12 months

Follow-up

Participants are monitored for complications and outcomes related to hyperparathyroidism

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Scheduling Navigation

Trial Overview The study is testing the effectiveness of 'Scheduling Navigation' compared to standard approaches without such assistance. It looks at whether this helps patients get surgical consultations and surgeries faster, and if it increases the number of patients getting surgery.

How Is the Trial Designed?

Group I: Scheduling Navigation Experimental Treatment 1 Intervention

Participants will be assigned to a scheduler.

Group II: Without Scheduling Navigation Active Control 1 Intervention

Participants will not be assigned to a scheduler.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

American College of Surgeons

Collaborator

Trials

18

Recruited

60,400+

Published Research Related to This Trial

The introduction of patient navigation for women directly referred for breast biopsies significantly reduced waiting times from 20 days in 1999 to 14 days in 2000, indicating improved efficiency in the diagnostic process.

Patient navigation not only enhances the timeliness of breast abnormality diagnoses but also has the potential to improve quality of life by providing quicker reassurance for benign conditions and facilitating earlier treatment for malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation: improving timeliness in the diagnosis of breast abnormalities. Psooy, BJ., Schreuer, D., Borgaonkar, J., et al.[2022]

The Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I) measure was validated in a study involving 783 participants, demonstrating high internal consistency and reliability (α ranging from 0.95 to 0.96).

The PSN-I effectively captures patient satisfaction with navigators, showing strong correlations with existing satisfaction measures, which suggests it is a reliable tool for assessing the quality of support provided to underserved cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: a multi-site patient navigation research program study. Jean-Pierre, P., Fiscella, K., Winters, PC., et al.[2022]

Patient navigation did not significantly improve the transition rate from hospital to the High-Risk Osteoporosis Clinic (HiROC) for patients with fragility fractures, with rates of 53% for navigated patients compared to 48% for those without navigation.

However, patient navigation did lead to a higher completion rate of Dual-energy X-ray Absorptiometry (DXA) scans (90% vs. 67%), suggesting that while it may not enhance overall transition rates, it can improve specific follow-up care aspects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporation of a patient navigator into a secondary fracture prevention program identifies barriers to patient care. Jia, KQ., Southerland, L., Phieffer, L., et al.[2022]

Patient navigation can significantly improve access to care and support for vulnerable cancer patients, particularly those with low income, low education, and multiple health issues, as shown by recent analyses of the Patient Navigation Research Program.

To be most effective, patient navigation programs should be tailored to address the specific challenges faced by these high-risk populations, requiring careful planning and integration into existing healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of evidence-based patient navigation programs. Freund, KM.[2017]

In a study involving 862 patients across 18 clinics, patient navigation (PN) significantly reduced the time to diagnostic resolution for individuals with abnormal cancer screening tests, showing a 65% higher resolution rate at 15 months compared to those without PN.

The benefits of PN became evident starting at six months after the detection of abnormalities, suggesting that this intervention could effectively address health disparities in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ohio Patient Navigation Research Program: does the American Cancer Society patient navigation model improve time to resolution in patients with abnormal screening tests? Paskett, ED., Katz, ML., Post, DM., et al.[2021]

In a study involving 862 participants, patient navigation (PN) significantly improved the time to diagnostic resolution for older adults (≥65 years) with abnormal cancer screenings, achieving a 127% higher resolution rate compared to usual care.

The effectiveness of PN for older adults was comparable to that of younger participants (<65 years), suggesting that PN can be beneficial across different age groups in reducing delays in cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Time to Diagnostic Resolution After an Abnormal Cancer Screening Exam in Older Adult Participants in the Ohio Patient Navigation Research Program. DeSalvo, JM., Young, GS., Krok-Schoen, JL., et al.[2022]

The breast cancer navigation (BCN) program significantly improved physician workflows, with many physicians stating it made their day easier and enhanced care coordination and patient experience.

Patients also reported high satisfaction with the support they received during diagnosis communication, indicating that the BCN program effectively met their needs during a challenging time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer Navigation: Using Physician and Patient Surveys to Explore Nurse Navigator Program Experiences. Dillon, EC., Kim, P., Li, M., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10988805/

Patient-reported outcome measures for primary ... This systematic review aimed to summarize and evaluate evidence on the measurement properties of PROMs used in adult patients with PHPT,

2. journalofsurgicalresearch.com journalofsurgicalresearch.com/article/S0022-4804(24)00036-2/fulltext

Which Localizing Strategy is the Most Cost-Effective in ... US-guided FNA with PTH is the most cost-effective confirmatory test after US localization. 4D-CT should be considered as the next best test after negative US.

3. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2542667

AAES Guidelines for Primary Hyperparathyroidism ... Surgeons who perform a high volume of operations have better outcomes. The possibility of multigland disease should be routinely considered.

4. academic.oup.com academic.oup.com/jbmr/article/37/11/2373/7512395

Surgical Aspects of Primary Hyperparathyroidism However, data indicate that the failure rate (ie, the rate of persistent hypercalcemia after surgery) is increased in patients with negative imaging. Data from ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12417237/

a meta-analysis and systematic review - PMC - PubMed Central The results demonstrated a significant efficacy of RFA in treating hyperparathyroidism ... primary hyperparathyroidism: an efficacy and safety ...

6. withpower.com withpower.com/trial/phase-hyperparathyroidism-7-2024-60089

Patient Navigation for Primary Hyperparathyroidism This N/A medical study run by University of Pennsylvania is evaluating whether Scheduling Navigation will have tolerable side effects & efficacy for ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40696258/

Data-Driven Surgical Referrals for Primary ... Conclusions: Simulation indicated that data-driven parathyroidectomy referrals can reduce SAE and advance surgical health equity. Data-driven ...

8. researchgate.net researchgate.net/publication/393930366_Data-Driven_Surgical_Referrals_for_Primary_Hyperparathyroidism_and_Associated_Surgical_Outcomes_A_Simulation_Study

(PDF) Data-Driven Surgical Referrals for Primary ... This study assessed the effect of “referring” patients to higher-performing facilities for parathyroidectomy. Methods A simulation study of adults who underwent ...

9. academic.oup.com academic.oup.com/jbmr/article/37/11/2293/7512381

Evaluation and Management of Primary Hyperparathyroidism For patients with asymptomatic PHPT, PTX achieved a biochemical cure in 97.8% (high quality evidence for cure rate). This percentage is consistent with the ...