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

Trial Summary

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 data supports the effectiveness of the treatment Scheduling Navigation for primary hyperparathyroidism?

Patient navigation, which includes helping patients schedule and manage their treatment, has been shown to improve outcomes in cancer care by reducing the time to diagnosis and treatment. This suggests that similar navigation support could help patients with primary hyperparathyroidism by addressing barriers to care and improving treatment scheduling. ^{1 2 3 4 5}

How does the treatment Scheduling Navigation for primary hyperparathyroidism differ from other treatments?

Scheduling Navigation is unique because it involves a patient navigator who helps coordinate and streamline the treatment process, ensuring timely care and addressing any barriers to accessing treatment. This approach is different from traditional medical treatments as it focuses on improving the patient's journey through the healthcare system rather than directly treating the condition itself. ^{1 2 3 6 7}

What is the purpose of 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?

Research Team

Rachel Kelz, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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.

My kidneys are in the final stage of failure.

I have had a kidney transplant.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Incorporation of a patient navigator into a secondary fracture prevention program identifies barriers to patient care. [2022]

2. England 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. [2022]

3. United States 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? [2021]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Breast Cancer Navigation: Using Physician and Patient Surveys to Explore Nurse Navigator Program Experiences. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Patient navigation: improving timeliness in the diagnosis of breast abnormalities. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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