Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Parathyroidectomy Surgical Outcome
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Prior Parathyroidectomy
- •End-stage Renal Disease
- •Renal Transplant
- •Vitamin D Deficiency
- •Metastatic Disease
- •Familial Hypocalciuric Hypercalcemia
- •No Indication for Surgery
- •Unable/Unwilling to provide consent
研究组 & 干预措施
Scheduling Navigation
Participants will be assigned to a scheduler.
干预措施: Scheduling Navigation (Other)
Without Scheduling Navigation
Participants will not be assigned to a scheduler.
干预措施: Without Scheduling Navigation (Other)
结局指标
主要结局
Parathyroidectomy Surgical Outcome
时间窗: Within 12 months
The primary outcome will be the proportion of patients who undergo parathyroidectomy
次要结局
- Parathyroidectomy complications(Assessed at 6 and 12 months after recruitment or surgery in all groups)
- Completion of Consultation(Through study completion, an average of 1 year after time of recruitment or surgery)
- Time to Consultation(Through study completion, an average of 1 year after time of recruitment or surgery)
- Time to Surgery(Through study completion, an average of 1 year after time of recruitment or surgery)
- Complications related to hyperparathyroidism(Assessed at 6 and 12 months after recruitment or surgery in all groups)
- Persistent hyperparathyroidism(Assessed at 6 and 12 months after recruitment or surgery in all groups)
- Recurrent hyperparathyroidism(Assessed at 6 and 12 months after recruitment or surgery in all groups)
- Surgical parathyroid re-exploration(Assessed at 6 and 12 months after recruitment or surgery in all groups)
研究者
Rachel Kelz
Executive Vice Chair
University of Pennsylvania