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临床试验/NCT05624788
NCT05624788已完成不适用

A Study to Characterize Access to Specialty Care Received by American Indians/Alaska Natives (CATORI)

Genentech, Inc.2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
2
主要终点
Percentage of All Participants Seen by a Specialist for Advanced Care After Primary Care Provider Referral to a Specialist at 6 Months

研究概览

简要总结

This is an observational study to define current care pathways for American Indian or Alaska Native patients who require specialty care and potential feasibility of conducting clinical research within the existing framework. The study is designed with the flexibility to enroll patients with any indication requiring referral to one of the following specialists: neurologist, ophthalmologist, or oncologist. Eligible patients will have recently (≤6 months) been referred to a specialty care provider and not yet seen a specialist (in addition to meeting the other eligibility criteria). The PPD virtual site can enroll patients from anywhere across the United States.

The study will collect data to determine whether a patient was seen by a specialist, diagnosed with a specialized disease, patient characteristics potentially associated with being seen or not seen by a specialist, and the reasons/barriers why a patient was not seen by a specialist through a number of patient surveys.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to read English at 8th grade proficiency or have a household member willing to assist in translation to complete patient surveys
  • Self-identification as American Indian or Alaska Native
  • Referred to a neurologist, ophthalmologist, or oncologist for the first time within 6 months of screening and has not been seen by the specialist. Exception: Patients referred to an oncologist who have had a first-time visit with an oncologist but have a pending follow-up visit or pending referral visit within 6 months of screening may be included in the study.
  • Personal landline or cell phone and/or access to internet
  • Willingness to complete all surveys in the study and participate for 12 months

排除标准

  • Currently under the care of a specialist (neurologist, ophthalmologist, or oncologist) to whom they are being referred to by the primary care provider (i.e., to be eligible, the specialty care physician should be new to the participant) at time of screening
  • Currently or planned to receive care that requires in participant visits for the indication requiring referral from the primary care provider (e.g., radiotherapy, chemotherapy for cancer diagnosis). Exception: Patients referred to an oncologist who have had a first-time visit with an oncologist but have a pending follow-up visit or pending referral visit may be included in the study.

结局指标

主要结局

Percentage of All Participants Seen by a Specialist for Advanced Care After Primary Care Provider Referral to a Specialist at 6 Months

时间窗: 6 Months

Percentage of All Participants Seen by a Specialist for Advanced Care After Primary Care Provider Referral to a Specialist at 12 Months

时间窗: 12 Months

次要结局

  • Percentage of Participants Seen by a Specialist and Treated for Their Disease at 6 Months(6 Months)
  • Percentage of Participants Seen by a Specialist and Treated for Their Disease at 12 Months(12 Months)
  • Percentage of Participants Seen by a Specialist After Primary Care Provider Referral Within Each of the Three Specialist Groups at 12 Months(12 Months)
  • Percentage of Responses by Participant-Reported Barriers to Specialty Referral Completion at 6 Months(6 Months)
  • Percentage of Participants Seen by a Specialist After Primary Care Provider Referral Within Each of the Three Specialist Groups at 6 Months(6 Months)
  • Percentage of Responses by Participant-Reported Barriers to Specialty Referral Completion at 12 Months(12 Months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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