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OpenTrials
Completed

NCT Number: NCT05624788

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

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.

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Key information

Conditions

Specialist Referral: Neurology Specialist Referral: Oncology Specialist Referral: Ophthalmology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

PPD Virtual - PPD - US, Wilmington, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

Participants who self-identify as American Indian or Alaska Native with any indication requiring referral to a specialist after a primary care provider standard of care visit will be observed to collect data, using several surveys at 6 and 12 months. No additional specialty care visits will be added for the purpose of this study given the intent to observe medical care received following primary care provider referral. Referral to a specialist will be based on local clinical practice.

Primary outcomes

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

    Time frame: 6 Months

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

    Time frame: 12 Months

Secondary outcomes

  1. Percentage of Participants Seen by a Specialist and Treated for Their Disease at 6 Months

    Time frame: 6 Months

  2. Percentage of Participants Seen by a Specialist and Treated for Their Disease at 12 Months

    Time frame: 12 Months

  3. Percentage of Responses by Participant-Reported Barriers to Specialty Referral Completion at 6 Months

    Time frame: 6 Months

  4. Percentage of Responses by Participant-Reported Barriers to Specialty Referral Completion at 12 Months

    Time frame: 12 Months

  5. Percentage of Participants Seen by a Specialist After Primary Care Provider Referral Within Each of the Three Specialist Groups at 6 Months

    Time frame: 6 Months

  6. Percentage of Participants Seen by a Specialist After Primary Care Provider Referral Within Each of the Three Specialist Groups at 12 Months

    Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Acronym: CATORI

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2022
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.