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

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

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.

Study Overview

• Status: Completed
• Conditions: Specialist Referral: Neurology; Specialist Referral: Ophthalmology; Specialist Referral: Oncology
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • PPD Virtual - PPD - US
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will focus exclusively on American Indians and Alaska Native patients who are seen by primary care providers and require an advanced care referral to a specialist.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Specialist Referral: Neurology	Other: No Intervention; 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.
Specialist Referral: Ophthalmology	Other: No Intervention; 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.
Specialist Referral: Oncology	Other: No Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of All Participants Seen by a Specialist for Advanced Care After Primary Care Provider Referral to a Specialist at 6 Months	6 Months
Percentage of All Participants Seen by a Specialist for Advanced Care After Primary Care Provider Referral to a Specialist at 12 Months	12 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Responses by Participant-Reported Barriers to Specialty Referral Completion at 6 Months	6 Months
Percentage of Responses by Participant-Reported Barriers to Specialty Referral Completion 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 6 Months	6 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

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Clinical Trials, Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2022
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): April 15, 2025

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ML44072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No