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

Sponsor
Genentech, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05624788
Collaborator
(none)
150
2
24.1
75
3.1

Study Details

Study Description

Brief Summary

This is an observational study to define current care pathways for American Indian or Alaska Native patients requiring 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 a specialist (neurologist, ophthalmologist, or oncologist). Eligible patients will have recently (<3 months) been referred to a specialty care provider and not yet seen.

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No Intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
A Study to Characterize Access to Specialty Care Received by American Indians/Alaska Natives (CATORI)
Actual Study Start Date :
Dec 2, 2022
Anticipated Primary Completion Date :
Dec 5, 2024
Anticipated Study Completion Date :
Dec 5, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • 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 (>3 months) 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)

  • 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) within 3 months of consent date

Contacts and Locations

Locations

Site City State Country Postal Code
1 Curebase Walnut California United States 91789
2 Avera Research Institute Sioux Falls South Dakota United States 57105

Sponsors and Collaborators

  • Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Genentech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT05624788
Other Study ID Numbers:
  • ML44072
First Posted:
Nov 22, 2022
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2023