Clinical trial NCT05624788: A Study to Characterize Access to Specialty Care Received by American Indians/Alaska Natives
Official title: A Study to Characterize Access to Specialty Care Received by American Indians/Alaska Natives (CATORI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Specialist Referral: Neurology
Specialist Referral: Ophthalmology
Specialist Referral: Oncology
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of All Participants Seen by a Specialist for Advanced Care After Primary Care Provider Referral to a Specialist at 6 Months
timeFrame: 6 Months
measure: Percentage of All Participants Seen by a Specialist for Advanced Care After Primary Care Provider Referral to a Specialist at 12 Months
timeFrame: 12 Months
Secondary outcomes:
measure: Percentage of Participants Seen by a Specialist and Treated for Their Disease at 6 Months
timeFrame: 6 Months
measure: Percentage of Participants Seen by a Specialist and Treated for Their Disease at 12 Months
timeFrame: 12 Months
measure: Percentage of Responses by Participant-Reported Barriers to Specialty Referral Completion at 6 Months
timeFrame: 6 Months
measure: Percentage of Responses by Participant-Reported Barriers to Specialty Referral Completion at 12 Months
timeFrame: 12 Months
measure: Percentage of Participants Seen by a Specialist After Primary Care Provider Referral Within Each of the Three Specialist Groups at 6 Months
timeFrame: 6 Months
measure: Percentage of Participants Seen by a Specialist After Primary Care Provider Referral Within Each of the Three Specialist Groups at 12 Months
timeFrame: 12 Months
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: PPD Virtual - PPD - US
state: North Carolina
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: