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

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

NCT ID: NCT05624788

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

Conditions: Official terms:
Neoplasms

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: No Intervention
Description: 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.
Arm group label: Specialist Referral: Neurology
Arm group label: Specialist Referral: Oncology
Arm group label: Specialist Referral: Ophthalmology

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.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Curebase

Address:
City: Walnut
Zip: 91789
Country: United States

Facility:
Name: PPD Virtual - PPD - US

Address:
City: Wilmington
Zip: 28401
Country: United States

Facility:
Name: Avera Research Institute

Address:
City: Sioux Falls
Zip: 57105
Country: United States

Start date: December 2, 2022

Completion date: April 1, 2025

Lead sponsor:
Agency: Genentech, Inc.
Agency class: Industry

Source: Genentech, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05624788