Specialist Referral: NeurologyCATORINCT05624788
A Study to Characterize Access to Specialty Care Received by American Indians/Alaska Natives
An observational study of Specialist Referral: Neurology and Specialist Referral: Ophthalmology, run by Genentech, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Specialist Referral: Neurology, Specialist Referral: Ophthalmology, Specialist Referral: Oncology
- How many people
- 84 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Dec 2022to 15 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Avera Research Institute
Sioux Falls, South Dakota, 57105
PPD Virtual - PPD - US
Wilmington, North Carolina, 28401
About this study
Official title: 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.
- Conditions
- Specialist Referral: Neurology, Specialist Referral: Ophthalmology, Specialist Referral: Oncology
- Being tested
- No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Specialist Referral: Neurology | Not described Receives: Other: No Intervention | |
| Specialist Referral: Ophthalmology | Not described Receives: Other: No Intervention | |
| Specialist Referral: Oncology | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of All Participants Seen by a Specialist for Advanced Care After Primary Care Provider Referral to a Specialist at 6 Months
Measured: 6 Months
Percentage of All Participants Seen by a Specialist for Advanced Care After Primary Care Provider Referral to a Specialist at 12 Months
Measured: 12 Months
Secondary outcomes (6)
Percentage of Participants Seen by a Specialist and Treated for Their Disease at 6 Months
Measured: 6 Months
Percentage of Participants Seen by a Specialist and Treated for Their Disease at 12 Months
Measured: 12 Months
Percentage of Responses by Participant-Reported Barriers to Specialty Referral Completion at 6 Months
Measured: 6 Months
Percentage of Responses by Participant-Reported Barriers to Specialty Referral Completion at 12 Months
Measured: 12 Months
Percentage of Participants Seen by a Specialist After Primary Care Provider Referral Within Each of the Three Specialist Groups at 6 Months
Measured: 6 Months
Percentage of Participants Seen by a Specialist After Primary Care Provider Referral Within Each of the Three Specialist Groups at 12 Months
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start2 Dec 2022
- Primary completion1 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specialist Referral: NeurologyStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624788
- Sponsor's protocol ID
- ML44072
- Acronym
- CATORI
- Status last verified
- Apr 2025
- First submitted
- 10 Nov 2022
- Last updated
- 25 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Characterize Access to Specialty Care Received by American Indians/Alaska Natives (CATORI)
- ClinicalTrials.gov ID
- NCT05624788
- Acronym / sponsor ID
- CATORI / ML44072
- Conditions
- Specialist Referral: Neurology, Specialist Referral: Ophthalmology, Specialist Referral: Oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 22 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Specialist Referral: Neurology | – | Other: No Intervention |
| Specialist Referral: Ophthalmology | – | Other: No Intervention |
| Specialist Referral: Oncology | – | Other: No Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionParticipants 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. | Other | Specialist Referral: Neurology, Specialist Referral: Oncology, Specialist Referral: Ophthalmology |
Primary outcome
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
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
6 secondary outcomes
Percentage of Participants Seen by a Specialist and Treated for Their Disease at 6 Months
Time frame: 6 Months
Percentage of Participants Seen by a Specialist and Treated for Their Disease at 12 Months
Time frame: 12 Months
Percentage of Responses by Participant-Reported Barriers to Specialty Referral Completion at 6 Months
Time frame: 6 Months
Percentage of Responses by Participant-Reported Barriers to Specialty Referral Completion at 12 Months
Time frame: 12 Months
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Specialist Referral: Neurology and Specialist Referral: Ophthalmology, run by Genentech, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.