A study to characterize access to specialty care received by American Indians/Alaska Natives (CATORI)
| ISRCTN | ISRCTN58893554 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58893554 |
| ClinicalTrials.gov number | NCT05624788 |
| Secondary identifying numbers | ML44072 |
- Submission date
- 11/10/2022
- Registration date
- 11/10/2022
- Last edited
- 08/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims:
The main purpose of this study is to explore ways to improve access to specialty care and clinical research for participants who are American Indians (AI) or Alaska Natives (AN). The study findings may also help reduce the amount of time needed to diagnose participants, could help improve the patient experience and reduce the overall cost of healthcare to society.
Who can participate?
People who are over 18 years of age, self-identify as American Indian or Alaska Native and have any indication requiring referral to a specialist (neurologist, ophthalmologist, or oncologist).
What does the study involve?
Participants will have to be a part of this study for 12 months (1 year).
Participants will be seen by their primary care provider (PCP) and specialists as per the Standard of Care (SoC) frequency. The participants will be asked to complete surveys and questionnaires during the study: up to twice during the study: after a visit with a new doctor or healthcare provider and at Months 6 and 12. The study visits at Months 6 and 12 may not coincide with the participants visit to the PCP or specialist. Study-specific data including surveys/ questionnaires will be collected during primary care office visits, specialty care office visits, by phone or virtually.
The surveys included in this study ask questions about trust in the healthcare system, financial burden, effects of medical conditions and barriers experienced when accessing the healthcare system.
What are the possible benefits and risks of participating?
Participants will not receive any health benefit from participating in this study, but the information learned in this study may help researchers and doctors learn more about medical conditions in general. Other patients with the medical conditions observed in this study may benefit from results of such research in the future.
Participants will receive monetary benefit on participating in this study.
There are no risks from participating in the study.
Where is the study run from?
Genentech (United States)
When is the study starting and how long is it expected to run for?
July 2022 to October 2024
Who is funding the study?
Genentech, Inc. (United States)
Who is the main contact?
global-roche-genentech-trials@gene.com
Contact information
Public
1 DNA Way
South San Francisco
94080
United States of America
| Phone | +1 888-662-6728 |
|---|---|
| global-roche-genentech-trials@gene.com |
Study information
| Study design | Prospective observational data collection study to define current care pathways for AI/AN participants. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Study to characterize access to specialty care received by American Indians/Alaska Natives (CATORI) |
| Study acronym | CATORI |
| Study hypothesis | The main aim of this study is to estimate the proportion of American Indians (AI)/ Alaska Natives (AN) participants who are seen by a specialist for advanced care of those referred following a primary care provider (PCP) referral to a specialist (referral completion) and to determine if this proportion is lower than that of the general population. |
| Ethics approval(s) | Approved, 28/09/2022, WCG IRB (1019 39th Ave., SE Suite 120 Puyallup, WA 98374, USA; +1 (0)855 818 2289; clientservices@wcgirb.com), ref: 20225255 |
| Condition | Participants requiring referral to specialty care (neurology, ophthalmology, oncology) |
| Intervention | Participants who self-identify as American Indian or Alaska Native with any indication requiring referral to a specialist (neurologist, ophthalmologist, and oncologist) after a PCP standard of care visit will be observed to collect data, using several surveys (e.g., for trust in the healthcare system, financial toxicity, reasons for not being seen by a specialist) for 12 months. Data will be collected to determine whether a participant was seen by a specialist, was diagnosed with a specialized disease, participant characteristics potentially associated with being seen or not seen by a specialist, and the reasons/barriers why a participant was not seen by a specialist. |
| Intervention type | Other |
| Primary outcome measure | Percentage of AI/AN participants seen by a specialist for advanced care after PCP referral to a specialist assessed using data collected in electronic case report forms (eCRF) at Months 6 and 12 |
| Secondary outcome measures | 1. Percentage of participants seen by a specialist and treated for their disease assessed using data collected in eCRF at Months 6 and 12 2. Participant reported barriers to specialty referral completion assessed using data collected from surveys at Months 6 and 12 |
| Overall study start date | 06/07/2022 |
| Overall study end date | 14/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Participant inclusion criteria | 1. Aged 18 years or more 2. Ability to read English at 8th grade proficiency or have a household member willing to assist in translation to complete patient surveys 3. Self-identification as American Indian or Alaska Native 4. Referred to an oncologist, neurologist, or ophthalmologist for the first time 5. Personal landline or cell phone and/or access to internet 6. Willingness to complete all surveys in the study and participate for 12 months |
| Participant exclusion criteria | 1. Currently under the care of a specialist (>3 months) to whom they are being referred to by the PCP (i.e., to be eligible, the specialty care physician should be new to the participant) 2. Currently or planned to receive care that requires in participant visits for the indication requiring referral from the PCP (e.g., radiotherapy, chemotherapy for cancer diagnosis) within 3 months of consent date |
| Recruitment start date | 14/10/2022 |
| Recruitment end date | 31/03/2024 |
Locations
Countries of recruitment
- United States of America
Study participating centre
United States of America
Sponsor information
Industry
1 DNA Way
South San Francisco
94080
United States of America
| Phone | +1 888-662-6728 |
|---|---|
| global-roche-genentech-trials@gene.com | |
| Website | https://www.roche.com/about_roche/roche_worldwide.htm |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Genentech, Inc., Genentech USA, Inc., Genentech USA
- Location
- United States of America
Results and Publications
| Intention to publish date | 14/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are not expected to be made available due to participant-level data not being a regulatory requirement and to protect patient privacy as this study is conducted in a small patient community. |
Editorial Notes
08/04/2024: ClinicalTrials.gov number added.
04/12/2023: The study website was added.
12/10/2023: The recruitment end date was changed from 14/10/2023 to 31/03/2024.
18/10/2022: The sponsor and funder name was changed from F. Hoffmann-La Roche Ltd to Genentech, Inc.
11/10/2022: Trial's existence confirmed by wcg IRB
