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

  • Cancer
  • Oncology
  • Eye Disorder
  • Ophthalmology
  • Neurology
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Recruiting

This trial runs in
Country
  • United States
Trial Identifier:

NCT05624788 ML44072

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      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. 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.

      Genentech, Inc. Sponsor
      NCT05624788,ML44072 Trial Identifier
      All Gender
      ≥18 Years Age
      No Healthy Volunteers

      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 [brain and nerve specialist], ophthalmologist [eye specialist], or oncologist [cancer specialist]).

      What does the study involve? (what interventions will be compared, will all participants receive the same treatment, what measurements will be taken)

      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

      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. 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.

      Genentech, Inc. Sponsor
      NCT05624788,ML44072 Trial Identifier
      No Intervention Treatments
      Specialist Referral: Neurology, Specialist Referral: Ophthalmology, Specialist Referral: Oncology Condition
      Official Title

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

      Eligibility criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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.

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