Specialist Referral: Neurology, Specialist Referral: Oncology, Specialist Referral: Ophthalmology
Conditions
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.
Interventions
OTHERNo Intervention
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.
Sponsors
Genentech, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of All Participants Seen by a Specialist for Advanced Care After Primary Care Provider Referral to a Specialist at 6 Months | 6 Months |
| Percentage of All Participants Seen by a Specialist for Advanced Care After Primary Care Provider Referral to a Specialist at 12 Months | 12 Months |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Responses by Participant-Reported Barriers to Specialty Referral Completion at 6 Months | 6 Months |
| Percentage of Responses by Participant-Reported Barriers to Specialty Referral Completion at 12 Months | 12 Months |
| Percentage of Participants Seen by a Specialist and Treated for Their Disease at 6 Months | 6 Months |
| Percentage of Participants Seen by a Specialist After Primary Care Provider Referral Within Each of the Three Specialist Groups at 12 Months | 12 Months |
| Percentage of Participants Seen by a Specialist After Primary Care Provider Referral Within Each of the Three Specialist Groups at 6 Months | 6 Months |
| Percentage of Participants Seen by a Specialist and Treated for Their Disease at 12 Months | 12 Months |
Countries
United States
Outcome results
None listed