Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specialist Referral: Neurology |
| ||
| Specialist Referral: Ophthalmology |
| ||
| Specialist Referral: Oncology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Seen by a Specialist and Treated for Their Disease at 6 Months | 6 Months | |
| Percentage of Participants Seen by a Specialist and Treated for Their Disease at 12 Months | 12 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Virtual - PPD - US | Wilmington | North Carolina | 28401 | United States | ||
| Avera Research Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 After Primary Care Provider Referral Within Each of the Three Specialist Groups 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 |
| Sioux Falls |
| South Dakota |
| 57105 |
| United States |