Age-Related Immunodeficiency, Cancer, Graft Versus Host Disease, HIV Infections, Immunodeficiency, Immunosuppression, Leukemia, Lymphoma, Multiple Myeloma, Transplant
Conditions
Keywords
COVID-19, Immunocompromised, Advanced Age, Medicare, Medicaid
Brief summary
The investigators will examine whether a combination of at-home nucleic acid amplification tests, on-demand telemedicine, and delivery of prescriptions such as Paxlovid quickly after testing positive for COVID-19, can reduce severe outcomes and hospitalization of immunocompromised patients and those who are 65 years and older. They will also analyze whether these efforts lower the cost of care compared to standard of care.
Detailed description
This study is a randomized control trial with 10,000 participants. Participation will last for a minimum of 3 months and maximum of 8 months, depending upon COVID-19 case rates. Half of participants will be randomized to the control group and continue their existing testing and healthcare practices. The remaining participants will be randomized into the intervention arm. Participants in the intervention will receive one Cue Cartridge Reader for the duration of the study and up to 10 Cue COVID Molecular tests per month for their own use and to share with others in their household. In the case that a Cue Flu+COVID Molecular Test is available through FDA EUA or other authorization, participants may be provided this multiplex test in lieu of the Cue COVID Molecular Test. All intervention participants will be asked to test themselves if they are exposed or when symptoms arise and share tests with members of their household who are exposed to COVID or symptoms arise. The primary outcome will be the number of hospitalizations. This study will also compare infection rates, ICU admissions, deaths, and cost of care between the control and intervention group. The hypothesis is that access to high sensitivity portable molecular testing and subsequent telemedicine and prescription delivery can significantly decrease hospitalization and thereby the cost of care. Interested individuals will access the study via the MyDataHelps platform by web or app to complete the eligibility and informed consent process. Within the MyDataHelps experience, participants will complete study activities such as surveys and sharing of claims data. Participants who are randomized to the intervention group will have the option to use Cue Care should they test positive for COVID-19. Cue Care contracts licensed Healthcare providers to deliver telemedicine and treatment for COVID-19. In the case that the COVID Flu+COVID test is available, the intervention group will also have the option to use Cue Care should they test positive for Influenza. To learn more and take the eligibility survey, visit https://ImmunoCARE.scripps.edu/
Interventions
OTHERAccess to Cue Health COVID-19 Remote testing and treatment for COVID-19
Participants will receive at home COVID-19 test for themselves and others in their household.
Sponsors
Cue Health
Scripps Translational Science Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* Living in the United States * 18 years or older * Can read and understand English * Use of smartphone with bluetooth, a camera and a compatible operating system (Android OS 9.0 or higher, Apple iOS 13.0 or higher) * Vaccinated against COVID-19 (completed at least the initial course, e.g. at least 2 doses of -Moderna or Pfizer, one dose of J&J) * Willing and able to participate in study interventions including: 1. Use of smartphone, including camera and bluetooth 2. Upload verification of diagnosis, if needed 3. Completing Surveys 4. Use of Cue Health App 5. Use of MyDataHelps Web or App * Immunocompromised due to disease or therapy, including: 1. Symptomatic HIV 2. Graft versus host disease 3. Immunoglobulin deficiency/Immunodeficiency 4. Immunosuppressive therapy 5. Leukemia 6. Lymphoma (Hodgkin or non-Hodgkin) 7. Metastatic Cancer 8. Multiple Myeloma 9. Solid organ malignancy 10. Transplant, hematopoietic stem cell 11. Transplant, solid organ * Age 1. 65 years and older Option if under 65 to share claims data as a member of one of the following insurance providers: 1. Anthem BlueCross and BlueShield 2. Anthem BlueCross 3. Empire BlueCross BlueShield 4. Empire BlueCross 5. Wellpoint 6. Carelon 7. Unicare 8. Simply Healthcare Plans 9. National Government Services, Inc. 10. MMM 11. Health Sun 12. HealthLink 13. Amerigroup 14. Medicare 15. Medicaid 16. Or another partner that can provide claims data on participant's behalf
Exclusion criteria
-Unable to meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hospitalizations Including COVID Medications | During study participation (on average 12 months) | In claims data COVID hospital admissions were defined as: claim type is HOSP or Institutional or location display contains inpatient with COVID diagnosis or COVID procedure or COVID medication in the same medical episode. In survey data, participants were asked to self-report COVID hospitalizations. |
| Cost of Care | During study participation (on average 12 months) | Investigators will compare the cost of care for COVID-19 infections between the control and intervention arms. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited remotely from across the United States.
Pre-assignment details
After completing consent, participants verify their eligibility by connecting their health plan or EHR data, or manually sharing information to verify their eligibility. After confirmation of eligibility, participants are randomized into control or intervention arms. Many participants completed enrollment but did not verify their eligibility and therefore are not included in the randomized participants count.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm Participants in this group will complete the baseline study activities, as described above. Additionally, participants will be instructed to create a Cue Health account and download the Cue Health App. Using the app and the 10 Cue Health COVID-19 molecular tests that are provided (or Cue Health Flu+COVID molecular tests if available and FDA authorized), the participant will perform tests after exposure or if symptoms arise. Participants can also use the test for close contacts who are exposed to COVID-19 and/or have symptoms. If COVID-19 infection occurs, participants will have access to telemedicine to discuss further with a healthcare professional. When clinically indicated, medication for the treatment of COVID-19 (and/or Influenza in case of Cue Health Flu+COVID test availability) will be prescribed and delivered to the participants' delivery address. Participants can also seek care through other healthcare providers or not seek care, at their discretion. | 310 |
| Control Arm Participants in the control group will complete the baseline study activities, as described above. If symptoms arise or COVID-19 infection occurs, participants will test and seek care as they normally would. | 285 |
| Total | 595 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 204 Participants | 178 Participants | 382 Participants |
| Age, Categorical Between 18 and 65 years | 88 Participants | 72 Participants | 160 Participants |
| Primary eligibility category Age 65+ | 134 Participants | 125 Participants | 259 Participants |
| Primary eligibility category Immunocompromised | 176 Participants | 160 Participants | 336 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants | 8 Participants | 16 Participants |
| Race/Ethnicity, Customized Black / African American | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic only | 5 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Middle Eastern | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Multiple races/ethnicities | 12 Participants | 12 Participants | 24 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Prefer not to answer | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized White only | 262 Participants | 218 Participants | 480 Participants |
| Sex/Gender, Customized Man | 90 Participants | 94 Participants | 184 Participants |
| Sex/Gender, Customized Nonbinary | 8 Participants | 4 Participants | 12 Participants |
| Sex/Gender, Customized Prefer not to answer | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Transgender | 0 Participants | 4 Participants | 4 Participants |
| Sex/Gender, Customized Woman | 198 Participants | 150 Participants | 348 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 495 | 0 / 521 |
| other Total, other adverse events | 0 / 495 | 0 / 521 |
| serious Total, serious adverse events | 0 / 495 | 0 / 521 |
Outcome results
Primary
Cost of Care
Investigators will compare the cost of care for COVID-19 infections between the control and intervention arms.
Time frame: During study participation (on average 12 months)
Population: Participants with claims and/or survey data were included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Arm | Cost of Care | 2,022 dollars |
| Control Arm | Cost of Care | 5,740 dollars |
Primary
Number of Participants With Hospitalizations Including COVID Medications
In claims data COVID hospital admissions were defined as: claim type is HOSP or Institutional or location display contains inpatient with COVID diagnosis or COVID procedure or COVID medication in the same medical episode. In survey data, participants were asked to self-report COVID hospitalizations.
Time frame: During study participation (on average 12 months)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Arm | Number of Participants With Hospitalizations Including COVID Medications | No COVID infection reported | 235 Participants |
| Intervention Arm | Number of Participants With Hospitalizations Including COVID Medications | COVID hospitalization | 15 Participants |
| Intervention Arm | Number of Participants With Hospitalizations Including COVID Medications | COVID medication | 59 Participants |
| Intervention Arm | Number of Participants With Hospitalizations Including COVID Medications | COVID ICU stay | 1 Participants |
| Control Arm | Number of Participants With Hospitalizations Including COVID Medications | COVID medication | 58 Participants |
| Control Arm | Number of Participants With Hospitalizations Including COVID Medications | No COVID infection reported | 192 Participants |
| Control Arm | Number of Participants With Hospitalizations Including COVID Medications | COVID ICU stay | 13 Participants |
| Control Arm | Number of Participants With Hospitalizations Including COVID Medications | COVID hospitalization | 22 Participants |