Cancer, Chronic Kidney Diseases, COPD, Coronary Artery Disease, Diabetes Mellitus, Type 2, Heart Failure, Obesity, Sickle Cell Disease
Conditions
Brief summary
As part of National Institutes of Health Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) program, the goal of the RADxUP study is to develop, test, and evaluate a rapid, scalable capacity building project to enhance COVID-19 testing in three regional community health centers (CHCs) in San Diego County, California. In collaboration with CHC partners, their consortium organization, Health Quality Partners (HQP), investigators are pursuing the following Specific Aims: 1) Compare the effectiveness of automated calls vs text messaging for uptake of COVID-19 testing among asymptomatic adult patients with select medical conditions and those 65 years of age and older receiving care at participating CHCs. Secondarily, investigators will invite all study participants to receive flu vaccination and will assess feasibility and acceptability of study participants to refer adult family household members who are essential workers for COVID-19 testing. 2) Gather patient, provider, CHC leadership, and community stakeholder insights to establish best practices for future scale-up of COVID-19 testing sustainability and vaccination.
Detailed description
Pronounced inequities and disparities in coronavirus disease (COVID-19)COVID-19 morbidity and mortality have been reported, largely due to comorbid conditions and social determinants of health. Approximately 95% of COVID-19 related deaths occur among individuals with underlying medical conditions. Of all racial/ethnic groups, Hispanic/Latino communities in San Diego County have experienced the greatest burden of COVID-19 disease and deaths. Furthermore, testing challenges to date are evident, including long turnaround of test results and longer waiting times for African American and Hispanics compared to whites. The goal of this community-engaged proposal is to develop, test, and evaluate a rapid, scalable capacity building project to enhance COVID-19 testing in three regional community health centers (CHCs) in San Diego County. In collaboration with CHC partners, their consortium organization (Health Quality Partners), and community stakeholders, investigators propose the following Specific Aims: 1) Compare the effectiveness of automated and live prompts and reminders and their combination for uptake of COVID-19 testing among adult patients with select medical conditions or those 65 years of age and older receiving care at participating CHCs. Secondarily, investigators will invite all study participants to receive flu vaccination and will assess feasibility and acceptability of study participants to refer adult family household members who are essential workers for COVID-19 testing. 2) Gather patient, provider, CHC leadership, and community stakeholder insights to establish best practices for future scale-up of COVID-19 testing sustainability and vaccination. This community-engaged project includes underserved (socioeconomically disadvantaged and large proportion of Hispanic/Latinos) as well as COVID-19 vulnerable individuals (patients with medical comorbidities and 65 years of age and older). The approach considers regional COVID-19 morbidity and mortality disparities to identify strategies to address disproportionate infection rates and follow-up. By working in partnership with health care providers, health care system leaders, and community stakeholders, the research team has the potential to build the evidence-base approaches and identify sustainable solutions to understand and address the current and future pandemics in underserved and vulnerable populations.
Interventions
OTHERCommunity outreach method
The method includes automated call and text messaging to increase testing for COVID-19
Sponsors
National Cancer Institute (NCI)
Jesse Nodora
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Eligible patients who don't opt out will be randomized to one of two arms (automated call vs text messaging)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible participants will include asymptomatic men and women receiving care at participating community health centers with at least one clinic visit in the last year, age 21 years and over, with co-morbid conditions deemed by the Centers for Disease Control and Prevention to increase risk for severe COVID-19 illness, including heart failure, coronary artery disease, cancer, chronic kidney diseases, COPD, obesity, sickle cell disease and type 2 diabetes mellitus, and those 65 years of age and older.
Exclusion criteria
* Under age 21, inability to communicate in English and other study languages, inability to complete anterior nasal swab sampling for COVID-19
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Tested Patients | 1 month | The percentage of patients who undergo testing within one month of initial contact (automated call vs text messaging) and by the end of the study period (to consider individuals who could not come to the clinic within one month) |
| Number (%) Tested (Total and by Clinic) | 1 month | Number (%) of patients who complete COVID-19 test (total and by clinic) |
| Number (%) Infected (Total and by Clinic) | 1 month | Number (%) of patients with positive COVID-19 test (total and by clinic) |
| Timeliness of Testing | 1 month | From time of contact to testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Refer for Testing | 1 month | The proportion of study participants with eligible household members who refer household member(s) for COVID-19 testing |
| Number of Household Members Referred for Testing | 1 month | The number of household members referred for COVID-19 testing |
| Number Vaccinated With Flu Vaccine | 1 month | Number of patients who receive flu vaccine |
Countries
United States
Participant flow
Recruitment details
Community health center staff will mail an introductory letter to eligible individuals describing the importance of COVID-19 testing, inviting them to receive a test, offering opt out instructions, and noting that follow-up contact (phone call, text message) will take place if they do not opt out. Patients who do not opt out and those whose mail is not returned will be randomized one week after the introductory letter is mailed.
Pre-assignment details
Participants will be randomized to one of two arms: test messaging and automated call
Participants by arm
| Arm | Count |
|---|---|
| Automated Call Patients receive up to two automated phone calls in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday.
Community outreach method: The method includes automated call and text messaging to increase testing for COVID-19 | 12 |
| Text Messaging Patients receive up to two text messages in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday.
Community outreach method: The method includes automated call and text messaging to increase testing for COVID-19 | 25 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4,477 | 4,606 |
Baseline characteristics
| Characteristic | Automated Call | Text Messaging | Total |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 13 | 57 years STANDARD_DEVIATION 13 | 61 years STANDARD_DEVIATION 13 |
| Race/Ethnicity, Customized Asian | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 7 Participants | 20 Participants | 27 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 19 Participants |
| Sex: Female, Male Male | 4 Participants | 13 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number (%) Infected (Total and by Clinic)
Number (%) of patients with positive COVID-19 test (total and by clinic)
Time frame: 1 month
Population: Because of extremely low testing uptake, slow accrual at participating health centers and continuously changing COVID pandemic, our team was forced to terminate the intervention study and pivot to alternate strategies. This would allow us to continue our efforts to deliver as many COVID-19 tests as possible to help limit the spread of COVID-19 in underserved communities.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Automated Call | Number (%) Infected (Total and by Clinic) | 0 Participants |
| Text Messaging | Number (%) Infected (Total and by Clinic) | 0 Participants |
Primary
Number (%) Tested (Total and by Clinic)
Number (%) of patients who complete COVID-19 test (total and by clinic)
Time frame: 1 month
Population: Because of extremely low testing uptake, slow accrual at participating health centers and continuously changing COVID pandemic, we were forced to terminate the intervention study and pivot to alternate strategies. This would allow us to continue our efforts to deliver as many COVID-19 tests as possible to help limit the spread of COVID-19 in underserved communities. Because of extremely low participants, there was no power to conduct statistical analysis for primary and secondary outcomes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Automated Call | Number (%) Tested (Total and by Clinic) | 12 Participants |
| Text Messaging | Number (%) Tested (Total and by Clinic) | 25 Participants |
Primary
Percentage of Tested Patients
The percentage of patients who undergo testing within one month of initial contact (automated call vs text messaging) and by the end of the study period (to consider individuals who could not come to the clinic within one month)
Time frame: 1 month
Population: Because of extremely low testing uptake, slow accrual at participating health centers and continuously changing COVID pandemic, our team was forced to terminate the intervention study and pivot to alternate strategies. Because the study was terminated, the data of the percentage of patients who undergo testing by the end of the study period (automated call vs text messaging) was not collected.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Automated Call | Percentage of Tested Patients | 12 Participants |
| Text Messaging | Percentage of Tested Patients | 25 Participants |
Primary
Timeliness of Testing
From time of contact to testing
Time frame: 1 month
Population: Because of extremely low testing uptake, slow accrual at participating health centers and continuously changing COVID pandemic, our team was forced to terminate the intervention study and pivot to alternate strategies. This would allow us to continue our efforts to deliver as many COVID-19 tests as possible to help limit the spread of COVID-19 in underserved communities. Because the study was terminated, the data of timeliness from time of contact to testing was not collected.
Secondary
Number of Household Members Referred for Testing
The number of household members referred for COVID-19 testing
Time frame: 1 month
Population: Because of extremely low testing uptake, slow accrual at participating health centers and continuously changing COVID pandemic, we were forced to terminate the intervention study and pivot to alternate strategies. This would allow us to continue our efforts to deliver as many COVID-19 tests as possible to help limit the spread of COVID-19 in underserved communities. Because the study was terminated, this data was not collected.
Secondary
Number Vaccinated With Flu Vaccine
Number of patients who receive flu vaccine
Time frame: 1 month
Population: Because of extremely low testing uptake, slow accrual at participating health centers and continuously changing COVID pandemic, we were forced to terminate the intervention study and pivot to alternate strategies. Because of extremely small number of participants, there was no power to conduct statistical analysis for both primary and secondary outcomes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Automated Call | Number Vaccinated With Flu Vaccine | 9 Participants |
| Text Messaging | Number Vaccinated With Flu Vaccine | 21 Participants |
Secondary
Proportion of Patients Who Refer for Testing
The proportion of study participants with eligible household members who refer household member(s) for COVID-19 testing
Time frame: 1 month
Population: Because of extremely low testing uptake, slow accrual at participating health centers and continuously changing COVID pandemic, we were forced to terminate the intervention study and pivot to alternate strategies. This would allow us to continue our efforts to deliver as many COVID-19 tests as possible to help limit the spread of COVID-19 in underserved communities. Because the study was terminated, this data was not collected.