Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 3UH3CA233314-02S1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Because of low testing uptake, slow accrual at participating health centers and continuously changing COVID pandemic, research investigators had to terminate the original study and consider alternate strategies.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated call | Active Comparator | 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. |
|
| Text messaging | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community outreach method | Other | The method includes automated call and text messaging to increase testing for COVID-19 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 month |
| Number (%) Tested (Total and by Clinic) | Number (%) of patients who complete COVID-19 test (total and by clinic) | 1 month |
| Number (%) Infected (Total and by Clinic) | Number (%) of patients with positive COVID-19 test (total and by clinic) | 1 month |
| Timeliness of Testing | From time of contact to testing | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number Vaccinated With Flu Vaccine | Number of patients who receive flu vaccine | 1 month |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elena Martinez, PhD | Moores Cancer Center, University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be randomized to one of two arms: test messaging and automated call
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Posted | Count of Participants | Participants | 1 month |
|
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 with extremely small number of participants, the adverse events were not monitored/assessed,
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 with extremely small number of participants, the adverse events were not monitored/assessed,
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jesse Nodora | University of California San Diego | (858) 822-3686 | jnodora@health.ucsd.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2021 | May 11, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003324 | Coronary Artery Disease |
| D009369 | Neoplasms |
| D051436 | Renal Insufficiency, Chronic |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009765 | Obesity |
| D000755 | Anemia, Sickle Cell |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
Not provided
Not provided
Eligible patients who don't opt out will be randomized to one of two arms (automated call vs text messaging)
Not provided
Not provided
Not provided
Not provided
| 1 month |
| Number of Household Members Referred for Testing | The number of household members referred for COVID-19 testing | 1 month |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | One participants has missing value for demographic variables. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | One participants has missing value for demographic variables. | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| Primary | Number (%) Tested (Total and by Clinic) | Number (%) of patients who complete COVID-19 test (total and by clinic) | 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. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Primary | Number (%) Infected (Total and by Clinic) | Number (%) of patients with positive COVID-19 test (total and by clinic) | 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. | Posted | Count of Participants | Participants | No | 1 month |
|
|
|
| Primary | Timeliness of Testing | From time of contact to testing | 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. | Posted | 1 month |
|
|
| Secondary | Number Vaccinated With Flu Vaccine | Number of patients who receive flu vaccine | 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. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| 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 | 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. | Posted | 1 month |
|
|
| Secondary | Number of Household Members Referred for Testing | The number of household members referred for COVID-19 testing | 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. | Posted | 1 month |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Native Hawaiian or Other Pacific Islander |
|
| Hispanic |
|