SCALE-UP Utah II: Community-Academic Partnership to Address COVID-19 Conversational Agent Study

Study Overview
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Brief Summary
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The long-term objective of SCALE-UP II is to increase the reach, uptake, and sustainability of COVID-19 testing among underserved populations. Through RADx-UP Phase I funding (SCALE-UP Utah), the team has established population health management (PHM) interventions that have been used since Feb 2021 to increase the uptake of COVID-19 testing and vaccination among community health center patients. Interventions are based on a PHM approach that uses widely available technology (i.e. cell phones and text messaging). SCALE-UP II will both build on SCALE-UP Utah PHM interventions and investigate novel resource conservation approaches (i.e., Request-Patient Navigation vs. No Patient Navigation and text messaging vs. conversational agent). SCALE-UP II builds on long standing partnerships among the University of Utah Clinical and Translational Science Institute (UofU CTSI), Association for Utah Community Health (AUCH), CHCs, and the Utah Department of Health(UDOH). CTSI and SCALE-UP II investigators are leading several COVID-19 initiatives that drive public health response and state government policies in Utah. Thus, the UofU team is uniquely positioned to lead this project.

Detailed Description
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Racial/ethnic minority, low socioeconomic status (SES), and rural populations suffer profound health inequities across a wide variety of diseases and conditions, including COVID-19. For example, as of June 2021, the cumulative COVID case rate in Utah per 100,000 was 10,803 among Whites vs. 17,541 among Latinos. The positivity rate was 14% among Whites vs. 24% among Latinos. Similar disparities persist across the nation for vaccination rates between urban vs. rural, high vs. low SES, and White vs. non-White populations. Low vaccination rates leave underserved populations at risk for local outbreaks, and more contagious and severe variants. Thus, interventions targeting these populations at the interplay between testing and vaccination among underserved populations are critical for pandemic control. Not only do underserved populations experience profound health inequities, but there is also a critical digital divide between high and low resource healthcare systems. Low resource settings are far less likely to adopt Health Information Technology approaches, and often do not have the capacity to implement large scale population health management (PHM) efforts utilizing data analytics and automated patient outreach. As such, research is needed utilizing targeted PHM approaches that proactively identify, reach, and navigate vulnerable patients to both increase opportunities to engage in vaccination and testing, and to address barriers to engagement. Community Health Centers (CHCs) are optimal settings for implementation of PHM interventions to increase the uptake of COVID-19 testing and vaccination among underserved populations. Eleven Utah CHC systems are participating in SCALE-UP II. Their 38 primary care clinics serve over 112,000 unique patients annually (36% Latino, 10% Native American, 63% <100% poverty level, 57% uninsured, and 42% of clinics are in rural/frontier areas). SCALE UP II is comprised of two distinct studies, the Text Message (TM) study and the Conversational Agent (CA) study. Patients will be triaged into one of two studies based on self-reported ownership of a smart phone with internet access. Patients who report not owning a smart phone with internet access will be included in the TM study. Additionally, patients who do not respond to the question regarding smart phone ownership will be included in the TM study. Patients who self-report ownership of a smart phone with internet access will be included in the CA study. SCALE-UP II: CA study will implement and evaluate practical, accessible, and scalable PHM interventions to increase COVID-19 testing and vaccine uptake based on the best evidence available, patients' specific barriers and hesitancy factors, and extensive collaboration with CHCs, AUCH, and UDHHS. This study is a 2x2 design with patients being initially randomized between receiving either text messages or the link to a conversational agent as well as into two distinct types of available patient navigation, Request-PN or No PN. Text Messaging (TM): bidirectional text messaging to connect patients to vaccination or mailed at-home rapid test kits for use, as needed. Conversational Agent (CA): automated, scripted and interactive agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Patient Navigation (PN): phone call from a community health worker to help address hesitancy and barriers, and to offer at-home rapid test kits. This study will examine two distinct forms of Patient Navigation: Request PN and No PN. Each patient will be randomized to receive either Request PN or No PN. Request PN allows patients to request patient navigation by responding PERSON to a text message/conversational agent. Patients who are randomized to receive No PN will not be provided the opportunity to speak with a patient navigator. The primary outcome, Testing, captures whether patients actually test with the mailed at-home test kit. Secondary outcomes include: Time-To-Vaccine (time-to-event outcome) as well as several implementation outcomes including Reach-Engage Testing (proportion of patients that reply to an offer to receive an at-home rapid test kit) and Reach-Accept Testing (proportion of patients that accept an offer to receive an at-home test kit). A similar set of implementation outcomes will be measured for vaccination (i.e., Reach-Engage Vaccine and Reach-Accept Vaccine). SCALE-UP II will include a Consortium Data Reporting Unit (CDRU) consisting of a Data Manager and one member the project's biomedical informatics team. The unit will attend regular meetings and dissemination activities organized by the CDCC. The CDRU will seek guidance from the CDCC with regard to data acquisition and consent for data sharing. As required by the NIH, SCALE-UP II will collect RADx-UP Tier 1 Common Data Elements for study participants who receive an at-home COVID test through the project. These data will be collected through surveys administered one month after the participant receives their at-home test. Data will be standardized according to the data dictionary provided by the CDCC. Our CDRU will work closely with the CDCC to establish a protocol for frequency, format, and exchange of data. SCALE-UP II will share identifiable data with the CDCC and NIH for the Data Hub as well as future research. Participants who complete the survey data will first complete an informed consent process. The informed consent will be administered to the patient at the time of survey collection. Lighthouse Research and Development will conduct phone surveys to assess patient reported use of COVID-19 at-home testing ( 2,300 participants) among patients who received test kits and do no respond to the online survey request. Lighthouse will send notifications (e.g., postcards, text messages, voice messages, etc.) to participants to alert them of the opportunity to complete the survey online or over the phone. Interviewers will complete up to 15 call attempts across weekday, evening, and weekend calling shifts over a one-month period to each participant. Patients will be compensated with a gift card for completing the survey.

Official Title
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SCALE-UP Utah II: Community-Academic Partnership to Address COVID-19 Testing and Vaccination Among Utah Community Health Centers

Conditions
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COVID-19

Intervention / Treatment
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* Behavioral: Text-Messaging (TM)
* Behavioral: Conversational Agent (CA)
* Behavioral: Patient Navigation (PN)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: current patient of a participating community health center have a working cellphone, have phone number listed in existing electronic medical record at their participating clinic speak English or Spanish. Exclusion Criteria: Minors

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patient-level, four-arm randomized design for Population Health Management interventions: (1) TM + No PN, (2) TM + Request PN, (3) CA + No PN, or (4) CA + Request PN
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Text Messaging (TM) + No Patient Navigation<br>Bidirectional text messaging with a one-touch response to connect patients to vaccination or mailed at-home rapid test kits for use as needed. Patients will not receive patient navigation. | Behavioral: Text-Messaging (TM)<br>* Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply yes will receive an additional message with information about how to receive a test kit.<br>|
| Active Comparator: Text Message (TM) + Request (RPN)<br>Bidirectional text messaging with a one-touch response to connect patients to vaccination or mailed at-home rapid test kits for use as needed. RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination. | Behavioral: Text-Messaging (TM)<br>* Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply yes will receive an additional message with information about how to receive a test kit.<br>Behavioral: Patient Navigation (PN)<br>* Participants in the PN condition will receive a call from a Community Health Worker to assist with the process of receiving a COVID test. At this time the participant has the option to opt-out of this follow up phone call. The patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy. There are two distinct different types of patient navigation. A person can be randomly assigned to either type, or no PN, or a combination of the two types.<br>|
| Active Comparator: Conversational Agent (CA)+ No Patient Navigation<br>Automated, scripted and interactive conversational agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Patients will not receive patient navigation. | Behavioral: Conversational Agent (CA)<br>* Patients in the CA condition will receive a link to an automated, scripted and interactive conversational agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits.<br>|
| Active Comparator: Conversational Agent (CA) + Request PN (RPN)<br>Automated, scripted and interactive conversational agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a CA offering connection to testing and/or vaccination. | Behavioral: Conversational Agent (CA)<br>* Patients in the CA condition will receive a link to an automated, scripted and interactive conversational agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits.<br>Behavioral: Patient Navigation (PN)<br>* Participants in the PN condition will receive a call from a Community Health Worker to assist with the process of receiving a COVID test. At this time the participant has the option to opt-out of this follow up phone call. The patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy. There are two distinct different types of patient navigation. A person can be randomly assigned to either type, or no PN, or a combination of the two types.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testing | Proportion of patients who use the at-home test out of those exposed to the intervention | Year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-Vaccine | Time to event outcome | Year 1 | 
| Reach-Engage Testing | Proportion of patients that reply to an offer to receive an at-home rapid test kit | Year 1 | 
| Reach-Accept Testing | Proportion of patients that accept an offer to receive an at-home test kit | Year 1 | 
| Reach-Engage Vaccine | Proportion of patients that reply to an offer to receive a vaccine | Year 1 | 
| Reach- Accept Vaccine | Proportion of patients that accept an offer to receive a vaccine | Year 1 |