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| ID | Type | Description | Link |
|---|---|---|---|
| 3UL1TR002538-03S2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Association for Utah Community Health | OTHER |
| Utah Department of Health | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Center for Advancing Translational Sciences (NCATS) |
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SCALE-UP Utah is a community-academic partnership to address COVID-19 among Utah community health centers. The long-term objective of the project is to increase the reach, acceptance, uptake, and long-term sustainability of COVID-19 screening and testing among Utah's Community Health Center patient population. The study will compare two practical, feasible, scalable interventions to increase COVID-19 testing uptake in Utah Community Health Centers:
The project will employ a rapid cycle research approach in which interventions are tested on a small scale, using short time frames (e.g., <1 month) and cyclical evaluation cycles. This process involves implementing intervention messages with a small number of clinics or patients, evaluating the outcomes, and either adapting the intervention messages based on findings (and retesting) or disseminating effective approaches to additional clinics or patients. A critical feature of these cycles is the ability to quickly test and refine messages in a limited setting before broader implementation. Throughout the study, intervention messages were updated or adapted in response to evolving public health guidelines, testing procedures, and policy recommendations (e.g., priority populations by age group or geographic area, as advised by the Utah Department of Health and Human Services and relevant federal agencies). However, these updates did not alter the fundamental structure of the intervention arms. Participants were randomized to one of two main conditions-Text Messaging (TM) or Text Messaging plus Patient Navigation (TM+PN)-and all participants within a given arm received interventions aligned with their assigned condition. Adaptations occurred within the content and timing of messages or navigation support, but the core components of the interventions remained consistent across participants within each arm. These adaptations were tracked and incorporated into implementation logs but did not constitute distinct intervention arms or conditions.
The specific aims are to:
SCALE-UP Utah is a patient-level intervention involving 12 Community Health Centers (39 individual clinics) across Utah. The study is designed to utilize Community Health Center participant records to proactively reach participants for COVID-19 screening and testing. This intervention includes a randomization component between two interventions, text messaging (TM) or text messaging with patient navigation (TM+PN). These two intervention paths are occurring simultaneously within the same clinics.
Text messaging (TM) and text messaging with patient navigation (TM+PN)
Overview:
Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. Texts will include a brief message regarding COVID-19 risk and will screen for if the participant or someone in their close social network should get tested. Participants who reply "yes" will receive additional messages with a recommendation to be tested, testing locations/hours/phone, and an option for an at-home test to be sent directly to their home. Participants who reply "no" will receive a text with the clinic phone number and a note to call if anything changes.
Participants in the TM+PN condition will receive the same text messages as the patients in the TM condition. Text messages will include a brief message regarding risk and will screen for if the patient should get tested. Patients who reply "yes" will receive the same options as those in TM only (a recommendation to be tested, testing locations/hours/phone, and an option for an at-home test to be sent directly to their home) in addition to a notice that a Community Health Worker will contact them for patient navigation. The Patient Navigation includes practical advice from navigators to address barriers to testing such as logistics, transportation, and expenses.
Step One: Primary Data Extraction To identify the cohort for the TM and TM+PN interventions, a subset of EHR data will be manually extracted from the Community Health Centers as text files generated by EHR reports. The first set of EHR reports will contain all patients seen at each of the Community Health Centers in the last 3 years. Subsequent reports will be obtained weekly, including all encounters in the previous week. Data fields will include risk factors such as age, gender, body mass index, encounter diagnoses for medical co-morbidities, participant demographics (e.g., zip code, insurance status, preferred language, race/ethnicity); as well as cellphone number for text messaging and patient navigation.
Step Two: Randomization & Cohort Selection Once the data are securely housed, all participants will be assigned to either the TM or TM+PN arm of the intervention. This assignment will remain consistent throughout the study. Cohort selection will be based on EHR data considering factors such as age, race/ethnicity, language, relevant medical comorbidities, and residence in hotspot areas. These selection criteria are consistent with recommendations from Utah Department of Health and the Centers for Disease Control and Prevention.
Step Three: Implementation SCALE-UP Utah will send HIPPA-compliant bidirectional texts, which is a communication method routinely used by the Community Health Centers, to patients in high risk cohorts. Text messages will be designed by the research team and sent using a HIPPA compliant text messaging service. The text messaging service will retrieve the participant cohort from the study database to send the texts to the participants. The text messages will appear to the participants as having originated from their Community Health Center. As part of their general Community Health Center care, participants have agreed to be contacted by their Community Health Center and text message communication is one of those established contact methods. Text messages will be repeated weekly, as needed, to continuously screen for COVID-19 testing eligibility and to provide updates. Every text message will include the option to reply STOP to opt-out of receiving text messages at any time.
The text messaging and patient navigation arms of the study will proactively provide patients with access to informative resources describing what would happen if they test positive and where to seek help.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text-Messaging (TM) | Active Comparator | Population health management intervention that analyzes electronic health record data to automatically identify participants with high risk for either infection or severe disease and proactivity reaches those participants via text message for testing needs (as advised by state and/or federal guidelines) and testing recommendation when applicable. This is a bi-directional text messaging system. |
|
| Text-Messaging plus Patient Navigation (TM+PN) | Active Comparator | Population health management intervention that includes the same bi-directional text-messaging system as Arm 1 (the text messaging condition) with the addition of patient navigation. Patient navigation includes real-time assistance from a community health worker to address barriers, provide motivation, and assist with logistics of COIVD testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text-Messaging (TM) | Behavioral | Patients in the TM condition will receive HIPAA-compliant bidirectional text messages. Texts will include a brief message regarding COVID-19 risk and will screen the participants for COVID testing needs. Participants who reply "yes" to accepting testing will receive additional messages with a recommendation to be tested, testing locations/hours/phone, and an offer to receive a free at-home test mailed to their home. Patients who reply "no" will receive a text with the clinic phone number and a note to call if anything changes. |
| Measure | Description | Time Frame |
|---|---|---|
| Reach-TM Engage | Proportion of patients that respond to the Text Messaging intervention. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Patients Tested for COVID as Indicated in Health Record Out of Total Patient Population in Study. (Uptake-Total) | Proportion of patients tested for COVID-19 out of the total patient population. Confirmation of COVID test as indicated in patient's health record. | 12 months |
| Reach PN-Engage-Logistics Assistance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Wetter, MS, PhD | University of Utah | Principal Investigator |
| Rachel Hess, MD, MS | University of Utah | Principal Investigator |
| Guilherme Del Fiol, MD, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute/ University of Utah | Salt Lake City | Utah | 84112 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Text-Messaging (TM) | Population health management intervention that analyzes electronic health record data to automatically identify participants with high risk for either infection or severe disease and proactivity reaches those participants via text message for testing needs (as advised by state and/or federal guidelines) and testing recommendation when applicable. This is a bi-directional text messaging system. Text-Messaging (TM): Patients in the TM condition will receive HIPAA-compliant bidirectional text messages. Texts will include a brief message regarding COVID-19 risk and will screen the participants for COVID testing needs. Participants who reply "yes" to accepting testing will receive additional messages with a recommendation to be tested, testing locations/hours/phone, and an offer to receive a free at-home test mailed to their home. Patients who reply "no" will receive a text with the clinic phone number and a note to call if anything changes. |
| FG001 | Text-Messaging Plus Patient Navigation (TM+PN) | Population health management intervention that includes the same bi-directional text-messaging system as Arm 1 with the addition of patient navigation (PN). PN includes real-time assistance from a community health worker to address barriers, provide motivation, and assist with logistics of COIVD testing. Text-Messaging (TM): Patients in the TM condition will receive HIPAA-compliant bidirectional text messages. Texts will include a brief message regarding COVID-19 risk and will screen the participants for COVID testing needs. Participants who reply "yes" to accepting testing will receive messages with a recommendation to be tested, testing locations/hours/phone, and an offer to receive a free at-home test mailed to their home. Patients who reply "no" will receive a text with the clinic phone number. PN: Patients in the PN condition, who respond "yes" to accepting testing will receive additional messages with a recommendation to be tested, testing locations/hours/phone, and an offer to receive a free at-home test. In addition they will receive a notice via text message that a Community Health Worker will contact them for patient navigation. At this time, patients will will have the option to opt-out of the phone call from the patient navigator. The Patient Navigation includes advice from navigators to address practical barriers to COVID testing such as logistics, transportation, and expenses as well as behavioral barriers such as hesitancy, fear, and uncertainty. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Text-Messaging (TM) | Population health management intervention that analyzes electronic health record data to automatically identify participants with high risk for either infection or severe disease and proactivity reaches those participants via text message for testing needs (as advised by state and/or federal guidelines) and testing recommendation when applicable. This is a bi-directional text messaging system. Text-Messaging (TM): Patients in the TM condition will receive HIPAA-compliant bidirectional text messages. Texts will include a brief message regarding COVID-19 risk and will screen the participants for COVID testing needs. Participants who reply "yes" to accepting testing will receive additional messages with a recommendation to be tested, testing locations/hours/phone, and an offer to receive a free at-home test mailed to their home. Patients who reply "no" will receive a text with the clinic phone number and a note to call if anything changes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Reach-TM Engage | Proportion of patients that respond to the Text Messaging intervention. | Proportion of patients that respond to the Text Messaging intervention | Posted | Count of Participants | Participants | 12 months |
|
This project used a non-systematic assessment method to evaluate adverse events. Although adverse events were not routinely assessed, data on adverse events were collected for up to 23 months after a participant's enrollment in the project.
Adapted intervention refers to the adaptation of messages, not interventions. Throughout the study, intervention messages were updated or adapted in response to evolving public health guidelines, testing procedures, and policy recommendations These updates did not alter the fundamental structure of the intervention arms and did not constitute distinct intervention arms or conditions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Text-Messaging (TM) | Population health management intervention that analyzes electronic health record data to automatically identify participants with high risk for either infection or severe disease and proactivity reaches those participants via text message for testing needs (as advised by state and/or federal guidelines) and testing recommendation when applicable. This is a bi-directional text messaging system. Text-Messaging (TM): Patients in the TM condition will receive HIPAA-compliant bidirectional text messages. Texts will include a brief message regarding COVID-19 risk and will screen the participants for COVID testing needs. Participants who reply "yes" to accepting testing will receive additional messages with a recommendation to be tested, testing locations/hours/phone, and an offer to receive a free at-home test mailed to their home. Patients who reply "no" will receive a text with the clinic phone number and a note to call if anything changes. |
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The outcomes (Uptake-Eligible) and (Uptake-Total) require the collection of individualized COVID-19 testing data. As COVID testing options evolved throughout the pandemic, our ability to track eligibility and collect testing outcomes from all available sources greatly diminished. We have no individualized testing data and therefore are unable to analyze Uptake-Total and Uptake-Eligible outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Wetter | Huntsman Cancer Institute at University of Utah | 801-213-6178 | david.wetter@hci.utah.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 23, 2022 | Aug 25, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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| NIH |
Patient-level, two-arm randomized design for the Population Health Management interventions, TM or TM+PN.
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Patients will not know if they are in the TM or TM+PN intervention arm.
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| Patient Navigation (PN) | Behavioral | Patients in the PN condition, who respond "yes" to accepting testing will receive additional messages with a recommendation to be tested, testing locations/hours/phone, and an offer to receive a free at-home test mailed to their home. In addition they will receive a notice via text message that a Community Health Worker will contact them for patient navigation. At this time, patients will will have the option to opt-out of the phone call from the patient navigator. The Patient Navigation includes advice from navigators to address practical barriers to COVID testing such as logistics, transportation, and expenses as well as behavioral barriers such as hesitancy, fear, and uncertainty. |
|
Proportion of patients offered Logistics Assistance Patient Navigator (PN-LA) that talk to a PN |
| 12 months |
| Reach PN-Engage-Requested Navigation | Proportion of patients offered Requested Navigation Patient Navigator (PN-RN) that talk to a PN | 12 months |
| Uptake-Eligible | Proportion of patients tested for COVID-19 out of those who meet screening criteria for testing. For each patient, we will define a separate Uptake-Eligible measurement for each week of the intervention period in which the patient either responds to a text message or contacts his/her Community Health Center to indicate the presence of symptoms or contact with someone with COVID-19 during the current week, but did not do so in the preceding week. | 12 months |
| BG001 | Text-Messaging Plus Patient Navigation (TM+PN) | Population health management intervention that includes the same bi-directional text-messaging system as Arm 1 with the addition of patient navigation (PN). PN includes real-time assistance from a community health worker to address barriers, provide motivation, and assist with logistics of COIVD testing. Text-Messaging (TM): Patients in the TM condition will receive HIPAA-compliant bidirectional text messages. Texts will include a brief message regarding COVID-19 risk and will screen the participants for COVID testing needs. Participants who reply "yes" to accepting testing will receive messages with a recommendation to be tested, testing locations/hours/phone, and an offer to receive a free at-home test mailed to their home. Patients who reply "no" will receive a text with the clinic phone number. PN: Patients in the PN condition, who respond "yes" to accepting testing will receive additional messages with a recommendation to be tested, testing locations/hours/phone, and an offer to receive a free at-home test. In addition they will receive a notice via text message that a Community Health Worker will contact them for patient navigation. At this time, patients will will have the option to opt-out of the phone call from the patient navigator. The Patient Navigation includes advice from navigators to address practical barriers to COVID testing such as logistics, transportation, and expenses as well as behavioral barriers such as hesitancy, fear, and uncertainty. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Text-Messaging Plus Patient Navigation (TM+PN) | Population health management intervention that includes the same bi-directional text-messaging system as Arm 1 with the addition of patient navigation (PN). PN includes real-time assistance from a community health worker to address barriers, provide motivation, and assist with logistics of COIVD testing. Text-Messaging (TM): Patients in the TM condition will receive HIPAA-compliant bidirectional text messages. Texts will include a brief message regarding COVID-19 risk and will screen the participants for COVID testing needs. Participants who reply "yes" to accepting testing will receive messages with a recommendation to be tested, testing locations/hours/phone, and an offer to receive a free at-home test mailed to their home. Patients who reply "no" will receive a text with the clinic phone number. PN: Patients in the PN condition, who respond "yes" to accepting testing will receive additional messages with a recommendation to be tested, testing locations/hours/phone, and an offer to receive a free at-home test. In addition they will receive a notice via text message that a Community Health Worker will contact them for patient navigation. At this time, patients will will have the option to opt-out of the phone call from the patient navigator. The Patient Navigation includes advice from navigators to address practical barriers to COVID testing such as logistics, transportation, and expenses as well as behavioral barriers such as hesitancy, fear, and uncertainty. |
|
|
| Secondary | Total Patients Tested for COVID as Indicated in Health Record Out of Total Patient Population in Study. (Uptake-Total) | Proportion of patients tested for COVID-19 out of the total patient population. Confirmation of COVID test as indicated in patient's health record. | No participant data were collected or analyzed. Due to rapid changes in testing and eligibility policies, it was not feasible for the state health department and our partnering clinics to track eligibility and collect individualized testing data, as patients may complete their COVID-19 tests at locations that did not share records, or complete a self-test and failed to report the result to the study. Therefore, these outcomes were not measured and will not be collected in the future. | Posted | 12 months |
|
|
| Secondary | Reach PN-Engage-Logistics Assistance | Proportion of patients offered Logistics Assistance Patient Navigator (PN-LA) that talk to a PN | Proportion of patients offered Logistics Assistance Patient Navigator (PN-LA) that talk to a PN | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Reach PN-Engage-Requested Navigation | Proportion of patients offered Requested Navigation Patient Navigator (PN-RN) that talk to a PN | Proportion of patients offered Requested Navigation Patient Navigator (PN-RN) that talk to a PN | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Uptake-Eligible | Proportion of patients tested for COVID-19 out of those who meet screening criteria for testing. For each patient, we will define a separate Uptake-Eligible measurement for each week of the intervention period in which the patient either responds to a text message or contacts his/her Community Health Center to indicate the presence of symptoms or contact with someone with COVID-19 during the current week, but did not do so in the preceding week. | No participant data were collected or analyzed. Due to rapid changes in testing and eligibility policies, it was not feasible for the state health department and our partnering clinics to track eligibility and collect individualized testing data, as patients may complete their COVID-19 tests at locations that did not share records, or complete a self-test and failed to report the result to the study. Therefore, these outcomes were not measured and will not be collected in the future. | Posted | 12 months |
|
|
| 0 |
| 22,145 |
| 0 |
| 22,145 |
| 0 |
| 22,145 |
| EG001 | Text-Messaging Plus Patient Navigation (TM+PN) | Population health management intervention that includes the same bi-directional text-messaging system as Arm 1 with the addition of patient navigation (PN). PN includes real-time assistance from a community health worker to address barriers, provide motivation, and assist with logistics of COIVD testing. Text-Messaging (TM): Patients in the TM condition will receive HIPAA-compliant bidirectional text messages. Texts will include a brief message regarding COVID-19 risk and will screen the participants for COVID testing needs. Participants who reply "yes" to accepting testing will receive messages with a recommendation to be tested, testing locations/hours/phone, and an offer to receive a free at-home test mailed to their home. Patients who reply "no" will receive a text with the clinic phone number. PN: Patients in the PN condition, who respond "yes" to accepting testing will receive additional messages with a recommendation to be tested, testing locations/hours/phone, and an offer to receive a free at-home test. In addition they will receive a notice via text message that a Community Health Worker will contact them for patient navigation. At this time, patients will will have the option to opt-out of the phone call from the patient navigator. The Patient Navigation includes advice from navigators to address practical barriers to COVID testing such as logistics, transportation, and expenses as well as behavioral barriers such as hesitancy, fear, and uncertainty. | 0 | 22,584 | 0 | 22,584 | 0 | 22,584 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D006298 | Health Services Administration |