Clinical trial NCT04939532: SCALE-UP Utah: Community-Academic Partnership to Address COVID-19 Testing Among Utah Community Health Centers
Official title: SCALE-UP Utah: Community-Academic Partnership to Address COVID-19 Among Utah Community Health Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: COVID19
Community Health
Health Information Technology
Population Health
Patient engagement
Rural
Scale up
Screening
Testing
Text messaging
Underserved population
Uninsured
Utah
Uptake
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Association for Utah Community Health
name: Utah Department of Health
name: National Institutes of Health (NIH)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2021-06-25
Enrollment: 110163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient-level, two-arm randomized design for the Population Health Management interventions, TM or TM+PN.
Primary purpose: SCREENING

Brief summary: 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:

1. Text Messaging (TM): population health management (PHM) intervention that analyzes EHR data to automatically identify patients with high risk for either infection or severe disease, reaches and screens those patients, and addresses testing logistics using bi-directional text messaging.
2. Patient Navigation (PN): PHM intervention to increase testing uptake among eligible patients (identified via TM) using patient navigation (e.g., motivating patients, addressing logistics and barriers).

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. The process will entail implementing interventions in a small number of clinics/patients, evaluating the results, and either adapting the intervention based on results (and retesting), or disseminating the results to other clinics/patients. A critical aspect of these rapid-research cycles is that change can be quickly tested on a small scale, and then disseminated to other clinics/patients. Moreover, we are able to update and adapt the interventions based on changes in guidelines, testing, procedures, etc. throughout the duration of the project.

The specific aims are to:

1. Implement and evaluate PHM interventions for increasing the uptake of COVID-19 testing among CHC patients across Utah. Our primary outcome, Uptake-Eligible, is defined as the proportion of patients who are tested for COVID-19 out of the patients who meet screening criteria for COVID-19 testing. Our study hypothesis is that patients in the TM+PN cohort will have higher rates of uptake-eligible than those in the TM cohort.
2. Examine implementation effectiveness outcomes, as well as characteristics of both clinics and patients that may influence intervention effects and implementation outcomes.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* current patient of a participating community health center
* own a working cellphone,
* have their phone number listed in their existing electronic medical record at a participating clinic,
* speak English or Spanish.

Exclusion Criteria:

* Minors

Primary outcomes:
measure: Uptake-Eligible
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
measure: Total patients tested for COVID as indicated in health record out of total patient population in study. (Uptake-Total)
timeFrame: Through study completion, an average of 2 years.
measure: Reach-TM Engage
timeFrame: Through study completion, an average of 2 years.
measure: Reach PN-Engage
timeFrame: Through study completion, an average of 2 years.
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute/ University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: David Wetter, MS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Rachel Hess, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Guilherme Del Fiol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: