SCALE-UP Utah: Community-Academic Partnership to Address COVID-19 Testing Among Utah Community Health Centers

NCT04939532 | Completed Results

• 2 other identifiers: 001360013UL1TR002538-03S2
• Study Type: interventional
• Target: 44,729
• Locations: 1 country
• Sites: 1

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. 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. 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).
3. 3.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.
4. 4.Examine implementation effectiveness outcomes, as well as characteristics of both clinics and patients that may influence intervention effects and implementation outcomes.

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

Outcome Measures

Primary Outcomes (1)

• Reach-TM Engage

  Proportion of patients that respond to the Text Messaging intervention.

  12 months

Secondary Outcomes (4)

• Total Patients Tested for COVID as Indicated in Health Record Out of Total Patient Population in Study. (Uptake-Total)

  12 months

• Reach PN-Engage-Logistics Assistance

  12 months

• Reach PN-Engage-Requested Navigation

  12 months

• Uptake-Eligible

  12 months

Study Arms (2)

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.

Behavioral: Text-Messaging (TM)

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.

Behavioral: Text-Messaging (TM); Behavioral: Patient Navigation (PN)

Interventions

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.

Text-Messaging (TM); Text-Messaging plus Patient Navigation (TM+PN)

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.

Text-Messaging plus Patient Navigation (TM+PN)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Minors

Sponsors & Collaborators

• University of Utah: lead
• Association for Utah Community Health: collaborator
• Utah Department of Health: collaborator
• National Institutes of Health (NIH): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Huntsman Cancer Institute/ University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

COVID-19; Patient Participation

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Limitations and Caveats

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.

Results Point of Contact

• Title: David Wetter
• Organization: Huntsman Cancer Institute at University of Utah

david.wetter@hci.utah.edu

801-213-6178

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not know if they are in the TM or TM+PN intervention arm.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Health Outcomes and Population Equity

Model Details: Patient-level, two-arm randomized design for the Population Health Management interventions, TM or TM+PN.

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: June 25, 2021
• Study Start: March 29, 2021
• Primary Completion: June 17, 2022
• Study Completion: February 28, 2023
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)