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

NCT04939519 | Completed Results

• 2 other identifiers: 00136001_23UL1TR002538-03S2
• Study Type: interventional
• Target: 65,300
• 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, and uptake of COVID-19 vaccines among Utah's Community Health Center patient population. The study will compare two practical, feasible, scalable interventions to increase COVID-19 vaccine uptake in Utah Community Health Centers:

1. 1.Text Messaging (TM): population health management (PHM) intervention that analyzes EHR data to automatically identify patients eligible for COVID-19 vaccination and uses bi-directional text messaging to help connect patients to a vaccination site;
2. 2.Patient Navigation (PN): PHM intervention to increase vaccination 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 vaccinations among CHC patients across Utah. Our primary outcome, Uptake-Eligible, is defined as the proportion of patients who receive a COVID-19 vaccination out of those who meet eligibility criteria for vaccination. 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; vaccinations; Text messaging; Underserved population; Uninsured; Utah; Uptake; Population Health Tool

Outcome Measures

Primary Outcomes (1)

• Uptake-Total

  Proportion of patients who receive a COVID-19 vaccine out of the total patient population

  12 months

Secondary Outcomes (3)

• Reach-TM Engage

  12 months

• Reach-PN Engage- Logistics Assistance

  12 months

• Reach-PN Engage- Requested Navigation

  12 months

Study Arms (2)

Text-Messaging (TM)

ACTIVE COMPARATOR

Population health management intervention that analyzes electronic health record data to automatically identify participants who are eligible for the COVID-19 vaccine and proactively reach those participants for vaccine scheduling. This is a bi-directional text messaging system.

Behavioral: Text-Messaging (TM)

Text-Messaging plus Patient Navigation

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 vaccination.

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

Interventions

Text-Messaging (TM) BEHAVIORAL

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 the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine.

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

Patient Navigation (PN) BEHAVIORAL

Participants in the PN condition will receive a message alerting them that a Community Health Worker will contact them to assist with the process of scheduling a vaccine. 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 vaccination such as logistics and transportation, as well as fear, skepticism, and hesitancy.

Text-Messaging plus Patient Navigation

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
• have a working cellphone,
• have phone number listed in existing electronic medical record at their participating clinic
• speak English or Spanish.

You may not qualify if:

• Minors

Sponsors & Collaborators

• Utah Department of Health: collaborator
• University of Utah: lead
• Association for Utah Community 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

During the analysis portion of this project, the investigators decided that the original primary outcome and a secondary outcome were duplicative due to the eventual widespread availability of the COVID-19 Vaccine. Therefore, the investigators decided to delete the primary outcome and keep the secondary outcome as the primary. Study protocol and Statistical Analytic plan were amended to reflect the changes.

Results Point of Contact

• Title: Dr. 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: December 12, 2025
• Results First Posted: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)