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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT04939519
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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

Key Dates

Start date
Mar 29, 2021
Status verified
Dec 2025
Primary completion
Jun 17, 2022
Completion
Feb 28, 2023

Study Design

Enrollment
65,300 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Active Comparator: Text-Messaging (TM)
    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.
  • Active Comparator: Text-Messaging plus Patient Navigation
    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.

Primary Outcome Measure

Uptake-Total [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer Institute/ University of UtahSalt Lake CityUtah84112-

Find similar trials in Salt Lake City, UT

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Huntsman Cancer Institute/ University of Utah· Salt Lake City, UT

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