跳至主要内容
临床试验/NCT05533918
NCT05533918已完成不适用

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

University of Utah2 个研究点 分布在 1 个国家目标入组 31,439 人开始时间: 2022年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31,439
试验地点
2
主要终点
Reach-Accept Testing

研究概览

简要总结

The long-term objective of SCALE-UP II is to increase the reach, uptake, and sustainability of COVID-19 testing among underserved populations. Through RADx-UP Phase I funding (SCALE-UP Utah), the team has established population health management (PHM) interventions that have been used since Feb 2021 to increase the uptake of COVID-19 testing and vaccination among community health center patients.

Interventions are based on a PHM approach that uses widely available technology (i.e. cell phones and text messaging). SCALE-UP II will both build on SCALE-UP Utah PHM interventions and investigate novel resource conservation approaches (i.e., Request-Patient Navigation vs. No Patient Navigation and text messaging vs. conversational agent).

SCALE-UP II builds on long standing partnerships among the University of Utah Clinical and Translational Science Institute (UofU CTSI), Association for Utah Community Health (AUCH), CHCs, and the Utah Department of Health(UDOH). CTSI and SCALE-UP II investigators are leading several COVID-19 initiatives that drive public health response and state government policies in Utah.

详细描述

Racial/ethnic minority, low socioeconomic status (SES), and rural populations suffer profound health inequities across a wide variety of diseases and conditions, including COVID-19. For example, as of June 2021, the cumulative COVID case rate in Utah per 100,000 was 10,803 among Whites vs. 17,541 among Latinos. The positivity rate was 14% among Whites vs. 24% among Latinos. Similar disparities persist across the nation for vaccination rates between urban vs. rural, high vs. low SES, and White vs. non-White populations. Low vaccination rates leave underserved populations at risk for local outbreaks, and more contagious and severe variants. Thus, interventions targeting these populations at the interplay between testing and vaccination among underserved populations are critical for pandemic control.

Not only do underserved populations experience profound health inequities, but there is also a critical digital divide between high and low resource healthcare systems. Low resource settings are far less likely to adopt Health Information Technology approaches, and often do not have the capacity to implement large scale population health management (PHM) efforts utilizing data analytics and automated patient outreach. As such, research is needed utilizing targeted PHM approaches that proactively identify, reach, and navigate vulnerable patients to both increase opportunities to engage in vaccination and testing, and to address barriers to engagement. Community Health Centers (CHCs) are optimal settings for implementation of PHM interventions to increase the uptake of COVID-19 testing and vaccination among underserved populations. Eleven Utah CHC systems are participating in SCALE-UP II. Their 38 primary care clinics serve over 112,000 unique patients annually (36% Latino, 10% Native American, 63% <100% poverty level, 57% uninsured, and 42% of clinics are in rural/frontier areas).

SCALE UP II is comprised of two distinct studies, the Text Message (TM) study and the Conversational Agent (CA) study. Patients will be triaged into one of two studies based on self-reported ownership of a smart phone with internet access. Patients who report not owning a smart phone with internet access will be included in the TM study. Additionally, patients who do not respond to the question regarding smart phone ownership will be included in the TM study. Patients who self-report ownership of a smart phone with internet access will be included in the CA study.

SCALE-UP II: TM study will implement and evaluate practical, accessible, and scalable PHM interventions to increase COVID-19 testing and vaccine uptake based on the best evidence available, patients' specific barriers and hesitancy factors, and extensive collaboration with CHCs, AUCH, and UDHHS. This study is a 1x2 design with all patients receiving text messages as well as either type of available patient navigation.

Text Messaging (TM): bidirectional text messaging to connect patients to vaccination or mailed at-home rapid test kits for use, as needed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Participant)

盲法说明

Patients will not know what intervention arm they are in.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Reach-Accept Testing

时间窗: Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]

Number of patients that accept an offer to receive an at-home test kit and verify mailing address

次要结局

  • Reach-Engage Testing(Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message])
  • PN-Request(Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message])
  • PN-Engage(Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message])
  • Opt-out(Daily [up to 90 days post intervention messaging))
  • Self Reported Testing(90 days post intervention messaging)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guilherme Del Fiol

Professor

University of Utah

研究点 (2)

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