跳至主要内容
临床试验/NCT05228886
NCT05228886已完成不适用

Intensifying Community Referrals for Health: The SINCERE Intervention to Address COVID-19 Health Disparities

Andrea Wallace2 个研究点 分布在 1 个国家目标入组 466 人开始时间: 2021年9月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
466
试验地点
2
主要终点
Change in Anxiety over 12-week time period

研究概览

简要总结

The goal of this real world efficacy study is to understand the benefit of universal social needs screening, community-based service referrals, and telephonic follow-up as a scalable strategy for preventing COVID-19 transmission, and for addressing the secondary health effects of the social, behavioral, and economic changes following the COVID-19 pandemic. With statewide community service providers, existing health information technology, and piloted methods, we seek to determine the effectiveness of universal social needs screening and community service referrals - the SINCERE intervention - in improving health outcomes of COVID-19 vulnerable and socioeconomically disadvantaged populations and whether intensive follow-up and collaborative goal-setting helps overcome barriers to community service use by patients seen in the emergency department and seeking COVID testing at community-based and mobile clinic locations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Care Provider)

盲法说明

Services to which participants are referred will not be aware of the participant's inclusion in the research study or their study arm.

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

  • Adult (> 17 years)
  • English or Spanish speaking
  • Completed the referral process at the UHealth ED, one of the COVID-19 testing sites or the Primary Children's ED and indicated both social needs and willingness to receive service low- and no-cost referrals from the United Way 211 community referral service
  • Able to be reached by phone during the intervention OR able to complete surveys sent by text or email

排除标准

  • Those unable to communicate verbally
  • Those living in nursing facilities, or those who are not otherwise responsible for self-care

研究组 & 干预措施

Call + Resources + Scheduled Follow-Up

Experimental

Participants receive standard care typically provided to 211 callers plus scheduled follow-up calls according to the Scheduled Follow-Up intervention description.

干预措施: Scheduled Follow-Up (Behavioral)

Call + Resources + SINCERE

Experimental

Participants receive standard care typically provided to 211 callers plus scheduled follow-up calls according to the SINCERE intervention description (scheduled follow up with active collaborative goal setting).

干预措施: SINCERE (Behavioral)

Call + Resources

Active Comparator

Participants receive standard care typically provided to 211 callers, including ad hoc follow-up.

干预措施: Standard of Care (Other)

结局指标

主要结局

Change in Anxiety over 12-week time period

时间窗: Baseline, 2-week, 4-week and 12-week surveys

Standardized PROMIS Anxiety- Short Form 7a. 7 questions create one outcome score. Each question is on a 1-5 scale with higher numbers indicating higher severity. The outcome variable will be PROMIS Anxiety with Time included as a variable in the model.

Change in Global Health over 12-week time period

时间窗: Baseline, 2-week, 4-week and 12-week surveys

Standardized PROMIS v1.2 Global Health. 10 questions create one outcome score. Each question is on a 1-5 scale with higher numbers indicating lower severity. The outcome variable will be PROMIS v1.2 Global Health with Time included as a variable in the model.

Change in Depression over 12-week time period

时间窗: Baseline, 2-week, 4-week and 12-week surveys

Standardized PROMIS Depression - Short Form 8b. 8 questions create one outcome score. Each question is on a 1-5 scale with higher numbers indicating higher severity. The outcome variable will be PROMIS Anxiety with Time included as a variable in the model.

次要结局

未报告次要终点

研究者

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

Andrea Wallace

Professor

University of Utah

研究点 (2)

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