At-risk and vulNerable Individuals To Infection With COVID-19 and ProActive inTervention With intEgrated Health and Social Care (ANTICIPATE): a Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Emotional Distress on the PROMIS-29 Profile c2.1 Scale
研究概览
简要总结
This randomized control trial aims to explore a data-driven, proactive approach to identifying patients at greatest risk during the pandemic, and assess the impact of an embedded System Navigator in a primary health care setting. The System Navigator works one-on-one with patients to identify and provide support to their biological, psychological and social needs (e.g. income, housing, food security). Investigators are doing this study to find out whether proactive identification of vulnerable patients and linking to a System Navigator leads to reduction in emotional distress associated with managing complex health conditions and unmet social needs during COVID-19, compared to usual care.
Investigators will involve approximately 180 patients from primary care clinics that are a part of the University of Toronto Practice-Based Research Network (UTOPIAN). The information from this study will be used to help us understand how proactive engagement within a primary health setting can help to improve the health of patients during COVID-19, and beyond.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At-risk and vulnerable patients of primary care organizations who are 60+ AND have one or more of:
- •chronic condition (diabetes, CHF, CAD, COPD or asthma)
- •serious mental illness (schizophrenia or bipolar disorder)
- •anticipated to live in poverty and/or be homeless/underhoused
排除标准
- •patients unable to provide informed consent
结局指标
主要结局
Emotional Distress on the PROMIS-29 Profile c2.1 Scale
时间窗: 3 months
Measure of emotional distress as measured by anxiety and depression systems
次要结局
- Social needs met(3 months)
- COVID related outcomes (patient-reported questionnaire built for this study)(3 months)
- Mortality related to COVID-19 and all cause mortality(12 months)
- Number of hospitalizations related to COVID-19 and all cause mortality(12 months)
