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
- 1
- 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
研究组 & 干预措施
Intervention - System Navigator
The intervention group will be connected to a system navigator who is a trained staff member embedded within the primary health clinic team with a focus to address participant's biological, psychological and social needs.
Working with the System Navigator will mean:
- Discussing patients' current health status and concerns
- Receiving support on management of chronic diseases and mental health including connection to local resources e.g. counseling, harm reduction, crisis support services
- Receiving information about benefits that they may be entitled to and learning about free services
- Receiving help from the System Navigator on forms or letters that are required to access resources
干预措施: System Navigator (Other)
Tailored list of community resources
Control group will be provided a tailored list of community resources.
干预措施: Tailored list of resources (Other)
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)