Addressing Social Needs to Improve Health in Adults With Multiple Chronic Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Receipt of social services
研究概览
简要总结
The investigators will conduct a comparative effectiveness randomized clinical trial with two "active comparator" arms. The investigators will evaluate the two current, usual care strategies (higher intensity "telephonic navigation" vs. lower intensity "virtual outreach") for addressing social needs among patients with multiple chronic conditions.
详细描述
The goal of the proposed research is to compare the effectiveness of two strategies for addressing social needs in a large, high-risk population of adults with multiple chronic conditions (MCC).
Specific Aims are to:
Aim 1 - Comparative Effectiveness Randomized Clinical Trial: Compare two evidence-based strategies for systematically addressing patient-reported social needs in a medically complex population: Higher Intensity (active telephonic outreach from a health navigator with follow-up contacts for up to 3 months) vs. Lower Intensity (outreach via text, email, and/or letter with materials that contain information about available local, state, and federal governmental benefits and services). Hypotheses (H) are framed in terms of relatively greater effectiveness of the Higher Intensity strategy, although through Aims 2 & 3 the investigators will investigate variation within different patient groups.
H1: Overall improvement will be greater in the Higher vs Lower Intensity strategy condition on the primary (receipt of social services, social needs met, clinical care gaps closed) and secondary (patient-centered) outcomes.
Aim 2 - Qualitative Assessment: The investigators will conduct patient focus groups and navigator interviews to examine intervention impact and mechanisms at each step in the pathway from intervention engagement to obtaining social resources to addressing social needs to improving clinical care and to explore associated barriers and facilitators. Exploratory Qualitative Hypotheses (QH) are:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two or more chronic medical conditions from a defined list of 24 chronic conditions
- •One or more gaps in evidence-based care (related to condition-specific risk factor management, evidence-based screening and preventive care, missed appointments, and medication non-adherence),
- •At least one self-reported social-related barrier to care or "social need" (e.g., transportation, food, housing, utilities, and/or financial insecurity).
排除标准
- •major cognitive barriers (dementia, psychosis).
- •multiple prior year hospitalizations ("extremely high utilizers")
研究组 & 干预措施
Telephonic Navigation
Higher Intensity (active telephonic outreach from a health navigator with follow-up contacts for up to 3 months)
干预措施: Telephonic Outreach (Behavioral)
Virtual Outreach
Lower Intensity (outreach via text, email, and/or letter with materials that contain information about available local, state, and federal governmental benefits and services)
干预措施: Virtual Outreach (Behavioral)
结局指标
主要结局
Receipt of social services
时间窗: approximately 6 months after enrollment
Patient survey re: receipt of resources from available programs
Reduction in number of social needs
时间窗: approximately 6 months after enrollment
Reduction from baseline in number of unmet social needs
Clinical care gap closure
时间窗: approximately 12 months after enrollment
Reduction in number of evidence-based clinical care gaps
次要结局
未报告次要终点
