跳至主要内容
临床试验/NCT06941519
NCT06941519招募中不适用

Addressing Social Needs to Improve Health in Adults With Multiple Chronic Conditions

Kaiser Permanente1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

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

Experimental

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

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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