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临床试验/NCT04234646
NCT04234646已完成不适用

Patient Navigation 2.0: Addressing the Challenge of Scaling Navigation Through Checklist-based Implementation

Northwestern University2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年12月9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
600
试验地点
2
主要终点
Patient Receipt of Clinical Cancer Preventive Services and Resolution of Social Determinants of Health Barriers

研究概览

简要总结

This study evaluates whether a "Patient Navigation 2.0 Checklist" intervention is effective in addressing patients' social determinants of health and recommended cancer-related screenings, behavioral counseling, and immunizations.

详细描述

Cancer patient navigation (PN) is an effective strategy for resolving patient barriers to care and improving completion and consistency of cancer screening, follow-up of abnormal findings, and treatment initiation. However, as the current standard one-on-one PN model is challenging to scale across cancers and economically difficult to sustain, the investigators propose to convert one-on-one PN into a learning health system "PN 2.0 Checklist" that will help coordinate navigation workflow and integrate clinical team members with community/local resources. This pragmatic, randomized trial tests whether this checklist strategy is as effective as one-on-one PN in addressing patients' social determinants of health and recommended cancer-related screenings, behavioral counseling, and immunizations.

In this study, half of the participants will be navigated using the "PN 2.0 Checklist". The other half will be navigated using the "One-on-One PN". All participants enrolled in the study will be asked to report their utilization of health services and be asked to complete a patient survey at the beginning of the program and every 6 months.

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 (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21 or older
  • Reside in one of the eight Chicago zip codes corresponding to Chinatown's geographical boundaries: 60605, 60607, 60608, 60609, 60616, 60623, 60632, 60653
  • Self-identify as Chinese
  • Not cognitively impaired
  • Have the ability to participate in verbal survey in Cantonese, English, Mandarin, or Toishanese

排除标准

  • Cognitive impairment
  • Incarceration
  • Under 21 years of age
  • Adult unable to consent

研究组 & 干预措施

Group 1: One-on-One Patient Navigation

Active Comparator

One-on-one Patient Navigation will be based on a Case Management Model where patients navigators perform appointment scheduling and reminders; facilitate communication between patients and care teams; and identify and reduce patient barriers through education, outreach, and referrals to community, local, and state resources.

干预措施: One-on-one Patient Navigation (PN) (Behavioral)

Group 2: Patient Navigation 2.0 Checklist

Experimental

The PN 2.0 Checklist intervention is centered on a learning health system checklist that enumerates a patient's Social Determinants of Health (SDoH) related barriers and tracks completion of services to address SDoH (at community oncology and community social service settings) as well as completion of USPSTF recommended cancer-related screenings, behavioral counseling, and immunizations.

干预措施: Patient Navigation (PN) 2.0 Checklist (Behavioral)

结局指标

主要结局

Patient Receipt of Clinical Cancer Preventive Services and Resolution of Social Determinants of Health Barriers

时间窗: through study completion, an average of 18 months

Patient Receipt of Clinical Cancer Preventive Services and Resolution of Social Determinants of Health (SDoH) Barriers is an adjusted, composite proportion of items completed/resolved in 2 domains: (1) USPSTF recommended cancer screenings, behavioral counseling, and immunizations; and (2) SDoH barriers resolved from those identified in the Accountable Health Communities Health-Related Social Needs (AHC HRSN) Screening Tool

次要结局

  • Timeliness of diagnostic resolution(through study completion, an average of 18 months)
  • Timeliness of treatment initiation(through study completion, an average of 18 months)

研究者

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

Melissa Simon

Principal Investigator

Northwestern University

研究点 (2)

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