Patient Navigation 2.0

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Patient Navigation (PN) 2.0 Checklist
* Behavioral: One-on-one Patient Navigation (PN)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Cognitive impairment Incarceration Under 21 years of age Adult unable to consent

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: One-on-One Patient Navigation<br>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. | Behavioral: One-on-one Patient Navigation (PN)<br>* The one-on-one Patient Navigation will be based on a Case Management Model where PNs 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<br>|
| Experimental: Group 2: Patient Navigation 2.0 Checklist<br>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. | Behavioral: Patient Navigation (PN) 2.0 Checklist<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Receipt of Clinical Cancer Preventive Services and Resolution of Social Determinants of Health Barriers | 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 | through study completion, an average of 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timeliness of diagnostic resolution | Time from an abnormal screening result to diagnostic resolution | through study completion, an average of 18 months | 
| Timeliness of treatment initiation | Time from diagnostic resolution to initiation of treatment | through study completion, an average of 18 months |