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Patient Navigation 2.0

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04234646
Enrollment
600
Registered
2020-01-21
Start date
2020-12-09
Completion date
2026-05-31
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

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

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.

Interventions

BEHAVIORALPatient Navigation (PN) 2.0 Checklist

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.

BEHAVIORALOne-on-one Patient Navigation (PN)

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

Sponsors

Northwestern University
Lead SponsorOTHER
Northeastern Illinois University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Receipt of Clinical Cancer Preventive Services and Resolution of Social Determinants of Health Barriersthrough study completion, an average of 18 monthsPatient 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

Secondary

MeasureTime frameDescription
Timeliness of diagnostic resolutionthrough study completion, an average of 18 monthsTime from an abnormal screening result to diagnostic resolution
Timeliness of treatment initiationthrough study completion, an average of 18 monthsTime from diagnostic resolution to initiation of treatment

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMelissa Simon, MD

Northwestern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026