Patient Navigation 2.0

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04234646
• Other study ID #: STU00211685
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2020
• Est. completion date: March 2025

Study information

• Verified date: June 2023
• Source: Northwestern University
• Contact: Melissa Simon, MD
• Phone: (312) 503-8780
• Email: m-simon2[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Patient 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.
• One-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

Locations

Country	Name	City	State
United States	Northwestern	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Northeastern Illinois University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Timeliness of diagnostic resolution	Time from an abnormal screening result to diagnostic resolution	through study completion, an average of 18 months
Secondary	Timeliness of treatment initiation	Time from diagnostic resolution to initiation of treatment	through study completion, an average of 18 months