Patient Navigation 2.0

Sponsor

Northwestern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04234646

Collaborator

Mercy Hospital and Medical Center, Illinois (Other), Chinese American Service League (Other), Rutgers, The State University of New Jersey (Other), Northeastern Illinois University (Other)

600

Enrollment

Location

Arms

50.7

Anticipated Duration (Months)

11.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Patient Navigation (PN) 2.0 Checklist Behavioral: One-on-one Patient Navigation (PN)	N/A

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 have their medical records reviewed and be asked to complete a patient survey at the beginning of the program, at the end of the program, and one year after the end of the program.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Dec 9, 2020

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1: One-on-One Patient Navigation 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) 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
Experimental: Group 2: Patient Navigation 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.	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.

Arm

Intervention/Treatment

Active Comparator: Group 1: One-on-One Patient Navigation

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)

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

Experimental: Group 2: Patient Navigation 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.

Behavioral: Patient Navigation (PN) 2.0 Checklist

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Timeliness of diagnostic resolution [through study completion, an average of 18 months]
Time from an abnormal screening result to diagnostic resolution
Timeliness of treatment initiation [through study completion, an average of 18 months]
Time from diagnostic resolution to initiation of treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Northwestern University
Mercy Hospital and Medical Center, Illinois
Chinese American Service League
Rutgers, The State University of New Jersey
Northeastern Illinois University

Investigators

Principal Investigator: Melissa Simon, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Melissa Simon, Principal Investigator, Northwestern University

ClinicalTrials.gov Identifier:

NCT04234646

Other Study ID Numbers:

STU00211685

First Posted:

Jan 21, 2020

Last Update Posted:

Apr 19, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 19, 2022