Patient Navigation 2.0

Sponsor
Northwestern University (Other)
Overall Status
Not yet 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
2
Arms
39
Anticipated Duration (Months)

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 DiseaseIntervention/TreatmentPhase
  • 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
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Timeliness of diagnostic resolution [through study completion, an average of 18 months]

    Time from an abnormal screening result to diagnostic resolution

  2. 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

No locations specified.

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:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 18, 2021