Translating Research Into Practice: Patient Navigation for Breast Cancer (TRIP)

Boston Medical Center (BMC)

Status: Completed

Conditions: Cancer, Breast

Treatments: Other: TRIP Patient Navigation Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03514433

1U01TR002070-01 (U.S. NIH Grant/Contract)

H-37314

Details and patient eligibility

About

The TRIP Project aims to overcome barriers to widespread implementation and dissemination of evidence-based practices that will improve the delivery of guideline-concordant care to vulnerable women with breast cancer. To accomplish this goal the study team will create (a) regional patient registries; (b) systematic screening for social barriers to care with a personalized referral plan; and (c) patient navigation services that integrate into one model of care to improve the quality and effectiveness of care delivery, for minority and/or low-income women with breast cancer in Boston.

Full description

This community-engaged program will demonstrate the feasibility of community-academic partnerships to provide innovations in information sharing and systems implementation targeted to reduce treatment disparities. Patient navigators will be able to utilize the patient database to track their patients throughout their treatment, and receive guidance regarding recommended social resources to patients experiencing hardships via the social determinants platform.

Who: The four Massachusetts Clinical and Translational Science Award (CTSA) hubs (Boston University, Harvard University, Tufts University, and University of Massachusetts) partnered with the Boston Breast Cancer Equity Coalition, and the 5 hospitals that care for women with breast cancer.

Patient population: about 1,300 vulnerable inner city women with risk for delay in breast cancer care. Massachusetts (MA) Cancer Registry data identified the following characteristics of Boston residents with greatest delays in breast cancer treatment: Black, Hispanic, non-English speaking, and public health insurance. Five health care institutions care for >90% of these women:

1. Beth Israel Deaconess Medical Center (site PI: Ted James, MD)
2. Boston Medical Center (PI: Tracy Battaglia MD, MPH)
3. Brigham Women's Hospital/Dana-Farber Cancer Institute (PI: Jennifer Haas MD, MPH)
4. Massachusetts General Hospital (site PI: Beverly Moy, MD)
5. Tufts Medical Center (PI: Karen Freund MD, MPH)

University of Massachusetts Medical Center (PI: Stephenie Lemon, PhD) will play an integral role in the planning and implementation of the TRIP intervention but is not a clinical site.

Enrollment: 1,725 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. are an adult female 18 years of age or older;
2. reside within 25 miles of the City of Boston;
3. have any of the following risk factors for delays in care: are Black and/or Hispanic ethnicity, do not speak English as their primary language, and/or have only public insurance or are uninsured at the time of diagnosis.

Exclusion criteria

1. cancer diagnosis made > 60 days prior to enrollment, such that the ability of the intervention to effect the outcome is limited;
2. presence of a cognitive impairment such as dementia or delirium from any cause (e.g. metabolic, medication or drug induced), given the unique challenges to their treatment decision making/ adherence and the fact that the intervention would not include the patient directly, but rather the family;
3. home residence is outside of the city of Boston, Massachusetts.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,725 participants in 2 patient groups

Control- Usual Care

No Intervention group

Description:

This study will be utilizing electronic health record data to identify patients that match the TRIP eligibility criteria and received patient navigation prior to study rollout. These patients will receive standard patient navigation at their care site and will act as controls in comparison to the TRIP experimental group.

TRIP Patient Navigation Intervention

Experimental group

Description:

This study will be enhancing current patient navigation at the participating 5 hospitals with the 3 components of the TRIP intervention (a shared patient registry, a social determinants of health platform, and additional training and support for Patient Navigators). All patients that are identified as TRIP eligible will receive these intervention benefits and will be categorized into the experimental arm of the study.

Treatment:

Other: TRIP Patient Navigation Intervention