Translating Research Into Practice (TRIP)

• ClinicalTrials.gov Identifier: NCT03514433
• Recruitment Status: Recruiting
• First Posted: May 2, 2018
• Last Update Posted: November 23, 2020
• Sponsor: Boston Medical Center
• Collaborators: Boston University; University of Massachusetts, Worcester; Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; Tufts Medical Center; Dana-Farber Cancer Institute; Massachusetts General Hospital
• Information provided by (Responsible Party): Boston Medical Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cancer, Breast	Other: TRIP Patient Navigation Intervention	Not Applicable

Detailed 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 CTSA hubs (Boston University, Harvard University, Tufts University, and University of Massachusetts) partnered with the Boston Breast Cancer Equity Coalition, and the 6 hospitals that care for women with breast cancer.

Patient population: 1,100 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. Six 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. Faulkner Hospital (site PI: Rachel Freedman, MD)
5. Massachusetts General Hospital (site PI: Beverly Moy, MD)
6. Tufts Medical Center (PI: Karen Freund MD, MPH)

UMass 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1100 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A randomized cluster stepped wedge design will be conducted. This pragmatic design involves a sequential, randomized roll-out of the intervention across 6 participating clinical sites or "clusters" over 3 month intervals or "steps". Consistent with a stepped wedge design with one cluster per step, prior to the collection of data in the pre-intervention period, the investigators will generate a set of uniform random numbers for each of the six clusters to assign a starting period for the study intervention. There will be no crossover of patients from usual care to the intervention. That is, patients at each site during the pre-intervention period will experience only usual care and will act as historical controls and those enrolled after the initiation of intervention will experience the intervention.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Translating Research Into Practice: A Regional Collaborative to Reduce Disparities in Breast Cancer Care
• Actual Study Start Date: August 6, 2018
• Estimated Primary Completion Date: August 2021
• Estimated Study Completion Date: January 2022

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Historical Control; 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 in June 2018. These patients will receive standard patient navigation at their care site and will act as historical controls in comparison to the TRIP experimental group.
Experimental: TRIP Patient Navigation Intervention; This study will be enhancing current patient navigation at the participating 6 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.	Other: TRIP Patient Navigation Intervention; The TRIP intervention will replace the current standard of care at the 6 participating hospitals once it is rolled out on-site. Any TRIP eligible patients receiving patient navigation services over the course of the study will receive the enhanced services.

Outcome Measures

Primary Outcome Measures :

1. Time-to-treatment post-diagnosis [ Time Frame: Within 90 days of enrollment ]
   The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality. The time element will be calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable will depend on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation, including but not limited to stage at diagnosis and co-morbid medical conditions.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: All women with breast cancer diagnosed at a participating study site during the study period will be eligible for inclusion if they meet three study criteria
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Tracy A Battaglia, MD, MPH; 617 638 7428; Tracy.Battaglia@bmc.org

Contact: Victoria Xiao; 617 638 8036; Victoria.xiao@bmc.org

Locations

United States, Massachusetts

Tufts Medical Center; Recruiting

Boston, Massachusetts, United States, 02111

Contact: Karen Freund, MD 617-636-1165 KFreund@tuftsmedicalcenter.org

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Contact: Jennifer Haas, MD MPH 617-724-1832 Jennifer.Haas@MGH.HARVARD.EDU

Contact: Beverly Moy, MD MPH bmoy@mgh.harvard.edu

Boston Medical Center; Recruiting

Boston, Massachusetts, United States, 02118

Contact: Sharon Bak 617-638-8036 Sharon.bak@bmc.org

Beth Israel Deaconess Medical Center; Recruiting

Boston, Massachusetts, United States, 02215

Contact: Ted James, MD 617-667-5509 ted.james@bidmc.harvard.edu

Contact: Karolina Ballester 617-667-5509 kballest@bidmc.harvard.edu

Brigham and Women's Faulkner Hospital; Active, not recruiting

Boston, Massachusetts, United States, 02215

Dana-Farber Cancer Institute; Recruiting

Boston, Massachusetts, United States, 02215

Contact: Deborah Toffler, MSW, LCSW Deborah_Toffler@DFCI.HARVARD.EDU

Principal Investigator: Rachel Freedman, MD MPH

Sponsors and Collaborators

Boston Medical Center

Boston University

University of Massachusetts, Worcester

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Tufts Medical Center

Dana-Farber Cancer Institute

Massachusetts General Hospital

Investigators

• Principal Investigator: Tracy Battaglia, MD., MPH; Boston Medical Center

More Information

• Responsible Party: Boston Medical Center
• ClinicalTrials.gov Identifier: NCT03514433
• Other Study ID Numbers: H-37314; 1U01TR002070-01 ( U.S. NIH Grant/Contract )
• First Posted: May 2, 2018
• Last Update Posted: November 23, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston Medical Center:

Patient Navigation; Disparity; Social Determinants

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases