Translating Research Into Practice (TRIP)
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|ClinicalTrials.gov Identifier: NCT03514433|
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : October 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer, Breast||Other: TRIP Patient Navigation Intervention||Not Applicable|
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:
- Beth Israel Deaconess Medical Center (site PI: Ted James, MD)
- Boston Medical Center (PI: Tracy Battaglia MD, MPH)
- Brigham Women's Hospital/Dana-Farber Cancer Institute (PI: Jennifer Haas MD, MPH)
- Faulkner Hospital (site PI: Rachel Freedman, MD)
- Massachusetts General Hospital (site PI: Beverly Moy, MD)
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1100 participants|
|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|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514433
|Contact: Tracy A Battaglia, MD, MPH||617 638 7428||Tracy.Battaglia@bmc.org|
|Contact: Cortney C Winkle-Miller, PhD||617 638 email@example.com|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Ted James, MD 617-667-5509 firstname.lastname@example.org|
|Contact: Karolina Ballester 617-667-5509 email@example.com|
|Brigham and Women's Faulkner Hospital||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Rachel Freedman, MD 617-582-4300 Rachel_Freedman@dfci.harvard.edu|
|Contact: Cortney Winkle-Miller, PhD 617-638-7512 firstname.lastname@example.org|
|Principal Investigator:||Tracy Battaglia, MD., MPH||Boston Medical Center|