Translating Research Into Practice: A Regional Collaborative to Reduce Disparities in Breast Cancer Care
Phase: NA
Conditions: Cancer, Breast
Sponsor: Boston Medical Center

1 
 
 
 
 
Translating Research into Practice (TRIP) 
 
ClinicalTrials.gov number: NCT03514433 
Protocol Version Number: 1.22 
Protocol Version Date: 23 November 2021  
Funding Mechanism: NIH Grant Number: 1U01TR002070 9/1/2017-5/31/2022 
Principal Investigator: Tracy Battaglia 
 
Phone: 617.638.8036 
 
E-mail: Tracy.Battaglia@bmc.org 
 
 
 
 
 
 
Statistical Analysis Plan pages 53-55 
 
 
 
 
CONFIDENTIAL 
 
This document is confidential and the property of Boston Medical Center. No part of it 
may be transmitted, reproduced, published, or used by other persons without prior 
written authorization from the study sponsor. 
 
 

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TABLE OF CONTENTS 
1 
List of Abbreviations ................................................................................................ 5 
2 
Protocol Summary .................................................................................................... 5 
3 
Background/Rationale & Purpose ............................................................................ 6 
3.1 
Background Information .......................................................................................... 6 
Research Question .................................................................................................... 7 
Hypothesis .................................................................................................................. 7 
3.2 
Rationale and Purpose .............................................................................................. 8 
4 
Objectives .................................................................................................................. 8 
4.1 
Study Objectives ........................................................................................................ 8 
4.2 
Study Outcome Measures ........................................................................................... 8 
4.2.1 
Primary Outcome Measures ...................................................................... 8 
4.2.2 
Secondary Outcome Measures ................................................................ 9 
5 
Study Design ........................................................................................................... 10 
5.1.1 
Study design ............................................................................................... 10 
5.1.2 
Randomization scheme ............................................................................ 11 
5.1.3 
Study sites ................................................................................................... 11 
5.1.4 
Study subjects ............................................................................................ 11 
5.1.5 
Accrual and Enrollment ............................................................................ 12 
5.1.6 
Data Sources/Collection........................................................................... 12 
6 
Potential Risks and Benefits .................................................................................. 13 
6.1 
Risks ............................................................................................................................ 13 
6.2 
Potential Benefits ..................................................................................................... 14 
6.3 
Analysis of Risks in Relation to Benefits .......................................................... 14 
7 
Study Subject Selection ......................................................................................... 14 
7.1 
Subject Inclusion Criteria ....................................................................................... 14 
7.2 
Subject Exclusion Criteria ..................................................................................... 14 
8 
Study Intervention ................................................................................................... 14 
9 
Study Procedures ................................................................................................... 16 
9.1 
Patient Navigation services ................................................................................... 16 
9.1.1 
Patient Navigator Training Methodology ............................................. 17 
9.1.2 
Human Subjects Protection Training ................................................... 18 
9.2 
Patient Navigator Oversight .................................................................................. 18 
9.2.1 
Patient Navigator Supervisor .................................................................. 18 
9.2.2 
Refresher Training ..................................................................................... 19 
9.2.3 
Observations of Patient Navigators ...................................................... 19 
9.3 
Use of Shared Registry ........................................................................................... 19 
9.3.1 
REDCap......................................................................................................... 19 
9.3.2 
User Permissions ....................................................................................... 20 
9.3.3 
Data elements ............................................................................................. 20 
9.3.4 
Patient Identification ................................................................................. 21 
9.3.5 
Reporting ...................................................................................................... 22 
9.3.6 
Notifying a Patient Navigator a patient has transferred care ......... 22 
9.3.7 
Interfacing with Aunt Bertha ................................................................... 22 
9.3.8 
Registry Training ........................................................................................ 23 

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9.3.9 
Technical support and troubleshooting .............................................. 23 
9.3.10 Communication on Registry revisions ................................................ 23 
9.4 
Screening for Social Determinants of Health (SDOH) .................................... 23 
9.4.1 
Aunt Bertha .................................................................................................. 23 
9.4.2 
Security and Compliance ......................................................................... 24 
9.4.3 
User Permissions ....................................................................................... 24 
9.4.4 
Screening for SDOH .................................................................................. 24 
9.4.5 
Aunt Bertha Needs Assessment ............................................................ 25 
9.4.6 
Frequency of Screening for SDOH ........................................................ 26 
9.4.7 
Using Aunt Bertha ..................................................................................... 26 
9.4.8 
Training ......................................................................................................... 27 
9.4.9 
Identifying resources ................................................................................ 27 
9.4.10 Reporting ...................................................................................................... 28 
9.4.11 Interfacing with Shared Registry ........................................................... 28 
9.4.12 Technical support and troubleshooting .............................................. 28 
9.4.13 Communication about modifications to Aunt Bertha ...................... 28 
10 
Data Management ................................................................................................... 29 
10.1 Study Data .................................................................................................................. 29 
10.1.1 Data Source: REDCap ............................................................................... 29 
10.1.2 Data Source: Aunt Bertha ........................................................................ 29 
10.1.3 Data Source: Quickbase .......................................................................... 29 
10.1.4 THRIVE .......................................................................................................... 29 
10.1.5 Data Source: Electronic Health Records ............................................. 30 
10.1.6 Data Source: Central Data Repository ................................................. 31 
10.1.7 Data Source: Cost Surveys ..................................................................... 32 
10.1.8 Data Source: Observations ..................................................................... 32 
10.1.9 Data Source: Key Informant Interviews ............................................... 33 
10.1.10 Data Source: Patient Interviews ............................................................. 36 
10.2 Data Safety Monitoring Plan (DSMP) .................................................................. 40 
10.2.1 Data Safety Monitoring Plan Overview ................................................ 40 
10.2.2 Oversight Responsibilities ...................................................................... 40 
10.2.3 Monitoring Procedures ............................................................................. 40 
10.2.4 General Electronic Data Procedures .................................................... 41 
10.2.5 General Security Procedures for Paper Data ..................................... 43 
10.3 Third Party Platforms .............................................................................................. 44 
10.3.1 REDCap Registry ....................................................................................... 44 
10.3.2 Social Determinants of Health Platform (Aunt Bertha) .................... 46 
10.3.3 Electronic Health Records ....................................................................... 48 
10.3.4 Central Data Repository ........................................................................... 48 
10.3.5 Protecting Confidentiality ........................................................................ 50 
10.4 Data Safety Meetings ............................................................................................... 50 
10.4.1 Participants .................................................................................................. 50 
10.4.2 Frequency .................................................................................................... 50 
10.4.3 Data for Meetings ....................................................................................... 50 

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10.4.4 Structure of Meetings ............................................................................... 50 
10.4.5 Addressing Data and Safety Concerns ................................................ 51 
10.5 Reporting .................................................................................................................... 51 
10.5.1 Responsibility ............................................................................................. 51 
10.5.2 Data and Safety Meetings Minutes ........................................................ 51 
10.5.3 Safety Definitions ....................................................................................... 51 
10.5.4 Safety Event Reporting............................................................................. 52 
10.5.5 Protocol Deviations ................................................................................... 52 
10.6 Quality Assurance of Data ..................................................................................... 52 
10.7 Stopping Rules .......................................................................................................... 53 
11 
Study Records Retention ....................................................................................... 53 
12 
Statistical Plan ........................................................................................................ 53 
12.1 Study Hypotheses .................................................................................................... 53 
12.2 Sample Size Determination .................................................................................... 53 
12.3 Statistical Methods .................................................................................................. 54 
13 
Ethics/Protection of Human Subjects .................................................................... 55 

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1 
List of Abbreviations 
Abbreviations 
Definitions 
AB 
Aunt Bertha 
BMC 
Boston Medical Center 
BU 
Boston University 
BIDMC 
Beth Israel Deaconess Medical Center 
BWH 
Brigham and Women's Hospital 
BWFH 
Brigham and Women’s Faulkner 
Hospital 
COC 
Commission on Cancer 
CTSI 
Clinical and Translational Science 
Institutes 
DFCI 
Dana Farber Cancer Institute 
DSMP 
Data Safety Monitoring Plan 
EHR 
Electronic Health Record 
HRSN 
Health Related Social Need 
MADPH 
Massachusetts Department of Public 
Health 
PN 
Patient Navigator 
SDOH 
Social Determinants of Health 
TRIP 
Translating Research into Practice 
 
 
2 
Protocol Summary 
 
Title: 
Translating Research into Practice: TRIP 
Population: 
Newly diagnosed breast cancer patients 18 years or older who 
live within a 35 mile radius of Boston, MA and have any of the 
following risk factors for delays in care: are Black and/or 
Hispanic race/ethnicity, do not speak English as their primary 
language, and/or have only public insurance or are uninsured 
at the time of diagnosis.  
Intervention: 
Implementation of three evidence-based tools that facilitate 
timely treatment: (a) shared patient registry to identify and 
track patients from diagnosis through treatment; (b) systematic 
screening for SDOH with a web-based platform to support a 
personalized referral plan to regional resources; and (c) one-
on-one patient navigation services. The integration of these 
tools into one integrated model of care will become the 
standard of care at each participating site, with the aim to 
improve the quality and timeliness of care delivery, for minority 
and/or low-income women with breast cancer. 

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Objectives: 
The main study objective is to implement an evidence-based 
integrated care delivery model (patient registry, screening for 
social determinants of health (SDOH) and patient navigation) 
across six health systems in Boston and evaluate the impact 
on clinical care outcomes among minority, low-income women 
with breast cancer. The primary objective is to test the clinical 
effectiveness of the intervention, as measured by the time to 
first cancer treatment and receipt of guideline concordant 
care. The secondary objective is to evaluate the 
implementation of the intervention (fidelity to intervention 
protocol, local adoption/sustainability, and acceptability). 
 
Design/Methodology: 
We will conduct a stepped wedge hybrid effectiveness-
implementation trial. The intervention proposed is a systems 
intervention. All subjects will be newly diagnosed breast 
oncology patients at one of the six participating clinical sites. 
In a stepped wedge design, sites are randomized to the time 
the site begins to implement the intervention and stratified by 
size. This will occur over an 18 month period, with a new site 
initiating the intervention every three months over this period. 
Historical data from each site serves as the comparison. Thus, 
24 months prior to the time when the intervention begins at 
each site, women who meet the eligibility criteria will be given 
usual care (control) arm. Newly diagnosed cancer patients at 
the site after the time allocated to begin the intervention will be 
in the intervention arm. There will be no crossover. 
Total Study Duration: 
August 2018- July 2022 
Subject Participation 
Duration: 
Varies depending upon each patient’s recommended cancer 
care as directed by their care team. Study participation will not 
influence the care recommended by the treatment team. 
Clinical outcomes will be collected from 0 to 24 months from 
the time of cancer diagnosis. 
 
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Background/Rationale & Purpose 
 
3.1 
Background Information 
 
 
In Boston (Massachusetts) inequities in breast cancer mortality have persisted and increased 
among Black, non-Hispanic women compared to women of other racial/ethnic groups. These 
inequities were reported in a national study of breast cancer mortality disparities in the 50 
largest U.S. cities and confirmed in local, more current data from the City of Boston and 
Commonwealth of Massachusetts public health departments. From 1990-1994 to 2005-2009, 
the Black-White breast cancer mortality rate ratio in Boston increased from 0.94 to 1.49. Local 
data for the period 2007-2012 show a continuing Black-White mortality rate ratio of 1.36, as well 
as a Black-Hispanic mortality rate ratio of 4.60 and a Black-Asian mortality rate ratio of 5.28. 
From 2001-2012, this health inequity resulted in 74 excess Black deaths among women less 
than 65 years. The inequity is especially striking given that Black women in Boston receive 
mammography screening at the same rates, have approximately equal likelihood of presenting 
with advanced disease (4-5%), and had a lower incidence of breast cancer than White women 

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during this time period. Eliminating disparities requires evidence-based interventions that 
address barriers to care in communities at risk.  
 
The transfer and application of scientific evidence into everyday practice is necessary to 
mitigate health disparities, yet roadblocks persist in broad implementation of evidence-based 
interventions among vulnerable communities experiencing disparities. The Boston Breast 
Cancer Equity Coalition was formed in 2014 in response to persistent city-wide disparities in 
breast cancer mortality among minority, low-income women. The Coalition identified three 
evidence-based strategies known to reduce delays in care that have yet to be deployed into 
clinical practice, due to a lack of implementation strategies. 
 
Translating Research into Practice (TRIP) draws upon the principles of community-engaged 
dissemination and implementation science to systematically facilitate deployment and utilization 
of: (a) regional patient registries; (b) systematic screening for SDOH with a personalized referral 
plan; and (c) patient navigation services into one integrated model of care to improve the quality 
and effectiveness of care delivery, in this case for minority and/or low-income women with 
breast cancer. The four Massachusetts CTSA hubs (Boston University, Harvard University, 
Tufts University, and University of Massachusetts) partnered with the 
Boston Breast Cancer Equity Coalition to overcome barriers to widespread implementation and 
dissemination of evidence-based practices that will improve the delivery of guideline-concordant 
care to vulnerable women. 
 
Research Question 
 
The goal of this study is to overcome barriers to widespread implementation and 
dissemination of evidence-based practices that will improve the delivery of guideline-
concordant care to vulnerable women.  
 
We plan to develop the three individual TRIP components (patient registry, systematic 
screening for SDOH using Aunt Bertha platform, patient navigation), and refine and integrate 
the intervention components into a cohesive package that can be implemented within the 
context of the clinical work flow of the partnering sites. 
 
Hypothesis 
Our main hypothesis is that widespread implementation of these tools will eliminate care 
delivery disparities by reducing delays in time to first treatment. CTSA hubs have the 
translational expertise to overcome barriers to such implementation. 
 
All participating sites currently provide patient navigation services, but none have evidence-
based protocols, functional registries or social determinants of health platforms to support their 
patient navigation programs. As an integrated care delivery model, TRIP will benefit patients 
with breast cancer through individualized support and guidance. The only potential risk is a 
breach of confidentiality of data shared among the navigation network and the research team. 
This study will be conducted in compliance with the protocol, applicable regulatory 
requirements, and BMC/BU Medical Campus Human Research Protection policies and 
procedures. 
 
 

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3.2 
Rationale and Purpose  
 
The TRIP intervention addresses a critical gap in the research enterprise, namely the transfer 
and application of scientific evidence that is necessary to mitigate health disparities into 
everyday practice. TRIP includes an integrated, multi-component intervention that builds from 
preliminary work of the investigative team and their community partner, the Coalition. Using a 
community engaged approach, this study is designed to overcome barriers to widespread 
implementation and dissemination of evidence-based practices that will improve the delivery of 
guideline-concordant care to vulnerable populations. Innovations include: a collaborative 
community-driven approach, the regional patient registry, the Aunt Bertha Social Determinants 
of Health (SDOH) platform and the study design. 
 
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Objectives 
 
4.1 
Study Objectives 
The main study objective is to conduct a stepped wedge hybrid effectiveness-implementation 
trial at six health systems (Beth Israel Deaconess Medical Center, Boston Medical Center, 
Brigham & Women’s Faulkner Hospital, Dana-Farber Cancer Institute, Massachusetts General 
Hospital and Tufts Medical Center) in Boston caring for minority, non-English speaking and/or 
low-income women with breast cancer to assess clinical effectiveness and implementation of 
the integrated intervention (patient registry, Aunt Bertha SDOH platform, and patient 
navigation). 
The primary objective is to test the clinical effectiveness of the intervention, as measured by the 
time to first cancer treatment and receipt of guideline concordant care. The secondary objective 
is to evaluate the implementation of the intervention (fidelity to intervention protocol). 
 
4.2 
Study Outcome Measures 
 
4.2.1 Primary Outcome Measures 
 
Our primary study outcome is Time to initiation of cancer treatment, a continuous outcome 
defined as the number of days from diagnosis (Time 0) to treatment initiation (Time 1). 
Treatment initiation is defined as the time from biopsy until first treatment for cancer, either 
surgical, radiation, or systemic therapy. Table 2 displays the specific data elements that will be 
used to define treatment initiation. As some patients have had pre-operative chemotherapy or 
hormone therapy, the time period will vary for each patient. This outcome has been widely used 
in existing navigation studies, as it has been linked to mortality and survival outcomes. Our 
study is powered on this clinical effectiveness outcome. 
 
4.2.1.1 Table 1. Data Elements for “Time to Initiation of Primary Breast Cancer 
Treatment” Calculations  
Time period 
Date of 
Time 0 
First definitive tissue diagnosis (i.e. biopsy) 
Time 1a 
First definitive surgical procedure (lumpectomy or mastectomy) 
Time 1b 
First external radiation therapy session 
Time 1c 
First chemotherapy infusion 
Time 1d 
First prescription for hormone therapy given 
 
 
 

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4.2.2 Secondary Outcome Measures 
 
Secondary clinical outcomes include select measures of Guideline Concordant or Quality 
cancer care, as defined jointly by the Commission on Cancer and the National Comprehensive 
Cancer Network. Specific measures of guideline concordant/quality care (yes/no) are defined in 
Table 3. These measures of quality will allow us to monitor initiation and completion of specific 
types of cancer therapy (radiation, chemotherapy and hormonal therapy) for different subsets of 
women. 
4.2.2.1 Table 2. Secondary clinical outcomes: Guideline Concordant Care Quality 
Measures 
Treatment Domain 
CoC* Criteria for Quality Cancer Care 
Radiation 
Radiation therapy administered within 365 days of diagnosis for women < 
70 years receiving breast conserving surgery. 
Radiation therapy is recommended or administered following any 
mastectomy within 1 year (365 days) of diagnosis of breast cancer for 
women with ≥ 4 positive regional lymph nodes. 
Chemotherapy 
Combination chemotherapy administered within 120 days of diagnosis for 
women <70 with AJCC T1c N0 M0, or Stage II or III ERA and PRA negative 
breast cancer. 
Completion of all planned chemotherapy cycles 
Hormonal 
Tamoxifen or third generation aromatase inhibitor administered within 365 
days of diagnosis for women with AJCC T1c N0 M0, or Stage II or III ERA 
and/or PRA + breast cancer. 
*CoC=Commission on Cancer; 
https://www.facs.org/quality%20programs/cancer/ncdb/qualitymeasures 
 
Outcomes that pertain to the implementation of the intervention in routine practice will be 
assessed through fidelity to the intervention protocol. 
Fidelity to Intervention Protocol 
The assessment of intervention fidelity will utilize existing databases developed for the 
intervention components, protocol adherence monitoring reports, which will be reviewed at 
monthly in-person PI meetings (See Table 3). As part of their routine functions, navigators utilize 
these systems to track and monitor their activities and keep track of individual patients. Monthly 
aggregate reports using these databases will be generated for each navigator and reviewed by 
the study team. If a navigator does not achieve high levels of performance as determined by 
their adherence to navigation guidelines for the program, they will receive training buffer 
sessions as needed. If performance deficiencies are identified across navigators in specific 
areas, group meetings will be held to determine if protocol modifications are needed.  
 
 
 
 
 
 
4.2.2.2 Table 3. Implementation outcomes 
 
Target 
Data source 
Time Period 
Example Metrics 

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Fidelity to 
intervention 
protocol 
Navigators 
REDCap 
Registry 
 
 
Monthly 
reports during 
intervention 
period 
- adherence to the intervention 
protocol: (% elements on 
navigator protocol achieved, 
noted areas of deficiency) 
 
Navigators 
Aunt Bertha 
Social Needs 
Screening 
platform 
Monthly 
reports during 
intervention 
period 
-adherence to the social 
determinants of health 
screening protocol: (% 
elements on navigator protocol 
achieved, noted areas of 
deficiency) 
 
 
5 
Study Design 
 
5.1.1 Study design 
We will conduct a randomized stepped wedge design. This pragmatic design involves a 
sequential, randomized roll-out of the intervention across 6 participating clinical sites over 3-
month intervals or “steps”. Thus, each site receives the intervention. Table 4 details this 
approach: 21-month full historical control period followed, sequential roll out of the intervention 
every 3 months over an 18-month period, then an additional 24 months of full study intervention. 
A 3-month wash-out period between the end of the historical control collection period and the 
beginning of the intervention roll-out period is designed to minimize subject crossover 
contamination. Subjects diagnosed with breast cancer during the washout periods will be 
excluded from analyses. 
5.1.1.1 Table 4. Stepped-wedge design of site rollout 2018-2019
 
 
 

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5.1.2 Randomization scheme 
Consistent with a stepped wedge design with one site implementing the intervention per step, 
prior to the collection of data in the pre-intervention period, a set of uniform random numbers 
has been generated 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 those 
enrolled after the initiation of intervention will experience the intervention. 
 
5.1.3 Study sites 
The city of Boston and surrounding area is home to 4 Clinical & Translational Science Institutes 
that will be working together to develop and lead the TRIP project. MA Cancer Registry data 
identified the following characteristics of Greater Boston residents with greatest delays in breast 
cancer treatment: Black, Hispanic, non-English speaking, public health insurance. Over 90% of 
these women are provided care by 6 health systems in Boston. Therefore, the study team has 
partnered with these 6 health systems for this study. Thus, this study is a collaborative effort 
comprised of 4 CTSI hubs and 6 distinct Boston-based clinical sites as outlined in table 5 
below. 
5.1.3.1 Table 5. Overview of clinical and lead sites 
 
  
CTSI hubs 
Clinical Site 
Boston University CTSI 
Beth Israel Deaconess Medical Center  
Harvard Catalyst CTSI 
Boston Medical Center 
Tufts CTSI 
Brigham and Women's Faulkner Hospital 
University of Massachusetts Worcester CTSI  
Dana Farber Cancer Institute  
 
Massachusetts General Hospital  
 
Tufts Medical Center 
 
 
5.1.4 Study subjects 
All adult females (18 years or older) with a new breast cancer diagnosis receiving or planning to 
receive care at a participating site during the study period will be eligible for inclusion if they 
have a residential ZIP code within a 35 mile radius of Boston and have any of the following risk 
factors for delays in care: are Black and/or Hispanic ethnicity, speak Non-English as their 
primary language, and/or have only public or no form of health insurance. Based on MA Cancer 
Registry statistics, 1,300 study subjects are expected over the study period (633 controls, 667 
intervention) as outlined below in table 6. 
 
 
 
 
 
 
 
 

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5.1.4.1 Table 6. Expected Recruitment Projections 
Sites 
Control 
Intervention 
Total 
Boston Medical 
Center (BMC) 
224 
224 
448 
Beth Israel 
Deaconess 
(BIDMC) 
85 
128 
213 
Brigham and 
Women’s/ DFCI 
156 
104 
260 
Faulkner Hospital 
(BWFH) 
58 
108 
166 
Tufts Medical 
Center (TMC) 
32 
39 
71 
Massachusetts 
General Hospital 
(MGH) 
78 
64 
142 
Total 
633 
667 
1300 
 
 
5.1.5 Accrual and Enrollment 
 
As the intervention is a health systems intervention targeting specific vulnerable patients 
seeking care across each of the participating health systems, TRIP’s partner sites have agreed 
to roll out the intervention as a new navigation standard of care. As such, all patients meeting 
study enrollment criteria also meet these new navigation standards. Thus, it is expected that all 
eligible subjects will be enrolled into the study for the purposes of our effectiveness testing. All 
women will receive usual clinical care as directed by their treatment team. Navigators are 
employees of the clinical site and typically are part of the care team for these patients. Given 
this, and the fact that the intervention is low risk and likely to only improve care delivery, the 
study team will obtain a waiver of informed consent for study subjects, as it is not practical to 
obtain their consent and their rights and welfare are protected by rigorous confidentiality 
measures for the Electronic Health Record (EHR) data.  
 
5.1.6 Data Sources/Collection  
 
(1) The Electronic Health Records (EHR) will serve as the data source for all socio-
demographic and clinical covariates, as well as the primary and secondary clinical 
effectiveness outcomes for historical controls and intervention subjects. At Boston 
Medical Center the EHR will also be used to source social needs screening data from a 
parallel instance of Aunt Bertha called THRIVE. The THRIVE SDOH for TRIP patients 
will be retrieved from BUMC’s Clinical Data Warehouse (CDW) and merged with the 
social needs screening data from the TRIP instance of Aunt Bertha by the TRIP analyst. 
The clinical and demographic EHR data from the 6 sites will be used in two ways: 1) to 
create a potential patient list to aid Patient Navigators in identifying potentially eligible 
patients with new breast cancer diagnoses (these data will be kept at the clinical site) 
and 2) treatment data needed for TRIP analysis (i.e., Chemotherapy regimens) 

13 
 
Treatment variables will be manually abstracted for both historical controls and enrolled 
intervention subjects. Abstraction into a HIPAA compliant REDCap form will be 
completed by trained study personnel 16-18 months after diagnosis to ensure complete 
treatment information is documented through the 12 months following diagnosis. The 
electronic health records will also be used to obtain patient contact information (mailing 
address and phone number) for patient interviews assessing patient acceptability of the 
intervention. 
(2) The REDCap registry and SDOH screening platforms (Aunt Bertha, THRIVE, 
QuickBase) are the main sources of implementation (Fidelity) data. Each will provide 
measures of fidelity to the intervention protocol. Navigators utilize these systems to track 
and monitor their activities related to individual patients. Monthly aggregate reports will 
be generated for each navigator, reviewed by the study team and used for performance 
improvement throughout the study. Fidelity metrics include categorical assessments of 
navigator use of these tools, and will be linked to outcomes. The REDCap registry and 
SDOH screening platforms will also be used to identify navigated patients for patient 
acceptability interviews. Only patients who have been contacted by a TRIP patient 
navigator and screened for social determinants of health will be contacted for 
participation in interviews. 
(3) Cost Surveys will be completed by both study personnel and site administrators to 
systematically track all costs associated with the development and delivery of the multi-
component intervention to estimate the costs that would be required to implement in 
practice. Patient Navigators and their Supervisors will fill out cost surveys daily for two 
weeks (10 consecutive working days), listing their time spent on a variety of navigation 
activities.  
(4) Qualitative Implementation Data Collection via the following activities will be the 
source of our fidelity, acceptability, and penetration implementation data.  
a. Observations: The study team will observe patient navigators in 4-hour sessions 
to 1) gain a more complete understanding of adherence to the core patient 
navigation intervention guidelines, and 2) determine barriers and facilitators to 
implementation of the patient navigation protocol. Observers will be observing 
the navigation process and the workflow of the navigators, but will not collect any 
patient information or PHI.  
b. Key Informant Interviews: The study team will interview the patient navigators 
delivering the intervention as well as other members of the care team who are 
not directly involved with TRIP, but who play a role in the navigation process, in 
order to assess the acceptability and penetration of the intervention. An interview 
guide (See Appendix I, II, III) for each group was created with sections for 
demographic questions, general knowledge and opinions of TRIP overall, 
intervention acceptability and penetration, and component specific questions 
about the navigation guidelines, the Aunt Bertha platform, and the shared 
REDCap registry.  
c. Patient Interviews: The study team will interview patients who received TRIP 
navigation services to assess the acceptability of the intervention from a patient 
perspective (see Appendix XIX for interview guide). 
 
6 
Potential Risks and Benefits 
 
6.1 
Risks 
Risks to participants of the intervention itself are minimal and no different than those in usual 
care. Currently providers and patient navigators often engage patients in discussions of the 

14 
 
barriers to care and their social needs. These discussions may cause some emotional distress; 
providers are available to speak with patients, and the intent of the discussions is to help with 
findings solutions and supports to alleviate the distress. The Aunt Bertha SDOH platform will 
allow navigators to provide specific, geographically convenient referrals to free or low cost 
services to address patient-identified social needs. 
The only potential risk identified for this study is loss of confidentiality, should any of the 
information in the registry, Aunt Bertha or the secure central data repository where data will be 
stored to be compiled and coded for analyses become stolen or inadvertently become public. 
Our Data Safety Monitoring Plan incorporates comprehensive plans for secure data collection, 
management and storage to minimize this risk. 
 
6.2 
Potential Benefits 
As the intervention will be implemented as “standard of care” at each of these sites, there are no 
direct tangible benefits to the participants in this study. The benefit of this evaluation of the 
implementation of a new standard of care will be generalizable knowledge for quality of care 
improvements at the 6 participating hospitals, and potentially dissemination to other institutions. 
 
6.3 
Analysis of Risks in Relation to Benefits 
 
The major risk of this study is loss of confidentiality which is reasonable in relation to anticipated 
benefits to generalizable knowledge to improve quality of care.  
 
 
7 
Study Subject Selection 
 
7.1 
Subject Inclusion Criteria 
 
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria: 
Eligibility criteria: All women with breast cancer diagnosed during the study period will be eligible 
for inclusion if they meet three study criteria:  
1. are an adult female 18 years of age or older; 
2. reside within a 35 mile radius of Boston; 
3. have any of the following risk factors for delays in care:  
a. Black and/or Hispanic race/ethnicity 
b. do not speak English as their primary language and/or  
c. have only public insurance or are uninsured at the time of diagnosis.  
 
Women who do not meet all three criteria will be excluded from the study. In some cases it is 
possible, due to the scope of the patient navigator’s responsibilities that patients who are 
ineligible will be entered into the Registry. As the registry is HIPAA compliant and these 
individuals will be excluded from compiled data sets, the study team does not perceive this to be 
a major risk. 
 
7.2 
Subject Exclusion Criteria 
None 
 
8 
Study Intervention 

15 
 
 
The TRIP intervention consists of an Integrated Patient Navigation Network that aims to 
reduce delays from diagnosis → treatment initiation → treatment completion among Greater 
Boston residents with newly diagnosed breast cancer. 
 
The Integrated Patient Navigation Network intervention has 3 components that are shared 
across 6 hospitals in Boston: 
 
1. Patient Navigation Services that are implemented according to evidence-based best 
practices. Patient Navigation services following standard operating procedures that are guided 
by the Principles of Care Management in collaboration with a network of navigators across the 
six health systems. This includes: a) identifying women eligible for navigation services; b) 
identifying barriers to engaging in timely cancer care services, with a particular emphasis on 
social barriers; c) providing assistance to address these barriers through local and regional 
resources; and, finally, d) tracking women over time across the participating clinical sites to 
ensure they complete their entire course of cancer care. The innovation here is the integrated 
network of navigation across regional health systems, where navigators attend quarterly 
trainings together and communicated directly about patients who transfer services across 
clinical sites. Navigators will be employees of the clinical site and will comply with site-specific 
practices and standards. 
 
2. REDCap Patient Registry will be used to track and monitor patients’ navigation activities and 
will be shared across the six health systems. The registry will be built using the HIPAA 
compliant REDCap platform and function as a “tickler file” embedded into the navigator 
workflow. This navigator tool provides navigators with the ability to determine prioritization of 
caseload, track their patient’s progress, and communicate across sites if patients transfer care. 
Sharing navigation process data across the health systems will address known fragmentation in 
care that leads to delays in treatment. 
 
3. Social Determinant of Health (SDOH) Platform systematically identifies barriers to care and 
links the patient to available resources in the community to address them. The 
screening/referral system has been built using the Aunt Bertha platform. At time of diagnosis, 
the navigator will ask patients a series of 17 questions to identify needs categorized into 10 
social domains (e.g., transportation, housing, food, paying for utilities). Women will then be 
referred to local resources aimed at addressing SDOH. These data will be available and stored 
in the Aunt Bertha platform for use by the patient navigators. At each contact, the navigator will 
check on the status of referrals and assess whether a woman would like to receive additional 
referrals for previously identified or new barriers to care. Sites that have a pre-existing platform 
for identifying and addressing social needs can continue to use their existing systems, and will 
document assessment and referral details in the shared REDCap registry to make it accessible 
to navigators at other sites.  
 
As stated in the TRIP study design, there is no control intervention. All controls are historical, 
thus they represent usual care, prior to implementation of the intervention at each site.  
 

16 
 
9 
Study Procedures 
 
For this pragmatic clinical trial, Patient Navigators at each of the six participating clinical sites 
will continue to meet and follow-up with their patients as they do currently. As each site’s 
navigators may have a different process for how many visits and follow-ups they will have with a 
patient and this may further vary depending on the treatment plan and navigation needs of an 
individual patient, this study does not have a set schedule of events. To understand the 
expected navigator coverage over the treatment spectrum please see Appendix IV in place of 
the schedule of events. 
 
Because the TRIP intervention is being implemented as a new standard of care, patients will 
receive care according to a schedule determined by their health care providers. Thus, number 
of visits for each patient will be specific to their specific treatment regimens. Within these patient 
visits, the TRIP intervention will be implemented in a standardized way. The schedule of events 
for the TRIP intervention within a patient visit will include all Patient Navigation services as 
detailed below. These events include all visits/contacts between the navigator and the patient 
(or other care provider) from the time of diagnosis to completion of treatment. At a minimum 
these events will include: time of diagnosis and at each transition in cancer care (i.e.: from 
surgery to radiation, from radiation to chemotherapy). Additional visits/contacts will occur based 
on identified barriers or patient needs.  
 
9.1 
Patient Navigation services 
 
Patient Navigation services at each site will follow standard operating procedures that are 
guided by the Principles of Care Management in collaboration with a network of navigators 
across the six health systems. In order to have the desired effect on treatment delays, we aim to 
disseminate the following ‘best practices’ of patient navigation across each hospital setting: 
 
• 
Patient navigation is a process not a person: no one person can navigate alone, there is 
potential role for lay, nurse and SW in the process of navigating a patient through their 
treatment; multiple ‘navigators’ may participate across the treatment trajectory; the 
optimal structure will be specific to the needs and resources at each hospital 
 
• 
The patient navigation process should begin within 7 days of diagnosis and continue 
until treatment recommendations have been completed 
 
• 
Patient navigation services include the following 4 procedures: 
 
1. Identify those in need of navigation: TRIP eligibility criteria have been chosen 
to identify those most at risk for delays in care (as defined by MA Cancer 
Registry Data). Navigators will identify eligible patients in partnership with the 
oncology care team by any of the following existing processes: reviewing 
automated potential patient lists generated from upcoming oncology schedules, 
reviewing pathology reports, attending tumor board meetings, manually reviewing 
physician schedules, or direct referrals from providers. Once identified as eligible 
for navigation services, they will obtain permission to contact the patient from the 
care team and create a Patient Profile in the REDCap Registry based on 
available information from the EHR. 

17 
 
2. Identify individual barriers to treatment: Patient navigators participating in the 
TRIP program will provide one-on-one guidance and assistance to individuals 
upon diagnosis. The principal function of the navigator is to identify and eliminate 
barriers to timely treatment and provide support for each individual. The 
navigator will initiate contact with the patient either by phone or in person during 
a scheduled visit to begin the navigation program. During this initial assessment, 
the navigator will conduct a social needs assessment (see intervention 
component #3 below) that systematically identifies patient reported barriers to 
care. This systematic assessment will be repeated at each treatment transition 
(ie from surgery to radiation, from radiation to chemotherapy and from 
chemotherapy to hormonal therapy), in recognition of the fact that barriers may 
arise that are specific to the type of treatment. 
3. Link patient to available resources to overcome those barriers: Women will 
be asked a series of questions to identify the precise services needed for each 
domain. These data will be available and stored in the TRIP instance of the Aunt 
Bertha platform (See intervention component #3 below) for use by the patient 
navigators. At each contact, the navigator will check on the status of referrals and 
assess whether a woman would like to receive additional referrals from similar or 
different domains. During these interactions, the navigator will provide assistance 
in accessing relevant services when appropriate. 
4. Track them over time to their treatment appointments: The navigator protocol 
includes tracking each upcoming treatment visit, to ensure compliance with 
recommended care. The REDCap Registry will be used to document the status 
of these visits, providing a tool for the navigators to prioritize their caseload. 
Navigators are expected to initiate contact with patients either via phone or in 
person whenever they miss an appointment, or are at risk to miss an 
appointment. During these interactions, they will coordinate services in order to 
address barriers to patient care and assist in the alignment of services and 
treatment goals and promote treatment preparation through patient education. 
They will track them and offer navigation services until their treatment is 
complete. 
 
• 
Navigators across hospitals work together to care for this population of women with 
breast cancer. First, they will be invited to quarterly Patient Navigation Network meetings 
where they will share resources and lessons learned. Second, when patients transfer 
care or are lost to follow up, navigators will utilize the registry to communicate patient 
needs. 
 
9.1.1 Patient Navigator Training Methodology 
 
All patient navigators will be asked to attend their respective site kick-off meeting, during which 
they will complete a workflow assessment and a navigator experience questionnaire. Navigators 
will complete the following training plan: 

18 
 
 
 
The TRIP research team will provide oversight to each site in all areas pertaining to data 
management, regulatory compliance, and patient identification. The research team will also 
provide navigator support and training throughout the course of the study. On-site or virtual 
visits via BMC Zoom with the navigator and their supervisors will be scheduled at 1-3, 3-6, and 
6-9 months post site initiation. 
 
 
 
 
9.1.2 Human Subjects Protection Training 
 
All study staff will be certified on HIPAA and Human Subjects. The format of the HIPAA 
authorization is established by the local IRB. Investigators should review information provided in 
Impact of the HIPAA Privacy Rule (https://www.citiprogram.org/) and contact their appropriate 
institutional officials to learn how the Privacy Rule applies to them, their organization, and their 
specific research project. Another helpful resource is Protecting Personal Health Information in 
Research: 
Understanding 
the 
HIPAA 
Privacy 
Rule, 
NIH 
Publication 
03-5388 
at 
(http://www.bumc.bu.edu/hipaa/). 
 
 
9.2 
Patient Navigator Oversight 
 
9.2.1 Patient Navigator Supervisor 
 
Workflow 
assessment
•PN is made 
aware of the 
purpose of the 
project
•PN participates 
in an on-site in-
person meeting 
with the TRIP 
team for the 
purpose of 
answering 
questions 
regarding their 
current 
workflow
Review of 
Navigation 
Protocol
•PN participates 
in an on-site in-
person meeting 
with the TRIP 
team for the 
purpose of:
•Reviewing the 
11 Navigation 
Guidelines 
•Identifying 
site-specific 
modifications 
to the 
navigation 
protocol
Platform 
demonstration 
webinar
•PN participates in a 
webinar hosted by 
the TRIP team via 
WebEx to review an 
introductory 
demonstration of 
both the REDCap 
Registry and Aunt 
Bertha SDOH 
platform
On-site Case-
based training
•PN participates 
in an on-site in-
person meeting 
with the TRIP 
team for the 
purpose of:
•Re-visiting the 
navigation 
protocol and 
any 
modifications 
needed
•Practicing use 
of REDCap and 
Aunt Bertha 
through a case 
study
Adherence 
Monitoring
•Navigators who 
do not follow 
the expected 
navigation 
protocol will 
receive 2 e-
mail follow-ups
•If email follow-
ups do not 
provide 
resolution, 
navigators will 
participate in 
an on-site 
refresher 
training session

19 
 
Patient Navigator supervisors, who are employed at the 6 hospital sites and already serving as 
supervisors, will receive the same initial training as the Patient Navigators as well as some 
additional elements to be provided as part of an in-person curriculum provided by the study 
team: 
• 
Navigation Protocol discussion 
• 
Platform (REDCap and Aunt Bertha) explanation and demonstration 
• 
Adherence monitoring reports and refresher training overview 
Adherence to protocol data will be provided to each site in the form of a monthly report. Sites 
that are non-compliant with the study protocol will be provided additional training and support. 
Site PIs will also be expected to maintain monthly contact with their patient navigator team to 
ensure adequate study communication. 
9.2.2 Refresher Training 
 
If, upon assessment review at 1-3, 3-6, and 6-9 months post site initiation a Patient Navigator is 
identified as inadequately adhering to the intervention protocol, the patient navigator supervisor 
and study team will meet to determine whether additional one on one study training and 
monitoring is required. This refresher training will be customized on an individual basis as 
needed. 
 
9.2.3 Observations of Patient Navigators 
 
Trained TRIP study personnel will visit each site to unobtrusively observe the TRIP patient 
navigators in their practice for two purposes: 1) gain a more complete understanding of 
adherence to the core patient navigation intervention guidelines, and 2) to determine barriers 
and facilitators to implementation of the patient navigation protocol.  The necessary 
authorization for observations will be obtained on a site by site basis. See Appendix V for the 
observation tool that will be used to collect data by TRIP study personnel. The data collected in 
the observation tool is considered research data and may be included in manuscripts and 
publications. 
 
9.3 
Use of Shared Registry 
 
9.3.1 REDCap 
 
A shared TRIP registry was developed using REDCap (Research Electronic Data Capture), a 
HIPAA compliant, secure web-based application for building and managing online surveys and 
databases. The purpose of the registry is to improve the workflow processes of the patient 
navigators as part of their routine clinical duties and as part of new standard of care. The 
registry will also permit close coordination of clinical care across hospitals for the estimated 20% 
of patients who receive their cancer care at more than one institution, or switch from one 
institution to another during their care. 
 
The REDCap registry developed for TRIP resides on BMC HIPAA compliant server. Access to 
the TRIP shared registry will be based on permissions granted by username and password 

20 
 
which will be managed by the Boston Medical Center Office of Information Technology. Only 
authorized study members will be able to enter or view data. 
 
9.3.2 User Permissions 
 
Prior to initial site rollout, all sites will provide a list of authorized users designated by ‘view only’ 
or ‘view and edit’. Patient navigators will be given highest level permissions in order to ensure 
that they can input patients, and run reports as needed. Navigator supervisors and any staff 
who provide coverage for navigators will also have full view and edit permission. Because the 
goal of the registry is to quickly allow navigators to coordinate care when patients move 
between hospitals, all navigators and supervisors will have access to all records in the registry.  
Other clinical providers (e.g., nurses, physicians, social workers) at the hospitals may request 
access to view the registry. After training, these clinicians will be granted view only status only 
of patients receiving care at their hospital site, to ensure that only individuals with active clinical 
roles in patient care will have access to the registry. 
 
Any changes to the site permissions list should be sent to the TRIP project team and will be 
updated in the system by BMC IT personnel responsible for assigning REDCap access. 
 
9.3.3 Data elements 
 
The data elements included in the registry are the minimum information needed by navigators to 
actively manage and support their patients, assist them in keeping clinical appointments, and 
address the social determinants that often result in patients delaying or falling out of clinical 
care. Therefore the registry will not have extensive clinical information about the type of cancer, 
specific types of treatment, medications, comorbidities or complications of care. Additionally, 
only MRN, patient first and last name, date of birth, phone number, and study eligibility criteria 
are required, all other fields are optional, and navigators will be the only individuals entering 
data in these fields. The registry will include the following categories of data elements: 
 
1. Patient demographics – Sufficient demographic information to uniquely identify 
women in the data base, including first and last name, date of birth and medical record 
number from each hospital system where a patient receives care. Preferred language, 
race/ ethnicity and gender identification fields will be available to assist navigators 
identify patients and their needs. A free text field will allow navigators to input specific 
biographical data which will help in the care of the patient (such as background, family 
structure, hobbies). 
2. Minimal clinical information necessary for navigators to conduct their work. This will 
include stage of diagnosis and date of diagnosis, as this information will help navigators 
focus on meeting clinical benchmarks including first surgery within 45 days and first 
treatment within 60 days.  It will also include insurance and a free text field to document 
any insurance restrictions/ need for prior authorizations, etc.  
3. Patient contact information – detailed information to assist navigators in 
communicating with patients, including address, phone numbers, email, and social 
media as appropriate 

21 
 
4. Family/ secondary contact information – detailed information on 2 – 3 individuals the 
navigator can contact in event of emergency or patient not keeping appointments, 
including phone, email. 
5.  Patient navigator information– who is the navigator for the patient, and contact 
information for navigator and his/her supervisor 
6. Referral source – how patient was referred to navigator and specific concerns that 
prompted referral 
7. Provider information – for each medical provider involved in care, their name, hospital, 
and best methods to reach them or their clinical team. This may include a best contact of 
a nurse or patient coordinator who works with the provider. 
8. Appointments – a listing of all medical appointments, including office visits, infusions, 
surgeries, radiation oncology visits, imaging studies will be listed by type of appointment, 
location, provider, and date and time.  The outcome of each appointment (attended, 
rescheduled, cancelled) can be documented. 
9. Navigator contacts with patients – the registry will include fields to document the date 
and time, type of contact (e.g., in person, phone, SMS message, email), duration and 
outcome of contacts with patients.  Free text fields will allow navigators to note additional 
information as necessary. 
10. Social Needs information—the registry includes fields for the navigator to indicate 
when a systematic assessment for social needs was conducted, the reason for doing the 
assessment, the type of assessment used (TRIP instance of Aunt Bertha or other 
validated tool, such as the THRIVE instance of Aunt Bertha at BMC), whether any needs 
were identified as a result of the assessment, and whether any referrals were made for 
the patient to address identified needs. 
 
All entries into the registry will be time and date stamped, and will indicate which user entered 
the data. 
 
Navigators can add information into the registry as frequently as is required depending upon the 
number of follow-up visits necessary, and the amount of contact the navigator has to support 
the patient through their care. This will be determined on a per patient basis, as it will likely vary 
from patient to patient.  
 
9.3.4 Patient Identification 
 
Navigators will identify patients in 2 ways: 1) using their standard methods as part of their 
clinical workflow. The majority of patients will be identified via physician or social worker referral 
at the clinical site of origin, or through discussion of the case in the Breast Cancer tumor board 
or case conference. 2) using a potential patient list provided by their site’s IT/Research 
Administration to review patients that match eligibility criteria prior to an upcoming scheduled 
oncology appointment. 
 
As part of the TRIP intervention, patient navigators at each of the 6 clinical sites are responsible 
for identifying eligible patients based on the aforementioned eligibility criteria. In order to 
facilitate effective identification of eligible patients as part of each navigator’s workflow, the TRIP 

22 
 
team is collaborating with Information Technology personnel at each clinical site to produce a 
potential patient report. At each individual site, these reports will be generated weekly from 
electronic medical records and produce a list of patients who meet the following criteria: 
 
1. A scheduled visit for a diagnosis of breast cancer in the next one to two weeks 
2. A ZIP code within a 35 mile radius of Boston 
3. Other key eligibility criteria (non-white, non-English speaking, and/or uninsured/public 
insurance) 
 
The PHI data included in these reports are patient name, MRN, appointment type, provider, 
race/ethnicity, primary language, ZIP code, and insurance (if available). These reports are 
unique to each site and are accessible locally via secure folder or encrypted email by a patient 
navigator and in some cases, study team personnel at their site.  
 
9.3.5 Reporting 
 
To support the workflow, the registry will have custom reporting that will be available to both 
users with ‘edit/view’ permissions (navigators, supervisors, back-up) as well as ‘view only’ 
permissions (research staff, other clinicians).  The study team plans to send weekly reports to 
each navigator, which will summarize patients who have been entered into REDCap and Aunt 
Bertha, and records that need to be reconciled. For navigators and clinicians, these may be at 
the patient level, navigator level or provider level. In addition, research staff can request reports 
at the hospital site and at the entire study level. The system will log all report requests by user 
and time. 
9.3.6 Notifying a Patient Navigator a patient has transferred care 
 
The registry will have a messenger function allowing navigators across hospitals to 
communicate with each other about patients. This feature will be used when a patient: 
a) seeks a second opinion at another hospital 
b) decides to receive different treatment modalities at different institutions (e.g.  Radiation at one 
institution, but medical oncology visits at another) 
c) decides to transfer all care to another hospital. The purpose of this feature, which we 
estimate will be used for 20% of cases, is to facilitate timely transitions and avoid delays in care. 
 
9.3.7 Interfacing with Aunt Bertha 
 
In order to standardize workflow and allow for direct accessibility to the Aunt Bertha Social 
Needs Assessment, an ‘in frame’ link to Aunt Bertha will be hosted within the REDCap forms. 
Navigators will log into REDCap using their assigned credentials and 2-factor authentication 
method (confirmation via Google Authenticator app or email), complete the intake and follow-up 
form as necessary, and click the link to Aunt Bertha to complete the assessment for each 
patient.  
 

23 
 
A referring URL within REDCap will be utilized to transfer the Subject ID number, First Name, 
and ZIP Code into the Aunt Bertha Assessment to ensure that patients are easily identifiable for 
referral retrieval and data matching purposes.  
 
9.3.8 Registry Training 
 
The TRIP Project team will provide comprehensive hands-on training to navigators and their 
supervisors via two required training sessions (see Patient Navigation section above for details). 
The initial one-on-one training on site with the navigator includes but is not limited to the 
following topics: 
1. How to log in 
2. What information is captured 
a. Data elements and definitions 
3. How to use the forms 
4. Log in and demonstration of usability 
5. Reporting 
a. Sorting 
b. Filtering 
Should any major changes be made to the Registry that impact usability or navigator workflow, 
the TRIP team will provide follow-up training for the navigator, either via Web-ex or in-person.  
 
9.3.9 Technical support and troubleshooting  
 
The REDCap registry will be housed locally on BMC virtual servers, thus any technical issues or 
user questions should be directed to the TRIP Research team at TRIPAdmin@bmc.org who will 
help to facilitate communication with local IT and ensure resolution of any issues identified. 
 
9.3.10 Communication on Registry revisions 
 
Development and alteration of the TRIP REDCap Registry is expected to be an iterative process 
as new needs are identified and each site is activated. Any maintenance shutdowns of the 
registry will be scheduled outside peak work hours to avoid impacting the workflow of the 
navigators. Patient navigators, site clinicians and navigator supervisors will be informed of any 
maintenance shutdowns, content changes or process alterations made to the REDCap registry 
at least 2 days prior to the expected date of occurrence. 
 
9.4 
Screening for Social Determinants of Health (SDOH) 
 
9.4.1 Aunt Bertha 
 
Aunt Bertha (https://www.auntbertha.com) is a public benefit corporation that works to connect 
people in need with social service agencies. The TRIP instance of Aunt Bertha provides a 
search, referral and application platform that will be used to screen and refer women to 
community resources. The TRIP instance of Aunt Bertha will be used for patient-specific 
tracking of SDOH domains and resources across sites. One site, Boston Medical Center, has a 

24 
 
separate contract with Aunt Bertha called the THRIVE program, which is a parallel system that 
screens for the same health-related social needs as the TRIP instance of Aunt Bertha, and is 
HIPAA-compliant and previously authorized by BMC. The THRIVE instance of Aunt Bertha is 
integrated with the site’s Epic EMR and has been used by BMC breast oncology navigators 
prior to TRIP rollout. As BMC already has a comparable systematic social needs assessment 
and referral platform as part of their standard of care, social needs data collected via THRIVE 
for TRIP patients will be made available to the study team to merge with the TRIP instance of 
Aunt Bertha for analysis. 
 
9.4.2 Security and Compliance 
 
All Aunt Bertha employees are required to take annual HIPAA training. Aunt Bertha is hosted on 
a Google Cloud platform using AES-256 encryption.  Data in transit on the Google Cloud 
platform is sent using AES-256 encryption, and on the internet the connection to the site is 
encrypted and authenticated using TLS 1.2, ECDHE_RSA with X25519, and AES_128_GCM. 
 
9.4.3 User Permissions 
 
Prior to initial site rollout all sites will provide a list of authorized users and their intended role in 
the TRIP project. The TRIP project team and Aunt Bertha team will predetermine the 
configuration of groups for the purposes of sharing notes and reporting. Patient navigators will 
be given highest level permissions in order to ensure that they can input patients, perform the 
social needs assessment and run reports as needed. Unless otherwise stipulated by the TRIP 
project team, accessory users such as clinicians will be granted permissions as ‘view only’ as 
requested. Any changes to the site permissions list should be sent to the TRIP project team and 
will be updated in the system by the Aunt Bertha Customer Success Manager. 
 
The TRIP team will let Aunt Bertha staff know if a user should no longer have access, and these 
accounts will be deactivated within 24 hours. In addition, Aunt Bertha will generate a quarterly 
list of individuals with account permissions. This will be reviewed by the TRIP team and 
permissions of any users who are no longer at the clinical sites or part of the research team will 
be removed.  
 
9.4.4 Screening for SDOH 
 
The TRIP team has developed a custom social needs assessment with input from the 
partnering hospital sites. The assessment will be used to determine care related needs of the 
patient in the following categories  
1. Transit 
2. Food Security 
3. Housing 
4. Utility bills 
5. Paying for Treatment 
6. Employment 
7. Education 
8. Child or family care 
9. Legal 

25 
 
10. Phone access 
 
9.4.5 Aunt Bertha Needs Assessment 
The TRIP Team has partnered with Aunt Bertha to host a needs assessment on the TRIP 
instance of their web-based screening and referral platform (See Appendix VI). The 
assessment will screen patients for SDOH falling into the following 10 domains: Transit, food 
security, housing, utilities, paying for treatment, employment, education, child or family care, 
legal, and phone access. The THRIVE instance of Aunt Bertha screens for the same domains, 
except for legal needs (see Appendix VII for a copy of the THRIVE needs assessment). At 
DFCI, the 17-question needs assessment has been built into their pre-existing QuickBase 
navigator database and directly mirrors the assessment in the TRIP instance of Aunt Bertha. 
This will allow for ease of clinical uptake at DFCI by integrating the assessment with an existing 
navigator database, while still allowing the navigator at DFCI to share assessment data with 
other sites through the REDCap registry. 
 
The following types of questions will assess a patient’s needs for each relevant domain, and the 
patient’s answers will be used to refer them to community resources that are appropriate, 
convenient and affordable. The needs assessments has been translated to Spanish (see 
Appendix VI Spanish translation of Aunt Bertha Needs Assessment on page 49). 
 
1. Transit 
a. In the past 12 months, has lack of reliable transportation kept you from medical 
appointments, work or from getting things needed for daily living? 
2. Food security 
a. In the last 12 months have you worried that your food would run out before you had 
the money to buy more? 
b. In the last 12 months, did the food you bought just not last and you didn't have the 
money to get more? 
c. Do you currently have trouble going out to shop for food or preparing food? 
3. Housing 
a. What is your housing situation today? 
b. How many times have you moved in the past 12 months? 
c. Think about the place you live. Do you have problems with any of the following?  
 
4. Paying utility bills 
a. In the past 12 months, has the electric, gas, oil or Water Company threatened to 
shut off or shut off services to your home? 
 
5. Paying for treatment 
a. Do you have trouble paying for your treatment, including medicines, visits or tests? 
b. Do you have trouble paying for other things related to your treatment, like wigs or 
prostheses? 
6. Your job or finding work 
a. Are you worried about taking time off from your job because of your health/ 
treatment? 
b. Do you plan to work during your treatment? 

26 
 
c. Are you currently unemployed and looking for a job, or working but looking for a 
better job? 
7. Education or training 
a. Are you interested in going to school or getting job training? 
8. Child or family care 
a. In the last 12 months, have you missed a health care visit or work because you 
needed to care for a child, family member or friend? 
9. Legal  
a. Do you currently have any legal concerns or needs (like to prevent eviction, being 
fired, or discrimination)? 
10. Phone Access 
a. In the past 12 months, has your phone service been shut off or disconnected? 
9.4.6 Frequency of Screening for SDOH 
The social needs assessment will be accessible during both the intake and follow-up visits with 
the patient navigators. At a minimum, the REDCap registry will remind navigators to perform 
SDOH screening on intake.  Navigators are also expected to complete a second SDOH 
assessment at either 3 months into treatment or upon transition between treatment modality 
(e.g., surgery, chemotherapy, radiation). 
 
9.4.7 Using Aunt Bertha 
 
There will be two ways for the PNs to use the TRIP instance of Aunt Bertha: (1) using the 
SDOH-specific screening tool noted above to systematically identify needs of patients and then 
link to relevant resources in Aunt Bertha; (2) targeted search for specific resources in response 
to a request from a patient. In a targeted search, a patient would request a specific type of 
service (i.e., transportation), and the navigator would use Aunt Bertha to search for resources 
that provide services in the patient’s zip code.  
 
Upon patient referral to a navigator, the navigator will log in to REDCap and complete the initial 
intake form. At the end of the intake form, the navigator will click a link into Aunt Bertha to 
complete the SDOH assessment and provide referrals to the patient either via email, or printed 
list. This activity will then be documented in the patient’s REDCap record. Upon follow-up the 
navigator will ask patients if they successfully used the referrals and if they need additional help. 
The needs assessment will be re-visited as needed. 
 
For Boston Medical Center navigators using the THRIVE instance of Aunt Bertha 
(staff.bmcthrive.org), three methods of using the platform exist: 1) using the embedded social 
needs assessment in Epic to systematically identify needs of patients and then link to relevant 
resources in Aunt Bertha; 2) targeted ZIP-code search for specific resources in response to a 
request from a patient; 3) using the smartphrase “.THRIVEREFER” in the Epic EHR, which will 
generate a prompt to document both a list of the referral programs/agencies used as well as the 
needs the navigator aims to address with that referral. Referrals can be provided to the patient 
via email or printed list. 
 

27 
 
For Boston Medical Center patients, referrals can be sent directly to the referral program or 
agency. For any referrals related to HIV/AIDS status, substance use disorder diagnosis, mental 
health, domestic violence counseling, rape victim counseling, or sexually transmitted disease 
(including, gonorrhea, syphilis, chlamydia), patient navigators will obtain verbal or written 
consent from the patient prior to sending the referral to a referral program or agency (Appendix 
XVI). Navigators will not document patients’ experiences with domestic violence or rape directly 
in the EHR.  
 
THRIVE data will be retrieved from all BMC TRIP patients through the BUMC Clinical Data 
Warehouse and the THRIVE instance of a SQL feed from Aunt Bertha on a monthly basis and 
merged with the Aunt Bertha study data. 
 
For Dana-Farber Cancer Institute navigators using QuickBase, navigators will complete the 17-
question TRIP social needs assessment and select referrals from an internal list of resources. If 
additional resources are needed, the navigator will perform a targeted search in the Aunt Bertha 
platform. QuickBase data on assessment and referral details will be securely transmitted to the 
study team and merged with the other social needs data sources into the BMC central data 
repository. 
 
9.4.8 Training 
 
The TRIP team will provide Aunt Bertha training to site personnel in person during the technical 
training session. This training will cover use of Aunt Bertha to do systematic and targeted 
screening. We will also use a “train the trainer” model where the TRIP team, who have already 
been trained, will train additional PNs one-on-one prior to the initiation of the intervention at their 
site. Staff will also have access to weekly office hours and webinar trainings hosted by the TRIP 
project team, as well as access to a Help Desk and Training Library 
 
The TRIP Project team will provide comprehensive hands-on training to navigators and their 
supervisors via two required training sessions (see Patient Navigation section above for details). 
The initial one-on-one training on site with the navigator includes the following topics: 
1. Discussion of barriers to care 
2. How to log in 
3. What information is captured 
4. How to use the social needs assessment 
5. How to log and track referrals 
6. Log in and demonstration of usability 
Should any major changes be made to the Aunt Bertha Platform that impact usability or 
navigator workflow, the TRIP team will provide follow-up training for the navigator, either via 
Web-ex or in-person.  
 
9.4.9 Identifying resources 
 
Aunt Bertha already contains listings for > 2000 social service agencies in the greater Boston 
area. These will be supplemented by resources currently used by navigators. In order to ensure 

28 
 
that the preferred resources of all currently active patient navigators who are participating in the 
TRIP project are present in Aunt Bertha, the TRIP team compiled lists of resources from each 
site to provide to the Aunt Bertha team. The Aunt Bertha team will be adding any additional 
resources to the platform at a global level (available to any Aunt Bertha user). This process is 
expected to be iterative as sites rollout and begin to use the platform and identify missing 
resources. 
 
9.4.10 Reporting 
 
The TRIP team is developing custom reporting in REDCap and Aunt Bertha that will be 
available to both users with ‘edit/view’ permissions (navigators and their supervisors), as well as 
‘view only’ permissions (research staff and clinicians) that will assist navigators in SDOH follow-
up and prioritization two different reporting structures will be available monthly.  
 
All report requests will be tracked by the TRIP Project team. In addition, Aunt Bertha reporting 
will enable tracking functionality such that a navigator can log in to see a live report of patients 
who have been screened. This report will allow the navigators to “screen” based on patient 
characteristics to generate a report to see who is in need of follow-up.  For example, a navigator 
will be able to generate a report that will show patients who requested referrals in the prior 
week. This will enable the navigator to follow-up with the patient to follow-up with a patient to 
see if a referral was successful (and if not address if additional referrals are needed). 
 
9.4.11 Interfacing with Shared Registry 
 
For details regarding connectivity between the REDCap registry and Aunt Bertha, please refer 
to the Registry section ‘interfacing with Aunt Bertha’. 
 
9.4.12 Technical support and troubleshooting  
 
Upon initial identification of an issue, the TRIP team recommends review of the Aunt Bertha 
frequently asked questions page (https://auntbertha.zendesk.com/hc/en-
us/categories/200221080-Frequently-Asked-Questions)  
 
The TRIP team has also developed a Technical Support Plan, in which at least one member of 
the study team is available by phone and email to troubleshoot technical issues during business 
hours (8:30-5:00pm EST, M-F). 
 
Aunt Bertha will provide technical support and troubleshooting during business hours (8:00 PM 
– 6:00 PM EST) via phone or online help desk. However, should an issue arise, site personnel 
should also contact the TRIP team at TRIPAdmin@bmc.org to ensure the study team is aware 
of any issues, and can facilitate any necessary follow-up.  
 
9.4.13 Communication about modifications to Aunt Bertha 
We will be assigned a customer success manager at Aunt Bertha. This person will keep us 
apprised of any platform changes and expected work flow modifications. Patient navigators, site 

29 
 
clinicians and navigator supervisors will be informed of any maintenance shutdowns, content 
changes or process alterations made to the Aunt Bertha platform at least 2 days prior to the 
expected date of occurrence. Navigators will be informed of content changes by email or in 
person contact depending on the nature of the change (e.g., will be informed by email of 
important updates in the referrals that are available/ no longer available, will be informed by 
phone or in person for changes in platform functionality. 
 
10 Data Management 
 
10.1 
Study Data 
 
10.1.1 Data Source: REDCap 
 
The Patient Navigators will collect participants’ intake and follow-up forms in a REDCap 
project housed on a BMC HIPAA compliant server. REDCap will assign an individual patient 
registry ID number to each participant. Data elements include personal identifying data, 
including contact information, and data on patient follow-up needs. 
 
10.1.2 Data Source: Aunt Bertha  
 
The study collects a social needs assessment and data on patient social determinants of 
health in the HIPAA compliant platform, Aunt Bertha. This program will also track patient 
referrals to community resources for social support services. 
 
While most data collection will be entered in real time and directly into the electronic 
platform, in some cases Patient Navigators may need to print out blank paper copies of the 
REDCap Registry forms and Aunt Bertha Social Needs Assessment to complete during their 
patient visits. The data from these forms will then be entered into the electronic registry and 
the paper forms shredded immediately afterwards.  
 
10.1.3 Data Source: Quickbase 
 
Dana-Farber Cancer Institute has their own instance of Quick Base, a cloud-based, low-
code development platform, to manage all of their navigation-related data. This platform 
hosts the 17-question TRIP social needs assessment for DFCI, and the results of baseline 
and follow-up assessments for each TRIP patient, as well as data on which social services 
programs patients have been referred to for addressing positively identified needs. Quick 
Base exports custom reports as .csv files, and the TRIP team will receive a .csv download of 
social needs assessment and referral data for TRIP patients on a monthly basis via upload 
to a secure Box.com folder or SFTP to be merged with the TRIP central data repository.  
 
10.1.4 THRIVE 
 
At BMC, THRIVE data for TRIP patients will be retrieved from the Clinical Data Warehouse 
(CDW) and from a SQL feed directly from Aunt Bertha on a monthly basis and merged with 

30 
 
the social needs data for other TRIP patients in the Aunt Bertha SQL database. The 
THRIVE instance of Aunt Bertha is parallel to the TRIP instance, and screens for the same 
domains of social needs. The THRIVE SQL feed and CDW will provide the study team with 
a download of the social needs identified and referrals made, for all BMC TRIP patients 
screened using THRIVE who have documentation in the EHR. 
 
This data will be merged with social needs data from the TRIP instance of Aunt Bertha in the 
Central Data Repository at BMC for analysis. 
 
10.1.5 Data Source: Electronic Health Records  
 
Treatment data elements will be manually abstracted for both historical control and 
intervention subjects from Electronic Health Records (EHR) at each site.  Abstraction from 
the EHR will be conducted by a trained Research Assistant employed by that site and 
overseen by the site PI. Data elements from EHR abstraction will be uploaded or entered 
directly into the TRIP REDCap abstraction project. For more information, see Figure 1 Table 
1. 
 
Intervention patients: Potential Patient Lists will be generated locally at each participating 
institution to aid Patient Navigators in identifying potentially eligible patients with new breast 
cancer diagnoses. Every week, Patient Navigators will receive a list of patients who meet 
TRIP eligibility criteria and have an upcoming appointment for the following week. These 
lists will be generated by the EHR via a script developed by each site’s IT department or 
research administration group and uploaded to a secure folder on the Patient Navigator’s 
local drive or sent locally through secure email. 
 
Historical Controls: Historical controls will be identified by working with each site’s tumor 
registrar to generate a list of all breast cancer patients during the historical time period. 
These data will be securely stored locally at each site, and transmitted to the TRIP study 
team at BMC via secure Box.com folder, SFTP, or secure email. The data will then be saved 
to the secure tripdata$ folder. These data will be reviewed by the TRIP data analyst to 
ensure completeness and correct formatting of files, and to exclude all ineligible patients 
according to TRIP eligibility requirements. Then the TRIP data analyst will upload the 
eligible patients’ data to a secure REDCap project for chart abstraction. This REDCap 
project will be used to store clinical data manually abstracted from each EHR, and entered 
by the site’s Research Assistant. 
  
Historical control datasets will include the following variables requested from each site: 
a. First Name 
b. Last Name 
c. MRN 
d. Sex 
e. Race/ethnicity 
f. Date of diagnosis 
g. Date of birth 

31 
 
h. ZIP code at diagnosis 
i. 
Primary institution 
j. 
Primary payer at diagnosis 
k. Date of last contact or death 
 
In order to identify which historical control patients transferred their care to multiple 
institutions, the TRIP team will cross-reference historical control cases with the 
Massachusetts Cancer Registry (MCR) at the Massachusetts Department of Public Health 
(MADPH). The TRIP team will transmit the following data via SFTP to MCR, which will 
perform a matching query to report which patients have received care at more than one 
institution: 
a. First Name 
b. Last Name 
c. MRN 
d. Date of diagnosis 
e. Date of birth 
f. Reporting institution 
 
The electronic health records will also serve as a data source for patient interviews. The 
site’s RA will query the electronic health records directly through Epic or other electronic 
medical record system at a site for the following data: 
a. First name 
b. Last name 
c. Mailing address 
d. Phone number 
 
These data will be securely stored locally at each site, and transmitted to the TRIP study 
team at BMC via secure Box.com folder, SFTP, or secure email. 
 
10.1.6 Data Source: Central Data Repository 
 
A Central Data Repository located on Boston Medical Center’s (BMC) HIPAA compliant 
server (\tripdata$)  will house datasets containing PHI from REDCap, Aunt Bertha and the 
EHRs to be compiled, de-identified and coded for analyses.  
 
Using the instance of SAS on BMC’s I2B2 restricted use server, the EHR data will be 
merged with the REDCap and Aunt Bertha data using medical record number (MRN) and 
date of birth, and incorporating the unique study ID assigned in REDCap. Once the EHR 
data is merged with project data, personal identifiers, such as patient name, medical record 
number, full address (excluding zip code) and phone number, will be removed from the 
dataset and stored as a separate encrypted dataset in a dedicated secure folder on the F 
drive within the restricted I2B2 BMC server.  An individual’s study ID will be the ‘crosswalk’ 
linking this master file containing PHI to the coded analytic dataset. Access to the master file 
will be limited to the BEDAC and BMC staff listed on this application who will be trained in 
handling confidential data and will be destroyed upon study completion.   
 

32 
 
Once treatment outcomes are verified by BMC staff, date of birth and treatment dates will be 
transformed into analytic variables (e.g. age at diagnosis, days to first treatment, # of days 
on chemotherapy, days to hormone therapy, etc.), removed from the dataset and stored as 
a separate encrypted dataset, linked only by the crosswalk file, as described above.  
For additional information regarding the data sources, process for codification and patient 
identifying variables see Figure 1, and Table 1. 
 
The master file containing an individual’s name and medical record number will be used to 
identify navigated patients to contact for interviews. The data analyst will generate a list of 
patient names, MRNs, and study IDs for navigated patients, stored on the tripdata$ server. 
This list will only be accessed by TRIP RAs when identifying navigated patients to contact 
for interviews.  
 
10.1.7 Data Source: Cost Surveys 
 
Using an annual survey of clinical site administrators and patient navigators, we will 
systematically assess all costs associated with the delivery of the multi-component intervention 
to estimate the costs that would be required to implement in other practice settings or continue 
the intervention in these settings at the conclusion of the study. This data collection will inform 
sustainability and dissemination efforts by assessing fixed and variable costs, including costs in 
developing the registry and Aunt Bertha platform; costs associated with training patient 
navigators; and costs associated with implementing the program. The surveys will collect 
aggregate data on the amount of time spent on discrete navigation activities and will not contain 
any patient-level information. 
 
Navigators and their supervisors will be sent a blank template of the survey via a secure 
electronic data capture system or secure email, or delivered a printed copy during a regularly 
scheduled site visit. They will be instructed to complete the survey once per day over a two-
week period (10 consecutive working days). At the end of each week, a research assistant will 
contact the navigator by secure email or phone to aid in completing the surveys and collect the 
paper forms, if there are any. If during the 2 week period the navigators do not interact with any 
TRIP participants or spend time on any TRIP activities, the process will occur again and they 
will be asked to fill out a cost survey for another 2 week period. The research team will send the 
completed surveys to the TRIP cost analyst, based at the Boston University Medical Campus, 
via secure email for analysis. Paper surveys will be scanned and stored in the secure Box.com 
folder, and paper copies shredded immediately afterward. 
 
10.1.8 Data Source: Observations 
 
To understand patient navigators’ adherence to navigation guidelines, we will conduct 
observations of all TRIP Patient Navigators across participating sites at 12 months of the 
intervention period. We expect to observe approximately 8-12 navigators, knowing that staffing 
changes may alter the number of TRIP navigators over time.  Observers will be IRB-approved 
study personnel. They will use implementation science frameworks and methods to examine the 
barriers and facilitators to implementation, as well as the Patient Navigators’ degree of fidelity, 

33 
 
to the TRIP intervention protocol. Trained research staff will complete a minimum of two 4-hour 
observations per navigator and data will be recorded on an observation tool (Appendix V) to 
take field notes, and check off when activities from the 11 Step Navigation Guidelines are 
completed. The observer will begin a new written observation sheet every 15 minutes.   
 
Pilot Observation Period: Observers will conduct a 2-hour pilot observation prior to formal 
observation activities.  The pilot will ensure observers are recording observations and writing 
observation summaries in alignment with study protocol. No research data will be collected. 
 
Formal Observation Period: Prior to the observation, the Study Coordinator will facilitate a warm 
hand-off between the observer and the patient navigator via email. The Study Coordinator will 
send an introductory email with additional details about the observation and confirm a time for 
the 4-hour observation periods. Observers will meet all site-specific criteria for visitor privileges 
ahead of the visit date. Before the start of the observation period, the observer will review an 
exempt information sheet (see Appendix XI) with the Patient Navigator, who will have the 
opportunity to provide verbal consent or opt out of the observation. The observer will also 
provide the business card of the PI, Dr. Tracy Battaglia. 
 
During the observation period, the observer may ask probing questions to clarify patient 
navigator activities. Should the observer witness an in-person patient interaction or a phone call, 
between the navigator and the patient, the navigator will ask for the patient’s permission for the 
observer to remain in the room using a provided script (Appendix XII). If the patient does not 
agree, the observer will leave the room until the navigator is done interacting with a patient. If 
the patient is comfortable with the observer’s presence, the observer will remain in the room and 
record notes. To remain as unobtrusive as possible this portion of the observation will be an 
“eyes-only” experience; the observer will not ask any questions while the patient is in the room 
or on the phone. Research team members will make all attempts to minimize their exposure to 
PHI throughout the observation period. Clinical staff can ask the research team members to 
leave the room at any time. 
 
Immediately after the observation, the observer will complete an observation summary 
(Appendix XIII) independently to reflect on activities witnessed during observations and 
document emergent themes and questions. The observation team will review the observation 
summary the following day.  The observer will update the summary with any remaining answers 
or clarifying information. No patient information will be recorded. 
 
All observation data will be stored at BMC. Paper copies of observation notes will be scanned 
and stored in a secure, restricted access Box.com folder.  Observers will type up hand-written 
field notes and store electronic copies, along with observation summaries, on a secure BMC 
Box.com folder. Hand-written notes will then be immediately destroyed. Observation data will be 
uploaded into Dedoose software for analysis by the subject’s unique study ID. We will use 
content analysis (where we conduct counts for specific activities, e.g. entering data into the 
EHR, and the amount of time spent on those activities) and thematic analysis to analyze the 
tasks and work flow observed by the research team. 
 
10.1.9 Data Source: Key Informant Interviews 
 
12-Month Interviews: Interviews will be conducted with Key Informants approximately 12 months 
after each site goes live with the TRIP intervention to assess two implementation outcomes: 
acceptability and penetration of the TRIP protocol. These Key Informants will be the TRIP 
Navigators across the 6 participating sites, as well as select members of the Non-TRIP 

34 
 
Navigation Team identified by the TRIP Navigator or during navigator observations, such as 
resource specialists, nurses, social workers, and other staff involved in the navigation process 
(see Appendix I for interview guide). There are separate, tailored interview guides for the 
non-TRIP Navigation Team and TRIP Clinical Champions (Appendix II and III).   
 
After the study information sheet (Appendix XVII) has been reviewed and the interview 
scheduled, study team personnel will arrange a time and location for the interview. The 
interview will be conducted preferably in person, but phone interviews will be permitted if 
scheduling constraints arise. Interviews will be arranged at a mutually agreeable time and 
private location (clinical space, research office). Prior to beginning the interview, the research 
team member will confirm that the participant agrees to have the conversation audio recorded. 
Navigator interviews will be focused on gathering their perspectives on the TRIP navigation 
protocol, experiences using the REDCap Registry and Aunt Bertha SDOH platform, and 
perceptions of TRIP in general. Non-TRIP Navigation Team interviews will focus on perceptions 
of the intervention, experiences with patients receiving the new standard of care, challenges 
encountered, and intention to continue implementing principles of TRIP after the study period. 
The interview will be conducted using a flexible interview guide, and participants will be provided 
with an opportunity at the end of the interview to ask questions or provide other information not 
solicited by the interviewer. Interviewees, both TRIP Navigators and non-TRIP navigation 
personnel, will each receive an honorarium of $50 for their time at the time of the interview. At 
the conclusion of the interview, the interviewer will make field notes, reflecting on the interview 
context, using an interview summary (Appendix XII). These notes will be marked with the 
participant’s study ID (no names or other identifying information). If the interview is cut short or 
interrupted for any reason, the interviewer and interviewee will identify a mutually agreeable 
time, by phone or in person, to complete the rest of the interview. 
 
Audio files will be transcribed by a verified transcription service and will be managed, coded and 
analyzed using qualitative data management software (either Dedoose or NVivo). All interview 
data – audio and written transcripts – will be stored securely in a restricted-access Box.com 
folder. 
 
For analysis, at least two members of the study team will independently review transcripts from 
each of the first 3 Navigator and Non-TRIP Navigation Team interviews to identify important 
concepts that emerge and create a codebook used for subsequent interviews. Then, two coders 
will independently code three randomly chosen cases for agreement analysis in Dedoose or 
NVivo. Coders will meet twice monthly to review code interpretation and to discuss new codes. 
Disagreements about code meanings will be resolved by consensus.  
 
The thematic analysis will focus on the perceptions of acceptability and penetration related to 
implementing the TRIP standard of care. After coding is finalized and consensus has been 
reached, codes will be reviewed to generate cross-cutting themes within each group. Similarities 
and differences in the themes will be compared across groups. This will allow us to identify the 
extent to which TRIP is seen as acceptable or having substantial reach within the health system 
among different sites.  
 
27-Month Interviews: Interviews will be conducted with Key Informants approximately 27 months 
after each site goes live with the TRIP intervention to assess four implementation outcomes: 
fidelity, acceptability, adoption, and penetration of the TRIP protocol. These Key Informants will 

35 
 
be the TRIP Navigators across the 6 participating sites, as well as their direct supervisor or 
program clinical champion (see Appendix XVI for interview guide). Key informants will be 
recruited by email or at a regularly scheduled TRIP meeting (e.g. clinical advisory panel, 
navigator network meeting, or site visit). 
 
After the study research information sheet (Appendix XVII) has been reviewed and the 
interview scheduled, study team personnel will arrange a time and location for the interview. 
The interview will be conducted preferably in person, but phone interviews will be permitted if 
scheduling constraints arise. Interviews will be arranged at a mutually agreeable time and 
private location (clinical space, research office). Prior to beginning the interview, the research 
team member will confirm that the participant agrees to have the conversation audio recorded. 
Navigator interviews will be focused on gathering their perspectives on the TRIP navigation 
protocol, experiences using the REDCap Registry and Aunt Bertha SDOH platform, and 
perceptions of TRIP in general. Supervisor and clinical champion interviews will focus on 
perceptions of the intervention, experiences with patients receiving the new standard of care, 
challenges encountered, and intention to continue implementing principles of TRIP after the 
study period. The interview will be conducted using a semi-structured interview guide, and 
participants will be provided with an opportunity at the end of the interview to ask questions or 
provide other information not solicited by the interviewer. The interviewee will complete a 
demographic survey, which is included at the end of the interview. Phone interviewees will 
receive the demographic survey as a REDCap survey link. Interviewees will each receive an 
honorarium of $50 for their time at the time of the interview. At the conclusion of the interview, 
the interviewer will make field notes, reflecting on the interview context, using an interview 
summary (Appendix XII). These notes will be marked with the participant’s study ID (no names 
or other identifying information). If the interview is cut short or interrupted for any reason, the 
interviewer and interviewee will identify a mutually agreeable time, by phone or in person, to 
complete the rest of the interview. 
 
Audio files will be transcribed by a verified transcription service and will be managed, coded and 
analyzed using qualitative data management software (either Dedoose or NVivo). All interview 
data – audio and written transcripts – will be stored securely in a restricted-access Box.com 
folder. 
 
For analysis, at least two members of the study team will independently review transcripts from 
each of the first 3 Navigator and Supervisor/Clinical Champion interviews to identify important 
concepts that emerge and create a codebook used for subsequent interviews. Then, two coders 
will independently code three randomly chosen cases for agreement analysis in Dedoose or 
NVivo. Coders will meet two to four times monthly to review code interpretation and to discuss 
new codes. Disagreements about code meanings will be resolved by consensus.  
 
The thematic analysis will focus on the perceptions of fidelity, adoption, acceptability, and 
penetration related to implementing the TRIP standard of care. After coding is finalized and 
consensus has been reached, codes will be reviewed to generate cross-cutting themes within 
each group. Similarities and differences in the themes will be compared across groups. This will 
allow us to identify the extent to which TRIP has been incorporated into an existing site 
according to the protocol, is seen as acceptable, or having substantial reach within the health 
system among different sites.  
 

36 
 
10.1.10 
Data Source: Patient Interviews 
 
Interviews will be conducted with 30 patients enrolled in the study across all 6 TRIP clinical sites 
to assess acceptability of the TRIP protocol, a key implementation outcome. Patients will be 
identified through the central data repository, which contains a record of patients who were 
navigated by a TRIP navigator and screened for social determinants of health. Patients will be 
sent an opt-out letter and research information sheet (Appendix XVIII and Appendix XX) to 
their mailing address listed in the clinical site’s electronic medical record. Approximately 1 week 
after the opt-out letter has been mailed, a researcher will call the patient at their phone number 
listed in the clinical site’s electronic medical record or the REDCap Patient Registry to schedule 
an interview time. All interviews will be conducted by phone. Patients who opt out will be 
removed from the calling list. This calling list will be stored in a secure Box.com folder. 
 
Prior to beginning the interview, the research team member will review the research information 
sheet (Appendix XX) with the participant and confirm that the participant agrees to have the 
conversation audio recorded. The interview will be conducted using a flexible interview guide 
(Appendix XIX), and participants will be provided with an opportunity at the end of the interview 
to ask questions or provide other information not solicited by the interviewer. Interviewees will 
each receive an honorarium of $25 for their time at the time of the interview. Participants’ 
responses will not be linked to identifiable information. Participants and interviewers will be 
asked to use pseudonyms during the interview. 
 
Audio files will be transcribed by a verified transcription service and will be managed, coded and 
analyzed using qualitative data management software (either Dedoose or NVivo). All interview 
data – audio and written transcripts – will be stored securely in a restricted-access Box.com 
folder. 
 
For analysis, at least two members of the study team will independently review transcripts from 
the first 3 interviews to identify important concepts that emerge and create a codebook used for 
subsequent interviews. Then, two coders will independently code three randomly chosen cases 
for agreement analysis in Dedoose or NVivo. Coders will meet twice monthly to review code 
interpretation and to discuss new codes. Disagreements about code meanings will be resolved 
by consensus.  
 
The thematic analysis will focus on the perceptions of acceptability related to implementing the 
TRIP standard of care. After coding is finalized and consensus has been reached, codes will be 
reviewed to generate cross-cutting themes within each group. Similarities and differences in the 
themes will be compared across groups. This will allow us to identify the extent to which TRIP is 
seen as acceptable by patients. 

37 
 
Figure 1 Data Sources and Codification Procedure 
  
 
BMC CDW provides THRIVE social needs data for TRIP patients 
, QuickBase 
Dataset A: REDCap and Social Needs 
Assessment data merged by Patient ID # 

38 
 
Table 1. Overview of Patient Identifying Elements 
Data Source 
Description 
Access 
Purpose of data 
PHI data elements 
HIPAA Compliant 
REDCap Registry 
A tool to support the daily work of Patient 
Navigators to manage their active caseload 
and share information with Navigators 
when they transfer their care to another 
institution in the TRIP program. Use of the 
registry is considered a standard part of the 
Navigator’s workflow. 
Patient Navigators 
across all 6 sites, Select 
members of the TRIP 
program team (all IRB 
approved and compliant) 
Implementation data: will 
determine if the standard 
of care navigation 
protocol was 
administered 
• 
Intake date 
• 
MRN 
• 
Patient Name 
• 
DOB 
• 
Address 
• 
Phone number 
• 
Email 
• 
Appointment dates 
HIPAA Compliant Aunt 
Bertha Platform 
A tool to support the daily work of Patient 
Navigators to systematically screen 
patients for barriers to care and identify 
local resources to help them overcome 
those barriers. Use of the platform is 
considered a standard part of the 
Navigator’s workflow. 
Patient Navigators 
across all 6 sites, Select 
members of the TRIP 
program team (all IRB 
approved and compliant) 
Implementation data: will 
determine if the standard 
of care navigation 
protocol was 
administered 
• 
Patient Name 
• 
Email 
• 
Phone Number 
• 
Zip Code 
• 
Date Social Needs Assessment 
Completed 
Electronic Health 
Record-Potential Patient 
List 
 
 
Automated list of patients scheduled for 
breast cancer care in the coming week is 
generated by the Site. Another tool for 
Navigators to identify who needs their 
services. Use of the list is considered a 
standard part of the Navigator’s workflow. 
Site Specific Navigators, 
Select members of the 
TRIP program team (all 
IRB approved and 
compliant) 
Implementation data: will 
determine if the standard 
of care navigation 
protocol was 
administered 
 
• 
MRN 
• 
Zip code 
• 
Patient Name 
• 
Race 
• 
Date of visit 
Electronic Health 
Records- Identification 
of historical controls 
Site tumor registrars will compile lists of 
patients who meet the TRIP eligibility 
criteria within the historical control period, 
in the form of a .csv file and securely 
transmit to the TRIP team via restricted-
access Box.com folders or via SFTP. 
These lists will be used to identify historical 
control cases for abstraction. 
Select members of the 
TRIP program team (all 
IRB approved and 
compliant) 
Identification of historical 
control cases 
• 
Patient name 
• 
MRN 
• 
DOB 
• 
Date of diagnosis 
• 
ZIP code 
• 
Race/ethnicity 
• 
Institution of care 
• 
Insurance type 
• 
Preferred language 
• 
Date of last contact/death 
Electronic Health 
Record- Manually 
abstracted chart data 
 
Clinical data from patient charts will be 
abstracted and entered into a REDCap 
database. The abstraction will be 
performed on site by a Research Assistant 
Site Specific Navigators, 
Select members of the 
TRIP program team (all 
IRB approved and 
compliant) 
Outcomes data: will 
provide clinical data to 
determine care received 
and if any delays in care 
persist after the new 
• 
MRN 
• 
Patient Name 
• 
DOB 
• 
ZIP Code 
• 
Insurance 

39 
 
Data Source 
Description 
Access 
Purpose of data 
PHI data elements 
employed by that site and overseen by the 
site PI. 
Patient navigation 
standard is put in place. 
• 
Institution of Care 
• 
Language 
• 
Date of diagnosis 
• 
Date of last contact or death 
• 
Breast cancer treatment dates 
• 
Hospital admission & ER visit 
dates 
BMC Electronic Health 
Record- THRIVE social 
needs data 
Social needs data collected via THRIVE for 
TRIP patients will be made available to the 
study team to merge with the TRIP 
instance of Aunt Bertha for analysis. 
Select members of the 
TRIP program team (all 
IRB approved and 
compliant) 
Implementation data: will 
determine if the standard 
of care navigation 
protocol was 
administered 
• 
Patient name 
• 
DOB 
• 
MRN 
• 
Date social needs assessment 
completed 
Electronic Health 
Record – Identification 
of navigated patients for 
interviews 
A list of patient contact information at each 
clinical site will be compiled by a site RA 
from the electronic health record and saved 
in a secure Box.com folder. These lists will 
be used to contact patients for acceptability 
interviews. 
Select members of the 
TRIP program team (all 
IRB approved and 
compliant) 
Contacting patients for 
interviews 
• 
Patient name 
• 
Mailing address 
• 
Phone number 

Translating Research into Practice: TRIP 
 Version 1.22 
 
40 
 
10.2 
Data Safety Monitoring Plan (DSMP) 
 
10.2.1 Data Safety Monitoring Plan Overview 
 
The Tufts CTSI provides a service for managing the Data Safety Monitoring Plan (DSMP) within 
their regulatory services that will be utilized for the proposed project. The DSMP for the trial will 
be managed by the study lead PIs and the site co-investigators, a biostatistician and additional 
clinical experts in breast cancer and health disparities.  
 
In collaboration with the multiple lead study PIs, Dr. Tracy Battaglia has created the Data Safety 
and Monitoring Plan below which includes sections on monitoring objectives, platform data 
security details, the data to be considered, roles and responsibilities, and meeting plans and 
reports. The meeting section will lay out the frequency of meetings, pre-meeting materials, 
structure of the meetings, how voting and quorum will be conducted, and how adverse events 
(AEs) or emergent data safety concerns will be addressed. 
 
10.2.2 Oversight Responsibilities 
 
The DSMP for the TRIP study aims to protect participant safety and confidentiality from adverse 
events associated with participation in the study. In addition, the DSMP assures regular 
oversight and maintenance of data quality. 
 
Oversight for the data and safety of the trial will be the responsibility of the study lead PIs (Dr. 
Battaglia, Dr. Freund, Dr. Haas, and Dr. Lemon). The DSMP has been created by Dr. Tracy 
Battaglia in collaboration with the Tufts CTSI Regulatory Knowledge Core and the study lead 
PIs.  
 
10.2.3 Monitoring Procedures 
 
While this project is intended to be ‘standard of care’ and will be reliant on a waiver of consent, 
principal investigators will ensure that all subjects meet eligibility criteria, and that the study is 
conducted according to the IRB-approved research plan.   
 
The study team will specifically monitor the performance of the trial and data quality of the study 
by reviewing: 
 
a. Enrollment – the team will monitor enrollment quarterly for adequacy of meeting 
enrollment goals and ensuring eligibility criteria are met. 
b. Follow-up – the team will monitor the study for completeness of registry and 
social needs assessment follow-up data on a quarterly basis. 
c. Other metrics of clinical trial performance including data integrity (verification of 
quality, complete data received in a timely manner), protocol adherence, subject 
privacy, data confidentiality (secure data storage and transfer) and study 
management will be monitored on a quarterly basis 
 

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The lead PIs will review study conduct inclusive of site enrollment, eligibility, and protocol 
adherence and deviations during the quarterly review. The lead PIs will review any issues 
identified in real-time and in aggregate during the quarterly review. The lead PIs will ensure all 
protocol deviations, adverse events, and unanticipated problems are reported to the NIH and 
BMC IRB according to the applicable regulatory requirements. The biostatistician and statistical 
analyst will prepare detailed reports on enrollment, data capture from the registry and from Aunt 
Bertha, each quarter to facilitate these sessions.   
10.2.3.1 Auditing and Risk Management 
 
The TRIP program manager and data analyst, along with the BMC Privacy Officer and BMC 
Associate Director of Network Security and Data Engineering, will be granted access to the 
REDCap audit trail logs in order to monitor patterns of patient registry records access and 
ensure that patient records are only being accessed by team personnel that are actively 
involved in the individual patient’s care.  
 
The TRIP team will use the FairWarning® Software to monitor the activity of the REDCap and 
Aunt Bertha project platforms to ensure that patient records are only being accessed by relevant 
personnel. FairWarning® Software incorporates data delivered from electronic medical records 
(EMR) or other data sources into its interface and runs analytical programs using artificial 
intelligence to identify patterns of misuse.  
 
Audit logs will be downloaded from REDCap and uploaded to the FairWarning® environment 
using a Secure File Transfer Protocol (SFTP). Audit logs from Aunt Bertha will be automatically 
uploaded via a SQL data feed. The FairWarning® environment will be used to generate reports 
to identify suspicious behavior. Should any aberrant patterns of misuse be detected the TRIP 
team will review these incidences with BMC Privacy and BMC Network. 
 
The audit trail log will be reviewed by the TRIP study team on a quarterly basis and by Privacy 
and Network Security as necessary. Should any aberrant patterns of patient navigators regularly 
accessing patient registry records for patients outside of their caseload be detected, the TRIP 
team will review these outliers with BMC Privacy and Security to determine the best course of 
action.   
 
 
10.2.4 General Electronic Data Procedures 
 
The study project manager will work with the navigators, IT at each site and the lead PIs to 
oversee uniform data management procedures.   
 
The REDCap database server will be backed up three times a day internally by BMC 
Information Technology (IT). The Aunt Bertha database server is backed up in real time at the 
secure Google analytics server facility. 
 

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All computers that will be used to collect and send data during implementation of the study or to 
receive or store data at all sites will be password protected. A password will be required to log 
on to the computer and a second, different username and password will be required to log in to 
both the REDCap Registry and the Aunt Bertha platform. REDCap requires two-factor 
authentication to complete log in. Both Aunt Bertha and REDCap require password changes 
every 60 days for all users. To train navigators on study activities, study personnel may use 
BMC’s version of Zoom to show the navigators patient data in the Aunt Bertha or REDCap 
Registry platforms. 
 
Electronic copies of forms will be stored on a secure dedicated server with appropriate firewalls. 
The system will use 128-bit encryption (SSL certificate) to transfer data between the machines. 
To add another level of security, the data stored within each database will be encrypted so that 
no one can read the actual contents, including the database administrators.  
 
Servers are scanned for viruses and systems are in-place to detect attempts at unauthorized 
entry. Any database transactions are stored in archive logs and are accessible to enable quick 
recovery of all data should the need arise. Backup files are written nightly to back up servers. 
The daily copies are kept onsite for a month. A monthly backup copy is stored off-site in 
perpetuity. 
 
Electronic files will consist of the following: 
1) REDCap registry records 
a. Individual patient registry record 
b. Compiled records reports including information on patient follow-up needs 
2) Aunt Bertha 
a. Individual patient social needs record 
b. Compiled records reports including information on patient social needs and 
referral resources 
3) Quick Base 
a. Individual patient social needs assessment and referral data 
4) Electronic Health Records (EHR) 
a. Lists of identified historical control patients for abstraction (.csv files) 
b. Historical control and TRIP subject demographic and cancer treatment data 
pertaining to breast cancer diagnosis & treatment 
c. Potential Patient List (site-specific)  
d. THRIVE Social needs data for TRIP patients (BMC-specific) 
5) Central Data Repository 
The central data repository will house all datasets listed above (1-4) for the project 
before the data is cleaned and coded in preparation of analysis. 
6) Interview transcripts and observation notes 
To minimize the chances that any personal information will be exposed, the following 
procedures are in place for interviews and observations:  
 
1. All study participants will be assigned to a unique study ID and identified by this 
number in all study documents.  Interviews and observation notes will only be 
labeled with a Study ID, and not by any individually identifiable information.  A 
separate, password-protected master code will document the participant’s study ID, 
role and institution.  Access to this password–protected file will be limited only to 

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study staff who have been trained in human subjects protection and are listed on the 
IRB application. The master code will be destroyed after data collection is complete. 
 
2. Interviews will include open-ended questions and a 1-page demographic survey. 
Neither the open-ended questions nor survey questions will collect identifiable 
information. Responses from paper-based demographic surveys will be transferred 
to a secure REDCap form, and scanned copies of the paper-based forms will be 
uploaded to a secure, restricted access Box.com folder. Paper copies will be 
immediately shredded after upload to Box.com. It is possible that participants will 
disclose personal information during the interview that was not solicited by the 
interviewer. To ensure confidentiality, all interview audio files will stored on a secure 
server or Box.com folder. Transcripts will be de-identified of participant information, 
including site name, before being professionally transcribed verbatim with a BMC-
approved transcription vendor. De-identified transcripts and audio files will be 
reviewed by members of the research team for accuracy and confirmation that all 
identifiable information is removed from transcripts, after which audio files will be 
destroyed. De-identified transcripts and audio files will be stored on a secure server. 
 
3. Observations will include hand-written notes by observers.  Observers will not 
record any patient navigator identifiable information in observation notes, including 
site name, and will only refer to patient navigators by study IDs in notes.  Observers 
will scan paper-based notes into electronic copies, which will be stored in a secure 
folder.  All paper-based notes will be immediately shredded after being uploaded to 
the secure, restricted access Box.com folder. 
 
 
10.2.5 General Security Procedures for Paper Data 
 
All study data will be collected electronically, however in some cases patient navigators may 
need to print out hard copies of the REDCap Registry forms or needs assessments to complete 
during their patient visits and will transcribe these responses into the electronic registry. 
 
Paper files will consist of the following: 
1) REDCap registry records 
a. Individual patient intake or follow-up forms 
2) Aunt Bertha Needs Assessment 
3) Observational notes 
4) Demographic surveys 
 
While most data collection will be entered in real time and directly into the electronic platform, in 
some cases patient navigators may need to print out blank paper copies of the REDCap 
Registry forms and Aunt Bertha Social Needs Assessment to complete during their patient 
visits. The data from these forms will then be entered into the electronic registry and the paper 
forms shredded immediately afterwards. 
   
Observational data will take the form of notes, which will remain in the possession of the 
research team during the observations and will be transported back to the study offices (801 
Massachusetts Avenue), where paper copies will be stored in a locked filing cabinet, to which 
only the PI and data Manager will have the key. Once data is entered into Dedoose software, 
electronic copies will be kept on BMC equipment, following all standard procedures for 
maintaining data security, and the paper copies immediately shredded. 
 
 

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10.3 
Third Party Platforms 
 
All data sources (REDCap Registry, Aunt Bertha platform, TRIP-patient THRIVE data, and 
TRIP-patient Quick Base data) utilized in this study are HIPAA compliant and will be accessible 
only to authorized and trained study personnel and only for the purposes of facilitating quality 
navigation related to clinical care. Good data management procedures to protect the electronic 
files will be followed as described above. 
 
 
10.3.1 REDCap Registry  
 
To facilitate effective patient navigation and improve the quality of care for our target population, 
the TRIP team is creating two electronic platforms: the REDCap patient registry and the TRIP-
specific Aunt Bertha Social Determinants of health platform. These platforms will be available to 
all participating navigators as well as some secondary site personnel on a case by case basis 
as determined by the TRIP team at the following sites: 
 
• 
Brigham and Women’s Faulkner Hospital 
• 
Beth Israel Deaconess Medical Center 
• 
Tufts Medical Center 
• 
Dana Farber Cancer Institute 
• 
Massachusetts General Hospital 
• 
Boston Medical Center 
 
As all participating sites are HIPAA-compliant entities and this intervention will be implemented 
as the standard of care across institutions. BMC general legal counsel determined inter-
institutional agreements for the shared registry to be unnecessary. 
 
The registry will be used to track and monitor patient progress across their treatment trajectory 
shared across the six health systems. The registry will be built using the HIPAA-compliant 
REDCap platform and function as a “tickler file” embedded into the navigator workflow. The 
REDCap registry will host a link to the Aunt Bertha platform within the patient intake form that 
will allow the Patient Navigators to login to Aunt Bertha to complete the social needs 
assessment. The only data element that will be automatically carried over via referring URL will 
the automatically generated REDCap subject ID to allow for data matching. 
 
10.3.1.1 Security and Compliance 
 
The REDCap registry developed for TRIP resides on BMC HIPAA compliant server. Access to 
the TRIP shared registry will be based on permissions granted by username and password 
which will be managed by the BU CTSI Informatics core (Bill Adams and Galina Lozinski – also 
TRIP team internal personnel). Only authorized study members will be able to enter or view 
data. 
 
 

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Study team members will log into REDCap using their assigned username and password. 
Usernames and passwords will never be shared among individuals. REDCap supports two-
factor authentication using e-mail or the Google Authenticator application. Two-factor 
authentication requires entry of a personal password and a second factor, something only the 
user has in their possession such as a mobile phone, or email, to provide unique identity 
verification. REDCap users are required to change their passwords every 90 days. Once a user 
is logged into REDCap the system will be set to automatically time out their session due to 
inactivity after 20 minutes. 
 
10.3.1.2 User Permissions 
 
Prior to initial site rollout, all sites will provide a list of authorized users designated by view only 
or view and edit. Patient navigators will be given highest level permissions in order to ensure 
that they can input patients and run reports as needed. Navigator supervisors and any staff who 
provide coverage for navigators will also have full view and edit permissions. Because the goal 
of the registry is to quickly allow navigators to coordinate care when patients move among 
hospitals, all navigators and supervisors participating in the study will have access to all cases 
in the registry.  
  
Other clinical providers (e.g., nurses, physicians, social workers) at the hospitals may request 
access to view the registry.  After training, these clinicians will be granted view only status to 
see patients receiving care at their hospital site. This will ensure that only individuals with active 
clinical roles in patient care will have access to the registry. 
 
10.3.1.3 Changes in site personnel 
 
Any changes to the site permissions list should be sent to the TRIP project team and will be 
updated in the system by BMC IT personnel responsible for assigning REDCap access. The 
TRIP research team will send an inquiry to confirm site personnel on a quarterly basis. Site 
Principal Investigators will be asked to update the TRIP team within a week of on-site personnel 
changes (new team member additions or current team member leaving). Site personnel will be 
reviewed by the TRIP team and confirmed with clinical site Principal Investigators on a quarterly 
basis. 
10.3.1.4 Auditing and Risk Management 
 
The TRIP program manager and data analyst along with BMC Privacy Officer and BMC 
Associate Director of Network Security and Data Engineering, will be granted access to the 
REDCap audit trail logs in order to monitor patterns of patient registry records access and 
ensure that patient records are only being accessed by team personnel that are actively 
involved in the individual patient’s care.  
 

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The TRIP team will use the FairWarning® Software to monitor the activity of the REDCap and 
Aunt Bertha project platforms to ensure that patient records are only being accessed by relevant 
personnel. FairWarning® Software incorporates data delivered from electronic medical records 
(EMR) or other data sources into its interface and runs analytical programs using artificial 
intelligence to identify patterns of misuse.  
 
Audit logs will be downloaded from REDCap and Aunt Bertha and uploaded to the 
FairWarning® environment using a Secure File Transfer Protocol (SFTP). The FairWarning® 
environment will be used to generate reports to identify suspicious behavior. Should any 
aberrant patterns of misuse be detected the TRIP team will review these incidences with BMC 
Privacy and BMC Network. 
 
The audit trail log will be reviewed by the TRIP study team on a quarterly basis and by Privacy 
and Network Security as necessary. Should any aberrant patterns of patient navigators regularly 
accessing patient registry records for patients outside of their caseload be detected, the TRIP 
team will review these outliers with BMC privacy and security to determine the best course of 
action.   
   
10.3.2 Social Determinants of Health Platform (Aunt Bertha) 
Aunt Bertha (https://www.auntbertha.com) is a public benefit corporation that works to connect 
people in need with social service agencies. Aunt Bertha provides a search, referral, and web 
application platform that will be used to assess SDOH and refer patients to community 
resources. The TRIP screening/referral system will be built using the Aunt Bertha platform.  
 
To accommodate existing clinical workflows at two of the TRIP sites, alternative sources of 
SDOH data will be utilized as follows: 
a) Boston Medical Center: THRIVE 
a. THRIVE is a BMC-operated parallel instance of the Aunt Bertha platform, and 
THRIVE assessment data is stored in the BMC EMR and will be sourced via the 
Clinical Data Warehouse in the form of a .csv file downloaded to the secure 
tripdata$ folder. 
b) Dana-Farber Cancer Institute: Quick Base 
a. The Dana-Farber Cancer Institute instance of QuickBase is a password-
protected application platform for managing navigation-related data, and is 
accessible only by authorized DFCI personnel. Authorized personnel at DFCI will 
securely send TRIP-patient QuickBase data to the study team via a secure, 
restricted-access Box.com folder or SFTP, which will be downloaded to the 
secure tripdata$ folder to be merged with other datasets for analyses. 
10.3.2.1 Security and Compliance 
1) Aunt Bertha 
a. All Aunt Bertha employees are required to take an annual HIPAA training course. 
Aunt Bertha is hosted on a Google Cloud platform using AES-256 encryption.  
Data in transit on the Google Cloud platform is sent using AES-256 encryption, 
and on the internet the connection to the site is encrypted and authenticated 
using TLS 1.2, ECDHE_RSA with X25519, and AES_128_GCM. 

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b. Study team members log into Aunt Bertha using their assigned username and 
password. Usernames and passwords are never shared between individuals. 
Once a user is logged into REDCap the system will be set to automatically time 
out their session due to inactivity after 30 minutes. 
2) THRIVE 
a. THRIVE data is governed by the same security and compliance protocols as the 
BMC EMR. Only the Clinical Data Warehouse Research Manager will have direct 
access to this data source, and she will securely transfer the THRIVE 
assessment data for BMC’s TRIP patients via the tripdata$ folder. 
10.3.2.2 Patches 
Aunt Bertha automated patch management solutions to update system and software patches as 
they are released.  Updates to code elements are updated as part of the software development 
life cycle process. 
 
For any code other than the site code developed by our internal team, the underlying operating 
system and associated applications are updated automatically. For our code we use a Software 
Development Life Cycle plan following an agile development process. 
 
10.3.2.3 Auditing and risk management 
Aunt Bertha is hosted on the Google App Engine platform, thus physical and environmental 
security is the responsibility of Google.  The Google data center has made a SOC2 report 
available for certification and auditing reports. Real-time alerts are set up for logs based on 
defined issues, but otherwise logs are reviewed monthly. For details regarding user audit log 
monitoring see section 11.2.6.4 Auditing and Risk Management. 
 
10.3.2.4 Breach of Data Security  
In the event of a security breach, Aunt Bertha performs an initial analysis to close the breach 
and investigate the scope of the breach. Once the situation is determined to be stable the 
notification process to the TRIP team would be implemented. 
 
The use of digital media such as USBs or external drives is disabled at endpoints within the 
Aunt Bertha internal network. 
10.3.2.5 User Permissions 
Prior to initial site rollout all sites will provide a list of authorized users and their intended role in 
the TRIP project. The TRIP project team and Aunt Bertha team will predetermine the 
configuration of groups for the purposes of sharing notes and reporting. Patient navigators will 
be given the highest level permissions in order to ensure that they can input patients, perform 
the social needs assessment and run reports as needed. Unless otherwise stipulated by the 
TRIP project team, accessory users such as clinicians will be granted permissions as ‘view only’ 
as requested. Any changes to the site permissions list should be sent to the TRIP project team 
and will be updated in the system by the Aunt Bertha Customer Success Manager. 
 

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Access to identifiable TRIP-patient THRIVE and QuickBase data will be restricted to only the 
TRIP data analysts and internal study team who have access to the tripdata$ folder and the 
restricted-access TRIP data Box.com folders.  
10.3.2.6 Changes in site personnel 
Site Co-Investigators will be asked to update the TRIP team within a week of on-site personnel 
changes (new team member additions or current team member leaving). The TRIP team will let 
Aunt Bertha staff know if a user should no longer have access, and these accounts will be 
deactivated within 24 hours.  
 
In addition, Aunt Bertha will generate a quarterly list of individuals with account permissions. 
This will be reviewed by the TRIP team and permissions of any users who are no longer at the 
clinical sites or part of the research team will be removed. 
 
10.3.3 Electronic Health Records 
EHR data has the highest level of security because it contains individually identifiable health 
information. Data from the EHR will be handled as follows in collaboration with IT teams at all 
participating sites (Figure 1, Data source #3): 
 
3A. Potential Patient List:The TRIP team will work with individual site Information Technology 
Services and Research Administration to create a report of patients that match eligibility criteria. 
These lists will be produced automatically on a weekly basis and provided to Patient Navigators 
via upload to a local secure folder or via secure email.  
 
3B. Treatment data for historical control and intervention subjects: Data for historical control and 
intervention subjects will be manually abstracted into a secure REDCap abstraction project from 
patient Electronic Health Records by trained study personnel at each participating site. This 
abstracted data will be checked for quality by TRIP study personnel by accessing the Electronic 
Health Records on a hospital-issued device using BMC’s VPN services, or viewing remotely 
through BMC’s instance of Zoom while using BMC’s VPN services. 
 
EHR data will be merged with data collected in the REDCap registry and Aunt Bertha using a 
medical record number (MRN) and date of birth and incorporating the unique Patient Registry ID 
assigned in the REDCap registry. 
All data will be kept for the duration of the 5-year study, as well as an additional 3 years until all 
data analysis and manuscript preparation is complete; at which time, all study related materials 
will be shredded and deleted off the server using a secure file deletion program by the BU Office 
of Information Security. All research staff will undergo HIPAA training as well as responsible 
conduct of research training. 
 
10.3.4 Central Data Repository  
Once the EMR data is merged with project data, personal identifiers, such as patient name, 
medical record number, full address (excluding zip code) and phone number, will be removed 
from the dataset and stored as a separate encrypted dataset.  An individual’s study ID will be 
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the master file will be limited to the BEDAC and BMC staff listed on this application who will be 
trained in handling confidential data.  
 
The master file will be destroyed upon study completion (June 2022). Once treatment outcomes 
are verified by BMC staff, date of birth and treatment dates will be transformed into analytic 
variables (e.g. age at diagnosis, days to first treatment, # of days on chemotherapy, days to 
hormone therapy, etc.), removed from the dataset and stored as a separate encrypted dataset, 
linked only by the crosswalk file, as described above.  
 
The central data repository will be maintained on a BMC secure, HIPAA compliant server for the 
purposes of matching the REDCap and Aunt Bertha data prior to de-identification for analyses. 
Good data management procedures to protect the electronic files will be followed as described 
above.  
 
All patient information for data analysis will be transferred to the TRIP Central Data Repository 
to be stored on BMC virtual servers via secure, HIPAA compliant data transfer methods, with all 
data encrypted.  Uploads into the repository will be protected using secure socket layering 
encryption technology.  Web-forms and accompanying database will be stored on secure 
servers professionally maintained by the Boston Medical Center IT group, stored behind the 
BMC ‘firewalls.’ Access to data systems will be controlled by usernames and passwords and 
restricted to study personnel.  
Datasets in SAS software will be stored on a HIPAA compliant network maintained by the BU 
Office of Information Security. Systems will be backed up incrementally and backups maintained 
offsite. All data will be stored in a HIPAA compliant manner and data storage techniques will be 
reviewed biannually by BU IT staff.  Specific procedures, which have been approved by our 
institution review board (IRB) and used successfully in prior research, include protecting 
participant confidentiality as follows: 
•     Data will be stored in a centralized data warehouse located within the BU/BMC data 
centers and security procedures will be consistent with those already followed for EHR 
data. 
•     All project staff will sign an oath of confidentiality to ensure their understanding of the 
terms of confidentiality required. 
•     Only project staff will have access to the system via a secure name and password. 
•     All reports and publications will preserve the subjects' anonymity. 
 
 

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10.3.5 Protecting Confidentiality  
This requires that identifying information (name, address, date of birth, social security or 
Medicare numbers) not be used as the final sources of identification for participants. 
Compliance of regulatory documents and study data accuracy and completeness will be 
maintained through an internal study team quality assurance process. Confidentiality throughout 
the trial is maintained by utilizing only HIPAA compliant systems to collect and store Patient 
Health Information. 
 
The major risk of the trial is loss of confidentiality.  Because of the nature of the information, 
data collected on the patients requires the presence of patient identifiers, until the final analytic 
file is complete for analysis. When a patient record is started in REDCap, the platform 
automatically assigns an identifying number to the patient. This number will then become the 
identifier of records for each participants (for all relevant data) once the data is coded for 
analytic purposes at the end of the study.  
 
 
10.4 
Data Safety Meetings  
 
10.4.1 Participants 
The TRIP team members and site investigators will participate in the Data and Safety Meetings. 
The meetings will be chaired by one of the lead PIs. For any decisions or resolutions requiring a 
vote, the four lead PIs, six site clinical advisors, and the biostatistician will be considered voting 
members. A quorum for voting will consist of at least three PIs and two additional voting 
members. 
 
10.4.2 Frequency 
The initial data and safety meeting will occur prior to the roll out of the intervention to discuss 
the protocol and establish guidelines for data review, and monitoring the study. Once the 
intervention is underway, the team will convene as often as necessary, but at minimum once a 
year (months 21, 33, 45, 57) to examine the enrollment data, review study progress and safety 
data, and discuss factors that might impact continuation of the study as designed. 
  
10.4.3 Data for Meetings 
Responsibilities for data reporting are as follows: 
• 
The data manager, in collaboration with the biostatistician will prepare detailed reports 
on enrollment, follow-up, data capture from the registry and from Aunt Bertha, monthly 
Quality Assurance reports and cancer care variables  
• 
The project manager will report on protocol adherence and violations 
• 
The data manager will report on data confidentiality and any reported adverse events 
from the database  
 
10.4.4 Structure of Meetings 
Meetings will be open to invited members of the study team. If needed, a closed session may 
follow to allow discussion among lead PIs, site clinical advisors, project manager(s), 
biostatistician, and the data manager. Voting members and the quorum are described above.   

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10.4.5 Addressing Data and Safety Concerns 
If issues are identified with data management or with participant safety or confidentiality, 
changes in the study protocol, data management, or data collection and maintenance will be 
discussed at the meeting and reflected in the minutes.   
 
10.5 
Reporting  
10.5.1 Responsibility 
It is the responsibility of the lead PIs to ensure that safety and data quality reports are prepared 
in a timely manner and submitted to the relevant IRB and sponsor(s). The project manager will 
assist with this and maintain copies of all reports in the regulatory binder. 
 
10.5.2 Data and Safety Meetings Minutes 
The minutes of the Data and Safety Meetings will be prepared by an assigned committee 
member and reviewed by the lead PIs. If required by the BMC/BU Medical Campus IRB, the 
minutes will also be sent to the IRB either after each meeting or on an annual basis for re-
certification.  The summary reports will be sent to each site investigator and filed with the BMC 
IRB. 
 
10.5.3 Safety Definitions 
10.5.3.1 Serious Adverse Events (SAEs):  
As this is a study monitoring the timeliness and quality of medical care in women with breast 
cancer, we do not anticipate any serious adverse events. Events that may occur during the 
course of the study of patients with cancer including treatment related events or death will not 
be considered SAEs for the purpose of reporting unless they are related or probably related to 
participation in the study. 
10.5.3.2 Adverse Events (AEs): 
The study has designed and instituted measures to preserve participant confidentiality. In 
particular, the study aims to prevent breach of data and loss of confidentiality, should any of the 
information in the registry, Aunt Bertha, or the secure central data repository become stolen or 
inadvertently become public. The study will also monitor for other possible AEs such as loss of 
contact with participants, misdirection or navigator error in participants’ appointments or transfer 
of care, or unauthorized disclosure of personal information.  
10.5.3.3 Unanticipated Problems (UPs): 
An unanticipated problem is defined as an event, experience or outcome that meets all three of 
the following criteria: 
• 
is unexpected; AND 
• 
is related or possibly related to participation in the research; AND 
• 
suggests that the research places subjects or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
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Possibly related means there is a reasonable possibility that the incident, experience, or 
outcome may have been caused by the procedures involved in the research. Unexpected 
means the nature, severity, or frequency of the event is not consistent with either: 
• 
The known or foreseeable risk of adverse events associated with the procedures 
involved in the research that are described in (a) the protocol–related documents, such 
as the IRB-approved research protocol, any applicable investigator brochure, and the 
current IRB-approved informed consent document, and (b) other relevant sources of 
information, such as product labeling and package inserts; OR 
 
The expected natural progression of any underlying disease, disorder, or condition of the 
subject(s) experiencing the adverse event. 
 
10.5.4 Safety Event Reporting 
The Principal Investigator at BMC/BU Medical Campus will report Unanticipated Problems, 
SAEs, safety monitors’ reports, and Adverse Events to the BMC/BU Medical Center IRB in 
accordance with IRB policies: 
• 
Unanticipated Problems occurring at any participating site involving a fatal or life-
threatening event will be reported to the IRB within 2 days of the investigator learning of 
the event. 
• 
Unanticipated Problems occurring at any participating site not involving a fatal or life-
threatening event will be reported to the IRB within 7 days of the investigator learning of 
the event. 
• 
Reports from the safety monitor with recommended changes after review by the lead PIs 
will be reported to the IRB within 7 days of the investigator receiving the report.  
• 
Adverse Events (including Serious Adverse Events) will be reported in summary at the 
time of continuing review, along with a statement that the pattern of adverse events, in 
total, does not suggest that the research places subjects or others at a greater risk of 
harm than was previously known. 
• 
Reports from the safety monitor with no recommended changes will be reported to the 
IRB at the time of continuing review. 
 
10.5.5 Protocol Deviations 
The lead PIs will ensure all protocol deviations are reported to the NIH and BUMC IRB 
according to the applicable regulatory requirements.  
 
10.6 
Quality Assurance of Data  
 
To ensure reliability of data entry and collection, a 15% random sample of completed manually 
abstracted data elements will be reviewed by the TRIP study team to ensure outcomes and 
covariates were accurately abstracted and data entered. This data will be checked for quality by 
TRIP study personnel by accessing the Electronic Health Records on a hospital-issued device 
using BMC’s VPN services, or viewing remotely through BMC’s instance of Zoom using BMC’s 
VPN services. Any differences identified will be documented and brought to the data manager 
for resolution. If the data manager cannot resolve the differences identified, they will be 
reviewed by the Clinical Adjudication Panel, which will meet as needed through BMC’s instance 
of Zoom. The Clinical Adjudication Panel will be composed of a rotating membership selected 

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from the six site clinical advisors, the study personnel who conducted the initial abstraction and 
the cross-check, the project manager, and the data manager. 
 
Quality assurance reports will be prepared by the data manager on a quarterly basis and 
reviewed by the Principal Investigators. The reports will inform the Principal Investigators about 
missing, invalid, inconsistent data on selected key variables. The statistician, in collaboration 
with the data manager on the project will oversee preparation of the reports. The reports will 
contain a summary of monthly accrual and cumulative accrual, a summary of key characteristics 
of the study participants, a summary of the completeness and quality of data. 
 
Quality assurance will involve engaging in good data management activities. Procedures that 
include checking the integrity of data storage (facilitate in collaboration with BMC IT) and 
examining frequency distributions statistically (in collaboration with the BU School of Public 
Health) to look for data anomalies such as an excessive number of ‘no response’ or problems 
with any skip patterns included in the REDCap registry forms will be in place. 
 
 
10.7 
Stopping Rules 
The study has no stopping rules. 
 
 
11 Study Records Retention 
 
This study will follow recommended Boston Medical Center retention guidelines requiring that 
study records be retained for at least seven years after completion of the study. As the study 
team is requesting a waiver of consent, retention of consent forms will not be required. Records 
will be preserved in their original form (hardcopy, electronic or other media) and saved as an 
electronic back-up copy whenever possible. All records will be made accessible for inspection 
and copying by authorized individuals.  
 
 
 
12 Statistical Plan 
 
12.1 
Study Hypotheses 
 
Our main hypothesis is that the TRIP intervention will result in timelier breast cancer treatment 
that is more concordant with guidelines, compared with historical control data.  
We also hypothesize that the integrated TRIP intervention will be implemented across each of 
the six study sites. 
 
12.2 
Sample Size Determination 
 
Sample size estimates assume 80% power and a two-sided alpha of 0.05 for cross-sectional 
stepped wedge studies comparing intervention to usual care in two-group statistical analyses. 
This method incorporates information on the number of steps used in the stepped wedge 
design, the number of subjects per time period, and the degree of clustering via the intra-class 
correlation coefficient (ICC) to compute the design effect. A sample size of 220 subjects per 

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group in a log rank test will provide 80% power at a two-sided alpha of 0.05 to detect a 
difference in the proportion of subjects with treatment at time, t, of 81% in the intervention group 
compared to 70% in the usual care group, a level estimated from recent data from the clinical 
sites for the planned study.  
 
This difference yields a hazard ratio of 1.75, a clinically meaningful effect size for time-to-
treatment post-diagnosis. Based on our planned number of steps, enrollment per study period, 
and a reasonable ICC of 0.1, the design effect is 2.29. Thus, we will need to enroll and follow at 
least 1,008 subjects to provide 80% power for analysis of intervention effectiveness. Our 
planned sample size of 1,300 women will therefore provide more than adequate power to test 
our primary outcome. 
 
12.3 
Statistical Methods 
 
Given the randomized stepped wedge design, we will report our results according to CONSORT 
guidelines. Our comparative analyses between the intervention and usual care (control) groups 
will employ the intent-to-treat principle. We will generate descriptive statistics (means, standard 
deviations, quantiles for continuous variables; counts/percentages for categorical variables) and 
schematic plots.  
 
We will compare the intervention and usual care groups on salient variables in order to assess 
balance in the distributions of these variables. Variables found to differ between the study 
groups will be further evaluated to assess their confounding effects of intervention vs. usual 
care differences on primary and secondary outcomes. Given the nature of the cluster 
randomization employed, we will employ statistical analytic methods that take the correlated 
nature of the data into account. 
 
Our primary analysis will use multiple logistic regression models to compare the proportion of 
patients with timely initiation of treatment across study groups, adjusting for the influence of 
race, language barriers to care, insurance status (private vs public), and other covariates that 
may have a significant effect on the outcome and may be unbalanced across the two study 
groups.  
 
• 
To examine heterogeneity in intervention effect, exploratory analyses using multiple 
logistic regression interaction models will examine whether the effect of the TRIP 
intervention vary by three covariates of interest:  
o patient race 
o patient preferred language 
o insurance status 
 
• 
Study groups will also be compared on the secondary clinical outcome of time to 
initiation of primary cancer treatment (the number of days from diagnosis to start of 
treatment) through Kaplan-Meier survival curves (unadjusted analyses) and Cox 
proportional hazards regression models controlling for cancer site and other covariates 
(adjusted analysis). 
 
• 
Receipt of quality care will be analyzed through logistic regression.  

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For the analysis of the rate of missed appointments, patients will differ on the number of 
scheduled appointments over the study period. The odds of missing an appointment will be 
analyzed through generalized estimating equation (GEE) logistic regression models for 
repeated measures (appointments within patient) dichotomous data. 
 
 
13 Ethics/Protection of Human Subjects 
 
This study is to be conducted according to applicable US federal regulations and institutional 
policies (which are based in federal regulations, guidance, and ICH Good Clinical Practice 
guidelines). 
 
This protocol and any amendments will be submitted to the Boston Medical Center and Boston 
University Medical Campus IRB, for formal approval of the study conduct. The decision of the 
IRB concerning the conduct of the study will be made in writing to the investigator.  
 
As this study is a health services quality improvement intervention meant to replace the current 
patient navigation process as the ‘standard of care’, the study team is seeking a waiver of 
consent for all eligible patients. Waiver of Consent will be documented as required by the IRB.