Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06034431 |
| Other study ID # |
23-285 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2023 |
| Est. completion date |
June 2026 |
Study information
| Verified date |
September 2023 |
| Source |
Brigham and Women's Hospital |
| Contact |
Wesley Chung |
| Phone |
617-525-8710 |
| Email |
wchung7[@]bwh.havard.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Investigators will address the overarching challenge of advancing health equity and reducing
disparities in prostate cancer by informing efforts to reduce travel burden in prostate
cancer (PCa) treatment access among Black men.
Description:
The following are the three aims of the proposal:
Aim 1: Determine how travel distance for PCa treatment impacts the outcome
Aim 2: Pilot a trial by offering ridesharing services for Black men seeking definitive PCa
treatment in Greater Boston to reduce missed appointments. The investigators will implement a
pre/post evaluation design with matched historical controls to estimate the impact of
rideshares on reducing missed appointments among Black men seeking care at the Mass General
Brigham Prostate Cancer Outreach Clinic. The investigators will also calculate the reduction
in time from diagnosis to receipt of treatment associated with the intervention.
What is the Prostate Cancer Outreach Clinic?
In 2018, MGB launched the United Against Racism initiative, a long-term, multi-million-dollar
commitment to address the many impacts that racism has on MGB patients, employees, and the
broader community. One of these projects, the Mass General Brigham Prostate Cancer Outreach
Clinic (PCOC), founded by Dr. Quoc-Dien Trinh (PI), as a response to widening inequities in
PCa care in Massachusetts. The PCOC serves as a catalyst to increase access for marginalized
communities through high-quality, accessible, and affordable PCa care in MGB's flagship
hospitals including Massachusetts General Hospital, Brigham and Women's Hospital, and Brigham
and Women's Faulkner Hospital.
Who are the target population?
The PCOC prospectively collects granular patient demographics and outcome metrics such as
missed appointments and time to treatment initiation, among others, making it an ideal
resource for a pre/post rideshare pilot trial. All data collected by the PCOC is found on
MGB's REDCAP. The target population is Black men with intermediate or high-risk PCa, as Black
men are more likely to report travel burden when accessing care and, therefore, most likely
to benefit from ridesharing services.
What is the study design?
The investigators will implement a pre/post-evaluation design with matched historical
controls to estimate the impact of rideshares on reducing missed appointments.
Historical controls will be sampled from the pre-intervention period of April 2022 to
September 2024 and the post-intervention period between October 2024 and November 2025, where
October 2024 represents the initiation of the intervention.
Participants who identify as Black and reside in a census tract in Massachusetts and are
recognized as having a high travel burden based on results from Aim 1 will be eligible to
receive the rideshare intervention. By restricting the intervention to Black men, the
investigators will ensure that men who are more likely to benefit from ridesharing services
are recruited. Controls will be matched based on age, comorbidities, treatment received, and
geographic characteristics identified in Aim 1. The investigators will prospectively collect
patient information that will be used to match the pre-and post-intervention cohorts. The
PCOC has the staff, resources, and patient load needed to conduct the pilot trial.
The number of rides offered will depend on the type of definitive treatment that participants
will receive (standard of care), but the investigators will offer as many rides as needed for
treatment completion. Historically, 45% of patients undergo surgery, 45% receive external
beam radiation, and 10% receive brachytherapy. On average, men who undergo surgery have 3 to
4 visits: preoperative evaluation, consultation for comorbidities, surgery, and postoperative
follow-up. Men who receive external beam radiation will have, on average, 20 to 28 sessions,
along with pre-and post-radiation evaluation (average of 30 visits), while men who have
brachytherapy will have on average, 5 to 6 visits. In addition to these rideshares, the
investigators have appropriately budgeted for some additional or emergency room visits, and
thus, do not anticipate issues covering or reimbursing any additional clinic or emergency
room visits.
What is the endpoint?
The primary endpoint is the rate of missed appointments, defined as any scheduled appointment
where a patient canceled or did not show up during the pre-and post-intervention periods. The
investigators will examine the time from diagnosis to treatment initiation in days as a
secondary endpoint.
What is the intervention?
At the time of referral, the PCOC community healthcare worker will collect patient
demographics and information that will be used for the analysis and will be stored on MGB's
REDCAP or Dropbox. The figure below describes the pilot trial's workflow.
Before the visit, the community healthcare worker will schedule the ride and contact the
patient via text or call with the trip details. Liaison escorts will be available to receive
the patient upon arrival and accompany the patient to the clinic. Upon completion of the
visit, the healthcare worker would schedule a ride back to the original destination. A
dedicated healthcare worker will manage all ride dispatches and will be responsible for
notifying the patient of trip details (scheduled time of the ride, reminders, expected time
of arrival at trip destination, name of the driver, and any delays or driver cancelations).
The investigators will partner with one rideshare vendor to facilitate ride dispatches and
simplify the billing system. Vendors like Uber Health or Lyft Healthcare have dashboards that
allow the scheduling, coordination, and tracking of rides in a HIPAA-secure environment.
Which analysis will the investigators be conducting?
Sixty patients (n=60) who received the intervention (post-intervention cohort) will be
matched 1:1 to pre-intervention patients (n=60), based on age, comorbidities, treatment,
insurance coverage type, and geographic characteristics using coarsened exact matching. The
investigators expect that a patient will have 12 visits on average. The outcome will be the
percentage of missed visits over the study period. The distribution of the percentage visits
is binomial, with extra variation due to the possible correlation of repeated visits on the
same patient. The comparison of the outcome across matched post-vs pre-intervention patients
will be performed with binomial logistic regression, with the intervention period as the
independent variable, with an over dispersion parameter to account for the extra variation in
the outcome due to the repeated visits on a patient. The investigators will adjust the
standard error to account for the matching using generalized estimated equations. The
investigators will also evaluate the time from diagnosis to treatment initiation using Cox
regression models.
Is the pilot study powered?
With 60 patients in the post-intervention group (rideshare) matched to 60 patients in the
pre-intervention group (usual care) and an average of 12 visits per patient, the
investigators have over 80% power (alpha=5%) to detect a decrease in missed visits from 20%
in the pre-intervention group to 10% in the post-intervention group using the binomial
logistic regression model. This effect size is consistent with the impacts of rideshare
interventions documented in the literature. In this power calculation, the investigators
conservatively assume the over-dispersion parameter (inflation in variance due to repeated
visits) is "strong" = 2.5, as well as a correlation of 0.1 between the matched pairs.
Because, in the last quarter, the investigators recruited more than 30 Black men, by
September 2024, the investigators expect to have more than 250 controls for whom the
investigators could match, and more than 120 patients have the potential to be recruited
between October 2024 and November 2025. Therefore, the investigators have enough patients to
conduct the pre/post-evaluation.
Are patients remunerated for participation?
Recruited patients will not receive compensation for participating in the trial, participants
will receive the ridesharing services as the intervention of the pilot trial.
Aim 3: Conduct multilevel semi-structured interviews to identify barriers to and facilitators
of ridesharing services through the PCOC.
In Aim 3.1, the investigators will engage the recipients (Men recruited in Aim 2) and the
initiators of the intervention to identify the successes and challenges of the intervention
through questions the investigators will develop with the team and stakeholder board.
In Aim 3.2, the investigators will collaborate with the stakeholder board to interpret and
contextualize the quantitative and qualitative findings by holding a town hall meeting. The
investigators will then employ a Delphi process to reach a consensus regarding the
epidemiologic and geographic targets among Black men with PCa associated with travel burden
and warrant intervention. The findings and recommendations will be published in a white paper
to inform future ridesharing programs and policy changes to reduce travel burden to PCa
treatment centers.
Who will be conducting the interviews?
Only research staff on this protocol will conduct interviews. The stakeholder board will help
develop the questionnaire but will not participate in the interview process.
Who are the informants the investigators will be recruiting?
The investigators will recruit 15 participants who are initiators of the intervention group
and 15 participants who are the recipients of ridesharing services.
The initiators will include clinicians, nurses, patient navigators, community healthcare
workers, social workers, and health equity officers at MGB who either work at the PCOC or
occupy managerial and executive roles within the institution, as well as urban planners and
ridesharing vendors (Uber and/or Lyft). The recipients will include participants who received
ridesharing services for PCa treatment (Aim 2) as well as members of community-based
organizations. The investigators have included community-based organizations in the recipient
group to represent the voices of potential patients who might benefit from ridesharing
services. This number of interviews will allow for sufficient thematic saturation among both
groups, while also being logistically feasible. The investigators have budgeted for 15
additional interviews, should a total of 30 interviews be insufficient to reach thematic
saturation.
What is the recruitment process?
Purposive sampling will be employed to identify and invite key informants. The investigators
have strong ties within MGB, and the investigators have commitments from the
multidisciplinary stakeholder board to help with the recruitment process. Based on
experience, the investigators expect 80% of the invited informants to participate.
How will the interviews be conducted?
Participants will be given the choice to be either interviewed in-person or remotely via
telephone or Zoom (a web-based communication platform). Interview guide domains and questions
will be developed by the investigators with relevant clinical and substantive expertise and
informed by the stakeholder board and prior literature.
What is the type of remuneration for participation in the interviews?
Interviews will be scheduled for approximately 45 minutes, and participants will be
remunerated a total of $50.
What type of questions will be asked in the interview?
Below is an overview of the type of questions the investigators will ask the recipients and
the initiators of the intervention. Although this is not a final list, the investigators
anticipate that the questionnaire will be very similar. The final questionnaire will be
appended to the protocol once it is developed and reviewed by the investigators of the study.
How will the interviews be analyzed?
Transcribed digital recordings and notes from semi-structured interviews will be analyzed
using standard qualitative methodologies described by the Office of Behavioral and Social
Sciences Research and others. Data analysis will be conducted separately for the initiators
and recipients and then together to extract themes for each of the RE-AIM domains (figure
above). A chronology of events will be examined in addition to key themes to assess the
complexity of the intervention. Two members of the research team will independently code
interview transcripts and develop a preliminary codebook. The investigators will use a
combination of inductive and deductive coding based on the interview domains. The analysis
will entail a multistep process, guided by Braun & Clarke. At least 2 members will
independently review all transcripts and engage in a multistage coding process to further
develop and generate the final codebook. Once consensus has been reached, reports will be
generated for each code, and the team will refine the themes to ensure the data within each
theme is both cohesive and distinct. In the final phase of analysis, illustrative quotes will
be selected to produce a succinct, cogent story of the data within and across the identified
themes from across sources of data. Qualitative study findings will be presented in a report
summarizing themes extracted from initiator and recipient interviews and circulated to key
participants for review and comment. The study team will then review the report to compare
the themes raised by respondents regarding the effectiveness and implementation of
ridesharing services and its ability in to reduce Black-White disparities in access to PCa
treatment.
What is the town hall forum the investigators will be holding to share the results?
The investigators will share the findings and themes in a town hall forum as a mechanism to
(1) share findings with the key informants, stakeholder board, and community; (2) further
contextualize findings; and (3) generate a comprehensive list of recommendations through
charette-style planning and a Delphi process. The investigators will work with members of the
stakeholder board to coordinate a culminating town hall meeting, at which key findings will
be shared. The investigators will encourage broad engagement and inclusivity by inviting key
community advocacy and patient support groups. During the town hall meeting, the
investigators will use elements of charrette-style planning to engage group members in the
process of making sense of the findings and generating recommendations. The investigators
plan to hold the town hall meeting in person.
What is the charette process for synthesizing recommendations?
Charette is an intensive, hands-on workshop for a solution-oriented design and planning
method. Charette participants will work in small task-oriented groups to explore findings
gathered during the intervention and themes extracted from interviews to generate
recommendations in a predefined timeframe. Each group will have a recorder who will keep
track of the ideas. Once the time is up, the recorder will move to the next group and present
the current state of the topic at hand. The purpose of the charette is to build on previous
discussions and propose new ideas. Once the topics have rotated among all the groups, the
results of each group session will be shared with the larger planning group for further
discussion. At the culmination of the group discussion, participants will use dot-polling,
which is an interactive process used during planning to prioritize items. Charette
participants will synthesize draft recommendations that will be reviewed by experts and
finalized through a Delphi process to develop stakeholder consensus to define
population-level epidemiologic and community characteristics that identify who faces travel
burden and where interventions are warranted to reduce travel burden for Black men with PCa.
What is the Delphi process?
The Delphi process is a consensus method used to systematically collect expert opinions. It
has been used widely in healthcare research to set priorities and develop practices when
obtaining high-level scientific evidence is impractical. The technique provides a transparent
and rigorous basis for assessing expert opinion and involves asking a panel to take part in a
series of rounds to identify, clarify, and refine thinking around topics. The investigators
will use a modified Delphi approach, which limits the number of rating rounds and relies to
some extent on anonymity, feedback, and replication so that individuals can express opinions
without being unduly influenced by others. Since the Delphi process is an iterative process
with a 2-week turnaround for each step, it will be held separately from the town hall meeting
and entirely over Zoom.
The investigators will select and invite the Delphi panel members based on guidance from the
stakeholder board, with the goal of ensuring that patients', community-based organizations',
clinicians', hospital administrators', transport planners', and national policymakers'
perspectives are all represented. The investigators will recruit approximately 25 members for
the Delphi process, making sure that relevant perspectives inform the discussion, and that
all have a chance to contribute meaningfully. The investigators will select participants who
are geographically, racially, ethnically, and professionally diverse. The investigators will
include experts in transportation planning, public health, health disparities, community
engagement, and patient advocacy.
The process will consist of the following steps. The draft recommendations, as developed
through charette-style discussion will be developed into an integrated list of
recommendations and used for the Delphi process. Following this, the investigators will hold
4 rounds: Round 1 - Participants will review the draft list of recommendations that will
identify those at risk of travel burden and identify a threshold for travel burden that
warrants an intervention, add any comments, and suggest others to add to the list (2-week
turnaround); Round 2 - Participants will rate each item on the list (2 weeks). The
traditional 9-point scale will be used, where 1 = not important and 9 = most important.
Results will be tabulated and distributed to all participants, with votes indicated so that
participants can see how each question was answered relative to other voters; Round 3 - A
webinar conference will be held with care taken to achieve a power balance and include
perspectives of the virtual participants. Round 4 - Approximately 4 weeks later, the
investigators will hold a concluding conference call to give participants an opportunity to
discuss the results of the webinar and to offer ideas for dissemination or additional
research. The goal is to go beyond merely stating that ridesharing services should be offered
to high-risk and underserved populations, but rather, to seek explicit strategic advice for
the feasibility and implementation of ridesharing services. Although the investigators cannot
say ahead of time what those recommendations will be, the investigators would expect these to
include strategies to align rideshare services with existing clinical structures and systems
for reimbursement of services as well as an infrastructure to include a partnership and
communication between rideshare options and clinical staff.
