Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05664867 |
| Other study ID # |
2022-1151 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 2023 |
| Est. completion date |
December 2027 |
Study information
| Verified date |
September 2023 |
| Source |
University of Illinois at Chicago |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is for researchers to compare the effectiveness of a
mainstreamed model of genetic testing (MGT) with an enhanced standard of care model (SOC+) on
the uptake of genetic testing among at risk patients in an urban Federally Qualified Health
Center (primary care) setting using a hybrid-effectiveness study design.
Aim 1 is to compare the effectiveness of MGT and SOC+ interventions on the uptake of genetic
testing among Black patients receiving primary care in an urban federally qualified health
center (FQHC) system using a randomized trial study design. The hypothesis is that the uptake
of testing will be higher among patients receiving services through MGT compared with SOC+
model.
Aim 2 is to evaluate the implementation outcomes (acceptability, feasibility and
sustainability) and the barriers and facilitators of cancer genetic service delivery
approaches within primary care at FQHCs via qualitative interviews with patients, primary
care providers and clinic staff, and organizational leaders, guided by the Explore, Prepare,
Implement, Sustain (EPIS) implementation framework.
Randomization of cancer genetic service models will occur at the clinic level. Participants
(patients, provider and staff) will be recruited to participate in interviews about their
experience with each model of care in the clinical trial.
Description:
More than 15 years after the release of evidence-based guidelines recommending hereditary
cancer risk assessment and testing for at-risk individuals, less than 1 in 5 patients
eligible for cancer genetic testing receive this evidence-based care.1-2 Utilization of
cancer genetics services is significantly lower among Black patients compared with White
patients. Addressing racial inequities in cancer genetic services is crucial, given that (1)
10-15% of cancers are caused by inherited mutations; and (2) early identification of high
risk Black patients can reduce disparities in cancer morbidity and mortality through
prevention and early detection.
Multilevel social determinants of health (SDoH) limit Black patients' access to cancer
genetic services. At the clinic level, Black populations often engage in care with clinics
with limited resources to systematically identify at-risk patients, have no or few genetic
specialists, and, have to outsource genetic services to other, potentially distant,
healthcare systems. At the interpersonal level, primary care providers lack confidence and
knowledge to deliver cancer genetics services9 and genetic specialists may not have
trustworthy relationships with Black patients. At the patient level, Black patients often
face economic, cultural, and educational barriers to genetic services.
There is an urgent need to develop innovative, multi-level, streamlined, and sustainable
system wide solutions to enhance cancer genetic services access and use. Extant standard of
care (SOC) at best resolves patient-level barriers through staff assistance for low literacy,
culturally targeted education materials, and access to free/low-cost services. Our team has
recently implemented an enhanced SOC (SOC+) in underserved clinical settings, which uses
universal standardized hereditary cancer risk assessments (HCRA) to identify at-risk
patients, informs providers about the need for referrals, and provides patient-level
interventions to enhance uptake (e.g., financial assistance, literacy support). Despite
better identification of at- risk patients, uptake of genetic services remains low with a
number of challenges remaining at provider (complexity of and confidence with care) and
clinic levels (time and resource intensive).
To address these challenges, our proposal will examine the effectiveness and implementation
of an alternative mainstream model of cancer genetic testing (MGT) into primary care. MGT
leverages patients' established relationship with their primary care provider (PCP) and care
team to address provider and clinic-level access issues. Specifically, patients receive risk
assessment and genetic testing in their medical homes, during regular visits, without
referral to a specialist. MGT thus efficiently reduces clinic-level demand for specialists
and referrals to specialty care; leverages trusted patient-provider relationships; and
maintains some benefits of SOC and SOC+ interventions. Past studies on MGT models have
focused primarily on cancer patients in oncology settings; thus, we have limited
understanding of how well MGT may address population- level disparities widely across primary
care sites with higher patient volumes and fewer clinic resources. To address this problem,
we propose to systematically test this alternative approach to reducing racial/ethnic
disparities through a hybrid effectiveness-implementation design. Specifically, we will:
Aim 1. Compare the effectiveness of MGT and SOC+ interventions on the uptake of genetic
testing among Black patients receiving primary care in an urban federally qualified health
center (FQHC) system using a randomized trial study design. Hypothesis: Uptake of testing
will be higher among patients receiving services through MGT compared with SOC+ model.
Aim 2. Evaluate the implementation outcomes (acceptability, feasibility and sustainability)
and the barriers and facilitators of cancer genetic service delivery approaches within
primary care at FQHCs via qualitative interviews with patients, primary care providers and
clinic staff, and organizational leaders, guided by the Explore, Prepare, Implement, Sustain
(EPIS) implementation framework.
Our work offers innovative solutions to increase equitable delivery of cancer prevention
services and overcome major gaps in the implementation of guideline-based care. Our project
leverages: (1) an unique, established, and robust partnership between a federally qualified
health center (FQHC), an academic institution, and specialty health services; and, (2) a
robust, transdisciplinary research team and advisory committee, employed to ensure that the
MGT model provides high quality care and is an acceptable and sustainable model that can work
for other FQHC systems after external funding ends. Successful integration, based on our
hybrid-effectiveness design, will inform the development of best practice solutions for
cancer genetic services delivery in underserved clinical settings. Ultimately, this will
reduce racial disparities in cancer.
