Implementation of Population Breast Cancer Genetic Services in Federally Qualified Health Centers (FQHC)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Developing and Optimizing Best Practice Solutions for Implementation of Population Based Cancer Genetic Services in Federally Qualified Health Centers

Conditions
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Hereditary Cancer Syndrome

Intervention / Treatment
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* Other: Mainstream Genetic Testing Model
* Other: Enhanced Standard of Care Model


Participation Criteria
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Eligibility Criteria
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Aim 1 and 2 Inclusion Criteria for patients Adults age 25+ English speaking Self identifies race as African American or Black Identified as eligible for cancer genetic testing for a hereditary breast or colon cancer syndrome (e.g., BRCA, Lynch or familial polyposis syndrome) as defined by NCCN criteria45-46 Screened positive and agreed to have study staff contact them in the future to participate in virtual/telephone interviews about their experiences with cancer genetics services. Patient receiving care from one of the 2 Mile Square Health Centers enrolled in the clinical trial Exclusion Criteria: Did not meet the inclusion criteria Did not screen positive on HCRA and/ or did not agree to have study staff contact them in the future to participate in virtual/telephone interviews about their experiences with cancer genetics services. Not a patient receiving care from the Mile Square Health Centers enrolled in the clincial trial Aim 2 Inclusion Criteria for Providers/Staff: Provider or staff member at one of the 2 MSHC clinics enrolled in the clinical trial English speaking Exclusion Criteria: 1. Does not meet inclusion criteria above

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: clinical trial with a hybrid effectiveness-implementation design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MGT (Mainstream Genetic Testing) Model<br>The mainstream genetic testing (MGT) model of cancer genetic services involves a non-genetics healthcare provider, such as the primary care provider, who engages patients in the counseling, consenting, and ordering of genetic testing. The provider/care team discloses the genetic test results and refers patients for genetic counseling only when genetic test results are abnormal. By eliminating the pre- and post-test counseling visits with a genetics provider, the MGT model has the potential to provide scalable access to genetic services. | Other: Mainstream Genetic Testing Model<br>* Mainstream Genetic Testing Model of Cancer Genetics Service Delivery<br>* Other names: MGT;|
| Active Comparator: SOC (Standard of Care) Model<br>The enhanced standard of care model (SOC+) is the current referral model of cancer genetic services delivery with an enhancement to include screening for and resources to address health literacy. This model begins with a health care provider's recognition, identification and then referral of a patient to a genetic counselor where genetic testing takes place if appropriate. This model is time- and resource- intensive and may not be scalable. | Other: Enhanced Standard of Care Model<br>* Enhanced Standard of Care Model of Cancer Genetic Service Delivery<br>* Other names: SOC+;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of genetic testing | compare the uptake of genetic testing among patients in both models of cancer genetic delivery who screen positive on hereditary cancer risk asserssment (HCRA) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to genetic testing | Time from screening positive on HCRA to genetic testing | 2 years | 
| Evaluate the implementation outcomes (acceptability, feasibility and sustainability) and the barriers and facilitators of cancer genetic service delivery approaches within primary care at FQHCs | Qualitative interviews with patients and providers in the clinical trial, guided by the Explore, Prepare, Implement, Sustain (EPIS) implementation framework. | 2 years |