Developing and Optimizing Best Practice Solutions for Implementation of Population Based Cancer Genetic Services in Federally Qualified Health Centers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Uptake of genetic testing
研究概览
简要总结
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 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 the MGT compared with the 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.
The study will take place at four community health clinics that are part of a Federally Qualified Health Center (FQHC) network in Chicago. Each clinic will use one of two ways of providing cancer genetic services: an enhanced standard of care model that includes patient navigation support (SOC+), or a mainstream genetic testing model (MGT) in which primary care providers offer testing directly. Information such as patients' demographic characteristics, referrals for genetic counseling, completion of genetic testing, and how long it takes to complete testing will be collected from clinic records. Patients, healthcare providers, and clinic staff will also be invited to take part in interviews to share their experiences and perspectives on how each model worked in practice.
详细描述
More than 15 years after the release of evidence-based guidelines recommending hereditary cancer risk assessment and testing for at-risk individuals, fewer than one in five eligible patients receive this care. Utilization of cancer genetic services remains substantially lower among racial and ethnic minority populations. Addressing inequities in access to these services is essential, as approximately 10 to 15 percent of cancers are linked to inherited mutations, and early identification of high-risk individuals can support prevention and early detection strategies that reduce disparities in cancer outcomes.
Multiple social determinants of health (SDoH) contribute to limited access to genetic services among underserved populations. At the clinic level, many community health centers have limited capacity to systematically identify at-risk patients, employ few or no genetic specialists, and must rely on external systems for genetic counseling and testing. At the provider level, primary care clinicians often report low confidence and limited training in cancer genetics, while genetic specialists may have limited presence or integration in these care settings. At the patient level, structural, economic, and cultural barriers continue to restrict engagement in genetic testing and counseling.
This project will evaluate and compare two models of cancer genetic service delivery in primary care to improve equitable access among patients served by Federally Qualified Health Centers (FQHCs). The enhanced standard of care model (SOC+) uses universal electronic hereditary cancer risk assessment (HCRA) to identify eligible patients, combined with patient navigation to address individual barriers such as financial concerns and literacy needs. The mainstream genetic testing model (MGT) embeds genetic testing directly into primary care visits, allowing patients to receive education, counseling, and test ordering from their primary care provider without referral to specialty care.
Aim 1: Compare the effectiveness of MGT and SOC+ on uptake of genetic testing among minority patients receiving primary care within an urban FQHC system.
Aim 2: Evaluate implementation outcomes (acceptability, feasibility, and sustainability) and identify barriers and facilitators to cancer genetic service delivery in primary care using qualitative interviews with patients, providers, and clinic staff, guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aim 1 and 2 Inclusion Criteria for patients
- •Adults age 25+
- •English speaking
- •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 4 Federally Qualified Health Center clinics enrolled in the clinical trial
排除标准
- •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 one of the clinics enrolled in the clincial trial
- •Inclusion Criteria for Providers/Staff:
- •Provider or staff member at one of the 4 clinics participating in the clinical trial
- •English speaking
- •Exclusion Criteria:
- •1. Does not meet inclusion criteria above
研究组 & 干预措施
MGT (Mainstream Genetic Testing) Model
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.
干预措施: Mainstream Genetic Testing Model (Other)
SOC (Standard of Care) Model
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.
干预措施: Enhanced Standard of Care Model (Other)
结局指标
主要结局
Uptake of genetic testing
时间窗: 2 years
compare the uptake of genetic testing among patients in both models of cancer genetic delivery who screen positive on hereditary cancer risk asserssment (HCRA)
次要结局
- Evaluate the implementation outcomes (acceptability, feasibility and sustainability) and the barriers and facilitators of cancer genetic service delivery approaches within primary care at FQHCs(2 years)
- Time to genetic testing(2 years)
研究者
Pamela Ganschow
Principal Investigator
University of Illinois at Chicago
