Table 4.
Access barriers and barrier evaluation and mitigation strategies identified in CSER project case studies
| Study name (Lead Institution) | Anticipated and encountered barriers to carea | Strategies to evaluate and mitigate barriers to care |
|---|---|---|
| CHARM (Kaiser Permanente Northwest) | Financial: - Cost/affordability issues - High uninsured rate - Limited referral options due to patient having public or no insurance - Disruptions in care (e.g., even with discount program, lapses in enrollment can create barriers to care) - Patient lack of primary care or incomplete family history impeding identification of indications for services Organizational: - Patient/provider time limitations - Transport/travel limitations - Referral-related challenges for genetic services (counseling, testing, etc.) - Lack of clinician knowledge about/ability to navigate referral options Social: - Lower literacy levels |
- Manage informed consent, saliva sample collection by mail and results disclosure by phone. - Offer streamlined online process for cancer risk assessment and standardized collection of family history. - Evaluate the Accessible, Relational, Inclusive and Actionable (ARIA) model for genetic counseling. - Compile list of community resources for patients. - Conduct interviews to better understand referral barriers and inform planning (e.g., make the case for bringing more genetic services in-house at Federally Qualified Health Centers). |
| ClinSeq (NIH/NHGRI) | Beliefs and perceptions: - Low awareness of research/genetics - Mistrust of researchers and health care system Financial: - Cost/affordability issues Organizational: - Patient time limitations - Transport/travel limitations |
- Use a recruiter from similar demographic background as underrepresented and/or underserved groups for in person recruitment. - Offer personalized/tailored recruitment. - Conduct focus groups to inform strategies to mitigate barriers to participation in clinical genomic research. - Develop targeted recruitment materials for underrepresented and/or underserved groups. - Return value to participants in the form of personal sequencing and other individual results. |
| KidsCanSeq (Baylor College of Medicine) | Financial: - Cost/affordability issues - High uninsured rate - Provider limitations due to patient having public insurance Social: - Language barriers/limited English proficiency - Cultural discordance between patients/parents/participants and clinicians/researchers - Lower literacy levels Organizational: - Access barriers to follow-up testing and care |
- Pilot test Spanish surveys to improve wording for language accessibility. - Employ bilingual staff at each clinical site. - Use trained medical interpreters to help communicate genomic sequencing results to families. - Assess Spanish-preferring participants’ perceptions of and satisfaction with Spanish interpretation. - Assess barriers to follow-up testing and care via interviews and open-ended survey items. |
| NCGENES 2 (University of North Carolina) | Financial: - Cost/affordability issues - High uninsured rate Social: - Low levels of active caregiver engagement - Mistrust of health care system Organizational: - Parent/family time limitations - Transport/travel limitations |
- Employ recruiters from similar demographics. - Recruit representative community stakeholder team to guide materials development, recruitment methods, and provide insight throughout. - Develop a plain-language pre-visit preparatory booklet with question prompt list through stakeholders’ input to support caregiver efficacy and engagement in child’s pediatric specialty appointments. - Use mixed methods (transcript analysis, surveys of caregivers and providers) to capture the effect of the preparatory materials on promoting active engagement of medically underserved patients. - Use surveys to assess caregiver experience, and understanding. - Use algorithms in clinical and claims data to identify patients who might benefit from but are not currently receiving genetic testing. |
| NYCKidSeq (Icahn School of Medicine at Mount Sinai & Montefiore Medical Center) | Financial: - Insurance denials of coverage for genetic panel testing Organizational: - Limited access to referred specialists and specialty care - Doctor unavailable Social: - Language barriers/limited English proficiency - Language discordance with clinicians |
- Develop a novel communication tool, Genomic Understanding, Information and Awareness (GUÍA) that allows providers to create a visual and narrative guide for personalized return of results in English or Spanish via a web-based platform. - Test GUÍA to facilitate the return of genomic sequencing results in English and Spanish. |
| P3EGS (University of California, San Francisco) | Financial: - Transport/travel limitations - Cost/affordability issues Organizational: - Parent/family time limitations - Disparities in access to prenatal specialty care - Some patients unable to follow through with referrals |
- Conduct interviews with families to explore full range of barriers to care (medical and non-medical support services). - Explore referral/enrollment barriers by conducting interviews with clinicians who refer patients for genetics consultation and work with medically underserved patients. - Offer virtual clinic appointments. |
| SouthSeq (HudsonAlpha Institute for Biotechnology) | Financial: - Cost/affordability issues Organizational: - Parent/family time limitations - Transport/travel limitations - Lack of social and clinical services in rural communities |
- Conduct interviews with clinicians and families to understand barriers and facilitators to accessing comprehensive genomic health services for newborns, and gaps in support. - Use of engagement studios to tailor recruitment and counseling materials to the needs of families. - Literacy expert review of written study materials and revision of materials using plain language. |
CSER, Clinical Sequencing Evidence-Generating Research consortium; NIH, National Institutes of Health; NHGRI, National Human Genome Research Institute; CHARM, Cancer Health Assessments Reaching Many; NCGENES 2, North Carolina Clinical Genomic Evaluation by Next-generation Exome Sequencing 2; P3EGS, Program in Prenatal and Pediatric Genome Sequencing; ARIA, Accessible, Relational, Inclusive and Actionable; GUÍA: Genomic Understanding, Information and Awareness.
a
Categories adapted from Andersen et al. [17]:
Beliefs and perceptions: attitudes, values, knowledge, perception of importance/magnitude of health issue.
Social: education, occupation, race and ethnicity, social networks.
Financial: insurance, cost, cost-sharing.
Organizational: nature of sources of care, transportation, travel time, waiting time.