Equity Concerns Across Pediatric Research Recruitment: An Analysis of Research Staff Interviews.

BACKGROUND AND OBJECTIVES: Difficulty recruiting individuals from minoritized and underserved populations for clinical research is well documented and has health equity implications. Previously, we reported findings from interviews with research staff about pediatric research recruitment processes. Respondents raised equity concerns related to recruitment and enrollment of participants from minoritized, low resourced, and underserved populations. We therefore decided to perform a secondary coding of the transcripts to examine equity-related issues systematically. METHODS: We conducted a process of secondary coding and analysis of interviews with research staff involved in recruitment for pediatric clinical research. Through consensus we identified codes relevant to equity and developed a conceptual framework including 5 stages of research. RESULTS: We analyzed 28 interviews and coded equity-related items. We report 6 implications of our findings. First, inequitable access to clinical care is an upstream barrier to research participation. Second, there is a need to increase research opportunities where underserved and under-represented populations receive care. Third, increasing research team diversity can build trust with patients and families, but teams must ensure adequate support of all research team members. Fourth, issues related to consent processes raise institutional-level opportunities for improvement. Fifth, there are numerous study procedure-related barriers to participation. Sixth, our analysis illustrates that individuals who speak languages other than English face barriers across multiple stages. CONCLUSIONS: Research staff members identified equity-related concerns and recommended potential solutions across 5 stages of the research process, which may guide those endeavoring to improve research recruitment for pediatric patients from minoritized and underserved populations.

Pilot Evaluation of the Family Bridge Program: A Communication- and Culture-Focused Inpatient Patient Navigation Program.

OBJECTIVE: Children with low income and minority race and ethnicity have worse hospital outcomes due partly to systemic and interpersonal racism causing communication and system barriers. We tested the feasibility and acceptability of a novel inpatient communication-focused navigation program. METHODS: Multilingual design workshops with parents, providers, and staff created the Family Bridge Program. Delivered by a trained navigator, it included 1) hospital orientation; 2) social needs screening and response; 3) communication preference assessment; 4) communication coaching; 5) emotional support; and 6) a post-discharge phone call. We enrolled families of hospitalized children with public or no insurance, minority race or ethnicity, and preferred language of English, Spanish, or Somali in a single-arm trial. We surveyed parents at enrollment and 2 to 4 weeks post-discharge, and providers 2 to 3 days post-discharge. Survey measures were analyzed with paired t tests. RESULTS: Of 60 families enrolled, 57 (95%) completed the follow-up survey. Most parents were born outside the United States (60%) with a high school degree or less (60%). Also, 63% preferred English, 33% Spanish, and 3% Somali. The program was feasible: families received an average of 5.3 of 6 components; all received >2. Most caregivers (92%) and providers (81% [30/37]) were "very satisfied." Parent-reported system navigation improved from enrollment to follow-up (+8.2 [95% confidence interval 2.9, 13.6], P = .003; scale 0-100). Spanish-speaking parents reported decreased skills-related barriers (-18.4 [95% confidence interval -1.8, -34.9], P = .03; scale 0-100). CONCLUSIONS: The Family Bridge Program was feasible, acceptable, and may have potential for overcoming barriers for hospitalized children at risk for disparities.

Implementation of a community health worker-focused team-based model of care: What modifications do clinics make?

Background: Team-based care offers potential for integrating non-clinicians, such as community health workers (CHWs), into the primary care team to ensure that patients and families receive culturally relevant care to address their physical, social, and behavioral health and wellness needs. We describe how two federally qualified health center (FQHC) organizations adapted an evidence-based, team-based model of well-child care (WCC) designed to ensure that the parents of young children, aged 0-3, have their comprehensive preventive care needs met at WCC visits. Methods: Each FQHC formed a Project Working Group composed of clinicians, staff, and parents to determine what adaptations to make in the process of implementation of PARENT (Parent-Focused Redesign for Encounters, Newborns to Toddlers), a team-based care intervention that uses a CHW in the role of a preventive care coach. We use the Framework for Reporting Adaptations and Modifications to Evidence-based interventions (FRAME) to chronicle the various intervention modifications and the adaptation process, focusing on when and how modifications occurred, whether it was planned or unplanned, and the reasons and goals for the modification. Results: The Project Working Groups adapted several elements of the intervention in response to clinic priorities, workflow, staffing, space, and population need. Modifications were planned and proactive, and were made at the organization, clinic, and individual provider level. Modification decisions were made by the Project Working Group and operationalized by the Project Leadership Team. Examples of modifications include the following: (1) changing the parent coach educational requirement from a Master's degree to a bachelor's degree or equivalent experience to reflect the needs of the coach role; (2) the use of FQHC-specific templates for the coach's documentation of the pre-visit screening in the electronic health record; and (3) the use of electronic social needs referral tools to help the coach track and follow up on social need referrals. The modifications did not change the core elements (i.e., parent coach provision of preventive care services) or intervention goals. Conclusions: For clinics implementing team-based care interventions, the engagement of key clinical stakeholders early and often in the intervention adaptation and implementation process, and planning for intervention modifications at both at an organizational level and at a clinical level are critical for local implementation.

A Parent Coach-Led Model of Well-Child Care for Young Children in Low-Income Communities: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: The Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) intervention was created as a team-based approach to well-child care (WCC) that relies on a health educator (Parent Coach) to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. OBJECTIVE: This study aims to evaluate the impact of PARENT using a cluster randomized controlled trial. METHODS: This study tested the effectiveness of PARENT at 10 clinical sites in 2 federally qualified health centers in Tacoma, Washington, and Los Angeles, California. We conducted a cluster randomized controlled trial that included 916 families with children aged ≤12 months at the time of the baseline survey. Parents will be followed up at 6 and 12 months after enrollment. The Parent Coach, the main element of PARENT, provides anticipatory guidance, psychosocial screening and referral, developmental and behavioral surveillance, screening, and guidance at each WCC visit. The coach is supported by parent-focused previsit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical examination and any concerns that require a clinician's attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines. We will examine parent-reported quality of care (receipt of nationally recommended WCC services, family-centeredness of care, and parental experiences of care), and health care use (WCC, urgent care, emergency department, and hospitalizations), conduct a cost analysis, and conduct a separate time-motion study of clinician time allocation to assess efficiency. We will also collect data on exploratory measures of parent-and parenting-focused outcomes. Our primary outcomes were receipt of anticipatory guidance and emergency department use. RESULTS: Participant recruitment began in March 2019. After recruitment, 6- and 12-month follow-up surveys will be completed. As of August 30, 2021, we enrolled a total of 916 participants. CONCLUSIONS: This large pragmatic trial of PARENT in partnership with federally qualified health centers will assess its utility as an evidence-based and financially sustainable model for the delivery of preventive care services to children in low-income communities. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03797898; https://clinicaltrials.gov/ct2/show/NCT03797898. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27054.