Development and testing of novel approaches for the first research contact of hospitalized patients

Background and Significance: The initial patient contact in clinical research recruitment is a crucial yet complex task, involving ethical, regulatory, and logistical considerations. However, this complexity can hinder patient autonomy, limit recruitment of underrepresented groups, and slow patient-centered research. Our proposal addresses the methodological gap of a lack of generalizable, tested, solutions to the variable and often restrictive institutional policies around first contact of patients for clinical research. Our results will be important to stakeholders from patients and caregivers to IRBs and investigators, as first contact is the most crucial task in screening and recruitment, and novel ways to accomplish this task will have broad impact across all patient centered research. Objectives: Our overarching Goal is to develop and test novel patient-centered approaches for the very first step in clinical research recruitment – the initial patient contact. We focus on acutely ill hospitalized patients, both adults and children, as most existing approaches for first contact are optimized for outpatient research, and pediatric health has long been understudied. Our Specific Aims are: 1. Develop multiple consensus approaches for first research contact of hospitalized patients through structured collaborative sessions with patient, caregiver, and professional stakeholders. 2. Test novel approaches for first contact in actively enrolling studies, using convergent mixed methods formative evaluation. Study Design or Approach: For Aim 1 (Development) we will start with focus groups with patient and caregiver stakeholders with recent hospitalized experience (n = 32) to explore perceptions of current approaches. We will then conduct nominal group technique sessions comprised of both professional stakeholders and representatives from the patient/caregiver focus groups (total n for two sessions = 16). These sessions will develop and formally rank alternative approaches to first contact. We will conduct engagement studios with additional patients and caregivers (n = 16), and frontline hospital professionals (n = 16), to identify perceived barriers and facilitators. For Aim 2 (Testing), we will test the approaches in multiple enrolling studies, using a convergent mixed methods design. Qualitative interviews with patients and caregivers (n = 96) contacted via these approaches, as well as front-line hospital professionals (n = 80), will gauge stakeholder perceptions. Quantitative statistical process control methods will assess research opportunity provision over time, in multiple trials (n>6), drawing from electronic health records and data capture forms. Continuous quality improvement will guide adaptations based on this mixed-methods evaluation. Both aims will benefit from the input of a longitudinal patient and caregiver advisory committee, ensuring ongoing consultation and meaningful engagement throughout the project. Our proposal aligns with our institutions’ commitment to undertake a multi-year revision of research operations, including approaches to first contact. This effort coincides with a major EHR upgrade across our health system that will provide new mechanisms for first contact. While our proposal is independent of these institutional projects, we will leverage their momentum, ensure patient and caregiver voices are heard, and harness this natural opportunity to generate new knowledge on optimal ways to conduct first contact. Study Protocol Submitted