Considerations When Designing and Implementing Pragmatic Clinical Trials That Include Older Hispanics

Abstract

Introduction Pragmatic clinical trials (PCTs) are designed to connect researchers with clinicians to assess the real-world effectiveness and feasibility of interventions, treatments, or health care delivery strategies in routine practice. Within PCTs larger, more representative sampling is possible to improve the external validity of the research. Older adults from underrepresented groups can benefit from PCTs given their historically lower engagement in clinical research. The current article focuses on older Hispanic adults with Alzheimer disease and related dementias (ADRDs). Older Hispanic adults represent 19% of the US population and have a higher prevalence of ADRDs than Whites. We provide data from 2 PCTs about the recruitment of older Hispanics with ADRDs and discuss unique challenges associated with conducting PCTs and propose strategies to overcome challenges. Data and Methods The first PCT outlined is the Patient Priorities Care for Hispanics with Dementia (PPC-HD) trial. PPC-HD is testing the feasibility of implementing a culturally adapted version of the Patient Priorities Care approach for older Hispanic adults with multiple chronic conditions and dementia. The second PCT is the Dementia Care (D-CARE) Study, which is a multisite pragmatic study comparing the effectiveness of a health care system–based approach and a community-based approach to dementia care to usual care in patients with ADRDs and their family caregivers. Lessons Learned and Recommendations for Future Studies The lessons learned are summarized according to the various stakeholders that need to work together to effectively recruit diverse participants for PCTs: individuals, health care systems, research teams, and communities. Individual-level considerations include communication, priorities, and flexibility. Health care system–level considerations are grounded in 4 principles of Community-Based Participatory Research and include collaboration/partnership, available resources, priorities of the health care system, and sustainability. Research team–level considerations include team members, intentionality, and communication. Community-level considerations highlight the importance of partnerships, community members, and appropriate incentives. Discussion PCTs provide a unique and potentially impactful opportunity to test interventions in real-world settings that must be culturally appropriate to reach underrepresented groups. Collectively, considering variables at multiple levels to address the needs of older adults with ADRDs is crucial, and the examples and suggestions provided in this report are a foundation for future research.