Families and patients as partners in hospital‐based research

Even after I became a “seasoned” hospital parent, I remember feeling physically, mentally and emotionally exhausted all the time. I remember not wanting to bother anyone and feeling stupid about asking questions. I still feel that way even after many years of hospital visits. I never want to take away from other patient's care when I have a question about something that may seem silly in comparison to other situations. In addition, I was so exhausted and worried that I couldn't retain anything I was being told. I also remember being frustrated with a certain situation that took place while in this state of shear exhaustion. While I was rocking my child trying to comfort him as he was very agitated from being ill, someone came into our room to ask me social work type questions. I completely understand that these things are necessary, at that point I really just needed rest with my child. This is one experience in particular that I remember. I also remember being scared to death at the different alarms going off that I didn't understand. Now that I have had more hospital experience and understand more about what they mean, I don't necessarily worry about them, but it is an annoyance when trying to rest with my child. Hospital-based research is critical to improve care and outcomes for acutely ill children. However, research is not likely to be top of mind for many families in the hospital with their child, especially those admitted for the first time. As the field of Pediatric Hospital Medicine grows, so does interest and capacity to conduct studies in the hospital setting. Just like clinical care, in research the perspective and expertise of patients and their families should be of paramount importance. Parents and other caregivers (hereafter referred to as families) are essential in supporting their child during hospitalization and in carrying out care plans after discharge. Their singular knowledge about their child and their family's context is also crucial to informing research at all stages. Including the voice of families before and during the research process can help ensure that the study is relevant to patients and parents and can facilitate successful recruitment and retention as well as uptake of study findings. However, familiar to those of us who practice inpatient medicine, hospitalization is a stressful time for families. The uniqueness of the hospital experience has implications for how best to engage parents and patients in hospital-based research. In this commentary, we discuss the continuum of parent and patient engagement that researchers may apply for hospital-based studies. While we focus primarily on engaging pediatric patients and their families, we believe our suggestions here can also be applied to adult patient engagement. We consider aspects of research where family input can be pivotal, barriers to engagement for hospital-based studies, and opportunities for innovation. Engaging the participants of research in the research process itself, often termed stakeholder/partner engagement or peer engagement, is an requisite step in the participatory research paradigm1; and many organizations have guidance on best practices for engagement.2-4 The level of engagement can be viewed on a continuum ranging from focused input in which the research participant serves in an advisory capacity (can be short-term5 or longer-term6), to scenarios where the research participants also serve as partners in the research team and collaboratively define study goals and conduct the research, including conducting and analyzing data.6 Not only is there an ethical imperative to understand the perspectives of research participants, but years of research drawing from community-based participatory research models demonstrate the benefit to research and participants.7 Further, partnering with patients in developing research questions improves their relevance to the target population. Family and patient perspectives are critical for helping researchers understand what types of interventions are likely to be most effective in the hospital setting.8-11 This includes interventions aimed at helping doctors and nurses practice according to evidence-based guidelines. Studies suggest that family and patient preference, both stated and perceived, are a factor when clinicians decide whether or not to follow guidelines.12, 13 For studies aiming to implement new practice standards, the family/patient perspective is especially helpful when clinicians are likely to struggle with cognitive biases such as loss aversion (i.e., how losses are more heavily weighted than gains) or action bias (i.e., the general preference for action over inaction).14-16 Ensuring that families’ and patients’ preferences and needs are accounted for is likely to make adoption of new interventions more feasible. Furthremore, engaging parents allows for better dissemination and implementation of study outcomes in relevant settings. As research increases in the inpatient pediatric setting, researchers face challenges to engaging families and patients in the research process. When the research focuses on improving aspects of hospital care for high-volume but self-limiting conditions like bronchiolitis, this may be the family's only experience with hospitalization. Furthermore, regardless of the reason for hospitalization, after the child is discharged the family may (understandably) want to move past the experience. While most hospitals have family advisory councils, they often don't reflect the full range of personal backgrounds and circumstances. Anecdotally, they draw families whose children have frequent contact with the healthcare system. While those families’ input is clearly valuable, their perspective is going to be different from families who have little/no interaction with the health system or who don't have the financial resources or time to volunteer.17, 18 Finally, when relevant, youth perspectives can be invaluable to study teams; however, researchers should take care to consider developmental appropriateness of engagement activities and compensation, how to structure engagement to minimize power imbalance, and adherence to regulatory and ethical standards. Acknowledging all of these realities—that family and patient engagement in research is valuable but can be challenging—what approach should hospital-based researchers use? We offer several suggestions to improve feasibility of getting input, accessibility of opportunities to families, and efficiency. Qualitative research is distinct from engaging families and patients in the research process; however, it can serve as a structured and rigorous way to gain input. Qualitative methods to explore clinician perspectives, preferences, needs, and workflows are a common step in preparation for implementation studies. A similar approach can be applied with families. For instance, conducting semi-structured interviews during hospitalization may improve feasibility of participation for some families. Brief qualitative interviews have been previously used in the context of a clinical trial to improve recruitment and retention of subjects.5, 19 Additionally, this same study used family and nurse feedback to optimize a post-discharge home visit intervention before a randomized control trial.20 In other work aiming to de-implement overuse of continuous vital sign monitors,21 qualitative interviews uncovered the common perception, unknown to the study team, that the continuous monitors were the only reason a child was hospitalized, and that the monitors helped parents feel connected to their child's care.21 Rooted in these findings, researchers created an educational video (https://www.youtube.com/watch?v=WULHPgv76AU) focused on the role of monitors in the hospital and rooted in those findings. Preferred timing and extent of family engagement is likely to vary by study and so in addition to drawing on more flexible qualitative methods, adaptability is key. Some studies may benefit from having longitudinal family or patient engagement, as parent or patient co-investigators, even if their experience differs slightly from the research participants in the study. One ongoing clinical trial22 has engaged three parent co-investigators throughout the 3-year study period. Other studies may benefit from shorter-term, focused engagement5; for example, feedback from participants intervention design or study experience. The fields of action research23 and youth participatory action research have established approaches that can enable all of these approaches and facilitate existing workflows. Researchers should encourage engagement, regardless of family circumstance. In addition to providing virtual meeting options at a variety of times for family or patient co-investigators, meeting leaders should communicate at an appropriate level, actively solicit feedback, and offer childcare and refreshments. Offering multiple modalities (e.g., email, text) may result in more respondents providing input. Importantly, research budgets should include appropriate compensation for family and patient partners. In future work, it will be important to innovate while defining engagement best practices. Creative solutions, such as just in-time education about ongoing research studies and real-time tracking of family/patient willingness to be approached for different types of input and interest in longer-term research engagement could be investigated in the context of larger studies. Just as newer models for consent advocate for integrating the consent process into clinical workflows,24 opportunities for engagement in hospital-based studies could align with institutional data gathering. Despite the challenges, engaging patients and their families throughout the research process demonstrates tremendous potential for improving the quality of research, capacity to disseminate results, and improving the experience of engagement for patient-families and researchers. Dr. Amanda Schondelmeyer's effort in contributing to this manuscript was partly funded by the Agency for Healthcare Research and Quality (Grant# K08 HS026763). The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding organizations. The funding organizations had no role in the design, preparation, review, or approval of this paper. Dr. Amanda Schondelmeyer is supported by the Agency for Healthcare Research and Quality (K08 HS026763) and the National Heart Lung and Blood Institute (U01HL159880, PI Bonafide). Dr. Ashley Jenkins is supported by a K23 award from the National Heart, Lung, and Blood Institute (K23HL17588-01d). The authors declare no conflicts of interest.