Well-Being, Psychological Clinical Trial
Official title:
A Phase I Clinical Trial Evaluating the Impact of the Family Room App on Caregiver Well-being, Satisfaction, and Engagement in the Intensive Care Unit
BACKGROUND/PURPOSE: Engaging families in patient care during serious illness can enhance care quality, reduce social isolation, boost satisfaction, and lower healthcare costs. Active involvement of family caregivers in patient care remains limited because there are no evidence-based tools to guide clinicians on how to include them effectively. Therefore, the purpose of this study is to conduct a clinical trial that includes information developed while engaged in previous work related to the development and testing of a point-of-care technology that operationalizes caregiver involvement during acute hospitalization The investigators engaged in hypothesis driven customer discovery, then performed an iterative user centered design development and testing process, and now conclude with a clinical trial in the inpatient environment.
For this phase 1 clinical trial, the investigators will use a 2-stage sequential cohort design with repeated measures The investigators will recruit a total of 100 family caregivers of ICU patients from 5 ICUs at a single tertiary medical center over an 18-month period. A convenience sampling technique will be used to recruit participants in the control group (n=50) followed by participants in the experimental group (n= 50). Participants will be eligible if they are age 19 or older and at the patient's bedside during the patient's ICU admission. Data will be measured at 2 timepoints (study enrollment [T1] and within 48 hours of ICU discharge [T2]), with the primary endpoint (caregiver well-being) being measured more frequently (every 48 hours while the patient is admitted to the ICU). Data will be collected through structured interviews using pre-designed questionnaires. Patient specific data will be extracted via chart review from the medical record. The questionnaires will include items related to demographic variables, caregiver psychological distress, engagement, and satisfaction. Trained research assistants will conduct either face to face, virtual (via Zoom), or phone depending on the participant's preference and availability. During the first 8 months of recruitment, participants will be enrolled into the control group which consists of routine care and informational practices of the ICU team. During the last 10 months of recruitment, participants will be enrolled into the experimental group where they will receive the Family Room application on their personal devices. Conditions will be implemented in sequential order, not concurrently. This is a practical approach because it is reasonable to expect that only slight variations will exist between the demographics of the initial cohort (control condition) The investigators will test differential selection post hoc to identify whether the caregivers differentiated in any systematic way on variables that might be related to the intervention outcomes (professional caregiving experience, confidence in caregiving ability, patient's severity of illness, etc). In addition, the use of 5 different ICUs is intended to dampen any historical effects experienced within a single unit. Intervention Details (Family Room App). The Family Room is a dynamic, point of care tool that holds the power to profoundly change family caregiver involvement. It guides families on how best to contribute to patient care by providing real time education, a sense of connection, emotional support, and resources that enable meaningful caregiving. Importantly, family caregivers receive virtual training on comfort-focused care activities that can be done at the bedside, as well as a mechanism within the electronic health record (EHR) to measure and record the effectiveness of the care they provide. The app has been developed in partnership with nurses and family caregivers and will be connected with the EHR to ensure family caregivers' contributions are visible to all members of the health care team. ;