Abstract
BACKGROUND: Over the last decade, health care delivery has shifted to partnering with patients and their families to improve health and quality of care, and to lower costs. Partnering with family members (FMs) of critically ill patients who lack capacity is particularly important for improving experiences and outcomes for both patients and FMs. How best to apply such partnering strategies, however, is yet unknown. The IMPACT trial will evaluate two interventions that enable partnerships with families of critically ill patients, each in a distinct content area, but similar in that they empower and support FMs. METHODS: This multi-center, open-label, randomized, phase II clinical trial aims to randomize 150 older, long-stay ICU patients and their families into one of three groups (50 in each group): (1) The OPTimal nutrition by Informing and Capacitating FMs of best practices (OPTICs) group, a multi-faceted intervention to engage and empower FMs to advocate for, and audit, best nutritional practices for their critically ill FMs, (2) A web-based decision-support intervention called the ICU Workbook (The Canadian Researchers at the End of Life Network (CARENET) ICU Workbook; https://www.myicuguide.ca/ . Accessed 3 Feb 2017.) to support families in shared decision-making process regarding goals of medical treatments, and (3) Usual care. The main outcomes for this trial include nutritional adequacy in hospital and hand-grip strength prior to hospital discharge; satisfaction with decision-making; decision conflict; and degree of shared decision-making. DISCUSSION: With the goal of improving the functional recovery of nutritionally high-risk older patients and the quality of care at the end of life for these patients and their FMs in the ICU, we have proposed two novel family capacitation strategies. We hope that the nutrition and decision-support interventions implemented and evaluated in our study will contribute to the evidentiary basis for best family partnered care pathways focused on optimizing the quality of ICU care for patients with life-threatening illness and their families. TRIAL REGISTRATION: Clinical trials.gov, ID: NCT02920086 . Registered on 30 September 2016. Protocol version dated 11 October 2016.