A randomised controlled trial of a nutrition and a decision support intervention to enable partnerships with families of critically ill patients

Aims and ObjectivesThe aim of the study was to investigate the effect of supporting family members to partner with health professionals on nutrition intakes and decision-making and to evaluate intervention and study feasibility. BackgroundFamily partnerships can improve outcomes for critically ill patients and family members. Interventions that support families to engage with health professionals require evaluation. DesignA multi-centre, randomised, parallel group superiority Phase II randomised controlled trial. MethodsIn nine intensive care units (ICUs) across three countries, critically ill patients >= 60 years, or those 55-59 years with advanced chronic diseases and expected ICU length of stay >72 h and their family member were enrolled between 9 May 2017 and 31 March 2020. Participants were randomised (1:1:1) to either a decision support or nutrition optimisation family-centred intervention, or usual care. Primary outcomes included protein and energy intake during ICU and hospital stay (nutrition intervention) and family satisfaction (decision support). Study feasibility was assessed as a composite of consent rate, intervention adherence, contamination and physician awareness of intervention assignment. ResultsWe randomised 135 patients/family members (consent rate 51.7%). The average rate of randomisation was 0.5 (0.13-1.53) per month. Unavailability (staff/family) was the major contributor to families not being approached for consent. Declined consent was attributed to families feeling overwhelmed (58/126, 46%). Pandemic visitor restrictions contributed to early study cessation. Intervention adherence for the decision support intervention was 76.9%-100.0% and for the nutrition intervention was 44.8%-100.0%. Nutritional adequacy, decisional conflict, satisfaction with decision-making and overall family satisfaction with ICU were similar for all groups. ConclusionsActive partnerships between family members and health professionals are important but can be challenging to achieve in critical care contexts. We were unable to demonstrate the efficacy of either intervention. Feasibility outcomes suggest further refinement of interventions and study protocol may be warranted. Relevance to Clinical PracticeInterventions to promote family partnerships in critical illness are needed but require a greater understanding of the extent to which families want and are able to engage and the activities in which they have most impact. Reporting MethodThis study has been reported following the Consolidated Standards of Reporting Trials (CONSORT) and the Template for Intervention Description and Replication (TIDieR) guidelines. Patient or Public ContributionPatients and caregivers were engaged in and contributed to the development and subsequent iterations of the two family-centred interventions use in this study. Clinical Trial Registration NumberTrial registration. Clinicaltrials.gov, ID: NCT02920086. Registered on 30 September 2016. First patient enrolled on 9 May 2017 .