A randomised controlled trial of a nutrition and a decision support intervention to enable partnerships with families of critically ill patients
Abstract
AIMS AND OBJECTIVES
The 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.
BACKGROUND
Family partnerships can improve outcomes for critically ill patients and family members. Interventions that support families to engage with health professionals require evaluation.
DESIGN
A multi-centre, randomised, parallel group superiority Phase II randomised controlled trial.
METHODS
In 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.
RESULTS
We 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 135 participants or records.
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