A Pilot Randomized Controlled Trial Assessing the Feasibility and Acceptability of Family-Partnered Delirium Prevention, Detection, and Management in Critically Ill Adults: The Activating Family Caregivers in the Identification Prevention and Management of Delirium (ACTIVATE) Study.

Abstract

Objectives background: Delirium remains frequently undetected by healthcare providers; partnering with family may be a novel way to identify and manage delirium. This study explores the feasibility of a family-administered intervention for delirium prevention, detection, and management.

Design: Pilot randomized controlled trial.

Setting: Two Canadian ICUs.

Subjects: Patient-family pairs (dyads) were included. Eligible patients had no primary brain injury, a Richmond Agitation-Sedation Scale score of greater than or equal to -3, and were expected to remain in the ICU for at least 24 hours to complete all study assessments.

Interventions: Dyads were randomly assigned to either standard care (control) or the intervention, which included delirium education and family-administered checklists with prevention/management strategies and a detection tool ("Sour Seven").

Measurements and main results: Outcomes included feasibility indicators, enrollment and completion rates, and psychological outcomes (Generalized Anxiety Disorder-7, Patient Health Questionnaire-9, and the Kessler Psychologic Distress (K-10) scales in the ICU and at 1- and 3-month follow-ups. Between January 2020 and June 2023, during the height of the COVID pandemic, 197 patient-family pairs were approached, with 64 (32%) consenting to participate; participation required both the patient and a family member. Despite recruitment challenges, 75% of families completed in-ICU questionnaires, and 38% completed all follow-ups. The family members in the intervention group demonstrated increased delirium knowledge compared with baseline delirium knowledge, and engagement in prevention strategies, with 8 of 19 (42%) family members identifying delirium using the Sour Seven. At the 3-month follow-up, seven family members showed significant anxiety, and five showed significant depression. Observations of ICU rounds revealed limited delirium discussions.

Conclusions: This pilot study demonstrated the feasibility of family-administered delirium care in ICU settings. However, the likely impact of the COVID-19 pandemic cannot be overlooked. The study faced recruitment challenges and demonstrated the difficulties of family involvement in delirium care, particularly during restricted family presence. A full evaluation of effectiveness requires a hypothesis-testing trial with procedural adjustments to streamline data collection and strengthen family-care team partnerships.

Trial registration: Clinicaltrials.gov (NCT04099472).