Evidence map›Paper›PMID 40844707›Full record

Trial reportCritical care explorations2025

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.

Kirsten M Fiest, Karla D Krewulak, Bonnie G Sept, Judy E Davidson, E Wesley Ely, Chel H Lee, Andrea Soo, Henry T Stelfox

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Critical care explorations, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04099472 (Family-administered Delirium Prevention, Detection, and Management in the Critically Ill), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04099472 nacompletednot on this map

Family-administered Delirium Prevention, Detection, and Management in the Critically Ill: a Randomized Control Trial

TypeinterventionalSponsorUniversity of CalgaryRan2020 to 2024Enrolled128ConditionsDelirium, Intensive Care Unit Delirium, Post Intensive Care Unit Syndrome, Post Intensive Care Unit Syndrome FamilyArmsDelirium Education, Prevention, and Management, Standard Care
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. The Critical Care Pain Observation Tool for Families (CPOT-Fam).Canadian journal of pain = Revue canadienne de la douleur · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Kirsten M FiestDepartment of Critical Care Medicine, University of Calgary and Alberta Health Services, Calgary, AB, Canada.ORCID 0000-0002-7299-6594
Karla D KrewulakDepartment of Critical Care Medicine, University of Calgary and Alberta Health Services, Calgary, AB, Canada.
Bonnie G SeptDepartment of Critical Care Medicine, University of Calgary and Alberta Health Services, Calgary, AB, Canada.
Judy E DavidsonDepartment of Nursing Education, Development and Research, University of California San Diego Health, San Diego, CA.
E Wesley ElyVeterans Affairs Tennessee Valley Geriatric Research Education Clinical Center (VA GRECC), Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, TN.
Chel H LeeDepartment of Critical Care Medicine, University of Calgary and Alberta Health Services, Calgary, AB, Canada.
Andrea SooDepartment of Critical Care Medicine, University of Calgary and Alberta Health Services, Calgary, AB, Canada.
Henry T StelfoxDepartment of Critical Care Medicine, University of Calgary and Alberta Health Services, Calgary, AB, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

OBJECTIVES

backgroundDelirium 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.

designPilot randomized controlled trial.

settingTwo 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.

interventionsDyads 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

resultsOutcomes 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.

conclusionsThis 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 registrationClinicaltrials.gov (NCT04099472).

Indexed as

CaregiversCritical IllnessDeliriumFamilyAdultAgedCanadaFeasibility StudiesFemaleHumansIntensive Care UnitsMaleMiddle AgedPilot Projectscritical caredeliriumfamilyintensive care unitspatient-centered care

Identifiers

PMID40844707
PMCPMC12377300

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.