A study protocol for a randomized controlled trial of family-partnered delirium prevention, detection, and management in critically ill adults: the ACTIVATE study

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Abstract

Background

Delirium is very common in critically ill patients admitted to the intensive care unit (ICU) and results in negative long-term outcomes. Family members are also at risk of long-term complications, including depression and anxiety. Family members are frequently at the bedside and want to be engaged; they know the patient best and may notice subtle changes prior to the care team. By engaging family members in delirium care, we may be able to improve both patient and family outcomes by identifying delirium sooner and capacitating family members in care.

Methods

The primary aim of this study is to determine the effect of family-administered delirium prevention, detection, and management in critically ill patients on family member symptoms of depression and anxiety, compared to usual care. One-hundred and ninety-eight patient-family dyads will be recruited from four medical-surgical ICUs in Calgary, Canada. Dyads will be randomized 1:1 to the intervention or control group. The intervention consists of family-partnered delirium prevention, detection, and management, while the control group will receive usual care. Delirium, depression, and anxiety will be measured using validated tools, and participants will be followed for 1- and 3-months post-ICU discharge. All analyses will be intention-to-treat and adjusted for pre-identified covariates. Ethical approval has been granted by the University of Calgary Conjoint Health Research Ethics Board (REB19–1000) and the trial registered. The protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.

Discussion

Critically ill patients are frequently unable to participate in their own care, and partnering with their family members is particularly important for improving experiences and outcomes of care for both patients and families.

Trial registration

Registered September 23, 2019 on Clinicaltrials.gov NCT04099472.

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Most cited references 35

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Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial.

Timothy Girard, John Kress, Barry Fuchs … (2008)

Approaches to removal of sedation and mechanical ventilation for critically ill patients vary widely. Our aim was to assess a protocol that paired spontaneous awakening trials (SATs)-ie, daily interruption of sedatives-with spontaneous breathing trials (SBTs). In four tertiary-care hospitals, we randomly assigned 336 mechanically ventilated patients in intensive care to management with a daily SAT followed by an SBT (intervention group; n=168) or with sedation per usual care plus a daily SBT (control group; n=168). The primary endpoint was time breathing without assistance. Data were analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00097630. One patient in the intervention group did not begin their assigned treatment protocol because of withdrawal of consent and thus was excluded from analyses and lost to follow-up. Seven patients in the control group discontinued their assigned protocol, and two of these patients were lost to follow-up. Patients in the intervention group spent more days breathing without assistance during the 28-day study period than did those in the control group (14.7 days vs 11.6 days; mean difference 3.1 days, 95% CI 0.7 to 5.6; p=0.02) and were discharged from intensive care (median time in intensive care 9.1 days vs 12.9 days; p=0.01) and the hospital earlier (median time in the hospital 14.9 days vs 19.2 days; p=0.04). More patients in the intervention group self-extubated than in the control group (16 patients vs six patients; 6.0% difference, 95% CI 0.6% to 11.8%; p=0.03), but the number of patients who required reintubation after self-extubation was similar (five patients vs three patients; 1.2% difference, 95% CI -5.2% to 2.5%; p=0.47), as were total reintubation rates (13.8%vs 12.5%; 1.3% difference, 95% CI -8.6% to 6.1%; p=0.73). At any instant during the year after enrolment, patients in the intervention group were less likely to die than were patients in the control group (HR 0.68, 95% CI 0.50 to 0.92; p=0.01). For every seven patients treated with the intervention, one life was saved (number needed to treat was 7.4, 95% CI 4.2 to 35.5). Our results suggest that a wake up and breathe protocol that pairs daily spontaneous awakening trials (ie, interruption of sedatives) with daily spontaneous breathing trials results in better outcomes for mechanically ventilated patients in intensive care than current standard approaches and should become routine practice.

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A communication strategy and brochure for relatives of patients dying in the ICU.

Alexandre Lautrette, Michael Darmon, Bruno MÉGARBANE … (2007)

There is a need for close communication with relatives of patients dying in the intensive care unit (ICU). We evaluated a format that included a proactive end-of-life conference and a brochure to see whether it could lessen the effects of bereavement. Family members of 126 patients dying in 22 ICUs in France were randomly assigned to the intervention format or to the customary end-of-life conference. Participants were interviewed by telephone 90 days after the death with the use of the Impact of Event Scale (IES; scores range from 0, indicating no symptoms, to 75, indicating severe symptoms related to post-traumatic stress disorder [PTSD]) and the Hospital Anxiety and Depression Scale (HADS; subscale scores range from 0, indicating no distress, to 21, indicating maximum distress). Participants in the intervention group had longer conferences than those in the control group (median, 30 minutes [interquartile range, 19 to 45] vs. 20 minutes [interquartile range, 15 to 30]; P<0.001) and spent more of the time talking (median, 14 minutes [interquartile range, 8 to 20] vs. 5 minutes [interquartile range, 5 to 10]). On day 90, the 56 participants in the intervention group who responded to the telephone interview had a significantly lower median IES score than the 52 participants in the control group (27 vs. 39, P=0.02) and a lower prevalence of PTSD-related symptoms (45% vs. 69%, P=0.01). The median HADS score was also lower in the intervention group (11, vs. 17 in the control group; P=0.004), and symptoms of both anxiety and depression were less prevalent (anxiety, 45% vs. 67%; P=0.02; depression, 29% vs. 56%; P=0.003). Providing relatives of patients who are dying in the ICU with a brochure on bereavement and using a proactive communication strategy that includes longer conferences and more time for family members to talk may lessen the burden of bereavement. (ClinicalTrials.gov number, NCT00331877.) 2007 Massachusetts Medical Society

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One-Year Outcomes in Caregivers of Critically Ill Patients.

Jill I Cameron, Leslie M Chu, Andrea Matte … (2016)

Few resources are available to support caregivers of patients who have survived critical illness; consequently, the caregivers' own health may suffer. We studied caregiver and patient characteristics to determine which characteristics were associated with caregivers' health outcomes during the first year after patient discharge from an intensive care unit (ICU).

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Author and article information

Contributors

Kirsten M. Fiest:

ORCID: http://orcid.org/0000-0002-7299-6594

kmfiest@ucalgary.ca

Journal

Journal ID (nlm-ta): BMC Health Serv Res

Journal ID (iso-abbrev): BMC Health Serv Res

Title: BMC Health Services Research

Publisher: BioMed Central (London )

ISSN (Electronic): 1472-6963

Publication date (Electronic): 24 May 2020

Publication date PMC-release: 24 May 2020

Publication date Collection: 2020

Volume: 20

Electronic Location Identifier: 453

Affiliations

[1 ]GRID grid.22072.35, ISNI 0000 0004 1936 7697, Department of Critical Care Medicine, , University of Calgary & Alberta Health Services, ; Calgary, Canada

[2 ]GRID grid.22072.35, ISNI 0000 0004 1936 7697, Department of Community Health Sciences & O’Brien Institute of Public Health, , University of Calgary, ; Calgary, Canada

[3 ]GRID grid.22072.35, ISNI 0000 0004 1936 7697, Department of Psychiatry & Hotchkiss Brain Institute, , University of Calgary, ; Calgary, Canada

[4 ]GRID grid.266100.3, ISNI 0000 0001 2107 4242, Department of Psychiatry, , UC San Diego School of Medicine, ; San Diego, California USA

[5 ]GRID grid.412807.8, ISNI 0000 0004 1936 9916, Tennessee Valley Veteran’s Affairs Geriatric Research Education Clinical Center (VA GRECC), , Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, ; Nashville, TN USA

Author information

Kirsten M. Fiest http://orcid.org/0000-0002-7299-6594

Article

Publisher ID: 5281

DOI: 10.1186/s12913-020-05281-8

PMC ID: 7245836

PubMed ID: 32448187

SO-VID: 5ae713da-749f-4020-b5a7-f7d9a5df4134

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 23 April 2020

Date accepted : 30 April 2020

Funding

Funded by: Canadian Institutes of Health Research (CA)

Award ID: TC1-165722

Award Recipient : Kirsten M. Fiest

Custom metadata

ScienceOpen disciplines: Health & Social care

Keywords: delirium,critical care,family-centered care,education,prevention

Data availability:

ScienceOpen disciplines: Health & Social care

Keywords: delirium, critical care, family-centered care, education, prevention

A study protocol for a randomized controlled trial of family-partnered delirium prevention, detection, and management in critically ill adults: the ACTIVATE study

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Abstract

Background

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Discussion

Trial registration

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Tobacco Prevention & Cessation

Most cited references 35

Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial.

A communication strategy and brochure for relatives of patients dying in the ICU.

One-Year Outcomes in Caregivers of Critically Ill Patients.

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