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A Randomized Trial of a Family-Support Intervention in Intensive Care Units
Open accessAbstract
BACKGROUND: Surrogate decision makers for incapacitated, critically ill patients often struggle with decisions related to goals of care. Such decisions cause psychological distress in surrogates and may lead to treatment that does not align with patients' preferences. METHODS: We conducted a stepped-wedge, cluster-randomized trial involving patients with a high risk of death and their surrogates in five intensive care units (ICUs) to compare a multicomponent family-support intervention delivered by the interprofessional ICU team with usual care. The primary outcome was the surrogates' mean score on the Hospital Anxiety and Depression Scale (HADS) at 6 months (scores range from 0 to 42, with higher scores indicating worse symptoms). Prespecified secondary outcomes were the surrogates' mean scores on the Impact of Event Scale (IES; scores range from 0 to 88, with higher scores indicating worse symptoms), the Quality of Communication (QOC) scale (scores range from 0 to 100, with higher scores indicating better clinician-family communication), and a modified Patient Perception of Patient Centeredness (PPPC) scale (scores range from 1 to 4, with lower scores indicating more patient- and family-centered care), as well as the mean length of ICU stay. RESULTS: A total of 1420 patients were enrolled in the trial. There was no significant difference between the intervention group and the control group in the surrogates' mean HADS score at 6 months (11.7 and 12.0, respectively; beta coefficient, -0.34; 95% confidence interval [CI], -1.67 to 0.99; P=0.61) or mean IES score (21.2 and 20.3; beta coefficient, 0.90; 95% CI, -1.66 to 3.47; P=0.49). The surrogates' mean QOC score was better in the intervention group than in the control group (69.1 vs. 62.7; beta coefficient, 6.39; 95% CI, 2.57 to 10.20; P=0.001), as was the mean modified PPPC score (1.7 vs. 1.8; beta coefficient, -0.15; 95% CI, -0.26 to -0.04; P=0.006). The mean length of stay in the ICU was shorter in the intervention group than in the control group (6.7 days vs. 7.4 days; incidence rate ratio, 0.90; 95% CI, 0.81 to 1.00; P=0.045), a finding mediated by the shortened mean length of stay in the ICU among patients who died (4.4 days vs. 6.8 days; incidence rate ratio, 0.64; 95% CI, 0.52 to 0.78; P<0.001). CONCLUSIONS: Among critically ill patients and their surrogates, a family-support intervention delivered by the interprofessional ICU team did not significantly affect the surrogates' burden of psychological symptoms, but the surrogates' ratings of the quality of communication and the patient- and family-centeredness of care were better and the length of stay in the ICU was shorter with the intervention than with usual care. (Funded by the UPMC Health System and the Greenwall Foundation; PARTNER ClinicalTrials.gov number, NCT01844492 .).
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“Family support interventions may help to reduce these psychological impacts, as suggested by four systematic reviews, 37,71,72,83 and two recent studies. 84,85”
From European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions (2021) · cites this paper as [84]
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“Elevated decisional conflict has been linked to delayed choices, post-decision regret, and strained clinician–family relationships, all of which can compromise care quality3.”
From Decisional conflict among Chinese family caregivers prior to ECMO initiation: a cross-sectional study (2025) · cites this paper as [3]
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“Previous trials led by ICU and palliative care clinicians have proven inefficacious in improving mental health outcomes in informal caregivers [5–11].”
From Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial (2019) · cites this paper as [11]
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“However, prior research has shown these interventions not only have limited success but that some may even exacerbate surrogates' traumatic stress responses (14-20).”
From EMPOWER: A Multi-Site Pilot Trial to Reduce Distress in Surrogate Decision-Makers in the ICU (2024) · cites this paper as [19]
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“a recent pragmatic trial of a nurse-led intervention in the ICU that provided intensive emotional support to families and frequent family meetings improved patient-centeredness of care and reduced length of stay, although it did not improve surrogates’ psychological distress (44).”
From Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation (2019) · cites this paper as [44]
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“In fact, the investigative team specifically noted that the interventionists did not have advanced training in patient counseling [9], and, similar to other trials, the results showed no significant effects on the primary mental health outcomes of anxiety or depression, or on secondary outcomes of PTSD [11].”
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“distinguishing it from several interventions that have not observed strong effects on psychological outcomes (14-20)”
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“which the majority of prior trials of surrogate interventions did not do (14-20)”
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“The support intervention did not affect family psychological outcomes but did improve perceived quality of communication and perception of patient- and family-centeredness of care.”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [538]
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“The timing of discussions of goals of care and prognosis in the ICU was addressed in one study where 26% of patients had infection or sepsis as a primary diagnosis [538].”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [538]
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“A reduction in ICU length of stay was noted, yet it is unknown if the reduction is due to increased mortality.”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [538]
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Metadata
- Authors
- White, D. B., Angus, D. C., Shields, A.-M., Buddadhumaruk, P., Pidro, C., Paner, C., Chaitin, E., Chang, C.-C. H., Pike, F., Weissfeld, L., Kahn, J. M., Darby, J. M., Kowinsky, A., Martin, S., & Arnold, R. M.
- Affiliations
- From the Program on Ethics and Decision Making in Critical Illness (D.B.W., A.-M.S., P.B.), Clinical Research, Investigation, and Systems Modeling of Acute Illness Center (D.B.W., D.C.A., A.-M.S., P.B., C. Pidro, C.-C.H.C., J.M.K.), Department of Critical Care Medicine (D.B.W., D.C.A., A.-M.S., P.B., C. Pidro, C.-C.H.C., J.M.K., J.M.D.), and the Section of Palliative Care and Medical Ethics, Division of General Internal Medicine (R.M.A.), Department of Medicine (C.-C.H.C., R.M.A.), University of...
- University of Pittsburgh (US)
- Eli Lilly (United States) (US)
- Statistics Collaborative (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2018-06-21
- Volume
- 378
- Issue
- 25
- Pages
- 2365-2375
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2804920713
- Semantic Scholar
- 13cba728b3b0dd015816bb018a6eb08f9d7048a8
- Cited by
- 524
- References
- 49
- Citations by year
- 2026: 63 · 2025: 55 · 2024: 59 · 2023: 67 · 2022: 65 · 2021: 82 · 2020: 66 · 2019: 53 · 2018: 13
- FWCI
- 70.49
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- The Greenwall Foundation (n/a)
- UPMC Innovation Fund (n/a)
- Topics
- Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Family and Patient Care in Intensive Care Units
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Palliative Care and End-of-Life Issues
- Health Sciences › Health Professions › General Health Professions › Ethics in medical practice
- Keywords
- family support interventions, surrogate decision makers, intensive care unit, goals of care, clinician-family communication, patient-centered care, anxiety and depression, psychological distress, multidisciplinary team, family-centered care, ICU length of stay, end-of-life decisions, Hospital Anxiety and Depression Scale
- MeSH terms
- Aged, Anxiety, Communication, Critical Care, Decision Making, Depression, Family, Female, Humans, Intensive Care Units, Length of Stay, Male, Middle Aged, Professional-Family Relations, Stress, Psychological, Critical Illness, Caregivers, Hospital Mortality, Third-Party Consent, Critical Care Nursing
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