Effect of a condolence letter on grief symptoms among relatives of patients who died in the ICU: a randomized clinical trial

Kentish-Barnes. Intensive Care Medicine 2017; first published on line 14th Feb. DOI 10.1007/s00134-016-4669-9

Clinical Question

• Among relatives who died in the Intensive Care Unit (ICU), does a condolence letter from a clinician, compared to no condolence letter, effect grief symptoms?

Background

• Studies have shown that over half of bereaved relatives experience grief symptoms, characterised by variably combined symptoms of anxiety, depression, stress and complicated grief
• Two previous RCT’s have shown that improving communication during end-of-life care alleviated grief symptoms in relatives of patients who had died in the ICU
• This RCT evaluates the effect of a simple implementation, a condolence letter, to try and improve communication and grief symptoms after death

Design

• Multicenter randomised control trial
• Randomisation occurred with 24 hours of the patient’s death
• Centralised internet-based randomisation procedure was used
• Stratified according to study centre with concealed sized permuted blocks
• Single relative per patient was included
• Informed consent was sought in the hours following patient’s death
  • the patient information sheet did not specify the nature of the intervention, but that a strategy to improve communication was being evaluated
• Intention to treat analysis
• Power calculation: 240 patients would give the study 90% power to detect a  decrease in the prevalence of anxiety and depression from 60% to 42%, and a 30% decrease in the Hospital Anxiety and Depression Scale Score

Setting

• 22 ICUs in France
• Dec 2014 – Oct 2015

Population

• Inclusion: age at least 18 years; at least one family visit prior to death; and an ICU stay of at least 2 days
• Exclusion: pregnant and family not fluent in French
• 242 relatives of patients that died in ICU
• Baseline characteristics were similar for key confounders apart from:
  • more of the follow up interviews occurred with spouses in the intervention group (38.5% vs 32.3%)
  • interviews with children were similar; ‘others’ were higher in the control group (26.2% vs 22%)
  • more family-clinician or intra-team conflicts in the control group, although small numbers 13 vs 9
  • more patients were intubated at time of death in the intervention group (58.5% vs 54.6%), and sedated at time of death (78.9% vs 76.5%)
  • preferred role of relatives of being only informed of end-of-life decision, lower in intervention group 25% vs 34%

Intervention

• Condolence letter
  • handwritten by the physician and nurse in charge
    • covered the following 5 domains: recognise the death and name the deceased; mention a personal impression of the deceased; recognise the family member; offer help; and express sympathy
  • sent by standard mail 15 days after the patient death

Control

• No condolence letter

In both groups

• Symptom control, timing of communication at the end-of-life and implementation of treatment-limitation decisions were at the clinician’s discretion
• After randomisation, the clinicians recorded all reactions or feedback (telephone calls, letters, visits, or other) from the relatives within 4 months following death
• Telephone interviews with family members occurred at 30 days and 6 months after the patient’s death. These were conducted by psychologists, sociologists, and research nurses blinded to study group

Outcome

• Primary outcome: at one month. Expressed as median (25th-75th percentile) unless stated otherwise
  • Hospital Anxiety and Depression Scale (HADS) Score: higher in the intervention group but did not reach statistical significance based on P value
    • 16 [10-22] vs 14 [8-21]; P=0.36, mean difference 0.77 (95% C.I. -1.7 to 3.3)
  • HADS-depression sub-scale scores: higher in the intervention group but no significant difference
    • 8 [4-12] vs 6 [2-12]; P=0.10, mean difference 1.1 (95% C.I. -0.5 to 2.6)
  • Relatives with symptoms of depression (sub-scale score >8): higher in the intervention group but no significant difference
    • 56% vs 42.4%; P=0.054, relative risk = 0.76 (95% C.I. 0.57-1.00)
  • HADS-anxiety sub-scale scores: no significant difference
    • 7 [4-11] vs 7 [4-12], P=0.92
  • Relatives with symptoms of anxiety (sub-scale score>8): no significant difference
    • 47.7% vs. 45.5%, P=0.97
• Secondary outcomes: at 6 months, and were all worse in the intervention group. Expressed as median (25th-75th percentile) unless stated otherwise
  • HADS score
    • 13 [6–19] vs. 9 [4–17]; P=0.04
  • HADS-depression sub-scale scores
    • 6 [2–10] vs. 3 [1–8]; P=0.01
  • Relatives with symptoms of depression (sub-scale score >8)
    • 37% vs. 25%; P=0.05
  • Impact of Event Scale Revised (IES-R) score
    • 28 [15-38] vs 20 [10-37]; P=0.09
  • Relatives with significant post traumatic stress disorder (PTSD) related symptoms (IES-R ≥26)
    • 52.4% vs 37.1%; P=0.03
  • Inventory of Complicated Grief (ICG) score
    • 16 [8-30] vs 13 [4-27]; P=0.07
  • Relatives at high risk for complicated grief (ICG ≥25)
    • 38% vs 27%; P=0.11

• Other
  • Feedback was received from 55 (44.7%) intervention- group relatives and 8 (6.7%) controls; P < 0.0001
    • Of the 55 intervention-group relatives who gave feedback, 50 did so to thank the clinician for the condolence letter
    • No relatives complained about the condolence letter

Authors’ Conclusions

• In relatives of patients who died in the ICU, a condolence letter failed to alleviate grief symptoms and may have worsened depression and PTSD-related symptoms

Strengths

• A relevant and important study evaluating the impact of a simple measure to support families of patients that have recently died on ICU
• Multicentre
• RCT including university and non-university hospitals
• Interviewers were blinded
• All letters complied with the study guidelines
• Trial registered on clinicaltrial.gov

Weaknesses

• All participating ICUs were in France, which may limit the general applicability of the findings, as end-of-life care and bereavement follow-up vary widely across countries
• All ICUs involved had a special interest in family-centred care
• Intervention was not standardised. Whilst the clinicians followed guidelines for the letter, they were otherwise free to write what they wanted to
• The psychological status of the relatives at the time they received the condolence letter was not evaluated
• The outcome measure were assessed at one and six months. This may have been too short to demonstrate any longer term benefit
• 14% relatives (34 patients) did not complete the HADS at one month

The Bottom Line

• This is an important study evaluating a simple intervention to try and improve grief symptoms amongst family members. It unexpectedly showed that condolence letters may increase depression and PTSD symptoms amongst family members at 6 months
• Grief is a complex process with many confounders, including individual adaptive response and external influences. These nuances and impact are difficult to evaluate
• Our current departmental policy of sending out condolence cards will continue. However, we will review the timing, content and potential deleterious effects

External Links

• [article] Effect of a condolence letter on grief symptoms among relatives of patients who died in the ICU: a randomized clinical trial
• [further reading] A communication strategy and brochure for relatives of patients dying in the ICU. NEJM 2007
• [further reading] Randomized trial of communication facilitators to reduce family distress and intensity of end‐of‐life care. Am J Respir Crit Care Med 2016

Metadata

Summary author: Steve Mathieu
Summary date: 21st June 2017
Peer-review editor: David Slessor