Policy About Families Being at Bedside During Code Blue
Original Article
Family Presence during Cardiopulmonary Resuscitation
List of authors.Abstruse
Background
The result of family presence during cardiopulmonary resuscitation (CPR) on the family members themselves and the medical team remains controversial.
Methods
We enrolled 570 relatives of patients who were in cardiac arrest and were given CPR by 15 prehospital emergency medical service units. The units were randomly assigned either to systematically offering the family member the opportunity to observe CPR (intervention grouping) or to follow standard practise regarding family presence (command grouping). The principal stop point was the proportion of relatives with post-traumatic stress disorder (PTSD)–related symptoms on solar day 90. Secondary stop points included the presence of anxiety and depression symptoms and the effect of family presence on medical efforts at resuscitation, the well-being of the health care team, and the occurrence of medicolegal claims.
Results
In the intervention group, 211 of 266 relatives (79%) witnessed CPR, equally compared with 131 of 304 relatives (43%) in the control group. In the intention-to-treat analysis, the frequency of PTSD-related symptoms was significantly higher in the control group than in the intervention group (adjusted odds ratio, ane.seven; 95% confidence interval [CI], 1.2 to 2.5; P=0.004) and among family members who did not witness CPR than among those who did (adapted odds ratio, i.six; 95% CI, 1.i to two.v; P=0.02). Relatives who did not witness CPR had symptoms of anxiety and depression more frequently than those who did witness CPR. Family unit-witnessed CPR did not affect resuscitation characteristics, patient survival, or the level of emotional stress in the medical team and did not outcome in medicolegal claims.
Conclusions
Family presence during CPR was associated with positive results on psychological variables and did not interfere with medical efforts, increment stress in the health care team, or result in medicolegal conflicts. (Funded by Program Hospitalier de Recherche Clinique 2008 of the French Ministry of Wellness; ClinicalTrials.gov number, NCT01009606.)
Methods
Study Blueprint, Participant Selection, and Study Procedures
This study was a prospective, cluster-randomized, controlled trial. Fifteen prehospital emergency medical service units (Service d'Aide Médicale d'Urgence) in French republic participated in the study from November 2009 through Oct 2011. These units are ambulance base stations equipped with i or more mobile intensive care units, consisting of an ambulance driver, a nurse, and a senior emergency physician every bit the minimum team.13 Simple randomization procedures were used to assign eight of the participating units to the intervention and vii to the control.
We included developed family members of adult patients in cardiac abort occurring at home. Nosotros evaluated only one first-caste relative per patient. The relative was chosen in accordance with the legislation on hospitalization at the request of a 3rd party in the following society of preference: spouse, parent, offspring, sibling. Exclusion criteria were advice barriers with the relative and cardiac-arrest cases in which resuscitation was not attempted.
For emergency medical service units assigned to the intervention, a medical team member systematically asked family members whether they wished to exist nowadays during the resuscitation. A communication guide (run into Table S1 in the Supplementary Appendix, bachelor with the full text of this article at NEJM.org) that was developed from published guidelines was available to help introduce the relative to the resuscitation scene and, when required, to assist with the declaration of the death.5,xiv,fifteen For units assigned to the control, family members were not routinely given the option to be present during CPR; instead, the physician squad leaders interacted with these family members in a standard manner during CPR. Relatives who chose to witness the resuscitation were taken to the room where it was being performed. Relatives who chose not to witness the resuscitation were taken to another room of the home or were taken outside the home if the space inside was bereft.
The report was canonical past the institutional review board (Comité de Protection des Personnes Ile-de-France 10). In accordance with French police, the lath waived the requirement for obtaining informed consent from patients because of the emergency setting of the research; all the same, deferred consent of the family members was required. All the relatives participating in the study provided written informed consent before the deviation of the health care team from the home. The commencement, next-to-terminal, and last authors assume responsibility for the abyss and accuracy of the data and analyses and for the allegiance of the study to the protocol, which is available at NEJM.org.
Follow-up and Psychological Assessment of Family Members
Ninety days after resuscitation, a trained psychologist who was unaware of the report-group assignments asked enrolled relatives to respond a structured questionnaire past phone. The interviewer asked relatives to complete the Affect of Consequence Scale (IES) and the Infirmary Anxiety and Depression Scale (HADS).xvi,17 A relative was deemed unreachable afterward 15 phone calls had gone unanswered.
The IES has been widely used for many years and is reliable across a wide range of traumatic events.eighteen Each of the 15 items is scored on a scale from 0 to 5, so the total score ranges from 0 (no PTSD-related symptoms) to 75 (severe PTSD-related symptoms).xix The HADS is made upwardly of ii subscales, one evaluating symptoms of anxiety (HADSA, seven items) and the other assessing symptoms of depression (HADSD, 7 items).17 Subscale scores range from 0 (no distress) to 21 (maximum distress). HADS subscale scores higher than 10 bespeak moderate-to-astringent symptoms of anxiety or depression.10,20 The satisfaction of the relatives at having been absent or nowadays was besides recorded.
The principal stop point was the proportion of relatives with PTSD-related symptoms (every bit indicated by an IES score higher than thirty) on day 90, in agreement with previous reports.xv,eighteen
Secondary Analyses
Secondary finish points included the effect of family presence on medical efforts at resuscitation, the well-being of the health care team, and the occurrence of medicolegal claims. Demographic and clinical data for the resuscitated patients were recorded according to the Utstein style.21 A series of items reflecting the relative's behaviors and the type of invasive procedures witnessed by the relative during CPR was recorded. The level of emotional stress in the medical team was evaluated subsequently each resuscitation with the employ of a visual-analogue calibration and a nine-particular questionnaire adapted from the literature review.22 Once the recruitment was completed, the principal investigator asked all centre investigators to report medicolegal claims, complaints, and words of thanks.
Statistical Analysis
Assumptions for sample-size calculation were based on the study by Azoulay et al.18 In that report, 28 family members of patients who died in the intensive care unit (50%) had an IES score higher than 30 at 90 days.18 On the basis of this expected pct, a sample of 340 relatives for whom data could exist analyzed was required to provide eighty% power to detect a fifteen% difference between the two groups, with a 2-sided type I error rate of 0.05 in the instance of independent statistical units. Because of the cluster randomization, the final sample required was 460 relatives for whom data could be analyzed.
The main analysis of the primary end indicate was based on the intention-to-care for population (i.e., all randomly assigned patients). For this main analysis, nosotros classified participants who did non complete the IES assessment considering of emotional distress as having PTSD-related symptoms, and we used multiple imputation for the other participants with missing data.23 Prespecified additional analyses according to family-presence status and two sensitivity analyses for IES score were performed. Start, nosotros restricted the assay to the participants who completed the IES assessment (observed-cases population). 2d, we restricted the analysis to family members whose relatives were deceased at day 28. No interim analysis was performed.
Information are reported equally means (±SD) or medians and interquartile ranges for continuous variables and as percentages for categorical variables. Univariate associations were evaluated with the use of Educatee's t-examination or the Wilcoxon signed-rank test for continuous information and the chi-square examination or Fisher's exact test, as appropriate, for categorical information. For psychological-assessment analyses, generalized estimating equations were used for chiselled information, and a mixed-model assay of variance was used for continuous data, with written report center as a random outcome and adjustment for the relative'southward human relationship to the patient. When necessary, normalizing transformations were performed. All statistical tests were two-tailed, with a type I error rate of 0.05. A P value of less than 0.05 was considered to indicate statistical significance. Statistical tests were performed with the utilise of SAS software, version ix.two (SAS Institute).
Results
Characteristics of Patients and Enrolled Family Members
Figure 1.
Figure 1. Randomization and Follow-up. The Bear upon of Event Scale (IES) was used to assess symptoms related to post-traumatic stress disorder (PTSD); scores range from 0 (no PTSD-related symptoms) to 75 (severe PTSD-related symptoms). CPR denotes cardiopulmonary resuscitation.
A total of 570 family members (intention-to-treat population) were enrolled in the study: 266 were systematically given the option of being nowadays during CPR (intervention grouping) and 304 were non routinely asked whether they wanted to be present (control group) (Figure 1). In total, 342 family members (60%) witnessed resuscitation and 228 did not.
Tabular array i.
Tabular array 1. Characteristics of Patients, Enrolled Family Members, and Cardiac Abort. At ninety days, 95 family members (17%) did non consummate the IES cess; therefore, 475 (observed-cases population) were included in the sensitivity analysis (Figure ane). The proportion of family unit members who were unable to complete the 90-day telephone interview because of emotional distress was significantly greater in the control group than in the intervention group (P=0.007) (Figure 1). The characteristics of patients and family unit members at the time of enrollment did not differ significantly between the 2 study groups (Table 1).
Resuscitation Characteristics and Outcomes
Table 2.
Tabular array 2. Characteristics and Outcome of Advanced Resuscitation According to the Presence or Absence of a Family Member. Twenty patients (four%) were still live at 24-hour interval 28. Characteristics of the resuscitation procedure, survival to hospital admission, and survival to day 28 did not differ significantly betwixt the intervention group and the control grouping (data non shown). Survival, the duration of advanced resuscitation, the blazon or dose of infused medications, and the number of shocks delivered were not afflicted by the presence or absence of the family member (Table two).
Psychological Cess
Master Criterion
Table 3.
Tabular array 3. Psychological Assessment of Family Members Enrolled in the Written report at 90 Days (Observed-Cases Population). In the intention-to-treat population (570 family members), the frequency of PTSD-related symptoms was significantly higher in the control grouping than in the intervention group (adjusted odds ratio, ane.vii; 95% confidence interval [CI], 1.ii to 2.5; P=0.004) and was significantly higher amidst family unit members who did not witness CPR than amongst those who did (adjusted odds ratio, 1.half-dozen; 95% CI, 1.1 to ii.5; P=0.02). The results were like for an assay that was restricted to the observed-cases population (P=0.01 for both comparisons) (Tabular array 3) and an analysis that excluded the 20 resuscitated patients who were alive at solar day 28 (P=0.009 for both comparisons).
Secondary Criteria
Analyses of psychological variables in the observed-cases population (475 persons) according to study group and family-presence status are reported in Table 3. The frequency of symptoms of anxiety was significantly college in the control group than in the intervention group and was also significantly higher among family members who did not witness resuscitation than among those who did (P<0.001 for both comparisons). The proportion of family members with symptoms of depression did non differ significantly between the command and intervention groups (P=0.xiii) but was significantly lower among family members who were present than among those who were absent (P=0.009).
Interference by Family Members
Data on the behaviors of family unit members and the invasive procedures that they witnessed during the resuscitation are presented in Table S2 in the Supplementary Appendix. Very few family unit members (<1%) were aggressive or in disharmonize with the medical team. Twenty-two of the 186 family members who did not witness CPR (12%) expressed regret at having been absent, equally compared with 9 of 289 relatives who witnessed CPR (3%) and who regretted being present (P<0.001).
Stress Assessment of Medical Teams
Table 4.
Tabular array 4. Evaluation of Stress in the Medical Squad (Due north=570). The median stress level equally measured on the visual-analogue scale was 5 out of 100 (interquartile range, 0 to 15) amid 1710 health care professionals evaluated. We institute no pregnant differences in stress levels according to family-presence status (Table 4).
Medicolegal Conflicts
With a mean follow-up of twenty±5 months, at that place were no claims for damages from any participating family members nor were there any medicolegal conflicts. Nosotros received one thank-you letter of the alphabet from a relative in the control group who observed CPR.
Discussion
In this multicenter, randomized trial, offering family members of patients undergoing CPR the pick of witnessing the resuscitation efforts was associated with a significantly lower incidence of PTSD-related symptoms than was following standard practice regarding family presence. Irrespective of whether the family unit members were offered the option, more favorable results of psychological testing were noted when family members were present.
Routinely offer family members the opportunity to stay with the patient during CPR remains a controversial issue.6 Observational and qualitative studies have favored family presence during CPR.4,5,9,25 In a recent study that involved 65 family unit members of patients undergoing CPR, there were no significant differences in overall PTSD or depression scores between those who witnessed CPR and those who did not.23 Nonetheless, this study was small and did non have a randomized design, thus limiting the conclusions that tin can be drawn from the results. The same authors conducted another minor, nonrandomized report and found that witnessing a failed CPR endeavor on a loved ane was associated with an increment in PTSD symptoms.8
Nosotros found that the effectiveness of resuscitation was not affected by the presence of a family member, nor was the elapsing of CPR, the choice of drugs, or the survival rate. These results are in contrast with the findings of two big surveys that revealed concerns nearly family interference with CPR.26,27 However, our results are in agreement with those of two studies involving resuscitation of children with trauma.22,28 Another study attempted to make up one's mind whether family presence influenced critical deportment performed past physicians during CPR, when simulated on a mannequin.29 In this virtual clinical written report, the time required to deliver the commencement defibrillation was significantly longer and the number of shocks was significantly smaller when a family member displayed aggressive reactions. Our results in existent patients did not confirm the results of this simulation. In fact, very few family unit members (<ane%) were aggressive or in disharmonize with the medical squad. This observation was consistent with the results of two comparative studies that evaluated the upshot of family unit presence on the efficiency of resuscitation efforts for children with trauma.22,28
Stress levels in the health care team were not afflicted by family unit presence during resuscitation. Our results are at odds with those of a similar evaluation involving emergency room staff members in 1987.4 In this pivotal study, 30% of the xx staff members reported that they had been hampered in their activities, mainly by anxiety about being observed or past business about possible emotional or disruptive behavior on the function of family unit members.4
Many medical team members are reluctant to allow the presence of family unit members during resuscitation because of fear of medicolegal conflicts. In a survey of 592 health professionals, 24% of 432 respondents who disapproved of the presence of family members listed medicolegal concerns every bit an explanation.27 We encountered no damage claims from families in this study, nor any lawsuits. Although our sample size is small and the medicolegal culture may be unlike in France than elsewhere, our findings should help allay physicians' medicolegal concerns.
The limitations of the electric current study need to be considered. First, this study was conducted in French republic. Although this fact may preclude generalizing the findings to other emergency medical systems, many studies evaluating this question in other settings have reported results in agreement with those of our written report, supporting their generalizability.4,ix,14,28 Second, non all patients included in the report died. Given that PTSD symptoms are related to mail-traumatic grief, it might be expected that the consequence of being nowadays during CPR would differ according to patient outcomes.30 However, nosotros conducted a sensitivity assay that excluded the 20 survivors at day 28. The results did not differ from those of the original analysis. Third, nosotros included in this written report relatives with various relationships to the patient. Ane might argue that the option of being present during CPR should be offered only to very close relatives, such as spouses. However, our results were adjusted for the relative'southward human relationship to the patient. Finally, our trial took identify in patients' homes and did not evaluate in-hospital cardiac arrests. Trials in the hospital setting, such as the emergency section or intensive care unit of measurement, are needed to ostend our results, although some studies of pediatric trauma resuscitation show that family presence is not associated with negative outcomes.22,28
Despite these limitations, sensitivity analyses confirmed the robustness of our primary results. Hence, the findings of this randomized clinical trial bolster the current international recommendations regarding family presence during CPR.
In conclusion, our results show that the presence of a family member during CPR of an developed patient, performed in the dwelling house, was associated with positive results on psychological evaluations and did not interfere with medical efforts, increase stress in the health care team, or event in medicolegal conflicts.
Supplementary Fabric
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Citing Articles (216)
Source: https://www.nejm.org/doi/full/10.1056/nejmoa1203366
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