Original Article

Family Presence during Cardiopulmonary Resuscitation

List of authors.
  • Patricia Jabre, Thousand.D., Ph.D.,
  • Vanessa Belpomme, M.D.,
  • Elie Azoulay, M.D., Ph.D.,
  • Line Jacob, M.D.,
  • Lionel Bertrand, One thousand.D.,
  • Frederic Lapostolle, Grand.D., Ph.D.,
  • Karim Tazarourte, M.D., Ph.D.,
  • Guillem Bouilleau, M.D.,
  • Virginie Pinaud, M.D.,
  • Claire Broche, M.D.,
  • Domitille Normand, Thou.S.,
  • Thierry Baubet, M.D., Ph.D.,
  • Agnes Ricard-Hibon, Thousand.D., Ph.D.,
  • Jacques Istria, M.D.,
  • Alexandra Beltramini, M.D.,
  • Armelle Alheritiere, Chiliad.D.,
  • Nathalie Assez, M.D.,
  • Lionel Nace, Yard.D.,
  • Benoit Vivien, One thousand.D., Ph.D.,
  • Laurent Turi, M.D.,
  • Stephane Launay, M.D.,
  • Michel Desmaizieres, M.D.,
  • Stephen W. Borron, One thousand.D.,
  • Eric Vicaut, M.D., Ph.D.,
  • and Frederic Adnet, Yard.D., Ph.D.

Abstract

Groundwork

The effect of family presence during cardiopulmonary resuscitation (CPR) on the family members themselves and the medical squad remains controversial.

Methods

Nosotros 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 group) or to follow standard practice regarding family presence (control grouping). The main end point was the proportion of relatives with post-traumatic stress disorder (PTSD)–related symptoms on day 90. Secondary end points included the presence of feet 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, as compared with 131 of 304 relatives (43%) in the command 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, one.7; 95% confidence interval [CI], one.2 to 2.5; P=0.004) and among family members who did non witness CPR than among those who did (adjusted odds ratio, 1.6; 95% CI, ane.1 to ii.5; P=0.02). Relatives who did not witness CPR had symptoms of anxiety and low more than ofttimes than those who did witness CPR. Family-witnessed CPR did not bear upon resuscitation characteristics, patient survival, or the level of emotional stress in the medical team and did non event in medicolegal claims.

Conclusions

Family presence during CPR was associated with positive results on psychological variables and did not interfere with medical efforts, increase stress in the wellness care squad, or result in medicolegal conflicts. (Funded by Plan Hospitalier de Recherche Clinique 2008 of the French Ministry of Wellness; ClinicalTrials.gov number, NCT01009606.)

Introduction

Cardiac arrest accounts for 600,000 deaths annually in industrialized countries.one,2 Family members who are nowadays at the fourth dimension of attempted resuscitation are at loftier risk for emotional and physical burdens.iii

Being present during cardiopulmonary resuscitation (CPR) may help the family member sympathize that everything possible to bring the patient back to life has been implemented.4,5 In addition to quelling suspicion about behind-closed-doors resuscitation efforts and unrealistic expectations of such efforts, the family member'south presence may offer the opportunity for a last cheerio and assistance that person grasp the reality of decease, with the hope that the bereavement process volition non be prolonged or complicated by pathologic mourning or postal service-traumatic stress disorder (PTSD). Yet the benefits and drawbacks of family presence during resuscitation have been argued since information technology was proposed in 1987.iv,half dozen,7 Indeed, the potential benefits must be weighed against the possibility of stress induced in health intendance providers and an increase in the emotional burden on family members, too as the take a chance of legal claims.5,6,8

The evaluation of the psychological effects of family ascertainment of resuscitation has so far come mostly from simple feedback or modest observational studies.4,5,ix The simply randomized, prospective evaluation of family unit presence during CPR to appointment was terminated after enrollment of just 25 patients. Clinical teams had go so convinced of the benefits to relatives that investigators feared the randomization process would exist intentionally compromised by staff.10 This premature interruption left the question unresolved for many, with the intervention remaining a thing of controversy. Despite these debates about benefits and harms, major international guidelines for CPR state that bachelor evidence supports family-witnessed resuscitation, and this activity is considered reasonable and by and large useful.7,11,12

Nosotros designed a multicenter, randomized, controlled trial of family presence during resuscitation. The main aim of this trial was to make up one's mind whether offering a relative the option of observing CPR might reduce the likelihood of PTSD-related symptoms. We also assessed the effect of family presence on medical efforts at resuscitation, the well-being of the health care team, and the occurrence of medicolegal claims.

Methods

Study Design, Participant Pick, 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 France participated in the written report from November 2009 through October 2011. These units are ambulance base stations equipped with ane or more than mobile intensive care units, consisting of an ambulance commuter, a nurse, and a senior emergency physician equally the minimum squad.thirteen Uncomplicated randomization procedures were used to assign eight of the participating units to the intervention and seven to the control.

Nosotros included developed family members of adult patients in cardiac arrest occurring at home. We evaluated simply one commencement-degree relative per patient. The relative was chosen in accordance with the legislation on hospitalization at the request of a third party in the following order of preference: spouse, parent, offspring, sibling. Exclusion criteria were communication 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 present during the resuscitation. A communication guide (encounter Table S1 in the Supplementary Appendix, available with the full text of this commodity at NEJM.org) that was developed from published guidelines was available to help introduce the relative to the resuscitation scene and, when required, to help with the announcement of the decease.5,14,xv For units assigned to the control, family members were not routinely given the option to be present during CPR; instead, the physician team 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 domicile or were taken exterior the dwelling if the space within was bereft.

The study was approved by the institutional review board (Comité de Protection des Personnes Ile-de-France x). In accordance with French constabulary, the board waived the requirement for obtaining informed consent from patients because of the emergency setting of the research; however, deferred consent of the family members was required. All the relatives participating in the study provided written informed consent before the departure of the wellness intendance team from the home. The offset, next-to-last, and concluding authors assume responsibility for the completeness and accurateness of the data and analyses and for the fidelity of the study to the protocol, which is bachelor at NEJM.org.

Follow-up and Psychological Assessment of Family Members

Ninety days subsequently resuscitation, a trained psychologist who was unaware of the study-grouping assignments asked enrolled relatives to reply a structured questionnaire by telephone. The interviewer asked relatives to complete the Touch on of Effect Scale (IES) and the Hospital Anxiety and Depression Calibration (HADS).16,17 A relative was deemed unreachable afterward fifteen telephone calls had gone unanswered.

The IES has been widely used for many years and is reliable across a broad range of traumatic events.18 Each of the 15 items is scored on a scale from 0 to v, so the total score ranges from 0 (no PTSD-related symptoms) to 75 (severe PTSD-related symptoms).nineteen The HADS is made up of two subscales, one evaluating symptoms of anxiety (HADSA, seven items) and the other assessing symptoms of low (HADSD, seven items).17 Subscale scores range from 0 (no distress) to 21 (maximum distress). HADS subscale scores higher than ten indicate moderate-to-severe symptoms of feet or low.10,20 The satisfaction of the relatives at having been absent or present was also recorded.

The main end point was the proportion of relatives with PTSD-related symptoms (as indicated by an IES score higher than 30) on day 90, in agreement with previous reports.fifteen,18

Secondary Analyses

Secondary terminate points included the effect of family presence on medical efforts at resuscitation, the well-being of the health intendance squad, and the occurrence of medicolegal claims. Demographic and clinical data for the resuscitated patients were recorded co-ordinate to the Utstein style.21 A series of items reflecting the relative's behaviors and the blazon of invasive procedures witnessed by the relative during CPR was recorded. The level of emotional stress in the medical team was evaluated after each resuscitation with the employ of a visual-analogue scale and a nine-item questionnaire adapted from the literature review.22 Once the recruitment was completed, the primary investigator asked all center investigators to report medicolegal claims, complaints, and words of thanks.

Statistical Analysis

Assumptions for sample-size calculation were based on the report by Azoulay et al.18 In that study, 28 family members of patients who died in the intensive intendance unit (50%) had an IES score higher than thirty at ninety days.18 On the footing of this expected percentage, a sample of 340 relatives for whom information could be analyzed was required to provide fourscore% power to notice a 15% difference between the two groups, with a two-sided blazon I error rate of 0.05 in the example of independent statistical units. Considering of the cluster randomization, the final sample required was 460 relatives for whom information could be analyzed.

The main analysis of the primary finish point was based on the intention-to-treat population (i.e., all randomly assigned patients). For this master analysis, we classified participants who did not complete the IES cess because of emotional distress equally having PTSD-related symptoms, and we used multiple imputation for the other participants with missing data.23 Prespecified additional analyses according to family-presence condition and 2 sensitivity analyses for IES score were performed. Start, we restricted the analysis to the participants who completed the IES cess (observed-cases population). Second, nosotros restricted the analysis to family members whose relatives were deceased at day 28. No interim analysis was performed.

Data are reported as means (±SD) or medians and interquartile ranges for continuous variables and equally percentages for categorical variables. Univariate associations were evaluated with the use of Pupil's t-test or the Wilcoxon signed-rank test for continuous data and the chi-square examination or Fisher's exact exam, as appropriate, for categorical data. For psychological-cess analyses, generalized estimating equations were used for chiselled data, and a mixed-model analysis of variance was used for continuous information, with written report center as a random effect and aligning for the relative's 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 use of SAS software, version 9.2 (SAS Found).

Results

Characteristics of Patients and Enrolled Family unit Members

Figure one. Figure i. Randomization and Follow-up.

The Bear upon of Issue Calibration (IES) was used to appraise 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 report: 266 were systematically given the option of being nowadays during CPR (intervention group) and 304 were non routinely asked whether they wanted to be present (control group) (Figure one). In total, 342 family members (60%) witnessed resuscitation and 228 did not.

Table 1. Table i. Characteristics of Patients, Enrolled Family Members, and Cardiac Arrest.

At xc days, 95 family members (17%) did non complete the IES cess; therefore, 475 (observed-cases population) were included in the sensitivity analysis (Figure 1). The proportion of family members who were unable to consummate the 90-twenty-four hour period 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 two study groups (Table i).

Resuscitation Characteristics and Outcomes

Table 2. Table 2. Characteristics and Event of Avant-garde Resuscitation According to the Presence or Absence of a Family Member.

Twenty patients (4%) were still live at twenty-four hours 28. Characteristics of the resuscitation procedure, survival to hospital admission, and survival to mean solar day 28 did not differ significantly between the intervention grouping and the control group (data non shown). Survival, the elapsing of advanced resuscitation, the type or dose of infused medications, and the number of shocks delivered were not affected by the presence or absence of the family member (Table 2).

Psychological Assessment

Chief Criterion

Table 3. Tabular array 3. Psychological Cess of Family Members Enrolled in the Study 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 command group than in the intervention group (adjusted odds ratio, i.7; 95% confidence interval [CI], 1.ii to ii.5; P=0.004) and was significantly higher among family members who did not witness CPR than among those who did (adjusted odds ratio, one.six; 95% CI, 1.one to 2.5; P=0.02). The results were similar for an assay that was restricted to the observed-cases population (P=0.01 for both comparisons) (Table three) and an analysis that excluded the xx resuscitated patients who were alive at twenty-four hours 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 Tabular array 3. The frequency of symptoms of feet was significantly higher in the control group than in the intervention group and was likewise significantly higher among family members who did not witness resuscitation than amongst those who did (P<0.001 for both comparisons). The proportion of family members with symptoms of low did not differ significantly between the control and intervention groups (P=0.xiii) but was significantly lower amidst family members who were nowadays than amongst 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 members (<1%) were aggressive or in conflict with the medical team. Twenty-2 of the 186 family members who did not witness CPR (12%) expressed regret at having been absent, as compared with ix of 289 relatives who witnessed CPR (3%) and who regretted being present (P<0.001).

Stress Cess of Medical Teams

Tabular array 4. Tabular array 4. Evaluation of Stress in the Medical Team (N=570).

The median stress level every bit measured on the visual-analogue scale was v out of 100 (interquartile range, 0 to 15) among 1710 wellness care professionals evaluated. Nosotros found no significant differences in stress levels co-ordinate to family-presence status (Table 4).

Medicolegal Conflicts

With a mean follow-up of 20±five months, there were no claims for damages from any participating family members nor were at that place whatsoever medicolegal conflicts. We received one thank-you alphabetic character from a relative in the control group who observed CPR.

Discussion

In this multicenter, randomized trial, offer 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 unit presence. Irrespective of whether the family unit members were offered the choice, more than favorable results of psychological testing were noted when family members were present.

Routinely offering family members the opportunity to stay with the patient during CPR remains a controversial event.6 Observational and qualitative studies have favored family presence during CPR.4,v,9,25 In a recent study that involved 65 family members of patients undergoing CPR, at that place were no significant differences in overall PTSD or depression scores betwixt those who witnessed CPR and those who did not.23 However, this study was small and did non have a randomized design, thus limiting the conclusions that can exist drawn from the results. The same authors conducted another small, nonrandomized study and found that witnessing a failed CPR endeavour on a loved one was associated with an increase in PTSD symptoms.8

We found that the effectiveness of resuscitation was not afflicted by the presence of a family member, nor was the duration of CPR, the selection of drugs, or the survival rate. These results are in contrast with the findings of two large surveys that revealed concerns about 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 decide whether family presence influenced critical actions performed by physicians during CPR, when false on a mannequin.29 In this virtual clinical written report, the time required to deliver the starting time 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 members (<i%) were aggressive or in disharmonize with the medical squad. This ascertainment was consistent with the results of ii comparative studies that evaluated the effect of family presence on the efficiency of resuscitation efforts for children with trauma.22,28

Stress levels in the health care team were not affected past family presence during resuscitation. Our results are at odds with those of a similar evaluation involving emergency room staff members in 1987.iv In this pivotal study, 30% of the 20 staff members reported that they had been hampered in their activities, mainly by anxiety about being observed or by business organisation about possible emotional or disruptive behavior on the part of family unit members.iv

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 different in France than elsewhere, our findings should help allay physicians' medicolegal concerns.

The limitations of the electric current report demand to be considered. Commencement, this study was conducted in France. 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 understanding with those of our study, supporting their generalizability.4,9,fourteen,28 2d, not all patients included in the study died. Given that PTSD symptoms are related to postal service-traumatic grief, it might be expected that the effect of being nowadays during CPR would differ according to patient outcomes.30 Even so, we conducted a sensitivity analysis that excluded the 20 survivors at day 28. The results did non differ from those of the original analysis. Third, we included in this study relatives with various relationships to the patient. I might fence that the option of beingness present during CPR should be offered only to very shut relatives, such as spouses. However, our results were adapted for the relative's relationship to the patient. Finally, our trial took identify in patients' homes and did not evaluate in-hospital cardiac arrests. Trials in the infirmary setting, such as the emergency department or intensive intendance unit, are needed to ostend our results, although some studies of pediatric trauma resuscitation testify that family presence is not associated with negative outcomes.22,28

Despite these limitations, sensitivity analyses confirmed the robustness of our principal 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 adult patient, performed in the home, was associated with positive results on psychological evaluations and did not interfere with medical efforts, increase stress in the wellness care team, or result in medicolegal conflicts.

Funding and Disclosures

Supported past Plan Hospitalier de Recherche Clinique 2008 of the French Ministry of Health.

Disclosure forms provided by the authors are bachelor with the full text of this article at NEJM.org.

We thank the Enquiry Delegation of Aid Publique–Hôpitaux de Paris (Aurélie Guimfack and Christine Lanau) for technical support; Martine Tanke, who monitored the ongoing results of the trial; Bruno Riou, for review of an earlier draft of the manuscript; and the physicians, nurses, and ambulance attendants at each centre for their valuable cooperation with the study.

Writer Affiliations

From Assistance Publique–Hôpitaux de Paris (AP-HP), Service d'Adjutant Médicale d'Urgence (SAMU) (P.J., F.L., D.N., A.A., M.D., F.A.), and AP-HP, Service de Psychiatrie (T.B.), Hôpital Avicenne, Bobigny; INSERM Unité 970, Heart de Recherche Cardiovasculaire de Paris, Université Paris Descartes (P.J.), AP-HP, SAMU de Paris, Hôpital Necker–Enfants Malades (P.J., B.V.), AP-HP, réanimation médicale, Hôpital Saint-Louis (Eastward.A.), AP-HP, Hôpital Lariboisière (C.B.), and AP-HP, Unité de Recherche Clinique, Hôpital Fernand Widal (E.V.), Paris; AP-HP, Hôpital Beaujon, Clichy (V.B., A.R.-H.); AP-HP, Hôpital Henri Mondor, Créteil (Fifty.J.); Hôpital de Montauban, Montauban (50.B.); Hôpital Melun, Melun (Yard.T.); Hôpital Chateauroux, Chateauroux (G.B.); Hôpital de Nantes, Nantes (V.P.); Hôpital Toulon, Toulon (J.I.); Hôpital de Dreux, Dreux (A.B.); Hôpital de Lille, Lille (N.A.); Hôpital Nancy, Nancy (L.N.); Hôpital Comminges Pyrennées, Saint Gaudens (Fifty.T.); and Hôpital Pontoise, Pontoise (South.L.) — all in France; and the Department of Emergency Medicine, Texas Tech Academy Health Sciences Center, El Paso (S.W.B.).

Address reprint requests to Dr. Adnet at Urgences, Hôpital Avicenne, 93000 Bobigny, French republic, or at [electronic mail protected].

Supplementary Material

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