A Team-Based Early Action Protocol to Address Ethical Concerns in the Intensive Care Unit

This quasi-experimental, pre-post (3 and 6 months) study was undertaken to investigate the effect of an ethics intervention on primary and secondary clinical outcomes and clinician outcomes. Clinical outcomes are reported in this article. At least 1 nurse researcher was responsible for study procedures at each hospital. The institutional review board at each medical center approved the study.

Six ICUs representing 5 specialties in 3 academic medical centers participated in this study: a surgical/trauma unit, a cardiac surgery unit, a transplant unit, a neurologic unit, and 2 medical units. All 5 types of ICU were included in the preintervention and 6-month postintervention data collection periods. Data were collected from 3 specialty units (medical, transplant, and neurologic ICUs) in the 3-month postintervention period. All ICU admissions during 1 month before the intervention (N = 672) and during 1 month in the 3-month (N = 438) and 6-month (N = 602) postintervention periods were included in the study. The total number of admissions was 1712, representing 1649 patients; 63 patients were readmitted during the data collection period. Intensive care unit admissions rather than patients were used as the standard of measure because the ethics intervention was initiated for all patient admissions and not just for first-time admissions.

The ethics intervention comprised 3 parts: (1) completion of a daily Ethics Early Action Protocol (see Figure 1, available online only at www.ajccon-line.org) requiring clinicians to analyze patient, family, and situational risk factors that, on the basis of evidence from physicians, nurses, and clinical ethi-cists,^26,27  indicate low, medium, or high risk for ethical conflict, with each risk level accompanied by an action plan; (2) an interactive, case-based protocol orientation developed by the authors of this article and delivered to ICU staff as a 15-minute, online video module; and (3) an ethics application developed by 2 of the authors (C.L.P., K.B.-S.) as an ongoing resource and support for health care teams as they implemented the ethics protocol, which defined ethics terms, provided communication guidelines for educating and supporting patients and families or surrogates, and offered resources for clinician and team well-being.

The Ethics Early Action Protocol integrated into daily care was the central feature of the ethics intervention. It was first pilot tested as a screening tool in ICU and oncology settings at 2 major medical centers.²⁸  The protocol was refined on the basis of the results. Subsequently, to establish content validity, 14 nationally known ethics experts (researchers, physicians, registered nurses, and social workers) assessed each protocol item for its relevance to ethical conflicts and appropriateness for follow-up action. Two items in the protocol were deleted, 1 item was added, and 5 items were subsequently revised for clarity. Nurses in the pilot study also suggested ongoing educational support, specifically on ethics-related communication. The ethics application was developed as a ready resource for these conversations. For the current study, health care teams were urged to incorporate the protocol into an existing care process in the ICU such as daily rounds. Most units assigned nurses to routinely initiate the ethics assessment and then alert the multidisciplinary team as needed to discuss an appropriate plan to mitigate the noted risk factors.

Research team members all used the same definitions for the primary outcome variables: family conferences (ie, formal family meetings), code discussions, and ethics consultations. Secondary clinical outcomes included social work, chaplain, and palliative care consultations, which referred to actual visits from representatives of these disciplines. In all settings, palliative care required physician orders, whereas ethics, social work, and chaplain referrals could be made by all members of the health care team.

Using the same data abstraction instrument at all sites, either the site’s primary investigator, nurse, or trained research assistant abstracted outcome data from the electronic health record for 1 month before the intervention and for 1 month at 3 and 6 months after the intervention. Two units abstracted data only before the intervention and at 6 months after the intervention. Information on family conferences and code discussions was extracted from narrative notes made by physicians, nurses, and social workers. The ethics consultation service in each setting provided data on ethics consultations for the ICU site. Poststudy focus groups were held at study sites to identify benefits, challenges, and suggestions for improvement.

All data analyses were conducted using SAS, version 9.4. As noted previously, patient ICU admissions (1712) rather than patients (1649) were used as sample units. Additionally, data were analyzed according to type of ICU, so we combined medical ICU data from 2 hospitals. Differences in patients’ demographics between the preintervention and postintervention groups were explored using χ² analyses for dichotomous variables and t tests or analyses of variance for normally distributed continuous variables. To ascertain whether significantly more patient admissions were receiving family conferences, social work consultations, palliative care consultations, code status discussions, chaplain visits, and ethics consultations at follow-up compared with before the intervention, simple bivariate (unconditional) logistic regression analyses were performed comparing preintervention and postintervention time points. Multivariate logistic regressions of the same outcomes comparing preintervention and postintervention time points were also performed, controlling for all patient demographic variables, primary diagnosis, ICU type, and ICU length of stay. Because postintervention data at 3 months represented 3 ICU types, all analyses comparing prein-tervention with 3 months postintervention were performed for these 3 ICU types. Separate analyses were performed comparing preintervention with 6-month postintervention data for all 5 ICU types. To determine whether the incidence ratio of receiving a family conference differed on any given day between the preintervention and 3-month postintervention and the preintervention and 6-month postintervention time points, survival analyses were conducted by using multivariate Cox regression models, controlling for all patient demographic variables, ICUs, primary diagnoses, and ICU length of stay.

The sample consisted of 1712 admissions for 1649 patients who entered the ICU during the data collection time periods: 672 admissions in the preintervention period, 438 in the 3-month postintervention period, and 602 in the 6-month postintervention period. Most patients were admitted for an acute illness. Although some surgical admissions in 1 unit were elective, most of those patients were experiencing life-threatening conditions requiring surgical intervention. Most of the patients were white (74%) and male (56%), and the mean age of the patients was 60 years. Patients in the preintervention and postintervention groups did not differ significantly in terms of demographic variables except for religion, primary diagnosis, and ICU type (Table 1). Additionally, the percentages of patients who had an advance directive (47%, 44%, and 47%), provider or medical orders for life-sustaining treatments (all 7%), or a named surrogate (56%, 52%, and 60%) did not differ significantly among the 3 groups.

In our comparison of preintervention and 3- and 6-month postintervention data, we noted increases in the proportion of admissions with family conferences (12%, 21%, 20%), chaplain visits (23%, 25%, 33%), code discussions (17%, 18%, 21%), social work visits (39%, 35%, 47%), and palliative care consultations (5%, 6%, 7%). Controlling for demographic variables, diagnosis, ICU type, and ICU length of stay, ICU admissions at both 3 months (Table 2) and 6 months after the intervention (Table 3) had significantly higher odds of receiving a family conference, with odds ratios (ORs) of 2.54 (P < .001) for 3 months and 1.77 (P = .001) for 6 months compared with preintervention admissions. The odds of experiencing a chaplain visit significantly increased at both 3 months (OR = 1.59, P = .008) and 6 months (OR = 1.65, P = .001) after the intervention compared with before the intervention.

The odds of receiving a palliative care consultation or code status discussion did not differ significantly at 3 months (OR = 1.12 for palliative care consultation and 1.40 for code status discussion) or 6 months (OR = 1.38 for palliative care consultation and 1.33 for code discussion) compared with before the intervention. Admissions at 6 months had significantly higher odds of receiving social work referrals (OR = 1.34, P = .02) compared with before the intervention. The number of ethics consultations was low before the intervention (N = 6) and increased to 14 at 3 months and 14 at 6 months after the intervention. The number of ICU admissions with “code status not discussed” was 136 (20%) before the intervention and decreased to 27 (6%) at 3 months and 64 (11%) at 6 months after the intervention.

To ascertain whether time to first family conference differed significantly between the preintervention period and each of the postintervention periods, we performed survival analysis using Cox regression models, controlling for all patient demographic variables including primary diagnosis and ICU type. At any particular time, with all covariates controlled for, a little more than twice as many admissions from the 3-month postintervention period received a family conference compared with preintervention admissions (hazard ratio [HR] = 2.22, P < .001; Table 4). At 6 months, this ratio decreased slightly to 1.73 (P < .001), indicating 73% more admissions receiving a family conference on a certain day compared with preintervention admissions, with all other covariates controlled for (Table 5). Kaplan-Meier survival graphs 1 and 2 (Figures 2 and 3, available online only) illustrate these findings. No significant differences were found for other timing variables or ICU length of stay.

The incidence of having a family conference differed significantly across ICU types. At 3 months, both transplant ICU and medical ICU admissions had HRs more than twice that of neurologic ICU admissions. At 6 months, HRs ranged from 2.99 for the surgical/trauma ICU to 5.09 for the cardiac surgery ICU compared with the neurologic ICU, indicating that neurologic ICU admissions had the lowest likelihood of receiving family conferences among all the ICU types. Patients’ age also differed significantly in the comparison between baseline and 6 months, with all other variables in the model controlled for. Patients older than 75 years were significantly more likely to receive a family conference than those in younger age groups, with HRs ranging from 0.32 for the 40 years or less age group to 0.54 for the 61 to 75 years age group (Table 5).

This study offers some evidence that routine implementation of a team-based ethics intervention can provide additional resources to patients and families during critical illness. The Ethics Early Action Protocol resulted in more formal communication with family members and increased attention to spiritual care needs. We also found that code status was discussed more often, which could indicate that the ethics protocol increased awareness and improved documentation regarding code status. Because moral distress is associated with delays in end-of-life conversations, opportunities to have these team discussions seem essential.²⁹ 

Although the number of patients who received chaplain visits at all 3 time points was low in our study (23% before the intervention, 25% at 3 months after the intervention, and 33% at 6 months after the intervention), the protocol significantly increased these visits. Evidence from other studies indicates that although physicians and nurses value spiritual care,^30,31  providers rarely explore patients’ spiritual needs,³²  despite evidence of the benefits of spiritual care such as improved quality of life³³  and increased satisfaction of patients.^34,35  Routinely assessing patients’ and families’ spiritual needs and providing support may be an overlooked aspect of critical care.

In our study, the number of ICU admissions that included at least 1 family conference increased significantly with protocol use. Evidence from other studies indicates that families not only benefit from family conferences³⁶  but also value the opportunity,³⁷  especially if provided time to share their perspectives.³⁸  Communication with patients and their families is a cornerstone of shared decision-making³⁹  and provides an opportunity for clinicians to prepare surrogates for informed decision-making. Improving family-clinician communication increases family members’ confidence in treatment decision-making and shortens the duration of life support among patients who die in the ICU,⁴⁰  promotes earlier consensus on goals of care for trauma patients⁴¹  and liver transplant patients,⁴²  and improves family satisfaction with end-of-life care in the ICU.⁴³ 

Another important resource for patients and families during critical illness is team collaboration. Teamwork is associated with factors that decrease inappropriate treatments,⁴⁴  increase information exchange among teams,⁴⁵  and decrease moral distress.⁴  In our study, the protocol prompted routine, team-based conversations about ethics-related aspects of care such as patients’ preferences, family perspectives, treatment benefits and burdens, and goals of care. Nurses who participated in poststudy focus groups at study sites indicated that proactive, team-based communication guided by the ethics protocol helped to clarify care goals, identify different viewpoints, coordinate care, and initiate early actions that provided multidisciplinary care for patients and offered informational and emotional support for families.

Our study also revealed potential gaps in ICU care. For example, very few ICU patients received palliative care consultation. Evidence suggests that patients with advanced heart failure who receive usual care plus a palliative care intervention manifest less anxiety and depression and enhanced spiritual well-being compared with similar patients who receive only the usual, standard treatment for heart failure.⁴⁶  Positive outcomes have also been noted for patients diagnosed with metastatic non–small cell lung cancer who receive standard oncology care plus palliative care, compared with those who receive standard care alone. The palliative care plus standard therapy group had significant improvements in perception of quality of life and mood, received less aggressive care at the end of life, and lived longer.⁴⁷  On the basis of its effectiveness, proactive palliative care is now recommended.⁴⁸  In our study, palliative care was an underused resource for ICU patients.

Very few ethics consultations occurred during the study period. Similarly, a prospective study conducted in an oncology ICU revealed that only 1% of ICU admissions had an ethics consultation; when implemented, ethics consultation reduced surrogate-clinician disagreements and increased referrals to palliative care and chaplain services.⁴⁹  Proactively offering valuable ethics-related resources to patients, families, and health care providers may improve patient outcomes such as quality of life, promote family trust and satisfaction with care, and prevent provider disengagement.⁹ 

A nonrandom and relatively small (3 months of patient admissions) sample naturally limits the study findings. The quasi-experimental, pre-post design does not account for variables that may have changed during the study time period, such as staffing changes. However, collecting data in 3 different settings and geographic regions helps to offset design limitations.

Even though site investigators worked from common outcome definitions, outcome data were sometimes difficult to extract because electronic health records did not have standardized chart locations for documenting family conferences or code discussions. Instead, investigators had to rely on reading health care providers’ narrative notes. This limitation was in effect at all 3 time points and in all settings. Family conference documentation may account for some of the results, although nurses participating in the focus groups commented frequently on how the protocol increased family conferences. One nurse commented, “Before the protocol, scheduling a family conference was like pulling teeth, putting them back in, and pulling them out again. Now they [family conferences] just happen.” To deepen understandings about the protocol’s impact, direct patient and family outcome measures should be included in future studies, along with direct observations of clinical outcomes such as family conferences. Differences in ICU types also need further exploration.

This study provides some evidence that the team-based Ethics Early Action Protocol increases family conferences, which could provide opportunities for sharing important information about patients. The ethics protocol also offers spiritual resources that could provide valuable support for patients and their families during critical illness. Data from other studies suggest that family conferences, spiritual support, palliative care interventions, and ethics consultations can improve patient experiences and contribute to family-team cohesiveness.^{21,24,35,36,43,46,47}  In total, these findings suggest that routine efforts such as the Ethics Early Action Protocol to provide more patient care services and promote interprofessional teamwork may be a valuable asset for critically ill patients and their families.