Evolution of Investigating Informed Assent Discussions about CPR in Seriously Ill Patients.

CONTEXT: Outcomes after cardiopulmonary resuscitation (CPR) remain poor. We have spent 10 years investigating an "informed assent" (IA) approach to discussing CPR with chronically ill patients/families. IA is a discussion framework whereby patients extremely unlikely to benefit from CPR are informed that unless they disagree, CPR will not be performed because it will not help achieve their goals, thus removing the burden of decision-making from the patient/family, while they retain an opportunity to disagree. OBJECTIVES: Determine the acceptability and efficacy of IA discussions about CPR with older chronically ill patients/families. METHODS: This multi-site research occurred in three stages. Stage I determined acceptability of the intervention through focus groups of patients with advanced COPD or malignancy, family members, and physicians. Stage II was an ambulatory pilot randomized controlled trial (RCT) of the IA discussion. Stage III is an ongoing phase 2 RCT of IA versus attention control in in patients with advanced chronic illness. RESULTS: Our qualitative work found the IA approach was acceptable to most patients, families, and physicians. The pilot RCT demonstrated feasibility and showed an increase in participants in the intervention group changing from "full code" to "do not resuscitate" within two weeks after the intervention. However, Stages I and II found that IA is best suited to inpatients. Our phase 2 RCT in older hospitalized seriously ill patients is ongoing; results are pending. CONCLUSIONS: IA is a feasible and reasonable approach to CPR discussions in selected patient populations.

Modifiable elements of ICU supportive care and communication are associated with surrogates' PTSD symptoms.

PURPOSE: To identify specific components of ICU clinician supportive care and communication that are associated with increased post-traumatic stress disorder (PTSD) symptoms for surrogate decision makers of patients with chronic critical illness (CCI). METHODS: We conducted a secondary analysis of data from a randomized controlled trial of palliative care-led meetings to provide information and support for CCI surrogates. The primary outcome for this secondary analysis was PTSD symptoms at 90 days, measured by the Impact of Event Scale-Revised (IES-R). Caregiver perceptions of clinician support and communication were assessed using a version of the After-Death Bereaved Family Member Interview (ADBFMI) instrument modified for use in non-bereaved in addition to bereaved caregivers. The association between ADBFMI items and IES-R score was analyzed using multiple linear regression. RESULTS: Ninety-day follow up was complete for 306 surrogates corresponding to 224 patients. Seventy-one percent of surrogates were female, and the mean age was 51 years. Of the domains, negative perception of the patient's physical comfort and emotional support was associated with the greatest increase in surrogate PTSD symptoms (beta coefficient 1.74, 95% CI 0.82-2.65). The three specific preselected items associated with increased surrogate PTSD symptoms were surrogate perception that clinicians did not listen to concerns (beta coefficient 10.7, 95% CI 3.6-17.9), failure of the physician to explain how the patient's pain would be treated (beta coefficient 12.1, 95% CI 4.9-19.3), and lack of sufficient religious contact (beta coefficient 11.7, 95% CI 2-21.3). CONCLUSION: Modifiable deficits in ICU clinician support and communication were associated with increased PTSD symptoms among CCI surrogates.

Rapid Response Events in Hospitalized Patients: Patient Symptoms and Clinician Communication.

CONTEXT: Patients triggering rapid response team (RRT) intervention are at high risk for adverse outcomes. Data on symptom burden of these patients do not currently exist, and current symptom management and communication practices of RRT clinicians are unknown. OBJECTIVES: We sought to identify the symptom experience of RRT patients and observe how RRT clinicians communicate with patients and their families. METHODS: We conducted a prospective observational study from August to December 2015. Investigators attending RRT events measured frequencies of symptom assessment, communication, and supportive behaviors by RRT clinicians. As the rapid response event concluded, investigators measured patient-reported pain, dyspnea, and anxiety using a numeric rating scale of 0 (none) to 10 (most severe), with uncontrolled symptoms defined as numeric rating scale score of ≥4. RESULTS: We observed a total of 52 RRT events. RRT clinicians assessed for pain during the event in 62% of alert patients, dyspnea in 38%, and anxiety in 21%. Goals of care were discussed during 3% of events and within 24 hours in 13%. For the primary outcome measure, at the RRT event conclusion, 44% of alert patients had uncontrolled pain, 39% had uncontrolled dyspnea, and 35% had uncontrolled anxiety. CONCLUSION: Hospitalized patients triggering RRT events have a high degree of uncontrolled symptoms that are infrequently assessed and treated. Although these patients experience an acute change in medical status and are at high risk for adverse outcomes, goals-of-care discussions with RRT patients or families are rarely documented in the period after the events.

Risk Factors for Post-Traumatic Stress Disorder Symptoms in Surrogate Decision-Makers of Patients with Chronic Critical Illness.

RATIONALE: Chronically critically ill patients are often dependent on family members for surrogate decision-making, and these surrogates are at high risk for emotional distress. We hypothesized that patient- and surrogate-specific risk factors for surrogate post-traumatic stress disorder (PTSD) symptoms can be identified early in the course of chronic critical illness. OBJECTIVES: To identify risk factors for PTSD symptoms in surrogate decision-makers of chronically critically ill patients. METHODS: We performed a secondary analysis of the database from a multicenter randomized trial of a communication intervention for chronic critical illness patients and surrogates. Variables preselected for plausible mechanism for increasing PTSD symptoms and identifiable by Day 10 of mechanical ventilation were included in the analysis for association with surrogate PTSD symptoms at 90 days, as measured by the Impact of Events Score-Revised (IES-R). Patient factors included demographics, insurance status, baseline functional status, chronic comorbidities, illness severity, and presence of advance directive. Surrogate variables included demographics, education level and employment, religion, relationship to patient, and Hospital Anxiety and Depression Scale score measured at enrollment. Multivariable linear regression models were then constructed for 26 potential risk factors, including biologically or mechanistically plausible confounders for each, with IES-R score as the outcome. All models were adjusted for multiple respondents, using a mixed model, considering the patients as a random factor. RESULTS: Our analysis included 306 surrogates for 224 patients. A total of 49% of patients were female, and mean age was 59 years (95% confidence interval [CI], 56.4-60.7). A total of 71% of surrogates were female, and mean age was 51 years (95% CI, 49.3-52.4). After examining each potential risk factor in a separate multivariable model, only Day-10 surrogate Hospital Anxiety and Depression Scale score (ß coefficient = 1.02; 95% CI, 0.73-1.30) and patient unresponsiveness (ß coefficient = 8.39; 95% CI, 0.83-15.95) were associated with higher IES-R scores. CONCLUSIONS: Among surrogate decision-makers for chronically critically ill patients, high anxiety and depression scores and patient unresponsiveness on or near Day 10 of mechanical ventilation are risk factors for PTSD symptoms at 90 days.

Obtaining consent from both parents for pediatric research: what does "reasonably available" mean?

OBJECTIVE: Circumstances surrounding parental availability and decision-making were examined in the setting of a research protocol involving newborn screening (NBS) for fragile X syndrome, in which the institutional review board (IRB) had determined that consent (permission) was required from both parents. METHODS: A survey was conducted with 3001 families who were approached to participate in optional NBS. In addition to basic demographics, observational notes detailed the reasons why fathers were not present or deemed "not reasonably available" (per IRB regulations), and content analysis identified the factors for this lack of availability. Logistic regression models estimated the likelihood that both parents would agree to enroll their infant in the screening project. RESULTS: Fathers were not present in 589 cases, including 158 in which fathers were ultimately determined to be not reasonably available. Primary reasons for father's unavailability were deployment with the military, incarceration, living out of state, or not involved in the mother's life. In cases in which both parents were available, 64% agreed to enroll in the NBS study. Criteria to guide researchers in making required determinations were developed from consultations with IRB officials and legal counsel. CONCLUSIONS: In a large-scale population-based study, 19.6% of fathers were absent for the consent process. Scenarios encountered underscore the complexity of parental relations and their implications for obtaining consent for research involving children. The algorithm developed may serve as a useful tool for others in applying the regulatory requirements for dual parental permission.

Parents' decisions to screen newborns for FMR1 gene expansions in a pilot research project.

OBJECTIVE: The goal of this study was to document rates of parental consent in a pilot study of newborn screening for FMR1 gene expansions, examine demographic characteristics of mothers who consented or declined, describe the reasons for their decision, and discuss ethical and social aspects of the consent process. METHODS: A brief survey was used to record basic demographic data from mothers and an open-ended question was used to elicit parents' reasons for accepting or declining screening. A descriptive analysis was conducted on the number of mothers who consented to or declined screening, and a logistic regression model predicted mothers' likelihood to agree to screening based on demographic characteristics. Reasons for decisions were analyzed using content analysis. The study was conducted at University of North Carolina Hospitals. A total of 2137 mothers were approached. RESULTS: The uptake rate for couples was 63%. Acceptance rates varied by race/ethnicity, with black respondents being less likely to accept screening. Primary reasons for accepting were "to know," "belief in research," and "the test was minimal/no risk." Reasons for declining included not wanting to know or worry, not being a good time, and issues with testing children or with genetic tests. CONCLUSIONS: Findings demonstrate that a majority of parents accepted newborn screening for FMR1 gene expansions, but decision rates and reasons for accepting or declining varied in part as a function of race/ethnicity and in part as a function of what parents most valued or feared in their assessment of risks and benefits.