Pandemic Effects on Stability of End-of-Life Preferences and Patient-Surrogate Dyad Congruence.

CONTEXT: Whether a largescale disaster alters people's previous decisions about their end-of-life care is unknown. OBJECTIVES: We examined the effects of a disaster, the COVID-19 pandemic, on stability of end-of-life care preferences among dialysis patients and on patient-surrogate goals-of-care congruence. METHODS: We used a natural experimental design to examine goals-of-care preferences pre- and postexposure to the pandemic during a pragmatic trial testing SPIRIT (sharing patient's illness representations to increase trust), an evidence-based advance care planning (ACP) intervention. There were 151 patient-surrogate dyads who prior to the pandemic lockdown had completed baseline (T1) and postintervention assessments (T2) regarding their goals-of-care preferences in two end-of-life scenarios. Of those 151 dyads, 59 intervention, and 51 usual care dyads consented to be in the present study and completed the goals-of-care tool two additional times, at enrollment (T3) and six months later (T4), along with the COVID stress scale (CSS). Dyad congruence was ascertained by comparing patient and surrogate responses to the goals-of-care tool. RESULTS: There were no changes over time in the proportions of patients who chose comfort-care-only in the goals-of-care tool. The proportion of patients who chose comfort-care-only and dyad congruence were higher in SPIRIT compared to usual care, but there was no interaction between that treatment effect and exposure to the pandemic. CSS was associated with neither patients' preferences nor dyad congruence. CONCLUSIONS: The pandemic alone did not appear to influence patients' goals-of-care preferences or dyad congruence. This finding supports the stability of value-based end-of-life preferences in general, even during a disaster.

Measures of Patient and Surrogate Preparedness for End-of-Life Decision-Making.

CONTEXT: Reliable and valid measures are critical in accurately assessing outcomes of advance care planning interventions (ACP) for end-of-life (EOL) decision-making. OBJECTIVES: To develop measures of preparedness for EOL decision-making for patients with end-stage renal disease and their surrogates (an exemplar population). METHODS: In this 3-phase study, Phases 1 and 2 included a cross-discipline concept analysis of the preparedness construct, item generation for patient and surrogate scales (82 items), evaluation of content validity and readability, cognitive interviewing, and item reduction. In phase 3, the retained 26 patient and 25 surrogate items were administered to 426 patients and 426 surrogates during a multisite trial of an ACP intervention versus care-as-usual and evaluated internal consistency, 2-week test-retest reliability, and construct validity. RESULTS: Scales were reduced to 20 patient and 19 surrogate items during phase 3. Cronbach's alphas were 0.86 (patient) and 0.90 (surrogate). There was a strong correlation between preparedness at baseline and two weeks for both scales (r = 0.66-0.69, P < 0.001). Confirmatory factor analysis and item-response analyses suggested unidimensionality. A significant correlation was shown between patient preparedness and patient decisional conflict (r = -0.53, P < 0.001), and surrogate preparedness and surrogate decision-making confidence (r = 0.44, P < 0.001). Among those who received the ACP intervention, the effect size of change was medium: Cohen's d = 0.54, P < 0.001 for patients and d = 0.57, P < 0.001 for surrogates. CONCLUSIONS: The preparedness scales demonstrated strong psychometric properties. Future studies should examine scale performance in other populations.

Effectiveness of an Advance Care Planning Intervention in Adults Receiving Dialysis and Their Families: A Cluster Randomized Clinical Trial.

Importance: Evidence of effectiveness of advance care planning (ACP) strategies for patients receiving dialysis and their families is needed. Objectives: To test the effectiveness of an ACP intervention to prepare patients and their surrogates for end-of-life (EOL) decision-making and to improve surrogate bereavement outcomes. Design, Setting, and Participants: This cluster randomized clinical trial, An Effectiveness-Implementation Trial of SPIRIT (Sharing Patients' Illness Representations to Increase Trust) in ESRD, was conducted from December 2017 to March 2023 and included 42 dialysis clinics in 5 US states (Georgia, New Mexico, North Carolina, Pennsylvania, and Virginia) randomized to provide intervention or usual care. Recruitment was from February 15, 2018, to January 31, 2022, and patient-surrogate dyads were followed up for 21 months (until January 17, 2023) or until patient death. Intervention: Each clinic selected 1 or 2 health care workers (eg, nurse practitioner, registered nurse, or social worker) to conduct 45- to 60-minute ACP discussions with dyads in the clinic or remotely. After March 13, 2020 (commencement of the COVID-19 emergency declaration), all discussions were conducted remotely. An ACP summary was placed in patients' medical records. Main Outcomes and Measures: The primary, 2-week preparedness outcomes were dyad congruence on EOL goals of care, patient decisional conflict, surrogate decision-making confidence, and a composite of dyad congruence and surrogate decision-making confidence. Secondary bereavement outcomes were anxiety, depression, and posttraumatic distress 3 months after patient death. To adjust for COVID-19 pandemic effects on bereavement outcomes, a variable to indicate the timing of baseline and 3-month assessment relative to the COVID-19 emergency declaration was created. Results: Of the 426 dyads enrolled, 231 were in the intervention clinics, and 195 were in the control clinics. Among all dyads, the mean (SD) patient age was 61.9 (12.7) years, and the mean (SD) surrogate age was 53.7 (15.4) years. At 2 weeks, after adjusting for baseline values, dyad congruence (odds ratio [OR], 1.61; 95% CI, 1.12-2.31; P = .001), decisional conflict scores (ß, -0.10; 95% CI, -0.13 to -0.07; P < .001), and the composite (OR, 1.57; 95% CI, 1.06-2.34; P = .03) were higher in the intervention group than in the control group. Surrogate decision-making confidence was similar between groups (ß, 0.06; 95% CI, -0.01 to 0.13; P = .12). Among 77 bereaved surrogates, after adjusting for baseline values and assessment timing, intervention group anxiety was lower than control group anxiety (ß, -1.55; 95% CI, -3.08 to -0.01; P = .05); however, depression (ß, -0.18; 95% CI, -2.09 to 1.73; P = .84) and posttraumatic distress (ß, -0.96; 95% CI, -7.39 to 5.46; P = .75) were similar. Conclusions and Relevance: In this randomized clinical trial, the ACP intervention implemented by health care workers at dialysis centers improved preparation for EOL decision-making but showed mixed effectiveness on bereavement outcomes. The ACP intervention implemented in dialysis centers may be an effective strategy to the dyad preparation for end-of-life care as opposed to the current focus on advance directives. Trial Registration: ClinicalTrials.gov Identifier: NCT03138564.

Effects of the WRITE Symptoms Interventions on Symptoms and Quality of Life Among Patients With Recurrent Ovarian Cancers: An NRG Oncology/GOG Study (GOG-0259).

PURPOSE: GOG-259 was a 3-arm randomized controlled trial of two web-based symptom management interventions for patients with recurrent ovarian cancer. Primary aims were to compare the efficacy of the nurse-guided (Nurse-WRITE) and self-directed (SD-WRITE) interventions to Enhanced Usual Care (EUC) in improving symptoms (burden and controllability) and quality of life (QOL). METHODS: Patients with recurrent or persistent ovarian, fallopian, or primary peritoneal cancer with 3+ symptoms were eligible for the study. Participants completed baseline (BL) surveys (symptom burden and controllability and QOL) before random assignment. WRITE interventions lasted 8 weeks to develop symptom management plans for three target symptoms. All women received EUC: monthly online symptom assessment with provider reports; online resources; and every 2-week e-mails. Outcomes were evaluated at 8 and 12 weeks after BL. Repeated-measures modeling with linear contrasts evaluated group by time effects on symptom burden, controllability, and QOL, controlling for key covariates. RESULTS: Participants (N = 497) reported mean age of 59.3 ± 9.2 years. At BL, 84% were receiving chemotherapy and reported a mean of 14.2 ± 4.9 concurrent symptoms, most commonly fatigue, constipation, and peripheral neuropathy. Symptom burden and QOL improved significantly over time (P < .001) for all three groups. A group by time interaction (P < .001) for symptom controllability was noted whereby both WRITE intervention groups had similar improvements from BL to 8 and 12 weeks, whereas EUC did not improve over time. CONCLUSION: Both WRITE Intervention groups showed significantly greater improvements in symptom controllability from BL to 8 and BL to 12 weeks compared with EUC. There were no significant differences between Nurse-WRITE and SD-WRITE. SD-WRITE has potential as a scalable intervention for a future implementation study.

Revisiting patient-related barriers to cancer pain management in the context of the US opioid crisis.

ABSTRACT: Patient fear of addiction is a well-documented barrier to the use of analgesic medications for cancer pain control. Over the past 2 decades in the United States, an "opioid crisis" has arisen, accompanied by risk messages delivered through news outlets, public health education, and patient-provider communication. The purpose of this study was to determine if patient-related barriers to cancer pain management-specifically, fears of addiction-and related pain outcomes (pain severity, pain interference with daily life, and adequacy of pain management) have worsened over the last 20 years. A sample of 157 outpatients with active recurrent or active metastatic cancer completed the Barriers Questionnaire-II (BQ-II) and measures of pain and analgesic use. We identified 7 comparison studies published between 2002 and 2020 that reported patient-related barriers using the BQ-II. Significant linear relationships were found between later year of publication and greater fear of addiction (harmful effect subscale score, B = 0.0350, R2 = 0.0347, F1,637 = 23.19, P < 0.0001) and between year of publication and more pain management barriers overall (total BQ-II score, B = 0.039, R2 = 0.065, F1,923 = 73.79, P < 0.0001). Relationships between BQ-II scores (harmful effect and total) and pain outcomes did not change over time. Despite worsening in patient-related barriers, the proportion of patients with adequate vs inadequate analgesic use did not differ over time. Notably, 40% of participants reported inadequate analgesic use, a statistic that has not improved in 20 years. Additional research is necessary to clarify factors contributing to changing beliefs. Findings indicate a continuing need for clinical and possibly system/policy-level interventions to support adequate cancer pain management.

Can Persons with Dementia Meaningfully Participate in Advance Care Planning Discussions? A Mixed-Methods Study of SPIRIT.

Background: Despite the importance of persons with dementia (PWDs) engaging in advance care planning (ACP) at a time when they are still competent to appoint a surrogate decision maker and meaningfully participate in ACP discussions, studies of ACP in PWDs are rare. Objective: We conducted an intervention development study to adapt an efficacious ACP intervention, SPIRIT (sharing patient's illness representations to increase trust), for PWDs in early stages (recent Montreal Cognitive Assessment [MoCA] score ≥13) and their surrogates and assess whether SPIRIT could help PWDs engage in ACP. Design: A formative expert panel review of the adapted SPIRIT, followed by a randomized trial with qualitative interviews, was conducted. Patient-surrogate dyads were randomized to SPIRIT in person (in a private room in a memory clinic) or SPIRIT remote (via videoconferencing from home). Setting/Subjects: Twenty-three dyads of PWDs and their surrogates were recruited from an outpatient brain health center. Participants completed preparedness outcome measures (dyad congruence on goals of care, patient decisional conflict, and surrogate decision-making confidence) at baseline and two to three days post-intervention, plus a semistructured interview. Levels of articulation of end-of-life wishes of PWDs during SPIRIT sessions were rated (3 = expressed wishes very coherently, 2 = somewhat coherently, and 1 = unable to express coherently). Results: All 23 were able to articulate their end-of-life wishes very or somewhat coherently during the SPIRIT session; of those, 14 PWDs had moderate dementia. While decision-making capacity was higher in PWDs who articulated their wishes very coherently, MoCA scores did not differ by articulation levels. PWDs and surrogates perceived SPIRIT as beneficial, but the preparedness outcomes did not change pre-post. Conclusions: SPIRIT engaged PWDs and surrogates in meaningful ACP discussions, but requires testing of efficacy and long-term outcomes.

Control Conditions That Are Neither Usual Care Nor No Treatment in Randomized Trials of Psychoeducational Palliative Care Interventions: A Systematic Review.

BACKGROUND:: Determining intervention efficacy depends as much on the control group as on the intervention, but little attention has been given to the control condition in psychoeducational trials in palliative care. OBJECTIVES:: To examine (1) research practice regarding control conditions that are neither usual care nor no-treatment controls in randomized trials of psychoeducational palliative care interventions and (2) the rationale and completeness of the descriptions of control conditions in trial reports. METHODS:: PubMed, EMBASE, PsycINFO, and Web of Science were searched. After screening 1603 articles, 70 full-text articles were assessed for eligibility. The final sample included 9 trial reports. We used the Delphi list for quality assessment and the modified intervention taxonomy checklist to assess active intervention and control conditions. RESULTS:: Four trials used an attention control designed to be equivalent to the structure of the active intervention. In another 4, the control condition included some aspects of attention control such that the mode of contact was similar to that in the active intervention, but either the amount or the intensity of attention was not similar. Only 3 trial reports explicitly stated the rationale for the choice of control condition. Although most reports contained delivery mode, materials, duration, frequency, and sequence, none described the qualifications or training required to deliver the control condition. Only 1 report mentioned the fidelity monitoring method, and none included fidelity data. CONCLUSION:: Our review of psychoeducational trials in palliative care calls for researchers' attention to appropriate selection, design, conduct and report of control conditions.

SPIRIT advance care planning intervention in early stage dementias: An NIH stage I behavioral intervention development trial.

People in the early stages of Alzheimer's disease and related dementias (ADRD) are encouraged to engage in advance care planning (ACP) while they are still competent to appoint a surrogate decision maker and meaningfully participate in ACP discussions with the surrogate. In this NIH Stage I behavioral intervention development trial, we will adapt and test an efficacious ACP intervention, SPIRIT (Sharing Patient's Illness Representation to Increase Trust), with people with mild dementia and their surrogates to promote open, honest discussions while such discussions about end-of-life care are possible. We will first adapt SPIRIT (in person) to target people with mild dementia and their surrogates through a process of modification-pretesting-refinement using stakeholders (persons with mild dementia, family caregivers, and clinicians) and experts, including adapting the delivery mode to interactive web-based videoconference format (SPIRIT-remote). Then in a 3-group RCT with 120 patient-surrogate dyads, we will evaluate the feasibility and acceptability of SPIRIT in-person and SPIRIT remote, and preliminary efficacy of SPIRIT compared to usual care on preparedness outcomes for end-of-life decision making (dyad congruence on goals of care, patient decisional conflict, and surrogate decision-making confidence) shortly after the intervention. This Stage I research of SPIRIT will generate valuable insights regarding how to improve ACP for people with mild dementia who will progress to an advanced stage of the disease in the foreseeable future. TRIAL REGISTRATION: ClinicalTrials.gov NCT03311711, Registered 10/12/2017.

One-Year Linear Trajectories of Symptoms, Physical Functioning, Cognitive Functioning, Emotional Well-being, and Spiritual Well-being Among Patients Receiving Dialysis.

BACKGROUND: This study evaluated 1-year linear trajectories of patient-reported dimensions of quality of life among patients receiving dialysis. STUDY DESIGN: Longitudinal observational study. SETTING & PARTICIPANTS: 227 patients recruited from 12 dialysis centers. FACTORS: Sociodemographic and clinical characteristics. MEASUREMENTS/OUTCOMES: Participants completed an hour-long interview monthly for 12 months. Each interview included patient-reported outcome measures of overall symptoms (Edmonton Symptom Assessment System), physical functioning (Activities of Daily Living/Instrumental Activities of Daily Living), cognitive functioning (Patient's Assessment of Own Functioning Inventory), emotional well-being (Center for Epidemiologic Studies Depression Scale, State Anxiety Inventory, and Positive and Negative Affect Schedule), and spiritual well-being (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale). For each dimension, linear and generalized linear mixed-effects models were used. Linear trajectories of the 5 dimensions were jointly modeled as a multivariate outcome over time. RESULTS: Although dimension scores fluctuated greatly from month to month, overall symptoms, cognitive functioning, emotional well-being, and spiritual well-being improved over time. Older compared with younger participants reported higher scores across all dimensions (all P<0.05). Higher comorbidity scores were associated with worse scores in most dimensions (all P<0.01). Nonwhite participants reported better spiritual well-being compared with their white counterparts (P<0.01). Clustering analysis of dimension scores revealed 2 distinctive clusters. Cluster 1 was characterized by better scores than those of cluster 2 in nearly all dimensions at baseline and by gradual improvement over time. LIMITATIONS: Study was conducted in a single region of the United States and included mostly patients with high levels of function across the dimensions of quality of life studied. CONCLUSIONS: Multidimensional patient-reported quality of life varies widely from month to month regardless of whether overall trajectories improve or worsen over time. Additional research is needed to identify the best approaches to incorporate patient-reported outcome measures into dialysis care.

The Role of Inflammation in the Pain, Fatigue, and Sleep Disturbance Symptom Cluster in Advanced Cancer.

CONTEXT: Symptom researchers have proposed a model of inflammatory cytokine activity and dysregulation in cancer to explain co-occurring symptoms including pain, fatigue, and sleep disturbance. OBJECTIVES: We tested the hypothesis that psychological stress accentuates inflammation and that stress and inflammation contribute to one's experience of the pain, fatigue, and sleep disturbance symptom cluster (symptom cluster severity, symptom cluster distress) and its impact (symptom cluster interference with daily life, quality of life). METHODS: We used baseline data from a symptom cluster management trial. Adult participants (N = 158) receiving chemotherapy for advanced cancer reported pain, fatigue, and sleep disturbance on enrollment. Before intervention, participants completed measures of demographics, perceived stress, symptom cluster severity, symptom cluster distress, symptom cluster interference with daily life, and quality of life and provided a blood sample for four inflammatory biomarkers (interleukin-1ß, interleukin-6, tumor necrosis factor-α, and C-reactive protein). RESULTS: Stress was not directly related to any inflammatory biomarker. Stress and tumor necrosis factor-α were positively related to symptom cluster distress, although not symptom cluster severity. Tumor necrosis factor-α was indirectly related to symptom cluster interference with daily life, through its effect on symptom cluster distress. Stress was positively associated with symptom cluster interference with daily life and inversely with quality of life. Stress also had indirect effects on symptom cluster interference with daily life, through its effect on symptom cluster distress. CONCLUSION: The proposed inflammatory model of symptoms was partially supported. Investigators should test interventions that target stress as a contributing factor in co-occurring pain, fatigue, and sleep disturbance and explore other factors that may influence inflammatory biomarker levels within the context of an advanced cancer diagnosis and treatment.

SPIRIT trial: A phase III pragmatic trial of an advance care planning intervention in ESRD.

Advance care planning (ACP) is a central tenet of dialysis care, but the vast majority of dialysis patients report never engaging in ACP discussions with their care providers. Over the last decade, we have developed and iteratively tested SPIRIT (Sharing Patient's Illness Representation to Increase Trust), a theory-based, patient- and family-centered advance care planning intervention. SPIRIT is a six-step, two-session, face-to-face intervention to promote cognitive and emotional preparation for end-of-life decision making for patients with ESRD and their surrogates. In these explanatory trials, SPIRIT was delivered by trained research nurses. Findings consistently revealed that patients and surrogates in SPIRIT showed significant improvement in preparedness for end-of-life decision making, and surrogates in SPIRIT reported significantly improved post-bereavement psychological outcomes after the patient's death compared to a no treatment comparison condition. As a critical next step, we are conducting an effectiveness-implementation study. This study is a multicenter, clinic-level cluster randomized pragmatic trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics, compared to usual care plus delayed SPIRIT implementation. Simultaneously, we will evaluate the implementation of SPIRIT, including sustainability. We will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from 30 dialysis clinics in four states. This trial of SPIRIT will generate novel, meaningful insights about improving ACP in dialysis care. TRIAL REGISTRATION: ClinicalTrials.govNCT03138564, registered 05/01/2017.

Process and impact of an advance care planning intervention evaluated by bereaved surrogate decision-makers of dialysis patients.

BACKGROUND: Few studies have examined the process and impact of an advance care planning intervention experienced by surrogate decision-makers of dialysis patients. AIM: To explore the perspectives of the bereaved surrogates of dialysis patients on the process and impact of an advance care planning intervention and to compare the perceived impacts of the intervention between African Americans and Whites. DESIGN: Qualitative interviews and thematic analysis. SETTING/PARTICIPANTS: 24 bereaved surrogates of patients from outpatient dialysis centers were interviewed. Both patients and surrogates had been participants in a larger efficacy study and had received an advance care planning intervention, SPIRIT (Sharing Patient's Illness Representations to Increase Trust). RESULTS: Two themes related to the process of SPIRIT were as follows: (1) SPIRIT provided a welcome opportunity to think about and discuss topics that had been avoided and (2) SPIRIT helped patients and surrogates to share their feelings. Four themes of the SPIRIT's impact were as follows: (1) SPIRIT was an eye-opening experience, acquiring knowledge and understanding of the patient's illness and end-of-life care, (2) SPIRIT helped strengthen relationships between patients and surrogates, (3) SPIRIT helped surrogates feel prepared during the time leading up to end-of-life decision-making, and (4) SPIRIT helped surrogates have peace of mind during and after actual end-of-life decision-making. Themes related to SPIRIT's impact on feeling prepared for end-of-life decision-making and the actual decision-making experience more frequently occurred in African Americans than in Whites. CONCLUSION: Our data may help explain the beneficial effects of SPIRIT on surrogates, but future trials should include data on control surrogates' perspectives.

A SMART design to optimize treatment strategies for patient and family caregiver outcomes.

Sequential multiple randomization trial (SMART) designs are experimental designs used to identify treatment strategies that maximize targeted health outcomes. SMART designs are receiving greater attention in nursing and other health disciplines to develop multicomponent interventions that are tailored to the patient's (or family caregiver's) needs and preferences. A SMART design resembles a traditional randomized controlled trial (RCT) design in that it scientifically examines intervention effects with randomization. However, the two designs address very different research inquiries. In this article, we compare traditional RCT designs and SMART designs, describe the adaptive treatment framework that underlies SMART designs and key features of SMART designs, and illustrate the application of a SMART design to develop an adaptive palliative care treatment to improve patient and caregiver outcomes.

Beliefs About Dysmenorrhea and Their Relationship to Self-Management.

Dysmenorrhea is highly prevalent and is the leading cause of work and school absences among women of reproductive age. However, self-management of dysmenorrhea is not well understood in the US, and little evidence is available on factors that influence dysmenorrhea self-management. Guided by the Common Sense Model, we examined women's representations of dysmenorrhea (beliefs about causes, symptoms, consequences, timeline, controllability, coherence, and emotional responses), described their dysmenorrhea self-management behaviors, and investigated the relationship between representations and self-management behaviors. We conducted a cross-sectional, web-based survey of 762 adult women who had dysmenorrhea symptoms in the last six months. Participants had varied beliefs about the causes of their dysmenorrhea symptoms, which were perceived as a normal part of life. Dysmenorrhea symptoms were reported as moderately severe, with consequences that moderately affected daily life. Women believed they understood their symptoms moderately well and perceived them as moderately controllable but them to continue through menopause. Most women did not seek professional care but rather used a variety of pharmacologic and complementary health approaches. Care-seeking and use of self-management strategies were associated with common sense beliefs about dysmenorrhea cause, consequences, timeline, and controllability. The findings may inform development and testing of self-management interventions that address dysmenorrhea representations and facilitate evidence-based management. © 2016 Wiley Periodicals, Inc.

Determining Consistency of Surrogate Decisions and End-of-Life Care Received with Patient Goals-of-Care Preferences.

BACKGROUND: Care consistent with preferences is the goal of advance care planning (ACP). However, comparing written preferences to actual end-of-life care may not capture consistency of care with preferences. OBJECTIVE: We evaluated four additional types of consistency, using prospective data on written preferences and active clinical decision making by patients and their surrogates. METHODS: Secondary analysis of data was done from a trial of an ACP intervention for patient-surrogate dyads. Forty-five patients died during the trial and comprised the sample for the analysis. Sources of data included patients' preferences in a written goals-of-care tool, medical record reviews, and two-week postbereavement interviews with surrogates to complement medical record reviews. RESULTS: Twenty-four patients (53.3%) received care consistent with written preferences and 11 (24.4%) inconsistent with written preferences. The remaining 10 patients (22.2%) died suddenly with no opportunity for treatment decision making. Eleven (24.4%) were able to participate in decision making with their surrogates; of those, 9 (81.8%) received care consistent with their expressed preferences. Twenty-two patients were incapacitated and thus the surrogate made treatment decisions alone; of those, 18 (81.8%) made decisions consistent with the patient's written preference. CONCLUSIONS: Simply comparing documented preferences for end-of-life care and medical records of care delivered does not adequately reflect the process of ACP and treatment decision making at the end of life. To understand consistency between preferences and end-of-life care, investigators need data on written and real-time expressed preferences.

Racial Differences in Outcomes of an Advance Care Planning Intervention for Dialysis Patients and Their Surrogates.

BACKGROUND: African Americans' beliefs about end-of-life care may differ from those of whites, but racial differences in advance care planning (ACP) outcomes are unknown. OBJECTIVE: The aim of this study was to compare the efficacy of an ACP intervention on preparation for end-of-life decision making and post-bereavement outcomes for African Americans and whites on dialysis. METHOD: A secondary analysis of data from a randomized trial comparing an ACP intervention (Sharing Patient's Illness Representations to Increase Trust [SPIRIT]) with usual care was conducted. There were 420 participants, 210 patient-surrogate dyads (67.4% African Americans), recruited from 20 dialysis centers in North Carolina. The outcomes of preparation for end-of-life decision making included dyad congruence on goals of care, surrogate decision-making confidence, a composite of the two, and patient decisional conflict assessed at 2, 6, and 12 months post-intervention. Surrogate bereavement outcomes included anxiety, depression, and post-traumatic distress symptoms assessed at 2 weeks, and at 3 and 6 months after the patient's death. RESULTS: SPIRIT was superior to usual care in improving dyad congruence (odds ration [OR] = 2.31, p = 0.018), surrogate decision-making confidence (ß = 0.18, p = 0.021), and the composite (OR = 2.19, p = 0.028) 2 months post-intervention, but only for African Americans. SPIRIT reduced patient decisional conflict at 6 months for whites and at 12 months for African Americans. Finally, SPIRIT was superior to usual care in reducing surrogates' bereavement depressive symptoms for African Americans but not for whites (ß = -3.49, p = 0.003). CONCLUSION: SPIRIT was effective in improving preparation for end-of-life decision-making and post-bereavement outcomes in African Americans.

Depressive symptom severity, contributing factors, and self-management among chronic dialysis patients.

Despite the high prevalence of depressive symptoms in patients receiving chronic dialysis, there has been inadequate attention to patient-related barriers to management of depressive symptoms, such as factors identified by these patients as contributing to their symptoms, and how they responded to the symptoms. Participants (N = 210) in an ongoing longitudinal observational study of multidimensional quality of life in patients receiving chronic dialysis completed a battery of measures monthly for 12 months. For each patient at each measurement point, an event report was generated if he or she scored outside of the normal range on the depressive symptom scale (Center for Epidemiologic Studies Depression Scale-Short Form [CESD-SF] ≥10) or expressed suicidal ideation. Of the 210 participants, 100 (47.6%) had a CESD-SF score ≥10 at least once resulting in 290 event reports. Of these 100 participants, 15 (15%) had also reported suicidal ideation in addition to having depressive symptoms. The most frequently stated contributing factors included "managing comorbid conditions and complications" (56 event reports, 19.3%), "being on dialysis" (50, 17.2%), "family or other personal issues" (37, 12.8%), and "financial difficulties" (31, 10.7%). On 11 event reports (3.8%) participants had been unaware of their depressive symptoms. On 119 event reports (41%) participants reported that they discussed these symptoms with their dialysis care providers or primary care providers, while on 171 event reports (59%) symptoms were not discussed with their health-care providers. The prevalence of depressive symptoms is high and many patients lack knowledge about effective self-management strategies.

Advance care planning and end-of-life decision making in dialysis: a randomized controlled trial targeting patients and their surrogates.

BACKGROUND: Few trials have examined long-term outcomes of advance care planning (ACP) interventions. We examined the efficacy of an ACP intervention on preparation for end-of-life decision making for dialysis patients and surrogates and for surrogates' bereavement outcomes. STUDY DESIGN: A randomized trial compared an ACP intervention (Sharing Patient's Illness Representations to Increase Trust [SPIRIT]) to usual care alone, with blinded outcome assessments. SETTING & PARTICIPANTS: 420 participants (210 dyads of prevalent dialysis patients and their surrogates) from 20 dialysis centers. INTERVENTION: Every dyad received usual care. Those randomly assigned to SPIRIT had an in-depth ACP discussion at the center and a follow-up session at home 2 weeks later. PRIMARY OUTCOMES: preparation for end-of-life decision making, assessed for 12 months, included dyad congruence on goals of care at end of life, patient decisional conflict, surrogate decision-making confidence, and a composite of congruence and surrogate decision-making confidence. SECONDARY OUTCOMES: bereavement outcomes, assessed for 6 months, included anxiety, depression, and posttraumatic distress symptoms completed by surrogates after patient death. PRIMARY OUTCOMES: adjusting for time and baseline values, dyad congruence (OR, 1.89; 95% CI, 1.1-3.3), surrogate decision-making confidence (ß=0.13; 95% CI, 0.01-0.24), and the composite (OR, 1.82; 95% CI, 1.0-3.2) were better in SPIRIT than controls, but patient decisional conflict did not differ between groups (ß=-0.01; 95% CI, -0.12 to 0.10). SECONDARY OUTCOMES: 45 patients died during the study. Surrogates in SPIRIT had less anxiety (ß=-1.13; 95% CI, -2.23 to -0.03), depression (ß=-2.54; 95% CI, -4.34 to -0.74), and posttraumatic distress (ß=-5.75; 95% CI, -10.9 to -0.64) than controls. LIMITATIONS: Study was conducted in a single US region. CONCLUSIONS: SPIRIT was associated with improvements in dyad preparation for end-of-life decision making and surrogate bereavement outcomes.

Making Visible a Theory-Guided Advance Care Planning Intervention.

PURPOSE: In reports of end-of-life communication interventions, it is difficult to find sufficient detail about the intervention to allow replication, extension, and translation into practice. The purpose of this article is to provide details about a theory-guided advance care planning intervention, sharing the patient's illness representations to increase trust (SPIRIT), an intervention that has been shown to be efficacious for patients and their surrogates with respect to preparation for end-of-life decision making. METHODS AND DESIGN: The description of SPIRIT is based on an intervention description checklist by Conn (2012), the Intervention Taxonomy from Schulz, Czaja, McKay, Ory, and Belle (2010) and on relevant segments of Consolidated Standards of Reporting Trials. DISCUSSION: The SPIRIT intervention was developed based on sound theoretical underpinnings and pilot tested with target patient populations and racial or ethnic groups. We describe details about the intervention's theoretical basis, requisite intervener training, implementation of each intervention component, and fidelity monitoring. CLINICAL RELEVANCE: The details about the components of a theory-guided advance care planning intervention may facilitate translation of the intervention to practice settings.