Variability of Prognostic Communication in Critically Ill Neurologic Patients: A Pilot Multicenter Mixed-Methods Study.

IMPORTANCE: Withdrawal-of-life-sustaining treatments (WOLST) rates vary widely among critically ill neurologic patients (CINPs) and cannot be solely attributed to patient and family characteristics. Research in general critical care has shown that clinicians prognosticate to families with high variability. Little is known about how clinicians disclose prognosis to families of CINPs, and whether any associations exist with WOLST. OBJECTIVES: Primary: to demonstrate feasibility of audio-recording clinician-family meetings for CINPs at multiple centers and characterize how clinicians communicate prognosis during these meetings. Secondary: to explore associations of 1) clinician, family, or patient characteristics with clinicians' prognostication approaches and 2) prognostication approach and WOLST. DESIGN SETTING AND PARTICIPANTS: Forty-three audio-recorded clinician-family meetings during which prognosis was discussed from seven U.S. centers for 39 CINPs with 88 family members and 27 clinicians. MAIN OUTCOMES AND MEASURES: Two investigators qualitatively coded transcripts using inductive methods (inter-rater reliability > 80%) to characterize how clinicians prognosticate. We then applied univariate and multivariable multinomial and binomial logistic regression. RESULTS: Clinicians used four distinct prognostication approaches: Authoritative (21%; recommending treatments without discussing values and preferences); Informational (23%; disclosing just the prognosis without further discussions); advisory (42%; disclosing prognosis followed by discussion of values and preferences); and responsive (14%; eliciting values and preferences, then disclosing prognosis). Before adjustment, prognostication approach was associated with center (p < 0.001), clinician specialty (neurointensivists vs non-neurointensivists; p = 0.001), patient age (p = 0.08), diagnosis (p = 0.059), and meeting length (p = 0.03). After adjustment, only clinician specialty independently predicted prognostication approach (p = 0.027). WOLST decisions occurred in 41% of patients and were most common under the advisory approach (56%). WOLST was more likely in older patients (p = 0.059) and with more experienced clinicians (p = 0.07). Prognostication approach was not independently associated with WOLST (p = 0.198). CONCLUSIONS AND RELEVANCE: It is feasible to audio-record sensitive clinician-family meetings about CINPs in multiple ICUs. We found that clinicians prognosticate with high variability. Our data suggest that larger studies are warranted in CINPs to examine the role of clinicians' variable prognostication in WOLST decisions.

A Pilot Randomized Trial of an Interactive Web-based Tool to Support Surrogate Decision Makers in the Intensive Care Unit.

Rationale: Breakdowns in clinician-family communication in intensive care units (ICUs) are common, yet there are no easily scaled interventions to prevent this problem.Objectives: To assess the feasibility, usability, acceptability, and perceived effectiveness of a communication intervention that pairs proactive family meetings with an interactive, web-based tool to help surrogates prepare for clinician-family meetings.Methods: We conducted a two-arm, single-blind, patient-level randomized trial comparing the Family Support Tool with enhanced usual care in two ICUs in a tertiary-care hospital. Eligible participants included surrogates of incapacitated patients judged by their physicians to have ≥40% risk of death or severe long-term functional impairment. The intervention group received unlimited tool access, with prompts to complete specific content upon enrollment and before two scheduled family meetings. Before family meetings, research staff shared with clinicians a one-page summary of surrogates' main questions, prognostic expectations, beliefs about the patient's values, and attitudes about goals of care. The comparator group received usual care enhanced with scheduled family meetings. Feasibility outcomes included the proportion of participants who accessed the tool before the first family meeting, mean number of logins, and average tool engagement time. We assessed tool usability with the System Usability Scale, assessed tool acceptability and perceived effectiveness with internally developed questionnaires, and assessed quality of communication and shared decision-making using the Quality of Communication questionnaire.Results: Of 182 screened patients, 77 were eligible. We enrolled 52 (67.5%) patients and their primary surrogate. Ninety-six percent of intervention surrogates (24/25) accessed the tool before the first family meeting (mean engagement time, 62 min ± 27.7) and logged in 4.2 times (±2.1) on average throughout the hospitalization. Surrogates reported that the tool was highly usable (mean, 82.4/100), acceptable (mean, 4.5/5 ± 0.9), and effective (mean, 4.4/5 ± 0.2). Compared with the control group, surrogates who used the tool reported higher overall quality of communication (mean, 8.9/10 ± 1.6 vs. 8.0/10 ± 2.4) and higher quality in shared decision-making (mean, 8.7/10 ± 1.5 vs. 8.0/10 ± 2.4), but the difference did not reach statistical significance.Conclusions: It is feasible to deploy an interactive web-based tool to support communication and shared decision-making for surrogates in ICUs. Surrogates and clinicians rated the tool as highly usable, acceptable, and effective.

Protocol for a randomised trial of an interprofessional team-delivered intervention to support surrogate decision-makers in ICUs.

INTRODUCTION: Although shortcomings in clinician-family communication and decision making for incapacitated, critically ill patients are common, there are few rigorously tested interventions to improve outcomes. In this manuscript, we present our methodology for the Pairing Re-engineered Intensive Care Unit Teams with Nurse-Driven Emotional support and Relationship Building (PARTNER 2) trial, and discuss design challenges and their resolution. METHODS AND ANALYSIS: This is a pragmatic, stepped-wedge, cluster randomised controlled trial comparing the PARTNER 2 intervention to usual care among 690 incapacitated, critically ill patients and their surrogates in five ICUs in Pennsylvania. Eligible subjects will include critically ill patients at high risk of death and/or severe long-term functional impairment, their main surrogate decision-maker and their clinicians. The PARTNER intervention is delivered by the interprofessional ICU team and overseen by 4-6 nurses from each ICU. It involves: (1) advanced communication skills training for nurses to deliver support to surrogates throughout the ICU stay; (2) deploying a structured family support pathway; (3) enacting strategies to foster collaboration between ICU and palliative care services and (4) providing intensive implementation support to each ICU to incorporate the family support pathway into clinicians' workflow. The primary outcome is surrogates' ratings of the quality of communication during the ICU stay as assessed by telephone at 6-month follow-up. Prespecified secondary outcomes include surrogates' scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses' scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation.We also discuss key methodological challenges, including determining the optimal level of randomisation, using existing staff to deploy the intervention and maximising long-term follow-up of participants. ETHICS AND DISSEMINATION: We obtained ethics approval through the University of Pittsburgh, Human Research Protection Office. The findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02445937.

Developing the family support tool: An interactive, web-based tool to help families navigate the complexities of surrogate decision making in ICUs.

INTRODUCTION: Although family members of incapacitated, critically ill patients often struggle in the role of surrogate decision maker, there are no low-cost, easily-scaled interventions to address this problem. AIM OF THE STUDY: To develop and pilot-test the Family Support Tool, an interactive, web-based tool to help individuals navigate the complexities of surrogate decision making in ICUs. MATERIAL AND METHODS: We used a mixed methods, user-centered process to create the Family Support Tool, including: 1) creation of a preliminary design by an expert panel; 2) engagement of a key stakeholder panel to iteratively refine the preliminary design; 3) user testing of a low-fidelity prototype of the tool by 6 former ICU surrogates; 4) creation of a web-based prototype; and 5) user testing of the web-based prototype with 14 surrogates and ICU physicians, including semi-structured interviews and quantitative measurement of usability, acceptability, and perceived effectiveness. RESULTS: The initial design contained a collection of videos and exercises designed to help individuals understand the surrogate's role and think through the patient's values and preferences. Based on family stakeholders' feedback about the emotional overwhelm they experience early in an ICU stay, we redesigned the tool to be viewed in sections, with the first section focused on decreasing surrogates' emotional distress, and later sections focused on helping surrogates prepare for family meetings. Surrogates actively making decisions in the ICU judged the final tool to be highly usable (mean summary score 83.5, correlating to 95th percentile when normalized to devices of its type), acceptable (mean 4.2 +/- 0.5 out of 5), and effective (mean 4.3 +/- 0.6 out of 5). All surrogates reported the tool helped them consider goals of care and all indicated they would recommend the tool to a friend. CONCLUSIONS: We successfully developed a web-based tool to help individuals navigate the complexities of surrogate decision making in ICUs that has high potential for scalability. Surrogates judged the tool to be usable, acceptable, and effective. These data support proceeding to test the tool in a pilot randomized clinical trial.

A Multicenter Study of the Causes and Consequences of Optimistic Expectations About Prognosis by Surrogate Decision-Makers in ICUs.

OBJECTIVES: Optimistic expectations about prognosis by surrogate decision-makers in ICUs are common, but there are few data about the causes and clinical consequences. Our objective was to determine the causes of optimistic expectations about prognosis among surrogates and whether it is associated with more use of life support at the end of life. DESIGN: Prospective, multicenter cohort study from 2009 to 2012. SETTING: Twelve ICUs from multiple regions of the United States. SUBJECTS: The surrogates and physicians of 275 incapacitated ICU patients at high risk of death. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Surrogates and physicians completed a validated instrument assessing their prognostic expectations for hospital survival. We determined the proportion of surrogates with optimistic expectations, defined as a prognostic estimate that was at least 20% more optimistic than the physician's, then determined how frequently this arose from surrogates miscomprehending the physicians' prognosis versus holding more hopeful beliefs compared with the physician. We used multivariable regression to examine whether optimistic expectations were associated with length of stay, stratified by survival status, and time to withdrawal of life support among nonsurvivors. Overall, 45% of surrogates (95% CI, 38-51%) held optimistic expectations about prognosis, which arose from a combination of misunderstanding the physician's prognostic expectations and from holding more hopeful beliefs compared with the physician. Optimistic expectations by surrogates were associated with significantly longer duration of ICU treatment among nonsurvivors before death (ß coefficient = 0.44; 95% CI, 0.05-0.83; p = 0.027), corresponding to a 56% longer ICU stay. This difference was associated with a significantly longer time to withdrawal of life support among dying patients whose surrogates had optimistic prognostic expectations compared with those who did not (ß coefficient = 0.61; 95% CI, 0.16-1.07; p = 0.009). CONCLUSIONS: The prevalent optimism about prognosis among surrogates in ICUs arises both from surrogates' miscomprehension of physicians' prognostications and from surrogates holding more hopeful beliefs. This optimism is associated with longer duration of life support at the end of life.

Protocol and Fidelity Monitoring Plan for Four Supports. A Multicenter Trial of an Intervention to Support Surrogate Decision Makers in Intensive Care Units.

Individuals acting as surrogate decision makers for critically ill patients frequently struggle in this role and experience high levels of long-term psychological distress. Prior interventions designed to improve the sharing of information by the clinical team with surrogate decision makers have demonstrated little effect on surrogates' outcomes or clinical decisions. In this report, we describe the study protocol and corresponding intervention fidelity monitoring plan for a multicenter randomized clinical trial testing the impact of a multifaceted surrogate support intervention (Four Supports) on surrogates' psychological distress, the quality of decisions about goals of care, and healthcare use. We will randomize the surrogates of 300 incapacitated critically ill patients at high risk of death and/or severe long-term functional impairment to receive the Four Supports intervention or an education control. The Four Supports intervention adds to the intensive care unit (ICU) team a trained interventionist (family support specialist) who delivers four types of protocolized support-emotional support; communication support; decisional support; and, if indicated, anticipatory grief support-to surrogates through daily interactions during the ICU stay. The primary outcome is surrogates' symptoms of anxiety and depression at 6-month follow-up, measured with the Hospital Anxiety and Depression Scale. Prespecified secondary outcome measures are the Patient Perception of Patient Centeredness Scale (modified for use with surrogates) and Impact of Event Scale scores at 3- and 6-month follow-up, respectively, together with ICU and hospital lengths of stay and total hospital cost among decedents. The fidelity monitoring plan entails establishing and measuring adherence to the intervention using multiple measurement methods, including daily checklists and coding of audiorecorded encounters. This approach to intervention fidelity may benefit others designing and testing behavioral interventions in the ICU setting. Clinical trial registered with www.clinicaltrials.gov (NCT01982877).

A Randomized Trial of a Family-Support Intervention in Intensive Care Units.

BACKGROUND: Surrogate decision makers for incapacitated, critically ill patients often struggle with decisions related to goals of care. Such decisions cause psychological distress in surrogates and may lead to treatment that does not align with patients' preferences. METHODS: We conducted a stepped-wedge, cluster-randomized trial involving patients with a high risk of death and their surrogates in five intensive care units (ICUs) to compare a multicomponent family-support intervention delivered by the interprofessional ICU team with usual care. The primary outcome was the surrogates' mean score on the Hospital Anxiety and Depression Scale (HADS) at 6 months (scores range from 0 to 42, with higher scores indicating worse symptoms). Prespecified secondary outcomes were the surrogates' mean scores on the Impact of Event Scale (IES; scores range from 0 to 88, with higher scores indicating worse symptoms), the Quality of Communication (QOC) scale (scores range from 0 to 100, with higher scores indicating better clinician-family communication), and a modified Patient Perception of Patient Centeredness (PPPC) scale (scores range from 1 to 4, with lower scores indicating more patient- and family-centered care), as well as the mean length of ICU stay. RESULTS: A total of 1420 patients were enrolled in the trial. There was no significant difference between the intervention group and the control group in the surrogates' mean HADS score at 6 months (11.7 and 12.0, respectively; beta coefficient, -0.34; 95% confidence interval [CI], -1.67 to 0.99; P=0.61) or mean IES score (21.2 and 20.3; beta coefficient, 0.90; 95% CI, -1.66 to 3.47; P=0.49). The surrogates' mean QOC score was better in the intervention group than in the control group (69.1 vs. 62.7; beta coefficient, 6.39; 95% CI, 2.57 to 10.20; P=0.001), as was the mean modified PPPC score (1.7 vs. 1.8; beta coefficient, -0.15; 95% CI, -0.26 to -0.04; P=0.006). The mean length of stay in the ICU was shorter in the intervention group than in the control group (6.7 days vs. 7.4 days; incidence rate ratio, 0.90; 95% CI, 0.81 to 1.00; P=0.045), a finding mediated by the shortened mean length of stay in the ICU among patients who died (4.4 days vs. 6.8 days; incidence rate ratio, 0.64; 95% CI, 0.52 to 0.78; P<0.001). CONCLUSIONS: Among critically ill patients and their surrogates, a family-support intervention delivered by the interprofessional ICU team did not significantly affect the surrogates' burden of psychological symptoms, but the surrogates' ratings of the quality of communication and the patient- and family-centeredness of care were better and the length of stay in the ICU was shorter with the intervention than with usual care. (Funded by the UPMC Health System and the Greenwall Foundation; PARTNER ClinicalTrials.gov number, NCT01844492 .).

Key stakeholders' perceptions of the acceptability and usefulness of a tablet-based tool to improve communication and shared decision making in ICUs.

PURPOSE: Although barriers to shared decision making in intensive care units are well documented, there are currently no easily scaled interventions to overcome these problems. We sought to assess stakeholders' perceptions of the acceptability, usefulness, and design suggestions for a tablet-based tool to support communication and shared decision making in ICUs. METHODS: We conducted in-depth semi-structured interviews with 58 key stakeholders (30 surrogates and 28 ICU care providers). Interviews explored stakeholders' perceptions about the acceptability of a tablet-based tool to support communication and shared decision making, including the usefulness of modules focused on orienting families to the ICU, educating them about the surrogate's role, completing a question prompt list, eliciting patient values, educating about treatment options, eliciting perceptions about prognosis, and providing psychosocial support resources. The interviewer also elicited stakeholders' design suggestions for such a tool. We used constant comparative methods to identify key themes that arose during the interviews. RESULTS: Overall, 95% (55/58) of participants perceived the proposed tool to be acceptable, with 98% (57/58) of interviewees finding six or more of the seven content domains acceptable. Stakeholders identified several potential benefits of the tool including that it would help families prepare for the surrogate role and for family meetings as well as give surrogates time and a framework to think about the patient's values and treatment options. Key design suggestions included: conceptualize the tool as a supplement to rather than a substitute for surrogate-clinician communication; make the tool flexible with respect to how, where, and when surrogates can access the tool; incorporate interactive exercises; use video and narration to minimize the cognitive load of the intervention; and build an extremely simple user interface to maximize usefulness for individuals with low computer literacy. CONCLUSION: There is broad support among stakeholders for the use of a tablet-based tool to improve communication and shared decision making in ICUs. Eliciting the perspectives of key stakeholders early in the design process yielded important insights to create a tool tailored to the needs of surrogates and care providers in ICUs.

Longitudinal associations of depressive symptoms and pain with quality of life in patients receiving chronic hemodialysis.

Depressive symptoms and pain are common in patients on chronic hemodialysis (HD), yet their associations with quality of life (QOL) are not fully understood. We sought to characterize the longitudinal associations of these symptoms with QOL. As part of a trial comparing two symptom management strategies in patients receiving chronic HD, we assessed depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9), and pain using the Short Form McGill Pain Questionnaire (SF-MPQ) monthly over 24 months. We assessed health-related QOL (HR-QOL) quarterly using the Short Form 12 (SF-12) and global QOL (G-QOL) using a single-item survey. We used random effects linear regression to analyze the independent associations of depressive symptoms and pain, scaled based on 5-point increments in symptom scores, with HR-QOL and G-QOL. Overall, 286 patients completed 1417 PHQ-9 and SF-MPQ symptom assessments, 1361 SF-12 assessments, and 1416 G-QOL assessments. Depressive symptoms were independently and inversely associated with SF-12 physical HR-QOL scores (ß = -1.09; 95% confidence interval [CI]: -1.69, -0.50, P < 0.001); SF-12 mental HR-QOL scores (ß = -4.52; 95% CI: -5.15, -3.89, P < 0.001); and G-QOL scores (ß = -0.64; 95%CI: -0.79, -0.49, P < 0.001). Pain was independently and inversely associated with SF-12 physical HR-QOL scores (ß = -0.99; 95% CI: -1.30, -0.68, P < 0.001) and G-QOL scores (ß = -0.12; 95%CI: -0.20, -0.05, P = 0.002); but not with SF-12 mental HR-QOL scores (ß = -0.16; 95%CI: -0.050, 0.17, P = 0.34). In patients receiving chronic HD, depressive symptoms and to a lesser extent pain, are independently associated with reduced HR-QOL and G-QOL. Interventions to alleviate these symptoms could potentially improve patients' HR-QOL and G-QOL.

Associations of depressive symptoms and pain with dialysis adherence, health resource utilization, and mortality in patients receiving chronic hemodialysis.

BACKGROUND AND OBJECTIVES: Depressive symptoms and pain are common in patients receiving chronic hemodialysis, yet their effect on dialysis adherence, health resource utilization, and mortality is not fully understood. This study sought to characterize the longitudinal associations of these symptoms with dialysis adherence, emergency department (ED) visits, hospitalizations, and mortality. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: As part of a trial comparing symptom management strategies in patients receiving chronic hemodialysis, this study prospectively assessed depressive symptoms using the Patient Health Questionnaire 9, and pain using the Short-Form McGill Pain Questionnaire, monthly between 2009 and 2011. This study used negative binomial, Poisson, and proportional hazards regression to analyze the longitudinal associations of depressive symptoms and pain, scaled based on 5-point increments in symptom scores, with missed and abbreviated hemodialysis treatments, ED visits, hospitalizations, and mortality, respectively. RESULTS: Among 286 patients, moderate-to-severe depressive symptoms were identified on 788 of 4452 (18%) assessments and pain was reported on 3537 of 4459 (79%) assessments. Depressive symptoms were independently associated with missed (incident rate ratio [IRR], 1.21; 95% confidence interval [95% CI], 1.10 to 1.33) and abbreviated (IRR, 1.08; 95% CI, 1.03 to 1.14) hemodialysis treatments, ED visits (IRR, 1.24; 95% CI, 1.12 to 1.37), hospitalizations (IRR, 1.19; 95% CI, 1.10 to 1.30), and mortality (IRR, 1.40; 95% CI, 1.11 to 1.77). Pain was independently associated with abbreviated hemodialysis treatments (IRR, 1.03; 95% CI, 1.01 to 1.06) and hospitalizations (IRR, 1.05; 95% CI, 1.00 to 1.10). Severe pain was independently associated with abbreviated hemodialysis treatments (IRR, 1.16; 95% CI, 1.06 to 1.28), ED visits (IRR, 1.58; 95% CI, 1.28 to 1.94), and hospitalizations (IRR, 1.22; 95% CI, 1.03 to 1.45), but not mortality (hazard ratio, 1.71; 95% CI, 0.81 to 2.96). CONCLUSIONS: Depressive symptoms and pain are independently associated with dialysis nonadherence and health services utilization. Depressive symptoms are also associated with mortality. Interventions to alleviate these symptoms have the potential to reduce costs and improve patient-centered outcomes.

Sexual function, activity, and satisfaction among women receiving maintenance hemodialysis.

BACKGROUND AND OBJECTIVES: Past studies that demonstrated that sexual dysfunction is common among women receiving chronic hemodialysis did not distinguish sexual dysfunction/difficulty from sexual inactivity. This study sought to differentiate these in order to elucidate the prevalence of true "sexual dysfunction" in this population. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: As part of a clinical trial of symptom management strategies in patients receiving chronic hemodialysis, female sexual function was prospectively assessed monthly for 6 months and quarterly thereafter using the Female Sexual Function Index, to which questions were added differentiating sexual dysfunction/difficulty from sexual inactivity. Beginning in month 7, patients were asked three questions about sexual activity, difficulty, and satisfaction monthly. RESULTS: Of the women enrolled in the clinical trial,125 participants completed 1721 assessments between 2009 and 2011. Scores on 574 of 643 (89%) quarterly Female Sexual Function Index assessments were consistent with sexual dysfunction, due largely to sexual inactivity, which was reported on 525 (82%) quarterly assessments. When reported (n=1663), the most frequently described reasons for sexual inactivity were lack of interest in sex (n=715; 43%) and lack of a partner (n=647; 39%), but rarely sexual difficulty (n=36; 2%). When reported (n=1582), women were moderately to very satisfied with their sexual life on 1020 (64%) assessments and on 513 of 671 (76%) assessments in which lack of interest was cited as a reason for sexual inactivity. Women indicated an interest in learning about the causes of and treatment for sexual dysfunction on just 5% of all assessments. CONCLUSIONS: Although many women receiving chronic hemodialysis are sexually inactive, few describe sexual difficulty. Most, including those with a lack of interest in sex, are satisfied with their sexual life and few wish to learn about treatment options. These findings suggest that true sexual dysfunction is uncommon in this population and that treatment opportunities are rare.

Associations of health literacy with dialysis adherence and health resource utilization in patients receiving maintenance hemodialysis.

BACKGROUND: Although limited health literacy is common in hemodialysis patients, its effects on clinical outcomes are not well understood. STUDY DESIGN: Observational study. SETTING & PARTICIPANTS: 260 maintenance hemodialysis patients enrolled in a randomized clinical trial of symptom management strategies from January 2009 through April 2011. PREDICTOR: Limited health literacy. OUTCOMES: Dialysis adherence (missed and abbreviated treatments) and health resource utilization (emergency department visits and end-stage renal disease [ESRD]-related hospitalizations). MEASUREMENTS: We assessed health literacy using the Rapid Estimate of Adult Literacy in Medicine (REALM) and used negative binomial regression to analyze the independent associations of limited health literacy with dialysis adherence and health resource utilization over 12-24 months. RESULTS: 41 of 260 (16%) patients showed limited health literacy (REALM score, ≤60). There were 1,152 missed treatments, 5,127 abbreviated treatments, 552 emergency department visits, and 463 ESRD-related hospitalizations. Limited health literacy was associated independently with an increased incidence of missed dialysis treatments (missed, 0.6% vs 0.3%; adjusted incidence rate ratio [IRR], 2.14; 95% CI, 1.10-4.17), emergency department visits (annual visits, 1.7 vs 1.0; adjusted IRR, 1.37; 95% CI, 1.01-1.86), and hospitalizations related to ESRD (annual hospitalizations, 0.9 vs 0.5; adjusted IRR, 1.55; 95% CI, 1.03-2.34). LIMITATIONS: Generalizability and potential for residual confounding. CONCLUSIONS: Patients receiving maintenance hemodialysis who have limited health literacy are more likely to miss dialysis treatments, use emergency care, and be hospitalized related to their kidney disease. These findings have important clinical practice and cost implications.

Comparison of symptom management strategies for pain, erectile dysfunction, and depression in patients receiving chronic hemodialysis: a cluster randomized effectiveness trial.

BACKGROUND AND OBJECTIVES: Pain, erectile dysfunction (ED), and depression are common yet frequently untreated in chronic hemodialysis patients. This study compared two management strategies for these symptoms in this patient population. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Pain, ED, and depression were assessed monthly during an observation usual care phase. Patients were then randomized to 12-month participation in either a feedback arm in which these symptoms were assessed monthly, renal providers were informed of patients' symptoms, and treatment was left treatment at their discretion; or a nurse management arm in which symptoms were assessed monthly and trained nurses were used to evaluate patients and generate and facilitate the implementation of treatment recommendations. RESULTS: Of 288 patients enrolled into observation between January 1, 2009 and March 30, 2010, 220 (76%) were randomized. Compared with the feedback approach, the results (shown as Δ symptom score [95% confidence interval]) indicated that nurse management was not associated with improved pain (0.49 [-0.56, 1.54]), ED (0.20 [-0.55, 0.95]), or depression (0.32 [-0.94, 1.58]). Relative to their symptoms during observation, feedback patients experienced small, statistically significant improvements in pain (-0.98 [-1.67, -0.28]), ED (-0.98 [-1.54, -0.41]), and depression (-1.36 [-2.19, -0.54]), whereas nurse management patients experienced small, statistically significant improvements in ED (-0.78 [-1.41, -0.15]) and depression (-1.04 [-2.04, -0.04]). CONCLUSIONS: Compared with informing renal providers of their patients' pain, ED, and depression and leaving management at their discretion, a nurse-implemented management strategy does not improve these symptoms. Both approaches modestly reduced symptoms relative to usual care.

Renal provider perceptions and practice patterns regarding the management of pain, sexual dysfunction, and depression in hemodialysis patients.

BACKGROUND: Although pain, sexual dysfunction, and depression are common in patients receiving chronic hemodialysis, these symptoms frequently remain untreated. We sought to characterize renal provider perceptions and practice patterns regarding the treatment of these symptoms. METHODS: We surveyed renal providers whose patients were participating in a clinical trial of symptom management at nine hemodialysis units in southwestern Pennsylvania. We used Spearman's correlation to assess the association of provider characteristics with the reported frequency of providing treatment. RESULTS: Overall, 27 of 35 (77%) providers completed the survey. While 21 (78%) believed symptom management to be "very" important and 23 (85%) reported spending a "moderate" to "a lot" of time managing symptoms, <50% reported treating pain and <20% reported treating sexual dysfunction or depression "most" or "all" of the time. Most providers believed it was nonrenal providers' responsibility to treat these symptoms. A greater reported comfort level managing symptoms was associated with a higher reported frequency of treating pain (r=0.6; p<0.01), sexual dysfunction (r=0.67; p<0.01), and depression (r=0.43; p<0.03). Providers who believed it was nonrenal providers' responsibility to treat these symptoms reported treating pain (r=-0.62; p<0.01) and depression (r=-0.48; p=0.02) less frequently. CONCLUSIONS: Despite reporting considerable importance and substantial time managing symptoms in general, renal providers commonly describe not treating pain, sexual dysfunction, and depression in hemodialysis patients. Given renal providers' beliefs that nonrenal clinicians are primarily responsible for treating these symptoms, multidisciplinary approaches to symptom management in these patients are needed.

Prevalence and demographic and clinical associations of health literacy in patients on maintenance hemodialysis.

BACKGROUND AND OBJECTIVES: Although limited health literacy is estimated to affect over 90 million Americans and is recognized as an important public health concern, there have been few studies examining this issue in patients with chronic kidney disease. We sought to characterize the prevalence of and associations of demographic and clinical characteristics with limited health literacy in patients receiving maintenance hemodialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: As part of a prospective clinical trial of symptom management strategies in 288 patients treated with chronic hemodialysis, we assessed health literacy using the Rapid Estimate of Adult Literacy in Medicine (REALM). We defined limited health literacy as a REALM score ≤60 and evaluated independent associations of demographic and baseline clinical characteristics with limited health literacy using multivariable logistic regression. RESULTS: Of the 260 patients who completed the REALM, 41 demonstrated limited health literacy. African-American race, lower educational level, and veteran status were independently associated with limited health literacy. There was no association of limited health literacy with age, gender, serologic values, dialysis adequacy, overall symptom burden, quality of life, or depression. CONCLUSIONS: Limited health literacy is common among patients receiving chronic hemodialysis. African-American race and socioeconomic factors are strong independent predictors of limited health literacy. These findings can help inform the design and implementation of interventions to improve health literacy in the hemodialysis population.

Subject Recruitment and Retention against Quadruple Challenges in an Intervention Trial of End-of-Life Communication.

Studies of end-of-life care face difficulties associated with enrollment and attrition. Information and exemplars can help end-of-life care researchers anticipate such difficulties and customize recruitment and retention strategies to achieve planned sample sizes. We analyzed data on recruitment and retention efforts used in a clinical trial of an end-of-life communication intervention that involved African American dialysis patients and their chosen surrogate decision makers. Despite the challenges the trial faced (e.g., recruiting a minority group of patients who were seriously ill, had a surrogate decision maker willing to join the study, and were willing to engage in end-of-life discussions), the planned sample size was met, and nearly 90% of the participants completed the study. Various strategies were used to sustain accrual during the study. Although a total of 16 contacts per dyad had been planned from enrollment to 3-months data collection, 27 contacts were actually needed. The strategies and procedures used in this study may be pertinent to other studies that involve African Americans with serious illness and require dyadic participation.

Methodology of a randomized clinical trial of symptom management strategies in patients receiving chronic hemodialysis: the SMILE study.

Despite the high prevalence of pain, sexual dysfunction, and depression in patients on chronic hemodialysis, these symptoms are often unrecognized and under-treated by renal providers. This report describes the rationale and methodology of the SMILE study (Symptom Management Involving End-Stage Renal Disease), a multi-center, randomized clinical trial comparing the effectiveness of two strategies for implementing treatment for these symptoms in patients receiving chronic hemodialysis. Approximately 250 patients from nine outpatient dialysis units will participate. Over a 2-12 month observational phase, participants complete monthly surveys characterizing their pain, sexual dysfunction, and depression. Following this observational period, subjects are randomized to one of two study arms to receive a 12-month intervention. In one study arm (feedback intervention), patients continue to complete the same three symptom surveys, and the presence and severity of the symptoms reported on these surveys is mailed to the patient's renal provider along with evidence-based algorithms outlining treatment options for these symptoms. Decisions on treatment are left at the discretion of the provider. Patients randomized to the other study arm (management intervention) also continue to complete the same monthly symptom surveys and are evaluated by a symptom management nurse trained in the management of these symptoms. This nurse then discusses the patient's symptoms with the renal provider, provides specific recommendations for treatment, and facilitates the implementation of treatment. The primary endpoints are changes in scores on pain, erectile dysfunction, and depression surveys. This report describes the rationale and methodology of this clinical trial.

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Randomized controlled trial of SPIRIT: an effective approach to preparing African-American dialysis patients and families for end of life.

This randomized controlled trial tested an intervention, Sharing Patients' Illness Representations to Increase Trust (SPIRIT), designed to enhance communication regarding end-of-life care between African Americans with end-stage renal disease (ESRD) and their chosen surrogate decision makers (N = 58 dyads). We used surveys and semi-structured interviews to determine the feasibility, acceptability, and preliminary effects of SPIRIT on patient and surrogate outcomes at 1 week and 3 months post-intervention. We also evaluated patients' deaths and surrogates' end-of-life decision making to assess surrogates' perceptions of benefits and limitations of the SPIRIT while facing end-of-life decisions. We found that SPIRIT promoted communication between patients and their surrogates and was effective and well received by the participants.