Factors associated with lower preoperative quality of life in patients with chronic limb-threatening ischemia in the BEST-CLI trial.

OBJECTIVES: There are few contemporary data regarding health-related quality of life (HRQOL) measures in patients with chronic limb-threatening ischemia (CLI). METHODS: The Best Endovascular versus Best Surgical Therapy in Patients with CLI (BEST-CLI) trial is an ongoing, National Institutes of Health-sponsored, multicenter, randomized, controlled trial comparing revascularization strategies in patients with CLI. BEST-CLI baseline HRQOL measures were evaluated for patient-specific variables that were associated with poor HRQOL and then compared with published outcomes. The HRQOL measures Vascular Quality of Life Questionnaire (VascQOL), European Quality of Life 5D (EQ-5D), and the Short Form 12 (SF-12) Index score, physical component score (PCS) and mental component score (MCS) were aggregated from preoperative questionnaires completed by trial patients at baseline visits. Multivariable linear regression models were fit to determine which baseline characteristics were associated with poor HRQOL. RESULTS: We randomized 1830 patients into BEST-CLI. The majority (94.9%, 95.8%, and 95.8%) completed the VascQOL, EQ-5D, and SF-12 instruments at baseline, respectively. In the VascQOL, female sex, smoking history, opioid use, and nonindependent ambulation predicted lower HRQOL scores. Overall, VascuQOL scores were similar to those of participants in the Bypass versus Angioplasty in Severe Ischemia of the Leg (mean, 3.07 ± 1.2 vs mean, 2.9 ± 1.1; P = .07). In EQ-5D, nonindependent ambulation predicted lower HRQOL scores. In the SF-12, female sex, opioid use, nonindependent ambulation, and a history of smoking predicted lower HRQOL scores. The mean SF-12 PCS for all patients in the study was 33.0 ± 8.5 and for the MCS was 46.4 ± 12.0), significantly lower than the national SF-12 scores for US population ages more than 60 years, which is a PCS of 46.5 ± 11.4 and an MCS of 52.9 ± 8.7. CONCLUSIONS: Patients with CLI entering the BEST-CLI trial have very low HRQOL scores, comparable with patients suffering from other chronic conditions characterized by physical limitations and chronic pain. A history of smoking, impaired ambulation, opioid use, and female sex predicted lower HRQOL in patients with CLI, using multiple HRQOL measurement tools.

Use of Telemedicine to Improve Interfacility Communication and Aid in Triage of Patients with Intracerebral Hemorrhage: A Pilot Study.

INTRODUCTION: Over the past several years there has been a dramatic increase in the implementation of telemedicine technology to aid in the delivery of care across community, inpatient, and emergency settings. This technology has proved valuable for acute life-threatening clinical scenarios. We aimed to pilot a novel neurosurgical telemedicine program within an academic tertiary care center to assist in consultation of patients with high-grade intracranial hemorrhage (ICH) (ICH score 4, 5). METHODS: A quality improvement conceptual framework was developed. Subsequently, a process map and improvement interventions were created. Patients in community hospitals with high-grade ICH or pre-existing Do Not Resuscitate/Do Not Intubate orders with an admitting diagnosis of ICH triggered a TeleNeurosurgery consultation. Patients who met the inclusion criteria, with consent of their decision makers, were enrolled in the study. Post-encounter physician surveys were used to evaluate overall satisfaction with the implementation. RESULTS: This 18-month pilot study proved feasible, with an enrollment of 63.6% (n = 14 of 22) of patients who met criteria. All patients who were enrolled in the study and participated in TeleNeurosurgery consultation remained at the presenting facility for end-of-life care and palliative medicine consultation. Both community emergency physicians and subspecialists who performed the consultations reported satisfaction with the TeleNeurosurgery consultation process and a perceived benefit both to patients, families, and emergency medicine physicians. CONCLUSIONS: The program proved feasible and several areas in need of improvement within the health system were identified. Emergency physicians reported comfort with the process, program effectiveness, and improved access to care by implementation of this program.

Impact of home-based, patient-centered support for people with advanced illness in an open health system: A retrospective claims analysis of health expenditures, utilization, and quality of care at end of life.

BACKGROUND: Home-based care coordination and support programs for people with advanced illness work alongside usual care to promote personal care goals, which usually include a preference for home-based end-of-life care. More research is needed to confirm the efficacy of these programs, especially when disseminated on a large scale. Advanced Illness Management is one such program, implemented within a large open health system in northern California, USA. AIM: To evaluate the impact of Advanced Illness Management on end-of-life resource utilization, cost of care, and care quality, as indicators of program success in supporting patient care goals. DESIGN: A retrospective-matched observational study analyzing medical claims in the final 3 months of life. SETTING/PARTICIPANTS: Medicare fee-for-service 2010-2014 decedents in northern California, USA. RESULTS: Final month total expenditures for Advanced Illness Management enrollees ( N = 1352) were reduced by US$4824 (US$3379, US$6268) and inpatient payments by US$6127 (US$4874, US$7682). Enrollees also experienced 150 fewer hospitalizations/1000 (101, 198) and 1361 fewer hospital days/1000 (998, 1725). The percentage of hospice enrollees increased by 17.9 percentage points (14.7, 21.0), hospital deaths decreased by 8.2 percentage points (5.5, 10.8), and intensive care unit deaths decreased by 7.1 percentage points (5.2, 8.9). End-of-life chemotherapy use and non-inpatient expenditures in months 2 and 3 prior to death did not differ significantly from the control group. CONCLUSION: Advanced Illness Management has a positive impact on inpatient utilization, cost of care, hospice enrollment, and site of death. This suggests that home-based support programs for people with advanced illness can be successful on a large scale in supporting personal end-of-life care choices.

Proactive case finding to improve concurrently curative and palliative care in patients with end-stage liver disease.

BACKGROUND: Palliative care and preparation for liver transplantation are often perceived as conflicting for patients with end-stage liver disease (ESLD). We sought to improve both simultaneously through a case finding and care coordination quality improvement intervention. METHODS: We identified patients with cirrhosis using validated ICD-9 codes and screened them for ESLD by assessing medical records at a VA hospital for either a model for end-stage liver disease (MELD) ≥14 or a diagnosis of hepatocellular carcinoma (HCC) between October 2012 and January 2013. A care coordinator followed veterans from the index hospitalization through April 2013 and encouraged treating physicians to submit liver transplant evaluation consults for all veterans with a MELD ≥14 and palliative care consults for all veterans with a MELD ≥20 or inoperable HCC. RESULTS: We compared rates of consultation for 49 hospitalized veterans and compared their outcomes to 61 pre-intervention veterans. Veterans were more likely to be considered for liver transplantation (77.6% versus 31.1%, p<0.001) and receive palliative care consultation during the intervention period, although the latter finding did not reach statistical significance (62.5% versus 47.1%, p=0.38). CONCLUSIONS: Active case finding improved consideration for liver transplantation without decreasing palliative care consultation.

Approaching patients and family members who hope for a miracle.

A clinical problem may arise when caring for patients or their surrogates who prefer continued aggressive care based on the belief that a miracle will occur, despite a clinician's belief that further medical treatment is unlikely to have any meaningful benefit. An evidence-based approach is provided for the clinician by breaking this complex clinical problem into a series of more focused clinical questions and subsequently answering them through a critical appraisal of the existing medical literature. Belief in miracles is found to be common in the United States and is an important determinant of how decisions are made for those with advanced illness. There is a growing amount of evidence that suggests end-of-life outcomes improve with the provision of spiritual support from medical teams, as well as with a proactive approach to medical decision making that values statements given by patients and family members.

Evaluating a palliative care intervention for veterans: challenges and lessons learned in a longitudinal study of patients with serious illness.

CONTEXT: Longitudinal studies examining care for seriously ill patients are needed to understand patients' experience of illness, evaluate interventions, and improve quality of care. Unfortunately, such studies face substantial methodological challenges. OBJECTIVES: This article describes such challenges and the strategies used to overcome them in a successfully implemented palliative care intervention trial for veterans. METHODS: Veterans admitted with a physician-estimated moderate-to-high one-year mortality risk were enrolled and followed up to three years, until death or study completion. Study protocols, procedures, and process data were intermittently analyzed to identify and develop strategies to address issues affecting study enrollment and interview completion rates. RESULTS: Of 561 patients who were eligible, 400 (71%) enrolled in the study; 357 (87%) alive at the end of Month 1 completed interviews; and 254 (88%) alive at Month 6 completed interviews. Of the 208 patients who died during the study and had identified a caregiver, we were able to conduct an after-death interview with 154 (74%) caregivers. A variety of strategies, such as systematic tracking and check-in calls, minimizing respondent burden, and maintaining interviewer-respondent dyads over time, were used to maximize enrollment rates, data collection, and retention. CONCLUSION: These data demonstrate that the use of diverse strategies and flexibility with regard to study protocols can result in successful recruitment, data collection, and retention of participants with serious illness. They thus show that longitudinal research can be successfully implemented with this population to evaluate interventions and examine patient experiences.

Survey study of anesthesiologists' and surgeons' ordering of unnecessary preoperative laboratory tests.

BACKGROUND: Nearly 20 years ago it was shown that patients are exposed to unnecessary preoperative testing that is both costly and has associated morbidity. To determine whether such unnecessary testing persists, we performed internal and external surveys to quantify the incidence of unnecessary preoperative testing and to identify strategies for reduction. METHODS: The medical records of 1000 consecutive patients scheduled for surgery at our institution were examined for testing outside of our approved guidelines. Subsequently, 4 scenarios were constructed to solicit physician views of appropriate testing: a 45-year-old woman for a laparoscopic ovarian cystectomy, a 23-year-old woman for right inguinal herniorrhaphy, a 50-year-old man for a hemithyroidectomy, and a 50-year-old man for a total hip replacement. One or more of these scenarios were sent to directors of preoperative clinics (all), United States anesthesiologists (all), gynecologists (cystectomy), general surgeons (herniorrhaphy), otolaryngologists (thyroidectomy), and orthopedists (hip replacement). Potential predictors of ordering and demographic information were collected. RESULTS: More than half of our patients had at least 1 unnecessary test based on our testing guidelines (95% lower confidence limit = 52%). The 17 responding preoperative directors were unanimous for 36 of the 72 combinations of test or consult (henceforth "test") and scenario as being unnecessary. Among the 175 anesthesiologists responding to the survey, 46% ordered 1 or more of the tests unanimously considered unnecessary by the preoperative directors for the given scenario. Among 17 potential predictors of anesthesiologists' unnecessary ordering, only training completed before 1980 significantly increased the risk of ordering at least 1 unnecessary test (by 48%, 95% confidence limits >29%). Anesthesiologists were 53% less likely to order at least 1 unnecessary test relative to gynecologists for the cystectomy scenario, 64% less likely than general surgeons for the herniorrhaphy scenario, 66% less likely than otolaryngologists for the thyroidectomy scenario, and 67% less likely than orthopedists for the hip replacement scenario. The 95% lower confidence limits were all >40%. CONCLUSIONS: The percentage of patients with at least 1 unnecessary test is a suitable end point for monitoring providers' ordering. The incidence can be high despite efforts at improvement, but may be reduced if anesthesiologists rather than surgeons order presurgical tests and consults. However, anesthesia groups should be cognizant of potential heterogeneity among them based on time since training.

The intersection of need and opportunity: assessing and capitalizing on opportunities to expand hospital-based palliative care services.

BACKGROUND: To develop and grow most effectively, palliative care programs must consider how best to align their mission with that of their institution. To do so, programs must identify their institutional mission and needs, what palliative care can do to address those needs given available resources, and how the palliative care team can measure and document its value. Such an approach encourages the palliative care team to think strategically and to see themselves and their service as a solution to issues and concerns within the institution. It also helps a palliative care team decide which, among many potential opportunities and possible initiatives, is the one most likely to be supported by the institution and have a recognized and significant impact. SUBJECTS AND METHODS: We present five case studies to demonstrate how successful programs identify and address institutional needs to create opportunities for palliative care program growth. These case studies can serve as models for other programs seeking to develop or expand their palliative care services.

Families' perceptions of end-of-life care in Veterans Affairs versus non-Veterans Affairs facilities.

BACKGROUND: The Veterans Affairs (VA) has made significant investments in care for veterans. However, it is not known whether these investments have produced improvements in end-of-life care in the VA compared to other settings. Therefore, the goal of this study was to compare families' perceptions of end-of-life care among patients who died in VA and non-VA facilities. DESIGN: Retrospective 32-item telephone surveys were conducted with family members of patients who died in VA and non-VA facilities. SETTING: Five Veterans Affairs medical centers and their affiliated nursing homes and outpatient clinics. PARTICIPANTS: Patients were eligible if they received any care from a participating VA facility in the last month of life and if they died in an inpatient setting. One family member per patient completed the survey. RESULTS: In bivariate analysis, patients who died in VA facilities (n = 520) had higher mean satisfaction scores compared to those who died in non-VA facilities (n = 89; 59 versus 51; rank sum test p = 0.002). After adjusting for medical center, the overall score was still significantly higher for those dying in the VA (beta = 0.07; confidence interval [CI] = 0.02-0.11; p = 0.004), as was the domain measuring care around the time of death (beta = 0.11; CI = 0.04-0.17; p = 0.001). CONCLUSION: Families of patients who died in VA facilities rated care as being better than did families of those who died in non-VA facilities. These results provide preliminary evidence that the VA's investment in end-of-life care has contributed to improvements in care in VA facilities compared to non-VA facilities.

Provider communication and patient understanding of life-limiting illness and their relationship to patient communication of treatment preferences.

Medical decision making in the context of serious illness ideally involves a patient who understands his or her condition and prognosis and can effectively formulate and communicate his or her care preferences. To understand the relationships among these care processes, we analyzed baseline interview data from veterans enrolled in a randomized controlled trial of a palliative care intervention. Participants were 400 inpatient veterans admitted with a physician-estimated risk of one-year mortality more than 25%; 260 (65%) had cancer as the primary diagnosis. Patients who believed that they had a life-limiting illness (89% of sample) reported that their provider had communicated this to them more frequently than those who did not share that belief (78% vs. 22%, P<0.001). Over half (53%) of the participants reported discussing their care preferences with their providers and 66% reported such discussions with their family; 35% had a living will. In multivariate analysis, greater functional impairment was associated with patients having discussed their care preferences with providers (P<0.05), whereas patient understanding of prognosis (P<0.05), better quality of life (P<0.01), and not being African American (P<0.05) were associated with patients having discussed their care preferences with family; higher education (P<0.001), and not being African American (P<0.01) were associated with having a living will. Patients with poor understanding of prognosis are less likely to discuss care preferences with family members, suggesting the importance of provider communication with patients regarding prognosis. Because functional decline may prompt physicians to discuss prognosis with patients, patients with relatively preserved function may particularly need such communication.

Families' perceptions of veterans' distress due to post-traumatic stress disorder-related symptoms at the end of life.

OBJECTIVES: To define the frequency of post-traumatic stress disorder (PTSD)-related symptoms among veterans who are near the end of life and to describe the impact that these symptoms have on patients and their families. METHODS: Patients had received inpatient or outpatient care from a participating VA facility in the last month of life, and one family member per patient was selected using predefined eligibility criteria. Family members then completed a telephone survey, The Family Assessment of Treatment at End-of-Life, which assessed their perceptions of the quality of the care that the patients and they themselves received during the patients' last month of life. RESULTS: Seventeen percent of patients (89 of 524) were reported to have had PTSD-related symptoms in the last month of life. PTSD-related symptoms caused discomfort less often than pain did (mean frequency score 1.79 vs. 1.93; Wilcoxon sign rank test, P<0.001) but more often than dyspnea did (mean severity score 1.79 vs. 1.73; Wilcoxon sign rank test, P<0.001). Family members of patients with PTSD-related symptoms reported less satisfaction overall with the care the patient received (mean score 48 vs. 62; rank sum test, P<0.001). Patients who received a palliative care consult (n=49) had lower ratings of discomfort attributed to PTSD-related symptoms (mean 1.55 vs. 2.07; rank sum test, P=0.007). CONCLUSION: PTSD-related symptoms may be common and severe among veterans near the end of life and may have a negative effect on families' perceptions of the quality of care that the veteran received.

Pain and palliative medicine.

Severe pain is highly prevalent, with rates of 40% to 70% in patients with advanced cancer, liver disease, heart failure, human immunodeficiency virus, and renal failure. Wide variations in pain assessment and reporting methods and the measurement of multiple symptoms should be addressed in future studies. Regarding psychological approaches, determining whether hypnotherapy or other individual psychotherapeutic interventions reduce pain and/or psychological distress in a palliative care population is difficult. Interest is increasing in the concept of demoralization syndromes and the role of posttraumatic stress disorder in modulating responses to pain at the end of life. We review evidence from multiple studies that the use of rehabilitative therapy improves functional status and pain control among patients with advanced cancer, and we raise the possibility that rehabilitation therapy will be helpful in patients with other advanced diseases. We summarize ongoing clinical trials of electronic order sets, clinical care pathways, and care management pathways to improve pain management in palliative care. Wagner's Chronic Illness Model provides a way of analyzing how healthcare systems can be changed to provide adequate and continuing pain management in palliative care. Much work remains to ensure that pain is recognized, treated, and monitored effectively.

Measuring outcomes in randomized prospective trials in palliative care.

Palliative care aims to improve the quality of life of patients and their families and reduce suffering from life-threatening illness. In assessing palliative care efficacy, researchers must consider a broad range of potential outcomes, including those experienced by the patient's family/caregivers, clinicians, and the health care system. The purpose of this article is to summarize the discussions and recommendations of an Outcomes Working Group convened to advance the palliative care research agenda, particularly in the context of randomized controlled trials. These recommendations address the conceptualization of palliative care outcomes, sources of outcomes data, application of outcome measures in clinical trials, and the methodological challenges to outcome measurement in palliative care populations. As other fields have developed and refined methodological approaches that address their particular research needs, palliative care researchers must do the same to answer important clinical questions in rigorous and credible ways.

The VA Ostomy Health-Related Quality of Life Study: objectives, methods, and patient sample.

OBJECTIVE: To present the design and methods of a multisite study of health-related quality of life (HR-QOL) in veterans living with ostomies. RESEARCH DESIGN AND METHODS: Veterans from Tucson, Indianapolis, and Los Angeles VA Medical Centers were surveyed using the validated City of Hope ostomy-specific tool (mCOH-QOL-Ostomy) and the SF-36V. Cases (ostomates) had a major gastrointestinal procedure that required an intestinal stoma, while controls had similar procedures for which an ostomy was not required. Ostomy subjects were recruited for four focus groups in each of two sites divided by ostomy type (colostomy versus ileostomy) and overall mCOH-QOL-Ostomy HR-QOL score (highest versus lowest quartile). The focus groups further evaluated barriers, concerns, and adaptation methods and skills. MAIN OUTCOME MEASURES: This report presents recruitment results, reliability of survey instruments, and demographic characteristics of the sample. RESULTS: The overall response (i.e., recruitment) rate across all sites was 48% and by site was 53%, 57%, and 37%, respectively (p < 0.001). Internal consistency reliability estimates indicated that both instruments remain reliable in this population (Cronbach's alpha for HR-QOL domains/scales: 0.71-0.96). Cases and controls were similar in demographic characteristics. Proportions of minority subjects matched projections from the site patient populations. Subjects with ostomies had significantly longer time since surgery than controls (p < 0.001). Focus groups were comprised of two to six subjects per group and demonstrated racial diversity at the Los Angeles site. CONCLUSIONS: The unique design of our study of VA patients with ostomies is an illustration of a successful mixed methods approach to HR-QOL research. We collected meaningful quantitative and qualitative data that will be used in the development of new approaches to care that will lead to improved functioning and well-being in persons living with ostomies. Subsequent reports will provide the results of this research project.

Palliative care assessment: what are we looking for?

Patients who have advanced illness present unique challenges to the specialist physician. Gastroenterologic care of this group of patients has changed substantially over the past 2 decades, with diagnostic and therapeutic procedures often supplanting the more communication-based aspects of care. At the same time,given the range of patients' palliative needs and the increasingly important role of the gastroenterologist in their overall care, the physician has a responsibility to develop basic competencies in palliative medical practice. Skill in palliative assessment can help the physician assure that care remains finely attuned to the goals, needs, and priorities of the patient and family. Acquiring and applying palliative care skills will, as a result, lead to both better outcomes for patients and families and a fully satisfying professional experience for the physician.

Negotiating end-of-life decision making: a comparison of Japanese and U.S. residents' approaches.

PURPOSE: To compare Japanese and U.S. resident physicians' attitudes, clinical experiences, and emotional responses regarding making disclosures to patients facing incurable illnesses. METHOD: From September 2003 to June 2004, the authors used a ten-item self-administered anonymous questionnaire in a cross-sectional survey of 103 internal medicine residents at two U.S. sites in Los Angeles, California, and 244 general medical practice residents at five Japanese sites in Central Honshu, Kyushu, Okinawa, Japan. RESULTS: The Japanese residents were more likely to favor including the family in disclosing diagnosis (95% versus 45%, p<.001) and prognosis (95% versus 51%, p<.001) of metastatic gastric cancer. Of residents who favored diagnostic or prognostic disclosure to both the patient and family, Japanese residents were more likely to prefer discussion with the family first. Trainees in Japan expressed greater uncertainty about ethical practices related to disclosure of diagnosis or prognosis. Many Japanese and U.S. residents indicated that they had deceived a patient at the request of a family (76% versus 18 %, p<.001), or provided nonbeneficial care (56% versus 72%, p<.05), and many expressed guilt about these behaviors. CONCLUSIONS: The residents' approaches to end-of-life decision making reflect known cultural preferences related to the role of patients and their families. Although Japanese trainees were more likely to endorse the role of the family, they expressed greater uncertainty about their approach. Difficulty and uncertainty in end-of-life decision making were common among both the Japanese and U.S. residents. Both groups would benefit from ethical training to negotiate diverse, changing norms regarding end-of-life decision making.