Lessons Learned Establishing the Palliative Care Research Cooperative's Qualitative Data Repository.

Data sharing is increasingly an expectation in health research as part of a general move toward more open sciences. In the United States, in particular, the implementation of the 2023 National Institutes of Health Data Management and Sharing Policy has made it clear that qualitative studies are not exempt from this data sharing requirement. Recognizing this trend, the Palliative Care Research Cooperative Group (PCRC) realized the value of creating a de-identified qualitative data repository to complement its existing de-identified quantitative data repository. The PCRC Data Informatics and Statistics Core leadership partnered with the Qualitative Data Repository (QDR) to establish the first serious illness and palliative care qualitative data repository in the U.S. We describe the processes used to develop this repository, called the PCRC-QDR, as well as our outreach and education among the palliative care researcher community, which led to the first ten projects to share the data in the new repository. Specifically, we discuss how we co-designed the PCRC-QDR and created tailored guidelines for depositing and sharing qualitative data depending on the original research context, establishing uniform expectations for key components of relevant documentation, and the use of suitable access controls for sensitive data. We also describe how PCRC was able to leverage its existing community to recruit and guide early depositors and outline lessons learned in evaluating the experience. This work advances the establishment of best practices in qualitative data sharing.

Association Between Patient Portal Activities and End-of-Life Outcomes Among Deceased Patients in the Last 12 Months of Life.

Objective: The objective of this study was to examine the association between portal use and end-of-life (EOL) outcomes in the last year of life. Methods: A retrospective cohort (n = 6,517) study at Kaiser Permanente Colorado among adults with serious illness deceased between January 1, 2016, and June 30, 2019. Portal use was categorized into engagement types: no use, nonactive, active without a provider, and active with a provider. EOL outcomes were hospitalizations in the month before death, last-year advance directive completion, and hospice use. Association between EOL outcomes and levels of portal use was assessed using χ2 statistics and generalized linear models. Results: Higher portal engagement types were associated with higher rates of hospitalizations (p = 0.0492), advance directive completion (p = 0.0226), and hospice use (p = 0.0070). Conclusion: Portal use in the last year of life was associated with increases in a poor EOL outcome, hospitalizations, and beneficial EOL outcomes, advance directives, and hospice care.

Measuring Quality of Life in Deprescribing Trials: A Scoping Review.

BACKGROUND: Quality of life (QoL) is an important outcome to capture in clinical trials evaluating deprescribing interventions. OBJECTIVE: We aimed to conduct a scoping review to examine how QoL has been measured in deprescribing trials among older people and identify potentially relevant QoL scales, to better inform QoL measurement in future deprescribing trials. METHODS: We searched MEDLINE, Embase, PsycINFO, the Cochrane Central Register of Controlled Trials, Google Scholar, Epistemonikos, ClinicalTrials.gov, and reference lists of eligible studies (from inception to October 2023). We included randomized and non-randomized comparative studies with a control group that evaluated deprescribing and polypharmacy reduction interventions in people ≥ 65 years of age and measured QoL as an outcome. We also included studies describing the development and validation of QoL scales related to deprescribing, polypharmacy, or medication burden in adults ≥ 18 years of age. Two independent reviewers screened titles and abstracts, then full texts. Two independent reviewers extracted data from 25% of eligible studies in order to verify agreement, then a single reviewer extracted data from the remaining studies, which a second reviewer cross-checked. We critically appraised scales based on the COSMIN checklist. RESULTS: We retrieved 7290 articles, of which 52 were eligible for inclusion, including 44 deprescribing trials and eight scale development studies. From these studies, we found 21 scales that have been used in the context of deprescribing/polypharmacy (12 generic scales used in clinical trials and nine medication-specific scales). Variations of the generic EQ-5D were the most used scales. The measurement properties of scales for capturing changes in QoL from deprescribing were uncertain. Medication-specific QoL scales have not been employed in deprescribing clinical trials and thus, their performance in this context is also not clear. CONCLUSIONS: Several existing QoL scales have been applied to the context of deprescribing/polypharmacy clinical trials, and new scales specific to the problem have been proposed. If deprescribing does impact QoL, our findings suggest it is uncertain whether existing QoL scales can practically and reliably capture such a change or whether any scale is best. However, this review compares various aspects of the scales that researchers and clinicians can consider in decisions about measuring QoL in deprescribing trials, and in planning future research. PROTOCOL REGISTRATION: Open Science Framework: osf.io/aez6w.

Advancing the Science of Palliative Care: Contributions of the Palliative Care Research Cooperative Group.

The Palliative Care Research Cooperative Group (PCRC) formed to lead, catalyze, and empower a community of scientists to build an evidence base to ensure high-quality care and optimal well-being for persons with serious illness and their caregivers. The PCRC grew to 630 members representing 220 distinct sites. The PCRC awarded 44 pilot grant awards (total investment $1.4 million), resulting in $15.8 million in extramural grant funding, supported monthly webinars, an annual mentorship selective, "Clinical Trials Intensives," research consultation, and grant review. Among the 169 Clinical Trials Intensive participants, 74 subsequently achieved extramural grant award funding with direct costs of over $139 million. The PCRC supported the submission of extramural research applications and fostered community through annual meetings, special interest groups, newsletters, and its website. The PCRC filled an important void in serious illness science and set the stage for the next era of advancing serious illness research.

Does a novel community-based outpatient palliative care intervention for Parkinson's disease and related disorders improve care? Qualitative results from patients and care partners.

BACKGROUND: Palliative care has the potential to address significant unmet needs in people with Parkinson's disease and related disorders, but models that rely on in-person specialty palliative care teams have limited scalability. AIM: To describe patient and care partner experiences with a novel, community-based palliative care intervention for Parkinson's disease. DESIGN: Qualitative study embedded in a randomized clinical trial to document participant experiences with a novel palliative care intervention (community neurologist training and remote team-based specialist palliative care). Transcripts were coded and thematically analyzed through a combination of team-based inductive and deductive coding. SETTING/PARTICIPANTS: Twenty-eight patients and 33 care partners purposively sampled from participants in a randomized clinical trial of a palliative care intervention for Parkinson's disease and related disorders conducted at nine sites. RESULTS: Benefits of the intervention included management of a wider range of non-motor symptoms, facilitation of conversations about the future, greater engagement with the health care team, and increased referrals to resources. Participants identified areas of improvement, including uptake of palliative care training by community neurologists, additional prognostic counseling, and clarity and timeliness of communication with the multidisciplinary team. CONCLUSIONS: Clinicians caring for people with Parkinson's disease and related disorders should screen for non-motor symptoms, provide regular prognostic counseling, and refer to specialty palliative care services earlier in the course of illness. Future interventions should be designed to promote uptake of palliative care training by community neurologists and further optimize referral to and coordination with in-person or remote specialty palliative teams.

Patient and Family Outcomes of Community Neurologist Palliative Education and Telehealth Support in Parkinson Disease.

Importance: Parkinson disease and related disorders (PDRD) are the fastest growing neurodegenerative illness in terms of prevalence and mortality. As evidence builds to support palliative care (PC) for PDRD, studies are needed to guide implementation. Objective: To determine whether PC training for neurologists and remote access to a PC team improves outcomes in patients with PDRD in community settings. Design, Setting, and Participants: This pragmatic, stepped-wedge comparative effectiveness trial enrolled and observed participants from 19 community neurology practices supported by PC teams at 2 academic centers from March 8, 2017, to December 31, 2020. Participants were eligible if they had PDRD and moderate to high PC needs. A total of 612 persons with PDRD were referred; 253 were excluded. Patients were excluded if they had another diagnosis meriting PC, were receiving PC, or were unable or unwilling to follow study procedures. Patients received usual care or the intervention based on when their community neurologist was randomized to start the intervention. Data were analyzed from January 2021 to September 2023. Intervention: The intervention included (1) PC education for community neurologists and (2) team-based PC support via telehealth. Main Outcomes and Measures: The primary outcomes were differences at 6 months in patient quality of life (QOL; measured by the Quality of Life in Alzheimer Disease Scale [QOL-AD]) and caregiver burden (Zarit Burden Interview) between the intervention and usual care. Results: A total of 359 patients with PDRD (233 men [64.9%]; mean [SD] age, 74.0 [8.8] years) and 300 caregivers were enrolled. At 6 months, compared with usual care, participants receiving the intervention had better QOL (QOL-AD score, 0.09 [95% CI, -0.63 to 0.82] vs -0.88 [95% CI, -1.62 to -0.13]; treatment effect estimate, 0.97; 95% CI, 0.07-1.86; P = .03). No significant difference was observed in caregiver burden (Zarit Burden Interview score, 1.19 [95% CI, 0.16 to 2.23] vs 0.55 [95%, -0.44 to 1.54]; treatment effect estimate, 0.64; 95% CI, -0.62 to 1.90; P = .32). Advance directive completion was higher under the intervention (19 of 38 [50%] vs 6 of 31 [19%] among those without directives at the beginning of the study; P = .008). There were no differences in other outcomes. Conclusions and Relevance: PC education for community neurologists and provision of team-based PC via telehealth is feasible and may improve QOL and advance care planning. Overall treatment effects were small and suggest opportunities to improve both the intervention and implementation. Trial Registration: ClinicalTrials.gov Identifier: NCT03076671.

Primary Author Characteristics Associated With Publication in the Journal of Pain and Symptom Management.

CONTEXT: Scientific journals are the primary source for dissemination of research findings, and this process relies on rigorous editorial and peer-review. As part of continuing efforts by the Journal of Pain and Symptom Management (JPSM) to advance equity, diversity, and inclusion, JPSM's leadership requested an external evaluation of their publication decisions. OBJECTIVES: 1) Describe primary author characteristics associated with final decisions to accept or reject manuscripts submitted for publication; 2) Report on whether there are potential publication biases in the JPSM editorial or peer-review processes. METHODS: Data consisted of self-reported primary author demographic characteristics associated with manuscript submissions between June 18, 2020, and December 31, 2022. Characteristics included region of residence, race, gender, and ethnicity. A multiple logistic regression model was used to estimate adjusted odds of rejection for each author characteristic. RESULTS: A total of 1940 submissions were evaluated. Compared to authors residing in North America, authors residing in Asia had six-fold greater odds of rejection, authors residing in Europe had four-fold greater odds of rejection, and authors residing in other regions had two-fold greater odds of rejection. Female authors submitted 1.7 times more papers than males, but there was no difference in acceptance rates of their papers in adjusted analysis. CONCLUSION: In this analysis of publication decisions by the JPSM, there were differences in acceptance rates by region of residence, ethnicity, and race but not by gender. Asian authors and authors residing in regions outside of North America had greater odds of rejection compared to White or North American authors.

The "Surprise Question" for Prognostication in People With Parkinson's Disease and Related Disorders.

CONTEXT: Parkinson's disease and related disorders (PDRD) are fatal neurodegenerative disorders characterized by a fluctuating course that can complicate prognostication. The "surprise question" (SQ: "Would you be surprised if your patient died in the next year?") has been used to identify patients with limited prognosis but has not been assessed in PDRD. OBJECTIVES: To determine the validity of the SQ in predicting 12-month mortality in PDRD. METHODS: Data was analyzed from 301 patients and 34 community-based neurologists who were participating in a clinical trial of outpatient palliative care for patients with PDRD. Clinicians answered the SQ for each patient at baseline. Descriptive statistics at baseline, chi-square tests of independence, 2 × 2 and 2 × 3 cross tables were used. Survival analysis compared SQ responses using Kaplan-Meier curves. Risk estimate analyses identified patient characteristics associated with clinicians' responses. RESULTS: Mortality was 10.3% (N = 31) at 1 year. The sensitivity and specificity of the SQ was 80.7% and 58.9%, respectively with AUC = 0.70, positive predictive value of 18.4% and negative predictive value of 96.4%. Older age, atypical parkinsonism, and dementia were associated with responding "no" to the SQ. CONCLUSION: The SQ is sensitive to 12-month mortality in PDRD, with a high negative predictive value. The SQ may be useful for identifying patients less likely to die within a year and may be useful for identifying patients with palliative care needs outside of end-of-life care. This latter use may assist in mobilizing early and timely referral to specialist palliative care.

Anxiety and Depression in Metastatic Cancer: A Critical Review of Negative Impacts on Advance Care Planning and End-of-Life Decision Making With Practical Recommendations.

PURPOSE: Providers treating adults with advanced cancer increasingly seek to engage patients and surrogates in advance care planning (ACP) and end-of-life (EOL) decision making; however, anxiety and depression may interfere with engagement. The intersection of these two key phenomena is examined among patients with metastatic cancer and their surrogates: the need to prepare for and engage in ACP and EOL decision making and the high prevalence of anxiety and depression. METHODS: Using a critical review framework, we examine the specific ways that anxiety and depression are likely to affect both ACP and EOL decision making. RESULTS: The review indicates that depression is associated with reduced compliance with treatment recommendations, and high anxiety may result in avoidance of difficult discussions involved in ACP and EOL decision making. Depression and anxiety are associated with increased decisional regret in the context of cancer treatment decision making, as well as a preference for passive (not active) decision making in an intensive care unit setting. Anxiety about death in patients with advanced cancer is associated with lower rates of completion of an advance directive or discussion of EOL wishes with the oncologist. Patients with advanced cancer and elevated anxiety report higher discordance between wanted versus received life-sustaining treatments, less trust in their physicians, and less comprehension of the information communicated by their physicians. CONCLUSION: Anxiety and depression are commonly elevated among adults with advanced cancer and health care surrogates, and can result in less engagement and satisfaction with ACP, cancer treatment, and EOL decisions. We offer practical strategies and sample scripts for oncology care providers to use to reduce the effects of anxiety and depression in these contexts.

Dissemination and Implementation of a Community Health Worker Intervention for Disparities in Palliative Care (DeCIDE PC): a study protocol for a hybrid type 1 randomized controlled trial.

BACKGROUND: There are persistent racial and ethnic health disparities in end-of-life health outcomes in the United States. African American patients are less likely than White patients to access palliative care, enroll in hospice care, have documented goals of care discussions with their healthcare providers, receive adequate symptom control, or die at home. We developed Community Health Worker Intervention for Disparities in Palliative Care (DeCIDE PC) to address these disparities. DeCIDE PC is an integrated community health worker (CHW) palliative care intervention that uses community health workers (CHWs) as care team members to enhance the receipt of palliative care for African Americans with advanced cancer. The overall objectives of this study are to (1) assess the effectiveness of the DeCIDE PC intervention in improving palliative care outcomes amongst African American patients with advanced solid organ malignancy and their informal caregivers, and (2) develop generalizable knowledge on how contextual factors influence implementation to facilitate dissemination, uptake, and sustainability of the intervention. METHODS: We will conduct a multicenter, randomized, assessor-blind, parallel-group, pragmatic, hybrid type 1 effectiveness-implementation trial at three cancer centers across the United States. The DeCIDE PC intervention will be delivered over 6 months with CHW support tailored to the individual needs of the patient and caregiver. The primary outcome will be advance care planning. The treatment effect will be modeled using logistic regression. The secondary outcomes are quality of life, quality of communication, hospice care utilization, and patient symptoms. DISCUSSION: We expect the DeCIDE PC intervention to improve integration of palliative care, reduce multilevel barriers to care, enhance clinic and patient linkage to resources, and ultimately improve palliative care outcomes for African American patients with advanced cancer. If found to be effective, the DeCIDE PC intervention may be a transformative model with the potential to guide large-scale adoption of promising strategies to improve palliative care use and decrease disparities in end-of-life care for African American patients with advanced cancer in the United States. TRIAL REGISTRATION: Registered on ClinicalTrials.gov (NCT05407844). First posted on June 7, 2022.

Patient and Caregiver Expression of Reluctance and Ambivalence During Palliative Care Encounters.

Context: Patients with serious illness and their caregivers often face challenging decisions. When faced with these decisions, patients and caregivers may display signs of ambivalence and reluctance toward end-of-life decision making. Methods: We recruited 22 palliative care clinicians to participate in a communication coaching study. Clinicians audio recorded four of their palliative care encounters with adult patients and family caregivers. A team of 5 coders used inductive coding methods to create a codebook and then coded instances of patients and caregivers expressing ambivalence and reluctance. They also coded when the decision-making process was initiated and whether a decision was made. The group coded 76 encounters, and 10% (n = 8) of those encounters were double coded to assess inter-rater reliability. Results: We found that ambivalence occurred in 82% (n = 62) of the encounters, while reluctance occurred in 75% (n = 57) of the encounters. The overall prevalence of either was 89% (n = 67). The presence of ambivalence was negatively associated with a decision being made once initiated (r = -0.29, p = 0.06). Conclusion: We found that coders can reliably identify patient and caregiver reluctance and ambivalence. Further, reluctance and ambivalence occur frequently in palliative care encounters. When patients and caregivers have ambivalence, decision making might be hampered.

Empathic communication between clinicians, patients, and care partners in palliative care encounters.

OBJECTIVE: Palliative care encounters often involve empathic opportunities conveyed by patients and their care partners. In this secondary analysis, we examined empathic opportunities and clinician responses with attention to how presence of multiple care partners and clinicians shapes empathic communication. METHODS: We used the Empathic Communication Coding System (ECCS) to characterize emotion-focused, challenge-focused, and progress-focused empathic opportunities and responses in 71 audio-recorded palliative care encounters in the US. RESULTS: Patients expressed more emotion-focused empathic opportunities than did care partners; care partners expressed more challenge-focused empathic opportunities than did patients. Care partners initiated empathic opportunities more frequently when more care partners were present, though they expressed fewer as the number of clinicians increased. When more care partners and more clinicians were present, clinicians had fewer low-empathy responses. CONCLUSION: The number of care partners and clinicians present affect empathic communication. Clinicians should be prepared for empathic communication focal points to shift depending on the number of care partners and clinicians present. PRACTICE IMPLICATIONS: Findings can guide development of resources to prepare clinicians to meet emotional needs in palliative care discussions. Interventions can coach clinicians to respond empathically and pragmatically to patients and care partners, particularly when multiple care partners are in attendance.

Best Practice Alerts Informed by Inpatient Opioid Intake to Reduce Opioid Prescribing after Surgery (PRIOR): A Cluster Randomized Multiple Crossover Trial.

BACKGROUND: Overprescription of opioids after surgery remains common. Residual and unnecessarily prescribed opioids can provide a reservoir for nonmedical use. This study therefore tested the hypothesis that a decision-support tool embedded in electronic health records guides clinicians to prescribe fewer opioids at discharge after inpatient surgery. METHODS: This study included 21,689 surgical inpatient discharges in a cluster randomized multiple crossover trial from July 2020 to June 2021 in four Colorado hospitals. Hospital-level clusters were randomized to alternating 8-week periods during which an electronic decision-support tool recommended tailored discharge opioid prescriptions based on previous inpatient opioid intake. During active alert periods, the alert was displayed to clinicians when the proposed opioid prescription exceeded recommended amounts. No alerts were displayed during inactive periods. Carryover effects were mitigated by including 4-week washout periods. The primary outcome was oral morphine milligram equivalents prescribed at discharge. Secondary outcomes included combination opioid and nonopioid prescriptions and additional opioid prescriptions until day 28 after discharge. A vigorous state-wide opioid education and awareness campaign was in place during the trial. RESULTS: The total postdischarge opioid prescription was a median [quartile 1, quartile 3] of 75 [0, 225] oral morphine milligram equivalents among 11,003 patients discharged when the alerts were active and 100 [0, 225] morphine milligram equivalents in 10,686 patients when the alerts were inactive, with an estimated ratio of geometric means of 0.95 (95% CI, 0.80 to 1.13; P = 0.586). The alert was displayed in 28% (3,074 of 11,003) of the discharges during the active alert period. There was no relationship between the alert and prescribed opioid and nonopioid combination medications or additional opioid prescriptions written after discharge. CONCLUSIONS: A decision-support tool incorporated into electronic medical records did not reduce discharge opioid prescribing for postoperative patients in the context of vigorous opioid education and awareness efforts. Opioid prescribing alerts might yet be valuable in other contexts.(Anesthesiology 2023; 139:186-96).

Local Area Hospice Capacity and Rural Disparities in Hospice Use among Older Adults with Metastatic Breast Cancer.

Background: Little is known about how local area hospice capacity and staffing levels impact hospice use in urban versus rural areas. Objectives: To examine the association between local hospice capacity and staffing levels and hospice use in the context of rural disparities in hospice use, among a sample of patients with metastatic breast cancer. Design: A retrospective cohort study using Surveillance Epidemiology End-Results (SEER)-Medicare linked data 2000-2010, Medicare Provider of Service files, and Census 2000 U.S. Zip Code Tabulation Areas files. Setting: Use of Medicare-certified hospice programs among older adults with metastatic breast cancer residing in one of the SEER program cancer registries designated by National Cancer Institute in the United States. Measurements: Measurements of geographic access to hospices include urban/rural characteristics of patient residence and driving time from the nearest Medicare-certified hospice headquarter. Measurements of local-area hospice capacity and staffing levels include per capita number of Medicare-certified hospice programs and full-time employees among older adults within a predefined radius. Results: Among the study population (N = 5418), remote and suburban areas were negatively associated with hospice use. Lower hospice use in remote and suburban areas was associated with fewer per capita number of Medicare-certified hospice program employees in local areas ≥70-minute driving radius (p = 0.0042), while per capita number of Medicare-certified hospice programs in local areas showed no impact. Conclusion: For older patients with metastatic breast cancer, availability of hospice staff, rather than driving distance or the number of hospice agencies, may limit hospice use in remote and suburban areas.

Use and Influence of Medical Aid in Dying Service on Physician Experiences.

Background: The involvement of Medical Aid in Dying (MAiD) experts to guide MAiD prescribers who may be unfamiliar with the process is unknown. Objective: To examine the involvement of consulting services on physician experiences participating in MAiD activities. Design: This is an anonymous survey. Participants: Colorado physicians (n = 583) likely to care for MAiD-eligible patients. Measures: Consulting services used in a recent MAiD case and perspectives on use of a MAiD service. Results: Of 300 physicians (response rate 55%), 49 physicians had served as a MAiD attending and/or consulting physician. In a recent MAiD case, commonly used services included palliative care (92%), hospice (81%), social work (78%), or a MAiD service (63%). When a MAiD service was not used vs. used, respondents felt the MAiD case was less professionally risky (28% vs. 7%, p = 0.04). Conclusion: Along with palliative care, hospice, and social work, use of an experienced MAiD service was relatively common. The role and function of MAiD services warrant further exploration.

A randomized controlled trial of a multi-modal palliative care intervention to promote advance care planning and psychological well-being among adults with advanced cancer: study protocol.

BACKGROUND: Up to half of adults with advanced cancer report anxiety or depression symptoms, which can cause avoidance of future planning. We present a study protocol for an innovative, remotely-delivered, acceptance-based, multi-modal palliative care intervention that addresses advance care planning (ACP) and unmet psychological needs commonly experienced by adults with metastatic cancer. METHODS: A two-armed, prospective randomized controlled trial (RCT) randomizes 240 adults with Stage IV (and select Stage III) solid tumor cancer who report moderate to high anxiety or depression symptoms to either the multi-modal intervention or usual care. The intervention comprises five weekly two-hour group sessions (plus a booster session one month later) delivered via video conferencing, with online self-paced modules and check-ins completed between the group sessions. Intervention content is based on Acceptance and Commitment Therapy (ACT), an acceptance, mindfulness, and values-based model. Participants are recruited from a network of community cancer care clinics, with group sessions led by the network's oncology clinical social workers. Participants are assessed at baseline, mid-intervention, post-intervention, and 2-month follow-up. The primary outcome is ACP completion; secondary outcomes include anxiety and depression symptoms, fear of dying, and sense of life meaning. Relationships between anxiety/depression symptoms and ACP will be evaluated cross-sectionally and longitudinally and theory-based putative mediators will be examined. DISCUSSION: Among adults with advanced cancer in community oncology settings, this RCT will provide evidence regarding the efficacy of the group ACT intervention on ACP and psychosocial outcomes as well as examine the relationship between ACP and anxiety/ depression symptoms. This trial aims to advance palliative care science and inform clinical practice. TRIAL REGISTRATION: Clinicaltrials.gov NCT04773639 on February 26, 2021.

Evaluation of a training intervention to improve cancer care in Zimbabwe: Strategies to Improve Kaposi Sarcoma Outcomes (SIKO), a prospective community-based stepped-wedge cluster randomized trial.

INTRODUCTION: Most Zimbabweans access medical care through tiered health systems. In 2013, HIV care was decentralized to primary care clinics; while oncology care remained centralized. Most persons in Zimbabwe with Kaposi sarcoma (KS) are diagnosed late in their disease, and the prognosis is poor. Little is known about whether educational interventions could improve KS outcomes in these settings. METHODS: Interventions to improve KS detection and management were evaluated at eight Zimbabwe primary care sites (four rural/four urban) that provided HIV care. Interventions included a standardized KS clinical evaluation tool, palliative care integration, standardized treatment and improved consultative services. Interventions were implemented between February 2013 and January 2016 using a randomized stepped-wedge cluster design. Sites were monitored for KS diagnosis rates and KS outcomes, including early diagnosis (T0 vs. T1 tumour stage), participant retention and mortality. Analyses controlled for within-clinic correlations. RESULTS: A total of 1102 persons with suspected KS (96% HIV positive) were enrolled: 47% incident (new diagnosis), 20% prevalent (previous diagnosis) and 33% determined as not KS. Early (T0) diagnosis increased post-intervention, though not significant statistically (adjusted odds ratio [aOR] = 1.48 [95% confidence interval (95% CI): 0.66-3.79], p = 0.37). New KS diagnosis rates increased 103% (95% CI: 11-273%), p = 0.02) post-intervention; although paired with an increased odds of incorrectly diagnosing KS (aOR = 2.08 [95% CI: 0.33-3.24], p = 0.001). Post-intervention, non-significant decreases in 90-day return rates (adjusted hazard ratio [aHR] = 0.69 [95% CI: 0.38-1.45], p = 0.21) and survival (aHR = 1.36 [95% CI: 0.85-2.20], p = 0.20) were estimated. CONCLUSIONS: KS training interventions at urban and rural Zimbabwe decentralized primary care clinics significantly increased overall and incorrect KS diagnosis rates, but not early KS diagnosis rates, 90-day return rates or survival.

Modeling of an alternative reimbursement method for palliative care.

OBJECTIVES: Patient and Caregiver Support for Serious Illness (PACSSI), a per-member per-month (PMPM) alternative reimbursement structure for palliative care (PC) services, has been described as overly generous by HHS. We developed a modified version, PACSSI-Flexible (PACSSI-F), by modeling reimbursement for PC based on the changes in patient functional status. We estimated reimbursement for the first year that an organization might implement the PACSSI-F for PC services. STUDY DESIGN: Secondary analysis using data from the Statin Discontinuation in Advanced Illness Trial. METHODS: We evaluated the PACSSI vs the PACSSI-F in 3 phases. In the first phase, we calculated variable-appropriate frequencies/relative frequencies or means/SDs for the study population's available demographics and comorbidities, focusing on age, Charlson Comorbidity Index score, race and ethnicity, gender, and continued statin use. Exploratory analyses specific to reimbursement were conducted in a second phase. For each payment structure, we calculated the (1) mean (SD) total reimbursement and (2) number of weeks that a health care system would receive reimbursement, with both weekly and PMPM (4-week) averages. The third phase was designed to quantify any within-person (paired) differences in reimbursement between the original PACSSI and the PACSSI-F. RESULTS: PACSSI-F provides reimbursement for sustainable PC services and was cost-advantageous over PACSSI by $69.92 PMPM for 28.6% of the seriously ill population. CONCLUSIONS: Modeling of the PACSSI-F using secondary data provides a novel example of economic forecasting for alternative reimbursement structures in PC. Alternative reimbursement payment policies are necessary to expand PC for the seriously ill population.

Meeting ethical challenges with authenticity when engaging patients and families in end-of-life and palliative care research: a qualitative study.

BACKGROUND: Delivering high quality, patient- and family-centered care depends upon high quality end-of-life and palliative care (EOLPC) research. Engaging patients and families as advisors, partners, or co-investigators throughout the research lifecycle is widely regarded as critical to ensuring high quality research. Engagement is not only an ethical obligation, it also raises ethical challenges of its own. We conducted a qualitative study to understand ethical challenges and potential solutions when engaging patients and families in EOLPC research. METHODS: We recruited and interviewed 20 clinical investigators and 22 patients or family caregivers through the Palliative Care Research Cooperative Group (PCRC). Interview transcripts were analyzed using constructivist grounded theory methodology. Analysis sought to identify ethical challenges and potential solutions, as well as to synthesize findings into practical recommendations tailored to engaging patients and families in EOLPC research. RESULTS: Our study identified 8 ethical challenges considered unique to the EOLPC research context and 11 potential solutions to these challenges. The most frequently described ethical challenges included the need to minimize burdens of engagement for patients and caregivers, challenges of dealing with death and illness, and paternalism or "gatekeeping" (i.e., withholding the opportunity to participate from patients or caregivers). Investigators and patients or family caregivers conceptualized ethics challenges differently; several issues appeared to fall outside a traditional research ethics paradigm and more into the ethics of relationships. We synthesized these findings into 4 practical recommendations hypothesized to support authentic engagement. CONCLUSIONS: Engaging patients and families in EOLPC research can raise unique ethical challenges. These challenges can be overcome to empower participation, minimize the unique burdens of EOLPC, and promote diversity. Whereas traditional research ethics tend to emphasize protecting research participants who may be vulnerable, an ethics approach based on authentic engagement that explores what it means for investigators and patients or family caregivers to be in a relationship may be needed. Future research is needed to explore this approach and test these recommendations in practice.

Empathic Communication in Specialty Palliative Care Encounters: An Analysis of Opportunities and Responses.

Background: Although empathic responding is considered a core competency in specialty palliative care (PC), patterns of empathic communication in PC encounters are not well understood. Objectives: In this secondary analysis, we delineate types and frequency of empathic communication and examine relationships between patient empathic opportunities and clinician responses. Design: We used the Empathic Communication Coding System to analyze empathic opportunities across three types: emotion (i.e., negative affective state), progress (i.e., stated recent positive life event or development), and challenge (i.e., stated problem or recent, negative life-changing event) and clinician responses. Setting/Subjects: Transcripts from a pilot randomized trial of communication coaching in specialty PC encounters (N = 71) audio-recorded by 22 PC clinicians at two sites in the United States: an academic health system and a community-based hospice and PC organization. Results: Empathic opportunities were frequent across encounters; clinicians often responded empathically to those opportunities (e.g., confirming or acknowledging patients' emotions or experiences). Even though challenge empathic opportunities occurred most frequently, clinicians responded empathically more often to progress opportunities (i.e., 93% of the time) than challenge opportunities (i.e., 75% of the time). One in 12 opportunities was impeded by the patient or a family member changing the topic before the clinician could respond. Conclusions: PC patients frequently express emotions, share progress, or divulge challenges as empathic opportunities. Clinicians often convey empathy in response and can differentiate their empathic responses based on the type of empathic opportunity. PC communication research and training should explore which empathic responses promote desired patient outcomes.