The Association of Unmet Palliative Care Needs and Physical Frailty With Clinical Outcomes: A Prospective Study of Adults With Heart Failure.

BACKGROUND: People with heart failure, particularly those who are physically frail, experience complex needs that can be addressed by palliative care (PC). However, we have a limited understanding of how the intersection of unmet PC needs and physical frailty contributes to health-related quality of life (HRQOL) and risk for hospitalization or mortality. OBJECTIVE: In this study, we sought to examine the association of unmet PC needs and physical frailty with clinical outcomes (baseline HRQOL and hospitalizations or mortality at 6 months). METHODS: We recruited a convenience sample of community-dwelling persons with heart failure from an urban hospital system who were older than 50 years and hospitalized in the last year. We measured physical frailty using the FRAIL scale (nonfrail, 0-2; frail, 3-5), PC needs using the Integrated Palliative Outcome Scale (range, 0-58; higher scores indicating higher needs), and HRQOL using the Kansas City Cardiomyopathy Questionnaire (range, 0-100; higher scores indicate higher HRQOL). We performed multivariable linear regression to test the relationships between physical frailty, PC needs, and HRQOL, and multivariable logistic regression for associations with all-cause 6-month hospitalization or mortality. We also performed an exploratory analysis of 4 PC needs/frailty groups (high PC needs/frail, high PC needs/nonfrail, low PC needs/frail, low PC needs/nonfrail) with outcomes. RESULTS: In our overall sample (n = 298), mean (SD) age was 68 (9.8) years, 37% were women (n = 108), 28% identified as Black/African American (n = 84), and 65% had heart failure with preserved ejection fraction (n = 194). Mean PC needs score was 19.7, and frail participants (n = 130, 44%) had a significantly higher mean PC needs score than nonfrail participants (P < .001). Those with higher PC needs (Integrated Palliative Care Outcome Scale ≥ 20) had significantly worse HRQOL (P < .001) and increased odds of hospitalization or mortality (odds ratio, 2.5; P < .01) compared with those with lower PC needs, adjusting for covariates. Physically frail participants had significantly worse HRQOL (P < .001) and higher odds of hospitalization or mortality at 6 months (odds ratio, 2.6; P < .01) than nonfrail participants, adjusting for covariates. In an exploratory analysis, physically frail participants with high PC needs had the lowest HRQOL score, with an average score of 28.6 points lower (P < .001) and 4.6 times higher odds of hospitalization or mortality (95% confidence interval, 2.03-10.43; P < .001) than low-needs/nonfrail participants. CONCLUSION: Higher unmet PC needs and physical frailty, separately and in combination, were associated with lower HRQOL and higher odds of hospitalization or mortality. Self-reported PC needs and physical frailty assessment in clinical settings may improve identification of patients at the highest risk for poor HRQOL and hospitalization or mortality amenable to PC intervention.

Interdisciplinary interventions that improve patient-reported outcomes in perioperative cancer care: A systematic review of randomized control trials.

INTRODUCTION: Interdisciplinary teams are often leveraged to improve quality of cancer care in the perioperative period. We aimed to identify the team structures and processes in interdisciplinary interventions that improve perioperative patient-reported outcomes for patients with cancer. METHODS: We searched PubMed, EMBASE, and CINAHL for randomized control trials published at any time and screened 7,195 articles. To be included in our review, studies needed to report patient-reported outcomes, have interventions that occur in the perioperative period, include surgical cancer treatment, and include at least one non physician intervention clinical team member: advanced practice providers, including nurse practitioners and physician assistants, clinical nurse specialists, and registered nurses. We narratively synthesized intervention components, specifically roles assumed by intervention clinical team members and interdisciplinary team processes, to compare interventions that improved patient-reported outcomes, based on minimal clinically important difference and statistical significance. RESULTS: We included 34 studies with a total of 4,722 participants, of which 31 reported a clinically meaningful improvement in at least one patient-reported outcome. No included studies had an overall high risk of bias. The common clinical team member roles featured patient education regarding diagnosis, treatment, coping, and pain/symptom management as well as postoperative follow up regarding problems after surgery, resource dissemination, and care planning. Other intervention components included six or more months of continuous clinical team member contact with the patient and involvement of the patient's caregiver. CONCLUSIONS: Future interventions might prioritize supporting clinical team members roles to include patient education, caregiver engagement, and clinical follow-up.

Sharing Health Care Wishes in Primary Care (SHARE) among older adults with possible cognitive impairment in primary care: Study protocol for a randomized controlled trial.

OBJECTIVE: Little is known about effective strategies to improve advance care planning (ACP) for persons with cognitive impairment in primary care, the most common setting of care. We describe a randomized controlled trial to test the efficacy of a multicomponent communication intervention, "Sharing Healthcare Wishes in Primary Care" (SHARE). PARTICIPANTS: Planned enrollment of 248 dyads of adults 80 years and older with possible cognitive impairment and their care partner, from primary care clinics at 2 Mid-Atlantic health systems. METHODS: The treatment protocol encompasses an introductory letter from the clinic; access to a designated facilitator trained in ACP; person-family agenda-setting to align perspectives about the family's role; and print education. The control protocol encompasses minimally enhanced usual care, which includes print education and a blank advance directive. Randomization occurs at the individual dyad-level. Patient and care partner surveys are fielded at baseline, 6-, 12-, and 24- months. Fidelity of interventionist delivery of the protocol is measured through audio-recordings of ACP conversations and post-meeting reports, and by ongoing monitoring and support of interventionists. OUTCOMES: The primary outcome is quality of end-of-life care communication at 6 months; secondary outcomes include ACP process measures. An exploratory aim examines end-of-life care quality and bereaved care partner experiences for patients who die by 24 months. CONCLUSIONS: Caregiver burden, clinician barriers, and impaired decisional capacity amplify the difficulty and importance of ACP discussions in the context of cognitive impairment: this intervention will comprehensively examine communication processes for this special subpopulation in a key setting of primary care. REGISTRATION: ClinicalTrials.gov: NCT04593472.

SHARING Choices: Lessons Learned from a Primary-Care Focused Advance Care Planning Intervention.

BACKGROUND: Few advance care planning (ACP) interventions have been scaled in primary care. PROBLEM: Best practices for delivering ACP at scale in primary care do not exist and prior efforts have excluded older adults with Alzheimer's Disease and Related Dementias (ADRD). INTERVENTION: SHARING Choices (NCT#04819191) is a multicomponent cluster-randomized pragmatic trial conducted at 55 primary care practices from two care delivery systems in the Mid-Atlantic region of the U.S. We describe the process of implementing SHARING Choices within 19 practices randomized to the intervention, summarize fidelity to planned implementation, and discuss lessons learned. OUTCOMES: Embedding SHARING Choices involved engagement with organizational and clinic-level partners. Of 23,220 candidate patients, 17,931 outreach attempts by phone (77.9%) and the patient portal (22.1%) were made by ACP facilitators and 1215 conversations occurred. Most conversations (94.8%) were less than 45 minutes duration. Just 13.1% of ACP conversations included family. Patients with ADRD comprised a small proportion of patients who engaged in ACP. Implementation adaptations included transitioning to remote modalities, aligning ACP outreach with the Medicare Annual Wellness Visit, accommodating primary care practice flexibility. LESSONS LEARNED: Study findings reinforce the value of adaptable study design; co-designing workflow adaptations with practice staff; adapting implementation processes to fit the unique needs of two health systems; and modifying efforts to meet health system goals and priorities.

Utilization of a primary care-based cancer survivorship clinic: patterns and patient characteristics.

PURPOSE: The Johns Hopkins Primary Care for Cancer Survivors (PCCS) Clinic was established in 2015 to improve care delivery for the growing cancer survivor population. We aim to describe areas of care addressed by PCCS and factors associated with clinic utilization. METHODS: We conducted a retrospective chart review of the first 301 patients' clinic visits. We used negative binomial regression models to identify factors associated with the rate of PCCS clinic visits overall and for cancer surveillance and treatment-related effects. RESULTS: There were 1702 clinic visits across 301 patients during the study period (77% female, median age 61). The most common areas of care addressed were chronic medical problems (80%), preventive health care (62%), cancer surveillance (59%), treatment-related effects (50%), and new/acute problems (46%). Multivariate analyses found that age > 60 years (IRR = 1.9, 95% CI = 1.2-3.0, p = 0.007) and higher number of comorbidities (IRR = 1.2, 95% CI = 1.1 - 1.2, p < 0.001) were associated with more overall PCCS visits, while female gender was associated with fewer visits (IRR = 0.6, CI = 0.4 - 0.8, p = 0.001). Gastrointestinal cancer type, shorter length of survivorship, male gender, and higher number of comorbidities were associated with a higher rate of visits addressing both surveillance and treatment-related effects (p < 0.05). CONCLUSIONS: The PCCS clinic addressed cancer and non-cancer related needs. Older patients and survivors with more comorbidities had significantly increased clinic utilization. IMPLICATIONS FOR CANCER SURVIVORS: As the cancer survivor population grows, increasing access to survivorship clinics based in primary care may help meet these patients' diverse oncologic and general health needs.

Palliative Care Needs of Physically Frail Community-Dwelling Older Adults With Heart Failure.

CONTEXT: Physical frailty is emerging as a potential "trigger" for palliative care (PC) consultation, but the PC needs of physically frail persons with heart failure (HF) in the outpatient setting have not been well described. OBJECTIVES: This study describes the PC needs of community dwelling, physically frail persons with HF. METHODS: We included persons with HF ≥50 years old who experienced ≥1 hospitalization in the prior year and excluded those with moderate/severe cognitive impairment, hospice patients, or non-English speaking persons. Measures included the FRAIL scale (0-5: 0 = robust, 1-2 = prefrail, 3-5 = frail) and the Integrated Palliative Outcome Scale (IPOS) (17 items, score 0-68; higher score = higher PC needs). Multiple linear regression tested the association between frailty group and palliative care needs. RESULTS: Participants (N = 286) had a mean age of 68 (range 50-92) were majority male (63%) and White (68%) and averaged two hospitalizations annually. Most were physically frail (44%) or prefrail (41%). Mean PC needs (IPOS) score was 19.7 (range 0-58). On average, participants reported 5.86 (SD 4.28) PC needs affecting them moderately, severely, or overwhelmingly in the last week. Patient-perceived family/friend anxiety (58%) weakness/lack of energy (58%), and shortness of breath (47%) were the most prevalent needs. Frail participants had higher mean PC needs score (26) than prefrail (16, P < 0.001) or robust participants (11, P < 0.001). Frail participants experienced an average of 8.32 (SD 3.72) moderate/severe/overwhelming needs compared to prefrail (4.56, SD 3.77) and robust (2.39, SD 2.91) participants (P < 0.001). Frail participants reported higher prevalence of weakness/lack of energy (83%), shortness of breath (66%), and family/friend anxiety (69%) than prefrail (48%, 39%, 54%) or robust (13%, 14%, 35%) participants (P < 0.001). CONCLUSION: Physically frail people with HF have higher unmet PC needs than those who are nonfrail. Implementing PC needs and frailty assessments may help identify vulnerable patients with unmet needs requiring further assessment and follow-up.

Patient-Reported Quality Measures for Palliative Care: The Time is now.

CONTEXT: While progress has been made in the ability to measure the quality of hospice and specialty palliative care, there are notable gaps. A recent analysis conducted by Center for Medicare and Medicaid Services (CMS) revealed a paucity of patient-reported measures, particularly in palliative care domains such as symptom management and communication. OBJECTIVES: The research team, consisting of quality measure and survey developers, psychometricians, and palliative care clinicians, used established state-of-the art methods for developing and testing patient-reported measures. METHODS: We applied a patient-centered, patient-engaged approach throughout the development and testing process. This sequential process included 1) an information gathering phase; 2) a pre-testing phase; 3) a testing phase; and 4) an endorsement phase. RESULTS: To fill quality measure gaps identified during the information gathering phase, we selected two draft measures ("Feeling Heard and Understood" and "Receiving Desired Help for Pain") for testing with patients receiving palliative care in clinic-based settings. In the pre-testing phase, we used an iterative process of cognitive interviews to refine draft items and corresponding response options for the proposed measures. The alpha pilot test supported establishment of protocols for the national beta field test. Measures met conventional criteria for reliability, had strong face and construct validity, and there was diversity in program level scores. The measures received National Quality Forum (NQF) endorsement. CONCLUSION: These measures highlight the key role of patient voices in palliative care and fill a much-needed gap for patient-reported experience measures in our field.

Perceived Barriers and Facilitators of Implementing a Multicomponent Intervention to Improve Communication With Older Adults With and Without Dementia (SHARING Choices) in Primary Care: A Qualitative Study.

INTRODUCTION: Implementing patient- and family-centered communication strategies has proven challenging in primary care, particularly for persons with dementia. To address this, we designed SHARING Choices, a multicomponent intervention combining patient and family partnered agenda setting, electronic portal access, and supports for advance care planning (ACP). This qualitative descriptive study describes factors affecting SHARING Choices implementation within primary care. METHODS: Semi-structured interviews or focus groups with patient/family dyads (family, friends, unpaid caregivers) and primary care stakeholders (clinicians, staff, administrators) elicited perceived barriers and facilitators of SHARING Choices implementation. Field notes and interview transcripts were coded using template analysis along the Consolidated Framework for Implementation Research (CFIR) constructs. Content analysis identified themes not readily categorized within CFIR. RESULTS: About 22 dyads, including 14 with cognitive impairment, and 30 stakeholders participated in the study. Participants were receptive to the SHARING Choices components. Enablers of SHARING Choices included adaptability of the intervention, purposive engagement of family (particularly for patients with dementia), consistency with organizational priorities, and the relative advantage of SHARING Choices compared to current practices. Perceived barriers to implementation included intervention complexity, space constraints, workflow, and ACP hesitancy. The ACP facilitator was perceived as supportive in addressing individual and organizational implementation barriers including patient health and technology literacy and clinician time for ACP discussions. CONCLUSIONS: Patients, family, and primary care clinicians endorsed the objectives and individual components of SHARING Choices. Strategies to enhance adoption were to simplify materials, streamline processes, leverage existing workflows, and embed ACP facilitators within the primary care team.

The Application of Minimal Clinically Important Differences in Palliative Research: Interpretation of Results of a Systematic Review.

CONTEXT: Interpreting clinical meaningfulness of patient reported outcomes (PROs) in palliative care research is key in evidence-based practice. Minimal clinically important differences (MCIDs) can help interpret whether changes in PROs are meaningful to patients. OBJECTIVE: To examine use of MCIDs in a recent systematic review on integrating palliative care into ambulatory care for U.S. adults with noncancer serious chronic illness and their effect on interpretation of key PROs. METHODS: Paired investigators abstracted MCIDs for each PRO in the systematic review from PubMed, tool specific websites, and Google Scholar. Investigators compared findings and resolved differences through consensus. MCIDs were interpreted alongside results from meta-analyses or individual studies to draw conclusions on effectiveness of interventions. RESULTS: MCIDs could be identified for 10 of 23 instruments affecting seven of nine outcomes. The most notable effect was for depressive symptoms, where three trials reported statistically significant differences that were not clinically meaningful based on available MCIDs. Although differences in statistical significance and MCIDs were noted for other outcomes, they were accounted for in meta-analyses or affected a minimal number of studies within the outcome category. CONCLUSIONS: Incorporating MCIDs affected the interpretation of almost all PROs in the systematic review. MCIDs are important measures of clinical meaningfulness for the interpretation of palliative care research involving PROs. Researchers should consider using instruments with well-established MCIDs and incorporate MCIDs, when available, in study design and interpretation.

Medicare Advantage coverage restrictions for the costliest physician-administered drugs.

OBJECTIVES: To examine the use of step therapy, prior authorization, and Part D formulary exclusion by 4 large Medicare Advantage (MA) insurers to manage 20 physician-administered drugs with the highest total Medicare expenditures (top 20 drugs). STUDY DESIGN: We collected data for United Healthcare, CVS/Aetna, Humana, and Kaiser plans to create a database of 2020 Part B coverage restrictions and conducted a retrospective analysis of 2018-2020 Part D formularies. METHODS: For each insurer, we calculated the number of top 20 physician-administered drugs subject to prior authorization and step therapy. For physician-administered drugs for which there were no similar or interchangeable alternatives, we examined which insurers required prior authorization or step therapy. Finally, we examined whether insurers restricted access to physician-administered drugs by reducing coverage on Part D formularies. RESULTS: Of the top 20 physician-administered drugs, 17 were subject to prior authorization and 10 were subject to step therapy by at least 1 insurer. For 5 physician-administered drugs without a similar or interchangeable alternative, none were subject to step therapy and all were subject to prior authorization by at least 1 insurer. Across the 4 insurers, 16 physician-administered drugs were covered on all or some of the Part D formularies in 2018, which decreased to 6 in 2020. CONCLUSIONS: Four large MA insurers managed access to expensive physician-administered drugs with a combination of prior authorization, step therapy, and Part D formulary design. When a low-cost alternative exists, these tools can help reduce wasteful spending, but the administrative barriers may also reduce access.

SHARING Choices: Design and rationale for a pragmatic trial of an advance care planning intervention for older adults with and without dementia in primary care.

BACKGROUND: Advance care planning (ACP) and involving family are particularly important in dementia, and primary care is a key setting. The purpose of this trial is to examine the impact and implementation of SHARING Choices, an intervention to improve communication for older adults with and without dementia through proactively supporting ACP and family engagement in primary care. METHODS: We cluster-randomized 55 diverse primary care practices across two health systems to the intervention or usual care. SHARING Choices is a multicomponent intervention that aims to improve communication through patient and family engagement in ACP, agenda setting, and shared access to the patient portal for all patients over 65 years of age. The primary outcomes include documentation of an advance directive or medical orders for life-sustaining treatment in the electronic health record (EHR) at 12 months for all patients and receipt of potentially burdensome care within 6 months of death for the subgroup of patients with serious illness. We plan a priori sub-analysis for patients with dementia. Data sources include the health system EHRs and the Maryland health information exchange. We use a mixed-methods approach to evaluate uptake, fidelity and adaptation of the intervention and implementation facilitators and barriers. CONCLUSIONS: This cluster-randomized pragmatic trial examines ACP with a focus on the key population of those with dementia, implementation in diverse settings and innovative approaches to trial design and outcome abstraction. Mixed-methods approaches enable understanding of intervention delivery and facilitators and barriers to implementation in rapidly changing health care systems. CLINICALTRIALS: gov Identifier: NCT04819191.

Challenges and Strategies for Patient Safety in Primary Care: A Qualitative Study.

Although most health care occurs in the ambulatory setting, limited research examines how providers and patients think about and enact ambulatory patient safety. This multimethod qualitative study seeks to identify perceived challenges and strategies to improve ambulatory safety from the perspectives of clinicians, staff, and patients. Data included interviews (N = 101), focus groups (N = 65), and observations of safety processes (N = 79) collected from 10 patient-centered medical homes. Key safety issues included the lack of interoperability among health information systems, clinician-patient communication failures, and challenges with medication reconciliation. Commonly cited safety strategies leveraged health information systems or involved dedicated resources (eg, providing access to social workers). Patients also identified strategies not mentioned by clinicians, emphasizing the need for their involvement in developing safety solutions. This work provides insight into safety issues of greatest concern to clinicians, staff, and patients and strategies to improve safety in the ambulatory setting.

Defining Clinical Excellence for Palliative Care Specialists: A Concept Whose Time Has Come.

Experts in the field of palliative care in the United States (U.S.) have defined competence, or "good," mainly for programs, trainees, or providers of primary palliative care. Our interprofessional workgroup of palliative care specialists proposes that setting a standard for clinical excellence, or "great," applicable to palliative care specialists of all professions will elevate the field in the U.S. by providing an aspirational target usable for individual assessment and self-assessment, highlighting the common ground between team roles, and promoting a deeper understanding of teamwork, utilization, and productivity. We call for research that utilizes inclusive methods and broad representation of diverse voices to design a vivid, practical, and evidence-based definition of clinical excellence for palliative care specialists.

Implementation and Effectiveness of Integrating Palliative Care Into Ambulatory Care of Noncancer Serious Chronic Illness: Mixed Methods Review and Meta-Analysis.

PURPOSE: To perform a mixed methods review to evaluate the effectiveness and implementation of models for integrating palliative care into ambulatory care for US adults with noncancer serious chronic illness. METHODS: We searched 3 electronic databases from January 2000 to May 2020 and included qualitative, mixed methods studies and randomized and nonrandomized controlled trials. For each study, 2 reviewers abstracted data and independently assessed for quality. We conducted meta-analyses as appropriate and graded strength of evidence (SOE) for quantitative outcomes. RESULTS: Quantitative analysis included 14 studies of 2,934 patients. Compared to usual care, models evaluated were not more effective for improving patient health-related quality of life (HRQOL) (standardized mean difference [SMD] of 4 of 8 studies, 0.19; 95% CI, ‒0.03 to 0.41) (SOE: moderate) or for patient depressive symptom scores (SMD of 3 of 9 studies, ‒0.09; 95% CI, ‒0.35 to 0.16) (SOE: moderate). Models might have little to no effect on patient satisfaction (SOE: low) but were more effective for increasing advance directive (AD) documentation (relative risk, 1.62; 95% CI, 1.35 to 1.94) (SOE: moderate). Qualitative analysis included 5 studies of 146 patients. Patient preferences for appropriate timing of palliative care varied; costs, additional visits, and travel were considered barriers to implementation. CONCLUSION: Models might have little to no effect on decreasing overall symptom burden and were not more effective than usual care for improving HRQOL or depressive symptom scores but were more effective for increasing AD documentation. Additional research should focus on identifying and addressing characteristics and implementation factors critical to integrating models to improve ambulatory, patient-centered outcomes.

A double-edged sword: The effects of social network ties on job satisfaction in primary care organizations.

BACKGROUND: Social ties between health care workers may be an important driver of job satisfaction; however, research on this topic is limited. PURPOSE: We used social network methods to collect data describing two types of social ties, (a) instrumental ties (i.e., exchange of advice that enables work) and (b) expressive ties (i.e., exchange of social support), and related those ties to workers' job satisfaction. METHODOLOGY: We surveyed 456 clinicians and staff at 23 primary care practices about their social networks and workplace attitudes. We used multivariable linear regression to estimate the relationship between an individual's job satisfaction and two network properties: (a) eigenvector centrality (a measure of the importance of an individual in a network) and (b) ego network density (a measure of the cohesiveness of an individual's network). We examined this relationship for both instrumental and expressive ties. RESULTS: Individuals who were more central in the expressive network were less satisfied in their job, b = -0.40 (0.19), p < .05, whereas individuals who had denser instrumental networks were more satisfied in their job, b = 0.49 (0.21), p < .05. CONCLUSION: Workplace relationships affect worker well-being. Centrality in an expressive network may require greater emotional labor, increasing workers' risk for job dissatisfaction. On the other hand, a dense instrumental network may promote job satisfaction by strengthening workers' access to full information, supporting competence and confidence. PRACTICE IMPLICATIONS: Efforts to increase job satisfaction should consider both the positive and negative effects of social networks on workers' sense of well-being.

Association of Implementation and Social Network Factors With Patient Safety Culture in Medical Homes: A Coincidence Analysis.

OBJECTIVES: The patient-centered medical home (PCMH) may provide a key model for ambulatory patient safety. Our objective was to explore which PCMH and patient safety implementation and social network factors may be necessary or sufficient for higher patient safety culture. METHODS: This was a cross-case analysis study in 25 diverse U.S. PCMHs. Data sources included interviews of a clinician and an administrator in each PCMH, surveys of clinicians and staff, and existing data on the PCMHs' characteristics. We used coincidence analysis, a novel method based on set theory and Boolean logic, to evaluate relationships between factors and the implementation outcome of patient safety culture. RESULTS: The coincidence analysis identified 5 equally parsimonious solutions (4 factors), accounting for all practices with higher safety culture. Three solutions contained the same core minimally sufficient condition: the implementation factor leadership priority for patient safety and the social network factor reciprocity in advice-seeking network ties (advice-seeking relationships). This minimally sufficient condition had the highest coverage (5/7 practices scoring higher on the outcome) and best performance across solutions; all included leadership priority for patient safety. Other key factors included self-efficacy and job satisfaction and quality improvement climate. The most common factor whose absence was associated with the outcome was a well-functioning process for behavioral health. CONCLUSIONS: Our findings suggest that PCMH safety culture is higher when clinicians and staff perceive that leadership prioritizes patient safety and when high reciprocity among staff exists. Interventions to improve patient safety should consider measuring and addressing these key factors.

Financial Burden of Drugs Prescribed for Cancer-Associated Symptoms.

PURPOSE: The financial toxicity of anticancer drugs is well-documented, but little is known about the costs of drugs used to manage cancer-associated symptoms. METHODS: We reviewed relevant guidelines and compiled drugs used to manage seven cancer-associated symptoms (anorexia and cachexia, chemotherapy-induced peripheral neuropathy, constipation, diarrhea, exocrine pancreatic insufficiency, cancer-associated fatigue, and chemotherapy-induced nausea and vomiting). Using GoodRx website, we identified the retail price (cash price at retail pharmacies) and lowest price (discounted, best-case scenario of out-of-pocket costs) for patients without insurance for each drug or formulation for a typical fill. We describe lowest prices here. RESULTS: For anorexia and cachexia, costs ranged from $5 US dollars (USD; generic olanzapine or mirtazapine tablets) to $1,156 USD (brand-name dronabinol solution) and varied widely by formulation of the same drug or dosage: for olanzapine 5 mg, $5 USD (generic tablet) to $239 USD (brand-name orally disintegrating tablet). For chemotherapy-induced peripheral neuropathy, costs of duloxetine varied from $12 USD (generic) to $529 USD (brand-name). For constipation, the cost of sennosides or polyethylene glycol was <$15 USD, whereas newer agents such as methylnaltrexone were expensive ($1,001 USD). For diarrhea, the cost of generic loperamide or diphenoxylate-atropine tablets was <$15 USD. For exocrine pancreatic insufficiency, only brand-name formulations were available, range of cost, $1,072 USD-$1,514 USD. For cancer-associated fatigue, the cost of generic dexamethasone or dexmethylphenidate was <$15 USD, whereas brand-name modafinil was more costly ($1,284 USD). For a 4-drug nausea and vomiting prophylaxis regimen, costs ranged from $181 USD to $1,430 USD. CONCLUSION: We highlight the high costs of many symptom control drugs and the wide variation in the costs of these drugs. These findings can guide patient-clinician discussions about cost-effectively managing symptoms, while promoting the use of less expensive formulations when possible.

Prescribing of low- versus high-cost Part B drugs in Medicare Advantage and traditional Medicare.

OBJECTIVE: Examine whether Medicare Advantage (MA) coverage is associated with more efficient prescribing of Part B drugs than traditional Medicare (TM) coverage. DATA SOURCES: Twenty percent sample of 2016 outpatient and carrier TM claims and MA encounter records and Master Beneficiary Summary File data. STUDY DESIGN: We analyzed whether MA enrollees compared to TM enrollees more often received the low-cost Part B drug in four clinical scenarios where multiple similarly effective drugs exist: (1) anti-VEGF agents to treat macular degeneration, (2) bone resorption inhibitors for osteoporosis, (3) bone resorption inhibitors for malignant neoplasms, and (4) intravenous iron for iron deficiency anemia. We then estimated differences in spending if TM prescribing aligned with MA prescribing. Finally, using linear probability models, we examined whether differences in MA and TM prescribing patterns were attributable to differences in the hospitals and clinician practices who treat MA and TM enrollees or differences in how these hospitals and clinician practices treat their MA versus TM patients. DATA COLLECTION/EXTRACTION METHODS: Not applicable. PRINCIPAL FINDINGS: In all cases, a larger share of MA enrollees received the low-cost drug compared to TM enrollees, ranging from 8 percentage points higher for anemia to 16 percentage points higher for macular degeneration in the unadjusted analysis. Results were similar in regression analyses controlling for enrollee characteristics and market factors (5-13 percentage points). If TM prescribing matched MA prescribing, we estimated savings ranging from 6% to 20% of TM spending for each scenario. Differences in prescribing patterns were driven both by MA enrollees receiving treatment at more efficient hospitals and clinician practices and hospitals and clinician practices more often prescribing low-cost drugs to their MA patients. CONCLUSIONS: Our findings show MA enrollees were more likely than TM enrollees to receive low-cost Part B drugs in four clinical scenarios where multiple similarly or equally effective treatment options exist.

Patient perceptions of safety in primary care: a qualitative study to inform care.

Patients' perspectives on patient safety have rarely been incorporated into quality initiatives in primary care. Our objective was to understand the patient perspective on patient safety in patient-centered medical homes (PCMHs). We conducted 12 patient focus groups/interviews in nine sites with 65 patients at a geographically diverse sample of National Committee on Quality Assurance Level 3 recognized PCMHs across three states. Using a patient safety framework, we coded and analyzed interviews for overarching themes and subthemes across patient safety domains. Overarching themes focused on (1) both clear and timely communication with and between clinicians and (2) trust in the care team, including being heard, respected, and treated as a whole person. Other themes important to specific patient safety domains included sharing of and access to information, patient education and patient-centered medication reconciliation process, clear documentation for the diagnostic process, patient-centered comprehensive visits, and timeliness of care. Communication and trust are key to patient perceptions of safe primary care. Focusing on these themes across safety domains may help to make primary care both more patient-centered and safer, and should be considered in future ambulatory safety initiatives.

Implementation of an Early Palliative Care Referral Program in Lung Cancer: A Quality Improvement Project at the Tata Memorial Hospital, Mumbai, India.

OBJECTIVES: Access to early palliative care (EPC) for all patients with metastatic lung cancer is yet to be achieved in spite of recommendations. This quality improvement (QI) project was initialized to improve the rates of such referrals from the thoracic oncology clinic for all new outpatients in a premier cancer center in India. MATERIALS AND METHODS: Change in the proportion of patients receiving referrals for EPC during and after intervention (April-May 2018), compared to baseline (January-March 2018) were explored. Interventions included understanding of the process flow, identification of key drivers, and root cause analysis which identified the gaps as lack of documentation for EPC. Teaching and encouraging staff at the clinic to incorporate referrals into all initial visits for patients with metastatic lung cancer were incorporated. RESULTS: The bundle of QI interventions increased referrals from an average of 50% to 75%, mean difference = 12.64 (standard deviation = 10.13) (95% confidence interval = 22.01-3.29), P = 0.016 (two-tailed) on paired sample test. CONCLUSION: Improved referral rates for EPC in a multidisciplinary cancer clinic is possible with a QI project. This project also identifies the importance of data documentation and patient information processes that can be targeted for improvement.