Deprescribing bisphosphonates for older adults with dementia: perspectives of caregivers.

Little is known about caregivers' perspectives on deprescribing bisphosphonates for older adults with dementia. Caregivers agreed that fracture prevention was important for maintaining functional independence but acknowledged that changing goals of care may justify deprescribing. Conversations grounded in "what matters most" can align fracture prevention treatment with goals of care. PURPOSE: The long-term fracture prevention benefits of bisphosphonates may begin to be overshadowed by the potential burden of adverse effects and polypharmacy for older adults living with dementia as the disease progresses. We characterized factors that influence caregiver decision-making for continuing versus deprescribing bisphosphonates for persons living with dementia. METHODS: We conducted 11 interviews with family or informal caregivers of older adults living with dementia in the community or in long-term care who had been treated with bisphosphonates. Interviews focused on experiences caring for someone who has experienced a fracture, perceived benefits and harms of bisphosphonates, and experiences with deprescribing. Analyses were conducted using a qualitative framework methodology guided by the Health Belief Model. RESULTS: Most caregivers were male (n = 8), younger than 65 (n = 8) and were an adult child caregiver (n = 8). Three caregivers were Black and five were Latino/a. Attempts to maintain functional independence despite high likelihood of falls was frequently discussed as contributing to fracture risk, in this population. Many caregivers perceived fracture prevention treatment as important, while several noted that it may become less important near the end of life. Perceived benefits of fracture prevention treatment for persons with dementia included improved quality of life and maintaining independence. Although most indicated that bisphosphonates were well tolerated, gastrointestinal adverse effects, preference for fewer treatments, and dementia-related behaviors that interfere with medication administration may be reasons for deprescribing. CONCLUSION: Conversations grounded in caregiver experiences and "what matters most" may help optimize fracture prevention treatment for older adults with dementia.

Validating claims-based definitions for deprescribing: Bridging the gap between clinical and administrative data.

BACKGROUND: Limited research has evaluated the validity of claims-based definitions for deprescribing. OBJECTIVES: Evaluate the validity of claims-based definitions of deprescribing against electronic health records (EHRs) for deprescribing of benzodiazepines (BZDs) after a fall-related hospitalization. METHODS: We used a novel data linkage between Medicare fee-for-service (FFS) and Part D with our health system's EHR. We identified patients aged ≥66 years with a fall-related hospitalization, continuous enrollment in Medicare FFS and Part D for 6 months pre- and post-hospitalization, and ≥2 BZD fills in the 6 months pre-hospitalization. Using a standardized EHR abstraction tool, we adjudicated deprescribing for a sub-sample with a fall-related hospitalization at UNC. We evaluated the validity of claims-based deprescribing definitions (e.g., gaps in supply, dosage reductions) versus chart review using sensitivity and specificity. RESULTS: Among 257 patients in the overall sample, 44% were aged 66-74 years, 35% had Medicare low-income subsidy, 79% were female. Among claims-based definitions using gaps in supply, the prevalence of BZD deprescribing ranged from 8.2% (no refills) to 36.6% (30-day gap). When incorporating dosage, the prevalence ranged from 55.3% to 65.8%. Among the validation sub-sample (n = 47), approximately one-third had BZDs deprescribed in the EHR. Compared to EHR, gaps in supply from claims had good sensitivity, but poor specificity. Incorporating dosage increased sensitivity, but worsened specificity. CONCLUSIONS: The sensitivity of claims-based definitions for deprescribing of BZDs was low; however, the specificity of a 90-day gap was >90%. Replication in other EHRs and for other low-value medications is needed to guide future deprescribing research.

Prescriber Perspectives and Experiences with Deprescribing Versus Continuing Bisphosphonates in Older Nursing Home Residents with Dementia.

BACKGROUND: Few guidelines address fracture prevention medication use in nursing home (NH) residents with dementia. OBJECTIVE: We sought to identify factors that influence prescriber decision-making for deprescribing of bisphosphonates for older NH residents with dementia. METHODS: We conducted 12 semi-structured interviews with prescribers who care for older adults with dementia in NHs. MAIN MEASURES: Interview prompts addressed experiences treating fractures, benefits, and harms of bisphosphonates, and experiences with deprescribing. Coding was guided by the social-ecological framework including patient-level (intrapersonal) and external (interpersonal, system, community, and policy) influences. RESULTS: Most prescribers were physicians (83%); 75% were female and 75% were White. Most (75%) spent less than half of their clinical effort in NHs and half were in the first decade of practice. Among patient-level influences, prescribers uniformly agreed that a prior bisphosphonate treatment course of several years, emergence of adverse effects, and changing goals of care or limited life expectancy were compelling reasons to deprescribe. External influences were frequently discussed as barriers to deprescribing. At the interpersonal level, prescribers noted that family/informal caregivers are diverse in their involvement in decision-making, and frequently concerned about the adverse effects of bisphosphonates, but perceive deprescribing as "withdrawing care." At the health system level, prescribers felt that frequent transitions make it difficult to determine duration of prior treatment and to implement deprescribing. At the policy level, prescribers highlighted the lack of guidelines addressing residents with limited mobility and dementia or criteria for deprescribing, including uncertainty in the setting of prior fractures and lack of bone densitometry in NHs. CONCLUSION: Systems-level barriers to evaluating bone densitometry and treatment history in NHs may impede person-centered decision-making for fracture prevention. Further research is needed to evaluate the residual benefits of bisphosphonates in medically complex residents with limited mobility and dementia to inform recommendations for deprescribing versus continued use.

Structure and integration of specialty palliative care in three NCI-designated cancer centers: a mixed methods case study.

INTRODUCTION: Early access to specialty palliative care is associated with better quality of life, less intensive end-of-life treatment and improved outcomes for patients with advanced cancer. However, significant variation exists in implementation and integration of palliative care. This study compares the organizational, sociocultural, and clinical factors that support or hinder palliative care integration across three U.S. cancer centers using an in-depth mixed methods case study design and proposes a middle range theory to further characterize specialty palliative care integration. METHODS: Mixed methods data collection included document review, semi-structured interviews, direct clinical observation, and context data related to site characteristics and patient demographics. A mixed inductive and deductive approach and triangulation was used to analyze and compare sites' palliative care delivery models, organizational structures, social norms, and clinician beliefs and practices. RESULTS: Sites included an urban center in the Midwest and two in the Southeast. Data included 62 clinician and 27 leader interviews, observations of 410 inpatient and outpatient encounters and seven non-encounter-based meetings, and multiple documents. Two sites had high levels of "favorable" organizational influences for specialty palliative care integration, including screening, policies, and other structures facilitating integration of specialty palliative care into advanced cancer care. The third site lacked formal organizational policies and structures for specialty palliative care, had a small specialty palliative care team, espoused an organizational identity linked to treatment innovation, and demonstrated strong social norms for oncologist primacy in decision making. This combination led to low levels of specialty palliative care integration and greater reliance on individual clinicians to initiate palliative care. CONCLUSION: Integration of specialty palliative care services in advanced cancer care was associated with a complex interaction of organization-level factors, social norms, and individual clinician orientation. The resulting middle range theory suggests that formal structures and policies for specialty palliative care combined with supportive social norms are associated with greater palliative care integration in advanced cancer care, and less influence of individual clinician preferences or tendencies to continue treatment. These results suggest multi-faceted efforts at different levels, including social norms, may be needed to improve specialty palliative care integration for advanced cancer patients.

Patterns of oral bisphosphonate deprescribing in older nursing home residents with dementia.

In a national sample of Medicare nursing home residents with dementia treated with bisphosphonates, 20% had bisphosphonates deprescribed. Residents with clinical characteristics representing decreased likelihood for long-term benefit were more likely to have bisphosphonates deprescribed. Future studies are needed to evaluate outcomes of deprescribing bisphosphonates in this population. INTRODUCTION: To determine incidence of deprescribing bisphosphonates among nursing home (NH) residents with dementia and identify factors associated with deprescribing. METHODS: 2015-2016 Medicare claims, Part D prescriptions, Minimum Data Set (MDS) 3.0, and Nursing Home Compare for non-skilled NH residents aged 65 + with dementia and prescriptions for oral bisphosphonates overlapping the first 14 days of the stay. Our primary definition for deprescribing was a 90-day gap in medication supply; we also explored the reliability of different deprescribing definitions (30-, 90-, 180-day gaps). We estimated associations of NH, provider, and resident characteristics with deprescribing bisphosphonates using competing risks regression models. RESULTS: Most NH residents with dementia treated with bisphosphonates (n = 5312) were ≥ 80 years old (72%), white (81%), and female (90%); about half were dependent for transfers (50%) or mobility (45%). Using a 90-day gap in supply, the 180-day cumulative incidence of deprescribing bisphosphonates was 14.8%. This increased to 32.1% using a 30-day gap and decreased to 11.7% using a 180-day gap. Factors associated with increased likelihood for bisphosphonate deprescribing were age ≥ 90 years, newly admitted (vs. prevalent stay), dependent for mobility, swallowing difficulty, > 1 hospitalization in the prior year, CCRC facility, and nurse practitioner primary provider (vs. physician). Cancer and western geographic region were associated with reduced likelihood for deprescribing. CONCLUSION: In a national sample of NH residents with dementia, bisphosphonate deprescribing was uncommon, and associated with clinical characteristics signifying poor prognosis and decreased likelihood for long-term benefit. Future studies should evaluate clinical outcomes of deprescribing bisphosphonates in this population.

Families Addressing Cancer Together (FACT): feasibility and acceptability of a web-based psychosocial intervention for parents with cancer.

PURPOSE: Although parents with cancer report that talking with their children about cancer and dying is distressing, accessible support is rare. We assessed the feasibility, acceptability, and preliminary effects of Families Addressing Cancer Together (FACT), a web-based, tailored psychosocial intervention to help parents talk about their cancer with their children. METHODS: This pilot study used a pre-posttest design. Eligible participants were parents with new or metastatic solid tumors who had minor (ages 3-18) children. Participants who completed baseline assessments received online access to FACT. We assessed feasibility through enrollment and retention rates and reasons for study refusal. Acceptability was evaluated by satisfaction ratings. We examined participants' selection of intervention content and preliminary effects on communication self-efficacy and other psychosocial outcomes (depression and anxiety symptoms, health-related quality of life, family functioning) at 2- and 12-week post-intervention. RESULTS: Of 68 parents we approached, 53 (78%) agreed to participate. Forty-six parents completed baseline assessments and received the FACT intervention. Of the 46 participants, 35 (76%) completed 2-week assessments, and 25 (54%) completed 12-week assessments. Parents reported that FACT was helpful (90%), relevant (95%), and easy to understand (100%). Parents' psychosocial outcomes did not significantly improve post-intervention, but parents endorsed less worry about talking with their child (46% vs. 37%) and reductions in the number of communication concerns (3.4 to 1.8). CONCLUSION: The FACT intervention was feasible, acceptable, and has potential to address communication concerns of parents with cancer. A randomized trial is needed to test its efficacy in improving psychological and parenting outcomes. TRIAL REGISTRATION: This study was IRB-approved and registered with clinicaltrials.gov (NCT04342871).

The design and conduct of a pragmatic cluster randomized trial of an advance care planning program for nursing home residents with dementia.

BACKGROUND/AIMS: A significant number of people with Alzheimer's disease or related dementia diagnoses will be cared for in nursing homes near the end of life. Advance care planning (ACP), the process of eliciting and documenting patient-centered preferences for care, is considered essential to providing high quality care for this population. Nursing homes are currently required by regulations to offer ACP to residents and families, but no training requirements exist for nursing home staff, and approaches to fulfilling this regulatory and ethical responsibility vary. As a result, residents may receive care inconsistent with their goals, such as unwanted hospitalizations. Pragmatic trials offer a way to develop and test ACP in real-world settings to increase the likelihood of adoption of sustainable best practices. METHODS: The "Aligning Patient Preferences-a Role Offering Alzheimer's patients, Caregivers, and Healthcare Providers Education and Support (APPROACHES)" project is designed to pragmatically test and evaluate a staff-led program in 137 nursing homes (68 = intervention, 69 = control) owned by two nursing home corporations. Existing nursing home staff receive standardized training and implement the ACP Specialist program under the supervision of a corporate lead. The primary trial outcome is the annual rate of hospital transfers (admissions and emergency department visits). Consistent with the spirit of a pragmatic trial, study outcomes rely on data already collected for quality improvement, clinical, or billing purposes. Configurational analysis will also be performed to identify conditions associated with implementation. RESULTS: Partnerships with large corporate companies enable the APPROACHES trial to rely on corporate infrastructure to roll out the intervention, with support for a corporate implementation lead who is charged with the initial introduction and ongoing support for nursing home-based ACP Specialists. These internal champions connect the project with other company priorities and use strategies familiar to nursing home leaders for the initiation of other programs. Standardized data collection across nursing homes also supports the conduct of pragmatic trials in this setting. DISCUSSION: Many interventions to improve care in nursing homes have failed to demonstrate an impact or, if successful, maintain an impact over time. Pragmatic trials, designed to test interventions in real-world contexts that are evaluated through existing data sources collected routinely as part of clinical care, are well suited for the nursing home environment. A robust program that increases access to ACP for nursing home residents has the potential to increase goal-concordant care and is expected to reduce hospital transfers. If successful, the ACP Specialist Program will be primed for rapid translation into nursing home practice to reduce unwanted, burdensome hospitalizations and improve the quality of care for residents with dementia.

Adapting the Connect-Home transitional care intervention for the unique needs of people with dementia and their caregivers: A feasibility study.

AIMS: After leaving skilled nursing facilities (SNF), 20% of people with dementia (PWD) are re-hospitalized within 30 days. We assessed fidelity, acceptability, preliminary outcomes, and mechanisms of the Connect-Home ADRD transitional care intervention. DESIGN: A feasibility study of Connect-Home ADRD. METHODS: The Connect-Home intervention was adapted for dementia-specific needs. PWD and caregiver dyads in 2 SNFs received transitional care. Data sources included interviews with PWD and caregivers and a review of health records. RESULTS: 19 of 34 eligible dyads (56%) were enrolled. The intervention was feasible (components delivered for >84% of dyads) and acceptable (dyads rated it very helpful and not difficult to use). Connect-Home ADRD adaptations included in-home support to manage symptoms of dementia and unplanned events, such as transition to hospice. IMPACT: Connect-Home ADRD is feasible, acceptable, and merits future research as an intervention to reduce rapid return to acute care following SNF stays.

Addressing hesitancy to COVID-19 vaccines in healthcare assistants.

COVID-19 vaccination rates have been suboptimal in frontline healthcare assistants (HCAs). We sought to characterize contributors to COVID-19 vaccine hesitancy among HCAs. We conducted an analysis of online survey responses from members of the National Association of Health Care Assistants from December 2020-January 2021. Respondents were asked what it would take for them to be vaccinated against COVID-19. Responses from 309 HCAs were coded to characterize respondents' willingness to be vaccinated and identify contributors to vaccine hesitancy. Approximately 60% (n = 185) of HCAs expressed hesitancy but would consider getting vaccinated under certain circumstances. We identified 8 overarching themes for contributors to COVID-19 vaccine hesitancy, the most common being safety concerns (70% of respondents). Others included efficacy (11.4%), workplace requirements (9.7%), societal influence (9.2%), and compensation (8.1%). Interventions to increase vaccine uptake among HCAs may be most effective by addressing concerns regarding the short-term and long-term safety implications of COVID-19 vaccines.

Quantifying cumulative anticholinergic and sedative drug load among US Medicare Beneficiaries.

PURPOSE: Medications with anticholinergic and sedative properties are widely used among older adults despite strong evidence of harm. The drug burden index (DBI), a pharmacological screening tool, measures these properties across drug classes, and higher DBI drug exposure (DBI > 1) has been associated with certain physical function-related adverse events. Our aim was to quantify mean daily DBI drug exposure among older adults in the United States (US). METHODS: We screened medications for DBI properties and operationalized the DBI for US Medicare claims. We then conducted a retrospective cohort study of a 20% random, nationwide sample of 4 137 384 fee-for-service Medicare beneficiaries aged 66+ years (134 757 039 person-months) from January 2013 to December 2016. We measured the monthly distribution based on mean daily DBI, categorized as (a) >0 vs 0 (any use) and (b) 0, 0 < DBI ≤ 1, 1 < DBI ≤ 2, and DBI > 2, and examined temporal trends. We described patient-level factors (eg, demographics, healthcare use) associated with high (>2) vs low (0 < DBI≤1) DBI drug exposure. RESULTS: The distribution of the mean daily DBI, aggregated at the month-level, was: 58.1% DBI = 0, 29.0% 0 < DBI≤1, 9.3% 1 < DBI≤2, and 3.7% DBI > 2. Predictors of high monthly DBI drug exposure (DBI > 2) included certain indicators of increased healthcare use (eg, high number of drug claims), white race, younger age, frailty, and a psychosis diagnosis code. CONCLUSIONS: The predictors of high DBI drug exposure can inform discussions between patients and providers about medication appropriateness and potential de-prescribing. Future Medicare-based studies should assess the association between the DBI and adverse events.

Caregiver-guided pain coping skills training for patients with advanced cancer: Results from a randomized clinical trial.

BACKGROUND: Pain is a major concern among patients with advanced cancer and their family caregivers. Evidence suggests that pain coping skills training interventions can improve outcomes, however they have rarely been tested in this population. AIM: To test the efficacy of a caregiver-guided pain coping skills training intervention. The primary outcome was caregiver self-efficacy for helping the patient manage pain. DESIGN: A randomized controlled trial compared the intervention to an enhanced treatment-as-usual control. Dyads in both conditions received pain education, and those in the intervention received three sessions of pain coping skills training. Caregiver outcomes (self-efficacy; caregiver strain, caregiving satisfaction, psychological distress) and patient outcomes (self-efficacy, pain intensity and interference, psychological distress) were collected at baseline and post-intervention. SETTING/PARTICIPANTS: Two hundred two patients with stage III-IV cancer and pain and their family caregivers were enrolled from four outpatient oncology clinics and a free-standing hospice/palliative care organization. RESULTS: Compared to those in the control arm, caregivers in the intervention reported significant increases in caregiving satisfaction (p < 0.01) and decreased anxiety (p = 0.04). In both conditions, caregivers reported improvements in self-efficacy, and patients reported improvements in self-efficacy, pain severity and interference, and psychological distress. CONCLUSIONS: This is the first study to test a pain coping skills intervention targeted to patients and caregivers facing advanced cancer. Findings suggest that pain education provides benefits for patients and caregivers, and coping skills training may be beneficial for caregivers. Further research is needed to optimize the benefits of education and pain coping skills training for improving cancer pain outcomes.Trial registration: ClinicalTrials.gov NCT02430467, Caregiver-Guided Pain Management Training in Palliative Care.

How well do documented goals-of-care discussions for patients with stage IV cancer reflect communication best practices?

BACKGROUND: Written clinical communication regarding patients' disease understanding and values may facilitate goal-concordant care, yet little is known about the quality of electronic health record (EHR) documentation. We sought to (1) describe frequency of communication best practices in EHR-documented goals-of-care discussions, and (2) assess whether templated notes improve quality of documentation. METHODS: Researchers pulled text of EHR-documented goals-of-care discussions for hospitalized patients with Stage IV cancer from admission to 60-days follow-up. Text was included when in a single encounter the clinician addressed: (a) prognosis and/or illness understanding; and (b) goals and/or treatment options. Researchers qualitatively coded text based on guidelines for communication best practices, and noted if an EHR template was used. RESULTS: Forty-two percent (206/492) of patients had EHR-documented goals-of-care discussions. Text frequently described communication of cancer progression (89%), though rarely included prognosis (22%). Text often included patients' goals and values (83%), and at least on specific treatment decision (82%). Communication about treatments was included for 98% of patients; common examples included cancer treatment (62%), hospice (62%), resuscitation (51%), or intensive care (38%). Clinicians documented making recommendations for 40% of patients. Text addressing patient emotional and spiritual concerns was uncommon (15%). Compared to free text, use of a template was associated with increased documentation of goals and values (80% vs. 61%, p < 0.01), but not other best practices. CONCLUSION: Insights from the study can be used to guide future training and research to study and improve the quality of documentation about goal of care, and its impact on goal-concordant care.

Elements of Palliative Care in the Last 6 Months of Life: Frequency, Predictors, and Timing.

IMPORTANCE: Persons living with serious illness often need skilled symptom management, communication, and spiritual support. Palliative care addresses these needs and may be delivered by either specialists or clinicians trained in other fields. It is important to understand core elements of palliative care to best provide patient-centered care. OBJECTIVE: To describe frequency, predictors, and timing of core elements of palliative care during the last 6 months of life. DESIGN: Retrospective chart review. SETTING: Inpatient academic medical center. PARTICIPANTS: Decedents with cancer, dementia, or chronic kidney disease (CKD) admitted during the 6 months preceding death. EXPOSURES: We identified receipt and timing of core elements of palliative care: pain and symptom management, goals of care, spiritual care; and specialty palliative care utilization; hospital encounters; demographics; and comorbid diagnoses. We ran Poisson regression models to assess whether diagnosis or hospital encounters were associated with core elements of palliative care. RESULTS: Among 402 decedents, the mean (SD) number of appropriately screened and treated symptoms was 2.9 (1.7)/10. Among 76.1% with documented goals of care, 58.0% had a primary goal of comfort; 55.0% had documented spiritual care. In multivariable models, compared with decedents with cancer, those with dementia or CKD were less likely to have pain and symptom management (respectively, 31% (incidence rate ratio [IRR], 0.69; 95% CI, 0.56-0.85) and 17% (IRR, 0.83; CI, 0.71-0.97)). There was a median of 3 days (IQR, 0-173) between transition to a goal of comfort and death, and a median of 12 days (IQR, 5-47) between hospice referral and death. CONCLUSIONS AND RELEVANCE: Although a high proportion of patients received elements of palliative care, transitions to a goal of comfort or hospice happened very near death. Palliative care delivery can be improved by systematizing existing mechanisms, including prompts for earlier goals-of-care discussion, symptom screening, and spiritual care, and by building collaboration between primary and specialty palliative care services.

Evaluating the care provision of a community-based serious-illness care program via chart measures.

BACKGROUND: Although quality-of-care domains for home-based primary and palliative programs have been proposed, they have had limited testing in practice. Our aim was to evaluate the care provision in a community-based serious-illness care program, a combined home-based primary and palliative care model. METHODS: Retrospective chart review of patients in an academic community-based serious-illness care program in central North Carolina from August 2014 to March 2016 (n = 159). Chart review included demographics, health status, and operationalized measures of seven quality-of-care domains: medical assessment, care coordination, safety, quality of life, provider competency, goal attainment, and access. RESULTS: Patients were mostly women (56%) with an average age of 70 years. Patients were multi-morbid (53% ≥3 comorbidities), functionally impaired (45% had impairment in ≥2 activities of daily living) and 32% had dementia. During the study period, 31% of patients died. Chart review found high rates assessment of functional status (97%), falls (98%), and medication safety (96%). Rates of pain assessment (70%), advance directive discussions (65%), influenza vaccination (59%), and depression assessment (54% of those with a diagnosis of depression) were lower. Cognitive barriers, spiritual needs, and behavioral issues were assessed infrequently (35, 22, 21%, respectively). CONCLUSION: This study is one of the first to operationalize and examine quality-of-care measures for a community-based serious-illness care program, an emerging model for vulnerable adults. Our operationalization should not constitute validation of these measures and revealed areas for improvement; however, the community-based serious-illness care program performed well in several key quality-of-care domains. Future work is needed to validate these measures.

Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation: A Randomized Clinical Trial.

Background: Treatment decisions commonly have to be made in intensive care units (ICUs). These decisions are difficult for surrogate decision makers and often lead to decisional conflict, psychological distress, and treatments misaligned with patient preferences. Objective: To determine whether a decision aid about prolonged mechanical ventilation improved prognostic concordance between surrogate decision makers and clinicians compared with a usual care control. Design: Multicenter, parallel, randomized, clinical trial. (ClinicalTrials.gov: NCT01751061). Setting: 13 medical and surgical ICUs at 5 hospitals. Participants: Adult patients receiving prolonged mechanical ventilation and their surrogates, ICU physicians, and ICU nurses. Intervention: A Web-based decision aid provided personalized prognostic estimates, explained treatment options, and interactively clarified patient values to inform a family meeting. The control group received information according to usual care practices followed by a family meeting. Measurements: The primary outcome was improved concordance on 1-year survival estimates, measured with the clinician-surrogate concordance scale (range, 0 to 100 percentage points; higher scores indicate more discordance). Secondary and additional outcomes assessed the experiences of surrogates (psychological distress, decisional conflict, and quality of communication) and patients (length of stay and 6-month mortality). Outcomes assessors were blinded to group allocation. Results: The study enrolled 277 patients, 416 surrogates, and 427 clinicians. Concordance improvement did not differ between intervention and control groups (mean difference in score change from baseline, -1.7 percentage points [95% CI, -8.3 to 4.8 percentage points]; P = 0.60). Surrogates' postintervention estimates of patients' 1-year prognoses did not differ between intervention and control groups (median, 86.0% [interquartile range {IQR}, 50.0%] vs. 92.5% [IQR, 47.0%]; P = 0.23) and were substantially more optimistic than results of a validated prediction model (median, 56.0% [IQR, 43.0%]) and physician estimates (median, 50.0% [IQR, 55.5%]). Eighty-two intervention surrogates (43%) favored a treatment option that was more aggressive than their report of patient preferences. Although intervention surrogates had greater reduction in decisional conflict than control surrogates (mean difference in change from baseline, 0.4 points [CI, 0.0 to 0.7 points]; P = 0.041), other surrogate and patient outcomes did not differ. Limitation: Contamination among clinicians could have biased results toward the null hypothesis. Conclusion: A decision aid about prolonged mechanical ventilation did not improve prognostic concordance between clinicians and surrogates, reduce psychological distress among surrogates, or alter clinical outcomes. Decision support in acute care settings may require greater individualized attention for both the cognitive and affective challenges of decision making. Primary Funding Source: National Institutes of Health.

Electronic Health Record Phenotypes for Identifying Patients with Late-Stage Disease: a Method for Research and Clinical Application.

BACKGROUND: Systematic identification of patients allows researchers and clinicians to test new models of care delivery. EHR phenotypes-structured algorithms based on clinical indicators from EHRs-can aid in such identification. OBJECTIVE: To develop EHR phenotypes to identify decedents with stage 4 solid-tumor cancer or stage 4-5 chronic kidney disease (CKD). DESIGN: We developed two EHR phenotypes. Each phenotype included International Classification of Diseases (ICD)-9 and ICD-10 codes. We used natural language processing (NLP) to further specify stage 4 cancer, and lab values for CKD. SUBJECTS: Decedents with cancer or CKD who had been admitted to an academic medical center in the last 6 months of life and died August 26, 2017-December 31, 2017. MAIN MEASURE: We calculated positive predictive values (PPV), false discovery rates (FDR), false negative rates (FNR), and sensitivity. Phenotypes were validated by a comparison with manual chart review. We also compared the EHR phenotype results to those admitted to the oncology and nephrology inpatient services. KEY RESULTS: The EHR phenotypes identified 271 decedents with cancer, of whom 186 had stage 4 disease; of 192 decedents with CKD, 89 had stage 4-5 disease. The EHR phenotype for stage 4 cancer had a PPV of 68.6%, FDR of 31.4%, FNR of 0.5%, and 99.5% sensitivity. The EHR phenotype for stage 4-5 CKD had a PPV of 46.4%, FDR of 53.7%, FNR of 0.0%, and 100% sensitivity. CONCLUSIONS: EHR phenotypes efficiently identified patients who died with late-stage cancer or CKD. Future EHR phenotypes can prioritize specificity over sensitivity, and incorporate stratification of high- and low-palliative care need. EHR phenotypes are a promising method for identifying patients for research and clinical purposes, including equitable distribution of specialty palliative care.

Caregiver-guided pain coping skills training for patients with advanced cancer: Background, design, and challenges for the CaringPals study.

BACKGROUND/AIMS: Pain is a major concern of patients with advanced cancer and their caregivers. There is strong evidence that pain coping skills training interventions based on cognitive-behavioral principles can reduce pain severity and pain interference. However, few such interventions have been tested for patients with advanced cancer and their family caregivers. This study aims to test the efficacy of a caregiver-guided pain coping skills training protocol on patient and caregiver outcomes. METHODS: A total of 214 patients age ≥18 with Stage III-Stage IV cancer and moderate to severe pain, along with their family caregivers, are being identified and randomized with a 1:1 allocation to the caregiver-guided pain coping skills training intervention or enhanced treatment-as-usual. Dyads in both conditions receive educational resources on pain management, and the caregiver-guided pain coping skills training intervention includes three weekly 60-min sessions conducted with the patient-caregiver dyad via videoconference. Measures of caregiver outcomes (self-efficacy for helping the patient manage pain, caregiver strain, caregiving satisfaction, psychological distress) and patient outcomes (self-efficacy for pain management, pain intensity and interference, psychological distress) are collected at baseline and post-intervention. Caregiver outcomes are also collected 3 and 6 months following the patient's death. The study is enrolling patients from four tertiary care academic medical centers and one free-standing hospice and palliative care organization. The primary outcome is caregiver self-efficacy for helping the patient manage pain. RESULTS: This article describes challenges in the design and implementation of the CaringPals trial. Key issues for trial design include the identification and recruitment of patients with advanced cancer and pain, and the follow-up and collection of data from caregivers following the patient's death. CONCLUSION: The CaringPals trial addresses a gap in research in pain coping skills training interventions by addressing the unique needs of patients with advanced cancer and their caregivers. Findings from this study may lead to advances in the clinical care of patients with advanced cancer and pain, as well as a better understanding of the effects of training family caregivers to help patients cope with pain.

How Surrogate Decision-Makers for Patients With Chronic Critical Illness Perceive and Carry Out Their Role.

OBJECTIVES: Family members commonly make medical decision for patients with chronic critical illness. This study examines how family members approach this decision-making role in real time. DESIGN: Qualitative analysis of interviews with family members in the intervention arm of a randomized controlled communication trial. SETTINGS: Medical ICUs at four U.S. hospitals. PARTICIPANTS: Family members of patients with chronic critical illness (adults mechanically ventilated for ≥ 7 d and expected to remain ventilated and survive for ≥ 72 hr) who participated in the active arm of a communication intervention study. INTERVENTIONS: Family members participated in at least two content-guided, informational, and emotional support meetings led by a palliative care physician and nurse practitioner. MEASUREMENTS AND MAIN RESULTS: Grounded theory was used for qualitative analysis of 66 audio recordings of meetings with 51 family members. Family members perceived their role in four main ways: voice of the patient, advocate for the patient, advocate for others, and advocate for oneself. Their decision-making was characterized by balancing goals, sharing their role, keeping perspective, remembering previous experiences, finding sources of strength, and coping with various burdens. CONCLUSIONS: Family members take a multifaceted approach as they participate in decision-making. Understanding how surrogates perceive and act in their roles may facilitate shared decision-making among clinicians and families during critical care.

Communication with children about a parent's advanced cancer and measures of parental anxiety and depression: a cross-sectional mixed-methods study.

PURPOSE: Parents with advanced cancer are faced with difficult decision-making about communication about their illness with their children. The objectives of this study were to describe how parents communicated with their children about advanced cancer and to explore associations between communication and parental depression and anxiety. METHODS: This was a cross-sectional, mixed-methods study of 42 patients with stage IV solid tumor malignancies who had at least one child less than 18 years of age. Participants completed a semi-structured interview and the Hospital Anxiety and Depression Scale (HADS). We used multiple linear regression to evaluate the association between extent of communication and HADS Anxiety and Depression scores. Interview data were analyzed using standard qualitative content and thematic techniques and triangulated with survey data. RESULTS: Higher HADS Anxiety scores, but not HADS Depression scores, were cross-sectionally associated with greater extent of parental communication (p = 0.003), even when controlling for performance status and children's ages. In qualitative analyses, parents who acknowledged the terminal nature of their illness or experienced higher symptom burden were more likely to report that they also communicated more extensively with children. A third of parents (n = 14, 33%) described difficulty with illness-related communication with their children. CONCLUSIONS: In this pilot study, parents with advanced cancer who reported more illness-related communication with their children also reported more symptoms of general anxiety. Future interventions should address psychological distress relevant to parenting and further assess how parental communication may be linked to parental mood symptoms.

The Voice of Surrogate Decision-Makers. Family Responses to Prognostic Information in Chronic Critical Illness.

RATIONALE: Information from clinicians about the expected course of the patient's illness is relevant and important for decision-making by surrogates for chronically critically ill patients on mechanical ventilation. OBJECTIVES: To observe how surrogates of chronically critically ill patients respond to information about prognosis from palliative care clinicians. METHODS: This was a qualitative analysis of a consecutive sample of audio-recorded meetings from a larger, multisite, randomized trial of structured informational and supportive meetings led by a palliative care physician and nurse practitioner for surrogates of patients in medical intensive care units with chronic critical illness (i.e., adults mechanically ventilated for ≥7 days and expected to remain ventilated and survive for ≥72 h). MEASUREMENTS AND MAIN RESULTS: A total of 66 audio-recorded meetings involving 51 intervention group surrogates for 43 patients were analyzed using grounded theory. Six main categories of surrogate responses to prognostic information were identified: (1) receptivity, (2) deflection/rejection, (3) emotion, (4) characterization of patient, (5) consideration of surrogate role, and (6) mobilization of support. Surrogates responded in multiple and even antithetical ways, within and across meetings. CONCLUSIONS: Prognostic disclosure by skilled clinician communicators evokes a repertoire of responses from surrogates for the chronically critically ill. Recognition of these response patterns may help all clinicians better communicate their support to patients and families facing chronic critical illness and inform interventions to support surrogate decision-makers in intensive care units. Clinical trial registered with www.clinicaltrials.gov (NCT 01230099).