Caring for caregivers and persons living with dementia under home-based primary care: protocol for an interventional clinical trial.

BACKGROUND: Approximately 7.5 million older adults are homebound, who have difficulty and/or need assistance to leave their homes. In this growing population, the prevalence of people living with dementia (PLWD) is approximately 50%. Current dementia care models in the USA were developed for traditional office-based primary care and have not been tailored to home-based primary care (HBPC) delivery models. Literature has shown that office-based collaborative interventions can improve caregiver outcomes including caregiver stress, well-being, and morbidity and patient outcomes including improved quality of life and reduced emergency department visits (Possin KL, Merrilees JJ, Dulaney S, Bonasera SJ, Chiong W, Lee K, JAMA Int Med 179:1658, 2019). To date, the evidence for HBPC dementia interventions is lacking. Though HBPC has demonstrated benefit in homebound older adults, there is limited literature on the effects of HBPC on persons living with dementia (Nguyen HQ, Vallejo JD, Macias M, Shiffman MG, Rosen R, Mowry V, J Am Geriatr Soc 70:1136-46, 2021). Our goal is to develop a HBPC-focused dementia care intervention that integrates the components of two previously developed dementia care models and test the feasibility of implementing it in HBPC practices to improve the quality of life and wellbeing of homebound PLWD and their caregivers. METHODS: We will first conduct qualitative focus groups at two HBPC practice sites, one in the Southeast and one in Hawaii in order to obtain preliminary feedback on the proposed intervention. At each site, there will be one focus group with caregivers of PLWD and another with HBPC clinicians and staff to help develop and refine our intervention. We will then conduct an open-pilot trial of the refined intervention at the two HBPC practices. A total of up to 25 patient/caregiver dyads will be recruited at each site (N = 50 total). Outcomes measured through pre-and-post assessments and exit interviews will include (a) feasibility for the caregiver to engage with and complete baseline assessments and access educational materials and community resources and (b) feasibility for the practice to identify potential caregivers/patients, assess eligible patient/caregiver dyads, use patient and caregiver assessments, recruit patient/caregiver dyads, recruit racial and ethnic minorities, use care modules, and engage with the tele-video case conference, (c) net promoter score, (d) acceptability of the intervention to caregivers and patients to participate in the intervention, (e) caregivers feeling heard and understood, and (f) caregiver well-being. DISCUSSION: Testing the feasibility and acceptability of the adapted intervention in these two HBPC practices will provide the basis for future testing and evaluation of a fully powered intervention for PLWD and their caregivers cared for in HBPC with the goal of disseminating high-quality and comprehensive dementia-care focused interventions into HBPC practices. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov NCT05849259 in May 2023.

Palliative Care Clinical Trials in Underrepresented Ethnic and Racial Minorities: A Narrative Review.

Introduction: A growing number of patients with serious illness who would benefit from palliative care are part of ethnoracial minority groups. Nevertheless, large disparities in provision of palliative services exist for minoritized populations. Furthermore, there is a relative dearth of palliative care research focused on minority groups and how best to provide high-quality, culturally tailored palliative care. The aim of this narrative review is to summarize the existing literature regarding palliative care clinical trials in underrepresented minority populations, describe methodological approaches, and provide guidance on future palliative care-focused clinical trials. Methods: We used the Scale for the Assessment of Narrative Review Articles (SANRA) and Cochrane's guidelines on conducting reviews. We used PubMed and Clinicaltrials.gov to review published, full-text articles or protocols (1950-2022), and limited to palliative care interventions focused on ethnoracial minority populations. We included randomized clinical trials (RCTs), including pilot and feasibility trials, protocols of RCTs, and studies that report RCT methodology. Two reviewers independently assessed eligibility. Results: Our search yielded 585 publications; of these, 30 met the full-text review criteria and 16 studies met our criteria for inclusion. We deemed nine articles as having low risk of bias and four as having high risk of bias. Discussion: Commonly used methodologic approaches for clinical trials in underrepresented minority populations included the following: the use of written and visual materials that were no higher than a sixth-grade reading level, the use of patient and lay health navigators, bilingual and multicultural study staff and study materials, race-concordant staff, the option of in-person and virtual visits that accommodated the patient and family's schedule, recruitment from faith communities, and the use of community-engaged research principles. Future palliative care clinical trials should expand on the strategies described in this article, adopt effective strategies currently used in nonpalliative care interventions, and innovate around the principles of community-engaged research.

Age-related differences in the occurrence, severity, and distress of symptoms in older patients at the initiation of chemotherapy.

BACKGROUND: Evaluate for differences in occurrence, severity, and distress ratings for 32 symptoms between younger older adults (YOA, < 70 years) and older adults (OA, ≥ 70 years) at initiation of chemotherapy. METHODS: Patients (n = 125) were recruited prior to the initiation of chemotherapy and completed the Memorial Symptom Assessment Scale. Differences in occurrence, severity, and distress ratings were evaluated using Independent sample t-tests and Chi-square or Fisher's exact tests. RESULTS: On average, the older patients reported ten concurrent symptoms that equates with a moderate symptom burden. Symptoms with the highest occurrence rates were not always the most severe and/or the most distressing. Few age-related differences were found in patients' symptom experiences. When age-related differences were identified, OA reported lower occurrence, severity, and distress ratings. Nine of the ten symptoms with highest occurrence rates were common for both age groups. For severity and distress, only half of the symptoms were common. In terms of severity and distress, all of the top ten ranked symptoms were in the moderate to severe range. CONCLUSIONS: Both YOA and OA reported a moderate symptom burden and severity and distress scores in the moderate to severe range. The symptoms with the highest occurrence rates were not always the most severe/or the most distressing. Our findings suggest that different dimensions of the symptom experience (i.e., occurrence, severity, and distress) warrant evaluation in older oncology patients.

Quality of life of older gynecologic oncology patients at the initiation of chemotherapy.

AIM: To evaluate older gynecologic oncology patients' quality of life (QOL) at the initiation of chemotherapy and compare their QOL scores with a female age-matched general population (GP) sample. DESIGN: Cross-sectional. METHODS: Older (n = 122) gynecologic oncology patients completed the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) that evaluates global health and five functional scales (range from 0 to 100). Differences in QOL scores between our sample and the GP were evaluated using one-sample t-tests and effect sizes were calculated using Cohen's d. RESULTS: Patients' mean age was 70.7 years (±6.6). Mean scores for the function scales ranged from 58.5 (±31.1) for role function to 86.1 (±17.0) for cognitive function. Compared to the GP, our sample reported significantly lower scores for global health status, social, role and physical functioning, and a significantly higher score for cognitive functioning. No differences were found in emotional functioning scores. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

Assessing the Acceptability and Feasibility of Leveraging Emergency Department Social Workers' Advanced Communication Skills to Assess Elderly Patients' Goals and Values.

Background: The Emergency Department (ED) has increasingly been recognized as an important site of care for older adults with unmet palliative care needs. Despite this, no clear model of care delivery has emerged. Aim: To assess the acceptability and feasibility of a scripted palliative care communication intervention in the ED directed by social workers. We hypothesized that the intervention would be feasible, acceptable to patients and ED social workers, and that the collection of patient outcomes would be possible. Design: A prospective, unblinded, pilot randomized clinical trial of older adults with serious illness presenting to the ED. Patients were randomized to either receive a social worker-directed palliative care intervention (n-65), which consisted of a conversation focused on patients' goals, values, hopes and worries, or to usual care (n-52). The intervention was evaluated for feasibility and acceptability. Results: Of patients randomized to the intervention arm, 66% (43/65) completed a conversation with the social worker. Focus group feedback with the social workers further demonstrated the feasibility of these conversations. There was minimal (12%) loss to follow-up. Of the patients who received the intervention, the majority reported that they appreciated the social workers bringing up their goals for the future (77%), their social workers asking about their fears and worries (72%), and they liked the way the conversation was set up (81%). Social workers administered 95% of the conversation components. Conclusions: This pilot trial demonstrated the feasibility and acceptability of a social worker-directed, scripted palliative care communication intervention in a single urban, academic ED.

Impact of persistent pain on function, cognition, and well-being of older adults.

BACKGROUND: We sought to determine the population-level associations between persistent pain and subsequent changes in physical function, cognitive function, and well-being, outcomes important to older adults. METHODS: We used data from National Health Aging Trends Study (NHATS) of community-dwelling Medicare beneficiaries age 65+ from 2011 to 2019. We defined "persistent pain" as being bothered by pain in the last month in both the 2011and 2012 interviews and "intermittent" pain including those reporting bothersome pain in one interview only. We used competing risks regression to estimate the association between persistent pain and the development of clinically meaningful declines in physical function, cognitive function, and well-being, adjusting for age, sex, race, education, and marital status at baseline. RESULTS: Of the 5589 eligible NHATS participants, 38.7% reported persistent pain and 27.8% reported intermittent pain. Over one-third described pain in five or more sites. Over the subsequent 7 years, participants with persistent pain were more likely to experience declines in physical function (64% persistent pain, 59% intermittent pain, 57% no bothersome pain; aHR 1.14, 95% CI 1.05-1.23) and well-being (48% persistent pain, 45% intermittent pain, 44% no bothersome pain; aHR 1.11, 95% CI 1.01-1.21), but were not more likely to experience cognitive decline (25% persistent pain, 24% intermittent pain, 23% no bothersome pain; aHR 1.02, 95% CI 0.90-1.16). CONCLUSIONS: Persistent pain is common in older adults and occurs in multiple body sites. Persistent pain contributes to meaningful declines in physical function and well-being over 7 years and warrants proactive interventions to mitigate pain.

Characteristics associated with decrements in objective measures of physical function in older patients with cancer during chemotherapy.

PURPOSE: Study purposes were to evaluate for inter-individual variability in the trajectories of three objective measures of physical function (PF) in older patients receiving chemotherapy (n = 112) and determine which characteristics were associated with worse PF. METHODS: Balance, gait speed, and chair-stand test were evaluated at initiation and 1, 3, 6, 9, and 12 months following chemotherapy. Hierarchical linear modeling was used to assess inter-individual variability in the trajectories of the three tests. Demographic, clinical, and symptom characteristics, and levels of cognitive function associated with initial levels and changes over time in each of the tests were determined. RESULTS: Gait speed and chair-stand tests improved over time. Balance declined until month 6, then increased. Characteristics associated with decreases in balance scores at initiation of chemotherapy were lower level of education and lower Karnofsky Performance Status (KPS) score. For initial levels of poorer gait speed, older age, poorer Trail Making Test B (TMTB), and worse Attentional Function Index scores were the associated characteristics. Lower KPS scores, higher body mass index, and poorer TMTB scores were associated with poorer chair-stand times at initiation of chemotherapy. Worse trajectories of chair-stand times were associated with poorer chair-stand time at enrollment. Characteristic associated with lower initial levels and improved trajectories of balance was older age at enrollment. CONCLUSIONS: Determination of characteristics associated with decrements in balance, gait speed, and chair-stand can assist clinicians to identify older oncology patients at risk for decrements in PF. Interventions to maintain and improve PF need to be implemented with higher risk patients.

Poetry as a Healing Modality in Medicine: Current State and Common Structures for Implementation and Research.

In healthcare institutions across the country, the role of poetry continues to emerge within the liminal spaces between the medical humanities and clinical care. While the field of narrative medicine is well-developed generally, formal review of the state of poetry as a healing modality is limited. Poetry in the medical humanities literature has often been described by its indefinability as much as by its impact on healing. The power of poetry in healthcare is thought to be multi-faceted and deserves to be explored further. Poetry can be medicine for both patient and clinician. "Poetic Medicine" is a modality that has been utilized for the healing of grief, loss, wounds of the psyche and spirit, and as a process for expanding resiliency in healthcare-applications that are particularly relevant to the practice of hospice and palliative medicine-for patient and clinician alike. While numerous approaches share common themes, current programs bringing poetry into healthcare have been operating largely in isolation from each other-with a lack of national consensus on definitions or structures of interventions. Such isolation is a major restriction to the study and growth of Poetic Medicine. While it is not known with certitude, the number of Poetic Medicine programs in healthcare in the United States appears to be growing. In this paper, we propose an initial framework to define the role and impact of poetry in healthcare and then describe two different, well-established Poetic Medicine programs in the United States.

Palliative care in the emergency department: A qualitative study exploring barriers, facilitators, desired clinician qualities, and future directions.

OBJECTIVE: To describe the perceived qualities of successful palliative care (PC) providers in the emergency department (ED), barriers and facilitators to ED-PC, and clinicians' perspectives on the future of ED-PC. METHOD: This qualitative study using semi-structured interviews was conducted in June-August 2020. Interviews were analyzed via a two-phase Rapid Analysis. The study's primary outcomes (innovations in ED-PC during COVID) are published elsewhere. In this secondary analysis, we examine interviewee responses to broader questions about ED-PC currently and in the future. RESULTS: PC providers perceived as successful in their work in the ED were described as autonomous, competent, flexible, fast, and fluent in ED language and culture. Barriers to ED-PC integration included the ED environment, lack of access to PC providers at all times, the ED perception of PC, and the lack of a supporting financial model. Facilitators to ED-PC integration included proactive identification of patients who would benefit from PC, ED-focused PC education and tools, PC presence in the ED, and data supporting ED-PC. Increased primary PC education for ED staff, increased automation, and innovative ED-PC models were seen as areas for future growth. SIGNIFICANCE OF RESULTS: Our findings provide useful information for PC programs considering expanding their ED presence, particularly as this is the first study to our knowledge that examines traits of successful PC providers in the ED environment. Our findings also suggest that, despite growth in the arena of ED-PC, barriers and facilitators remain similar to those identified previously. Future research is needed to evaluate the impact that ED-PC initiatives may have on patient and system outcomes, to identify a financial model to maintain ED-PC integration, and to examine whether perceptions of successful providers align with objective measures of the same.

Common and distinct characteristics associated with self-reported functional status in older patients with cancer receiving chemotherapy.

PURPOSE: To evaluate for inter-individual differences in two subjective measures of functional status in older patients (n = 112), as well as to determine which demographic, clinical, and symptom characteristics, and levels of cognitive function, were associated with initial levels and with the trajectory of the two measures. METHODS: Functional status was assessed using self-report measures of physical function (PF) and role function (RF) from the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire at the initiation of chemotherapy and at 1, 3, 6, 9, and 12 months after its initiation. Hierarchical linear modeling was used to assess inter-individual differences in and characteristics associated with initial levels and changes in PF and RF. RESULTS: Characteristics associated with decreases in PF at the initiation of chemotherapy were higher numbers of comorbidities and higher depression, pain, and dyspnea scores. For initial levels of poorer RF, lower Karnofsky Performance Status scores and higher pain and fatigue scores were the associated characteristics. Characteristic associated with worse trajectories of PF was not having had surgery. For RF, worse trajectories were associated with lower cognitive function and higher RF at enrollment. Characteristic associated with both lower initial levels and improved trajectories of PF was having lower performance status at enrollment. CONCLUSIONS: Older patients undergoing chemotherapy experience reduced functional performance. Characteristics associated with decrements in PF and RF need to be assessed and interventions implemented to maintain and increase functional status in older oncology patients.

Emerging Palliative Care Innovations in the ED: A Qualitative Analysis of Programmatic Elements During the COVID-19 Pandemic.

CONTEXT: Health systems have aspired to integrate palliative care (PC) into the emergency department (ED) to improve care quality for over a decade, yet there are very few examples of implemented models in the literature. The coronavirus disease 2019 (COVID-19) pandemic led to an increase in the volume of seriously ill patients in EDs and a consequent rapid increase in PC integration in many EDs. OBJECTIVES: To describe the new PC-ED delivery innovations that emerged during the COVID-19 pandemic. METHODS: For this qualitative study of PC programs in EDs, semistructured interviews were conducted with ED and PC clinicians between June 30, 2020 and August 18, 2020. Participants were asked about PC-ED integration before, during, and after COVID. We conducted a two-phased rapid analysis using a rapid analysis template and consolidated matrix to identify innovations. RESULTS: Using purposive and snowball sampling, we interviewed 31 participants, representing 52 hospitals. Several new innovations in care delivery were identified. These included elements of fully embedded PC, the use of PC extenders, technology both within the electronic medical record and outside it, and innovations in training emergency clinicians in primary PC skills to support care delivery. Most PC efforts focused on increasing goals-of-care conversations. Institutions that implemented these programs reported that they increased PC utilization in the ED, were well received by clinicians, and changed patient's care trajectories. CONCLUSION: Several new innovations in PC-ED care delivery emerged during COVID. Many innovations leveraged different types of clinicians to deliver care, an increased physical presence of PC in the ED, and used technology to enhance care delivery. These innovations may serve as a framework for institutions as they plan for evolving needs in the ED during and after COVID. Additional research is needed to evaluate the impact of these programs and understand their applicability beyond the pandemic.

How to Quantify and Interpret Treatment Effects in Comparative Clinical Studies of COVID-19.

Clinical trials of treatments for coronavirus disease 2019 (COVID-19) draw intense public attention. More than ever, valid, transparent, and intuitive summaries of the treatment effects, including efficacy and harm, are needed. In recently published and ongoing randomized comparative trials evaluating treatments for COVID-19, time to a positive outcome, such as recovery or improvement, has repeatedly been used as either the primary or key secondary end point. Because patients may die before recovery or improvement, data analysis of this end point faces a competing risk problem. Commonly used survival analysis techniques, such as the Kaplan-Meier method, often are not appropriate for such situations. Moreover, almost all trials have quantified treatment effects by using the hazard ratio, which is difficult to interpret for a positive event, especially in the presence of competing risks. Using 2 recent trials evaluating treatments (remdesivir and convalescent plasma) for COVID-19 as examples, a valid, well-established yet underused procedure is presented for estimating the cumulative recovery or improvement rate curve across the study period. Furthermore, an intuitive and clinically interpretable summary of treatment efficacy based on this curve is also proposed. Clinical investigators are encouraged to consider applying these methods for quantifying treatment effects in future studies of COVID-19.

Can the Safety Net be Age-Friendly? How to Address Its Important Role in Caring for Older Adults with Geriatric Conditions.

The safety net, a collection of public hospitals, federally qualified health centers (FQHCs), and publicly funded community-based healthcare entities, provides essential care to middle-aged and older adults with geriatric conditions. The role of the safety net for these adults will intensify over the next two decades with the growing numbers of middle-aged and older adults with adverse social determinants of health and premature geriatric conditions. The foundation for addressing their needs is to detect geriatric conditions and then focus care plans on the impact of these factors on function, which predicts mortality and quality of life more than chronic conditions alone. To detect geriatric conditions in safety net populations, the Age-Friendly Health System (AFHS) framework offers an evidence-based focus on the 4Ms: Mentation, Mobility, Medications, and what Matters. Further incorporating geriatric care models that target the 4Ms and are adapted to safety net populations will enable age-friendly care that optimizes health and addresses what matters to older people.

Strength of evidence relating periodontal disease and atherosclerotic disease.

This review assesses the strength of evidence relating periodontal disease and atherosclerotic disease (ischemic heart disease, peripheral arterial disease, and ischemic stroke). Periodontal disease and atherosclerotic disease may be linked causally, or their relationship could be explained, wholly or partially, by common risk factors. Many potential pathways for the relationship have been postulated. This article focuses on evaluating the overall body of evidence, according to the following standard causal inference criteria: strength of association, dose-response relationship, time sequence, consistency, specificity, biologic plausibility, and independence from confounding. Each criterion is reviewed and evaluated against the existing literature. In summary, the overall strength of evidence for causal criteria for the relation between periodontal disease and atherosclerotic disease is as follows: The magnitude and consistency of the association is stronger for ischemic stroke (and is low for ischemic heart disease), some evidence for dose response exists, time sequence has been established with more evidence for stroke, and there is definitely biologic plausibility for all these associations. Independence from confounding is also stronger for ischemic stroke and peripheral arterial disease. Specificity is not established for any of these associations, as there are multiple risk factors for atherosclerotic disease; however, specificity is not considered an important criterion for causality. Because the underlying pathogenesis of atherosclerosis is common across the diseases, it is likely that if additional studies show consistent associations, periodontal disease may be an important independent causal risk factor for atherosclerotic disease, especially for ischemic stroke.

A nationwide VA palliative care quality measure: the family assessment of treatment at the end of life.

OBJECTIVES: To evaluate the FATE (Family Assessment of Treatment at End of Life) Survey for use as a nationwide quality measure in the VA health care system. DESIGN: Nationwide telephone survey. SETTING: Five VA medical centers. PARTICIPANTS: Eligible patients received inpatient or outpatient care from a participating VA facility in the last month of life. One respondent/patient was selected using predefined eligibility criteria and invited to participate. MEASUREMENTS: The FATE survey consists of 32 items in 9 domains: Well-being and dignity (4 items), Information and communication (5 items), Respect for treatment preferences (2 items), Emotional and spiritual support (3 items), Management of symptoms (4 items), Choice of inpatient facility (1 item), Care around the time of death (6 items), Access to VA services (4 items), and Access to VA benefits after the patient's death (3 items). RESULTS: Interviews were completed with 309 respondents. The FATE showed excellent psychometric characteristics, with good homogeneity (e.g., Cronbach (alpha = 0.91) and no evidence of significant ceiling effects. The FATE also demonstrated good discriminant validity. For instance, FATE scores varied across facilities (range 44-72; Kruskal Wallis test p < 0.001). Patients who were seen by a palliative care service had better scores (mean 66 versus 52; rank sum test p < 0.001), as did patients who were referred to hospice (67 versus 49; rank sum test p < 0.001). CONCLUSIONS: The FATE survey offers an important source of quality data that can be used to improve the end-of-life care of all veterans, regardless of the type of care they receive or their site of death.

Evaluation of an educational intervention to encourage advance directive discussions between medicine residents and patients.

INTRODUCTION: Most medical schools are remiss in preparing physicians in end-of-life communication skills. As a result, many residents are uncomfortable with approaching the patient, have not developed the skills required to discuss the patients' wishes, and avoid end-of-life conversations. OBJECTIVE: To evaluate an educational intervention focused on teaching residents skills to discuss advance directives. METHODS: Medicine Residents attended a morning report consisting of both didactic training and participation in a role-play exercise. Charts of inpatients were audited ten days prior to and five days subsequent to the intervention to ascertain if there was a documented do-not-resuscitate (DNR) discussion. RESULTS: Seventy-nine records of patients assigned to eight physicians who attended the intervention and who were responsible for patients before and after the intervention were reviewed. Of the patients assigned to these residents before the intervention, 32% had a documented DNR discussion. Thirty-four (34%) of the physicians had discussions after the intervention, demonstrating only minimal improvement. CONCLUSIONS: A single intervention may be inadequate to affect physician practices related to DNR discussions. Physicians may need more interactive, experiential learning opportunities and related supervision over the course of their training in order to improve these communication skills. A chart review that only records if a DNR discussion was documented in the medical record may not be the best tool to evaluate the success of this educational intervention. Improvement in attitudes and knowledge were not able to be measured.