Barriers to recruitment into emergency department-initiated palliative care: a sub-study of a multi-site, randomized controlled trial.

BACKGROUND: Emergency department (ED) visits among older adults are common near the end of life. Palliative care has been shown to reduce ED visits and to increase quality of life among patients, but recruitment into these programs is often challenging. This descriptive analysis explores the barriers to enrolling seriously ill patients scheduled for discharge from the ED into palliative care research. METHODS: This descriptive sub-study aims to assess the reasons why patients with advanced illness scheduled for discharge home from 11 EDs across the United States decline to participate in Emergency Medicine Palliative Care Access (EMPallA), a Phase IV randomized controlled trial (RCT) comparing two modes of palliative care delivery. Our aim was to understand why patients decline to enroll to improve future recruitment rates and expand care for patients discharged home from the ED. Research coordinators documented reasons that patients declined to enroll in the larger EMPallA trial; reasons for refusing participation were independently analyzed by two researchers to identify overarching themes. RESULTS: Enrollment rate across all sites was 45%; of the 504 eligible patients who declined participation, 47% (n = 237) declined for reasons related to illness severity. 28% of refusals (n = 143) were related to the mode of palliative care delivery, while 24% (n = 123) were due to misconceptions or stigma related to palliative care. Less commonly, patients refused due to general research barriers (16.5%), family/caregiver barriers (11.7%), and physician-related barriers (< 1%). CONCLUSIONS: Patients with advanced illnesses presenting to the ED often refuse to participate in palliative care research due to the severity of their illness, the mode of care delivery, and misconceptions about palliative care. In contrast with other studies, our study found minimal physician gatekeeping, which may be the result of both changing attitudes toward palliative care and the nature of the ED setting. Robust training programs are crucial to overcome these misconceptions and to educate patients and providers about the role of palliative care. Future palliative care programs and study designs should recognize the burden this vulnerable population endures and consider alternative modes of care delivery in an effort to increase participation and enrollment. CLINICAL TRIALS REGISTRATION: NCT03325985 , October 30, 2017.

Pragmatic Considerations in Incorporating Stakeholder Engagement Into a Palliative Care Transitions Study.

BACKGROUND: Stakeholder involvement in health care research has been shown to improve research development, processes, and dissemination. The literature is developing on stakeholder engagement methods and preliminarily validated tools for evaluating stakeholder level of engagement have been proposed for specific stakeholder groups and settings. OBJECTIVES: This paper describes the methodology for engaging a Study Advisory Committee (SAC) in research and reports on the use of a stakeholder engagement survey for measuring level of engagement. METHODS: Stakeholders with previous research connections were recruited to the SAC during the planning process for a multicenter randomized control clinical trial, which is ongoing at the time of this writing. All SAC meetings undergo qualitative analysis, while the Stakeholder Engagement Survey instrument developed by the Patient-Centered Outcomes Research Institute (PCORI) is distributed annually for quantitative evaluation. RESULTS: The trial's SAC is composed of 18 members from 3 stakeholder groups: patients and their caregivers; patient advocacy organizations; and health care payers. After an initial in-person meeting, the SAC meets quarterly by telephone and annually in-person. The SAC monitors research progress and provides feedback on all study processes. The stakeholder engagement survey reveals improved engagement over time as well as continued challenges. CONCLUSIONS: Stakeholder engagement in the research process has meaningfully contributed to the study design, patient recruitment, and preliminary analysis of findings.

Data from emergency medicine palliative care access (EMPallA): a randomized controlled trial comparing the effectiveness of specialty outpatient versus telephonic palliative care of older adults with advanced illness presenting to the emergency department.

BACKGROUND: The Emergency Medicine Palliative Care Access (EMPallA) trial is a large, multicenter, parallel, two-arm randomized controlled trial in emergency department (ED) patients comparing two models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. This report aims to: 1) report baseline demographic and quality of life (QOL) data for the EMPallA cohort, 2) identify the association between illness type and baseline QOL while controlling for other factors, and 3) explore baseline relationships between illness type, symptom burden, and loneliness. METHODS: Patients aged 50+ years with advanced cancer (metastatic solid tumor) or end-stage organ failure (New York Heart Association Class III or IV heart failure, end stage renal disease with glomerular filtration rate < 15 mL/min/m2, or Global Initiative for Chronic Obstructive Lung Disease Stage III, IV, or oxygen-dependent chronic obstructive pulmonary disease defined as FEV1 < 50%) are eligible for enrollment. Baseline data includes self-reported demographics, QOL measured by the Functional Assessment of Cancer Therapy-General (FACT-G), loneliness measured by the Three-Item UCLA Loneliness Scale, and symptom burden measured by the Edmonton Revised Symptom Assessment Scale. Descriptive statistics were used to analyze demographic variables, a linear regression model measured the importance of illness type in predicting QOL, and chi-square tests of independence were used to quantify relationships between illness type, symptom burden, and loneliness. RESULTS: Between April 2018 and April 3, 2020, 500 patients were enrolled. On average, end-stage organ failure patients had lower QOL as measured by the FACT-G scale than cancer patients with an estimated difference of 9.6 points (95% CI: 5.9, 13.3), and patients with multiple conditions had a further reduction of 7.4 points (95% CI: 2.4, 12.5), when adjusting for age, education level, race, sex, immigrant status, presence of a caregiver, and hospital setting. Symptom burden and loneliness were greater in end-stage organ failure than in cancer. CONCLUSIONS: The EMPallA trial is enrolling a diverse sample of ED patients. Differences by illness type in QOL, symptom burden, and loneliness demonstrate how distinct disease trajectories manifest in the ED. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03325985 . Registered October 30, 2017.

Psychometric Properties of the Functional Assessment of Cancer Therapy-General for Evaluating Quality of Life in Patients With Life-Limiting Illness in the Emergency Department.

Background: The Functional Assessment of Cancer Therapy-General (FACT-G) is a widely used quality-of-life measure. However, no studies have examined the FACT-G among patients with life-limiting illnesses who present to emergency departments (EDs). Objective: The goal of this study was to examine the psychometric properties of the FACT-G among patients with life-limiting illnesses who present to EDs in the United States. Methods: This cross-sectional study pooled data from 12 EDs between April 2018 and January 2020 (n = 453). Patients enrolled in the study were adults with one or more of the four life-limiting illnesses: advanced cancer, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, or End-Stage Renal Disease. We conducted item, exploratory, and confirmatory analyses (exploratory factor analysis [EFA] and confirmatory factor analysis [CFA]) to determine the psychometric properties of the FACT-G. Results: The FACT-G had good internal consistency (Cronbach's alpha α = 0.88). The simplest EFA model was a six-factor structure. The CFA supported the six-factor structure, evidenced by the adequate fit indices (comparative fit index = 0.93, Tucker-Lewis index = 0.92, root-mean-square error of approximation = 0.05; 90% confidence interval: 0.04 - 0.06). The six-factor structure comprised the physical, emotional, work and daily activities-related functional well-being, and the family and friends-related social well-being domains. Conclusions: The FACT-G is a reliable measure of health-related quality of life among patients with life-limiting illnesses who present to the ED. Clinical Trial Registration: NCT03325985.

What's in This For You? What's in This For Me?: A Win-Win Perspective of Involving Study Advisory Committee Members in Palliative Care Research.

Study advisory committees (SACs) provide critical value to clinical trials by providing unique perspectives that pull from personal and professional experiences related to the trial's healthcare topic. The Emergency Medicine Palliative Care Access (EMPallA) study had the privilege of convening a 16-person SAC from the project's inception to completion. The study team wanted to understand the impact this project had on the SAC members. In this narrative, we use reflective dialogue to share SAC members' lived experiences and the impact the EMPallA study has had on members both personally and professionally. We detail the (1) benefits SAC members, specifically patients, and caregivers, have had through working on this project. (2) The importance of recruiting diverse SAC members with different lived experiences and leveraging their feedback in clinical research. (3) Value of community capacity building to ensure the common vision of the clinical trial is promoted.

Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA).

BACKGROUND: Involving patient and community stakeholders in clinical trials adds value by ensuring research prioritizes patient goals both in conduct of the study and application of the research. The use of stakeholder committees and their impact on the conduct of a multicenter clinical trial have been underreported clinically and academically. The aim of this study is to describe how Study Advisory Committee (SAC) recommendations were implemented throughout the Emergency Medicine Palliative Care Access (EMPallA) trial. EMPallA is a multi-center, pragmatic two-arm randomized controlled trial (RCT) comparing the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. METHODS: A SAC consisting of 18 individuals, including patients with palliative care experience, members of healthcare organizations, and payers was convened for the EMPallA trial. The SAC engaged in community-based participatory research and assisted in all aspects from study design to dissemination. The SAC met with the research team quarterly and annually from project inception to dissemination. Using meeting notes and recordings we completed a qualitative thematic analysis using an iterative process to develop themes and subthemes to summarize SAC recommendations throughout the project's duration. RESULTS: The SAC convened 16 times between 2017 and 2020. Over the course of the project, the SAC provided 41 unique recommendations. Twenty-six of the 41 (63%) recommendations were adapted into formal Institutional Review Board (IRB) study modifications. Recommendations were coded into four major themes: Scientific, Pragmatic, Resource and Dissemination. A majority of the recommendations were related to either the Scientific (46%) or Pragmatic (29%) themes. Recommendations were not mutually exclusive across three study phases: Preparatory, execution and translational. A vast majority (94%) of the recommendations made were related to the execution phase. Major IRB study modifications were made based on their recommendations including data collection of novel dependent variables and expanding recruitment to Spanish-speaking patients. CONCLUSIONS: Our study provides an example of successful integration of a SAC in the conduct of a pragmatic, multi-center RCT. Future trials should engage with SACs in all study phases to ensure trials are relevant, inclusive, patient-focused, and attentive to gaps between health care and patient and family needs. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT03325985, 10/30/2017.

Clinical research should involve patient and community stakeholder perspectives to make sure the study addresses questions important to the studied population. One way to do this is by creating a group of stakeholders who can advise on the conduct of a study. We assembled a Study Advisory Committee (SAC) for the Emergency Medicine Palliative Care Access (EMPallA) trial. The purpose of this clinical trial is to compare the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. This paper describes how the SACs involvement translated into direct impacts on the EMPallA trial. The trial research team held regular meetings with the SAC throughout the trial process. Their involvement led to many significant changes in the trial, such as  expanding recruitment inclusion criteria (Spanish-speaking patients), and including survey instruments to measure lonelines and caregiver burden. The SAC also devised strategies to overcome patient and caregiver recruitment and retention challenges, including the creation of patient-friendly materials and training for research coordinators. This study provides a successful example of how actively engaging patient and community stakeholders, through committee engagement, can promote patient priorities in all phases of a trial while facilitating patient recruitment and retention.

Engagement, Advance Care Planning, and Hospice Use in a Telephonic Nurse-Led Palliative Care Program for Persons Living with Advanced Cancer.

Persons living with advanced cancer have intensive symptoms and psychosocial needs that often result in visits to the Emergency Department (ED). We report on program engagement, advance care planning (ACP), and hospice use for a 6-month longitudinal nurse-led, telephonic palliative care intervention for patients with advanced cancer as part of a larger randomized trial. Patients 50 years and older with metastatic solid tumors were recruited from 18 EDs and randomized to receive nursing calls focused on ACP, symptom management, and care coordination or specialty outpatient palliative care (ClinicialTrials.gov: NCT03325985). One hundred and five (50%) graduated from the 6-month program, 54 (26%) died or enrolled in hospice, 40 (19%) were lost to follow-up, and 19 (9%) withdrew prior to program completion. In a Cox proportional hazard regression, withdrawn subjects were more likely to be white and have a low symptom burden compared to those who did not withdraw. Two hundred eighteen persons living with advanced cancer were enrolled in the nursing arm, and 182 of those (83%) completed some ACP. Of the subjects who died, 43/54 (80%) enrolled in hospice. Our program demonstrated high rates of engagement, ACP, and hospice enrollment. Enrolling subjects with a high symptom burden may result in even greater program engagement.

Stress among Emergency Health Care Workers on Nuclear or Radiation Disaster: A Preliminary State Survey.

BACKGROUND: The nuclear or radiation disaster risk within the French Auvergne-Rhone-Alpes state is low (but not absent) due to its proximity to four Nuclear Power Generation Centers and two regional cancer control centers. This study aims to compare subjective stress ratings for emergency health care workers regarding nuclear and radiation disasters between two locations: at work versus at home. MATERIALS AND METHODS: We distributed an anonymous online questionnaire via RedCap® to all emergency health care workers who could be involved in patient care after a nuclear or radiation disaster. It comprised 18 questions divided into three parts-theoretical knowledge and practical assessment, stress assessment, and sociodemographic criteria. RESULTS: We analyzed 107 responses. There was a significant 11-point increase in stress levels between work and home regarding nuclear or radiation disaster risks (p = 0.01). Less than 25% of emergency health care workers surveyed benefited from annual training. CONCLUSION: The stress levels of emergency health care workers regarding nuclear or radiation disaster were higher at work than at home and increased without annual training. It is important to increase knowledge about these protocols and to mandate yearly training for all workers potentially involved in these disasters.

Impact of Air Transport on SpO2/FiO2 among Critical COVID-19 Patients during the First Pandemic Wave in France.

During the first wave of the COVID-19 pandemic, some French regions were more affected than others. To relieve those areas most affected, the French government organized transfers of critical patients, notably by plane or helicopter. Our objective was to investigate the impact of such transfers on the pulse oximetric saturation (SpO2)-to-inspired fraction of oxygen (FiO2) ratio among transferred critical patients with COVID-19. We conducted a retrospective study on medical and paramedical records. The primary endpoint was the change in SpO2/FiO2 during transfers. Thirty-eight patients were transferred between 28 March and 5 April 2020, with a mean age of 62.4 years and a mean body mass index of 29.8 kg/m2. The population was 69.7% male, and the leading medical history was hypertension (42.1%), diabetes (34.2%), and dyslipidemia (18.4%). Of 28 patients with full data, we found a decrease of 28.9 points in SpO2/FiO2 (95% confidence interval, 5.8 to 52.1, p = 0.01) between the starting and the arrival intensive care units (SpO2/FiO2, 187.3 ± 61.3 and 158.4 ± 62.8 mmHg, respectively). Air medical transfers organized to relieve intensive care unit teams under surging conditions during the first COVID wave were associated with significant decreases in arterial oxygenation.

Perceptions of extended-release naltrexone, methadone, and buprenorphine treatments following release from jail.

BACKGROUND: Few studies have documented patient attitudes and experiences with extended-release naltrexone (XR-NTX) opioid relapse prevention in criminal justice settings. This study assessed barriers and facilitators of jail-to-community reentry among adults with opioid use disorder (OUD) treated with XR-NTX, buprenorphine, methadone, and no medications. METHODS: This qualitative study conducted individual interviews with a purposeful and convenience sample of adults with OUD who were recently released from NYC jails. XR-NTX, no medication, and methadone participants were concurrently enrolled in a large randomized controlled trial evaluating XR-NTX vs. a no medication Enhanced Treatment As Usual (ETAU) condition, or enrolled in a non-randomized quasi-experimental methadone maintenance cohort. Buprenorphine participants were referred from NYC jails to a public hospital office-based buprenorphine program and not enrolled in the parent trial. Interviews were audio recorded, transcribed, independently coded by two researchers, and analyzed per a grounded theory approach adapted to the Social Cognitive Theory framework. The research team reviewed transcripts and coding to reach consensus on emergent themes. RESULTS: N = 33 adults with OUD (28 male, 5 female) completed a single individual interview. Purposeful sampling recruited persons leaving jail on XR-NTX (n = 11), no active medication treatment (n = 9), methadone (n = 9), and buprenorphine (n = 4). Emergent themes were: (1) general satisfaction with XR-NTX's long-acting antagonist effects and control of cravings; (2) "testing" XR-NTX's blockade with heroin upon reentry was common; (3) early discontinuation of XR-NTX treatment was most common among persons with high self-efficacy and/or heavy exposure to drug use environments and peers; (4) similar satisfaction regarding effects of methadone and buprenorphine maintenance among retained-in-treatment individuals, alongside general dissatisfaction with daily observed dosing requirements and misinformation and stigmas regarding methadone adverse effects; (5) unstable housing, economic insecurity, and exposure to actively using peers were attributed to early termination of treatment and relapse; (6) individual motivation and willpower as central to long-term opioid abstinence and reentry success. CONCLUSIONS: In the context of more familiar agonist maintenance treatments, XR-NTX relapse prevention during jail-to-community reentry was viewed as a helpful and unique intervention though with important limitations. Commonly described barriers to treatment retention and heroin abstinence included homelessness, economic insecurity, and drug-using peers. Trial registration ClinicalTrials.gov, NCT01999946 (XOR), Registered 03 December 2013, https://clinicaltrials.gov/ct2/show/NCT01999946 .

Buprenorphine prescribing practice trends and attitudes among New York providers.

Buprenorphine office-based opioid maintenance is an increasingly common form of treatment for opioid use disorders. However, total prescribing has not kept pace with the current opioid and overdose epidemic and access remains scarce among the underserved. This study sought to assess current provider attitudes and clinical practices among a targeted sample of primarily New York City public sector buprenorphine prescribers. A cross-sectional online survey purposefully sampled buprenorphine prescribers in NYC with a focus on those serving Medicaid and uninsured patient populations. Expert review of local provider networks, snowball referrals, and in-person networking generated an email list, which received a survey link. A brief 25-question instrument queried provider and practice demographics, prescribing practices including induction approaches and attitudes regarding common hot topics (e.g., buprenorphine diversion, prescriber patient limits, insurance issues, ancillary treatments). Of 132 email invitations, N=72 respondents completed (n=64) or partially completed (n=8) the survey between January and April 2016. Most (79%) were Medicaid providers in non-psychiatric specialties (72%), working in a hospital-based or community general practice (51%), and board-certified in addiction medicine or psychiatry (58%). Practice sizes were generally 100 patients or fewer (71%); many providers (64%) individually prescribed buprenorphine <25% of total practice time to a median 23 patients (mean 31, range 0-102). Unobserved (home) induction for new patients was a common practice: 49% predominantly prescribed unobserved induction; 16% mixed unobserved and observed inductions. Adjunctive psychosocial counseling was routinely recommended (46%) or considered on a case-by-case basis (17%) versus mandated (37%). Medication prior authorization requirements were the highest rated barriers to practice, followed by inadequate clinic space, limited clinic time and/or support staff, and inadequate psychiatric services for dual diagnoses. Buprenorphine diversion was not rated as an important practice barrier. In conclusion, this targeted survey of buprenorphine prescribers in NYC treating primarily underserved populations showed a consistent pattern of part-time prescribing to modest volumes of patients, routine use of unobserved buprenorphine induction, and primarily elective referrals to psychosocial counseling. Barriers to prescribing included prior authorization requirements, lack of clinical resources (space, staff) and psychiatric services. Federal and local efforts to reduce such barriers may improve buprenorphine access among the underserved.

Public sector low threshold office-based buprenorphine treatment: outcomes at year 7.

BACKGROUND: Buprenorphine maintenance for opioid dependence remains of limited availability among underserved populations, despite increases in US opioid misuse and overdose deaths. Low threshold primary care treatment models including the use of unobserved, "home," buprenorphine induction may simplify initiation of care and improve access. Unobserved induction and long-term treatment outcomes have not been reported recently among large, naturalistic cohorts treated in low threshold safety net primary care settings. METHODS: This prospective clinical registry cohort design estimated rates of induction-related adverse events, treatment retention, and urine opioid results for opioid dependent adults offered buprenorphine maintenance in a New York City public hospital primary care office-based practice from 2006 to 2013. This clinic relied on typical ambulatory care individual provider-patient visits, prescribed unobserved induction exclusively, saw patients no more than weekly, and did not require additional psychosocial treatment. Unobserved induction consisted of an in-person screening and diagnostic visit followed by a 1-week buprenorphine written prescription, with pamphlet, and telephone support. Primary outcomes analyzed were rates of induction-related adverse events (AE), week 1 drop-out, and long-term treatment retention. Factors associated with treatment retention were examined using a Cox proportional hazard model among inductions and all patients. Secondary outcomes included overall clinic retention, buprenorphine dosages, and urine sample results. RESULTS: Of the 485 total patients in our registry, 306 were inducted, and 179 were transfers already on buprenorphine. Post-induction (n = 306), week 1 drop-out was 17%. Rates of any induction-related AE were 12%; serious adverse events, 0%; precipitated withdrawal, 3%; prolonged withdrawal, 4%. Treatment retention was a median 38 weeks (range 0-320) for inductions, compared to 110 (0-354) weeks for transfers and 57 for the entire clinic population. Older age, later years of first clinic visit (vs. 2006-2007), and baseline heroin abstinence were associated with increased treatment retention overall. CONCLUSIONS: Unobserved "home" buprenorphine induction in a public sector primary care setting appeared a feasible and safe clinical practice. Post-induction treatment retention of a median 38 weeks was in line with previous naturalistic studies of real-world office-based opioid treatment. Low threshold treatment protocols, as compared to national guidelines, may compliment recently increased prescriber patient limits and expand access to buprenorphine among public sector opioid use disorder patients.

Extended-release naltrexone opioid treatment at jail reentry (XOR).

BACKGROUND: Extended-release naltrexone (XR-NTX) is an injectable monthly sustained-release mu opioid receptor antagonist, which blocks the typical effects of heroin and other opioid agonists. Use of XR-NTX among opioid dependent persons leaving jails and prisons is increasing despite scant high-quality evidence regarding XR-NTX's effectiveness at re-entry. METHODS: This 24-week, open-label randomized controlled trial examines the effectiveness of XR-NTX as opioid relapse prevention at release from jail (N=85) compared to enhanced treatment as usual (ETAU, N=85). A third, non-randomized, quasi-experimental naturalistic arm of participants who have newly initiated a jail-to-community methadone treatment program (MTP, N=85) allows for comparisons to a methadone standard-of-care. RESULTS: We describe the rationale, design, and primary and secondary outcomes of the study. The primary outcome is an opioid relapse event; the primary contrast is a time-to-relapse comparison of XR-NTX and ETAU over a 24-week treatment phase. Secondary outcomes are rates of: (a) post-release opioid treatment participation, (b) opioid, alcohol, and cocaine use, (c) injection drug use and HIV sexual risk behaviors, (d) overdose (fatal and non-fatal) and all-cause mortality, and, (e) re-incarceration. CONCLUSIONS: XR-NTX is a potentially important, effective treatment and relapse prevention option for a large US population of persons with opioid use disorders leaving jails. This study will estimate XR-NTX's effectiveness relative to existing standards of care, including counseling-only treatment-as-usual and methadone maintenance.