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IntroductionDespite the pressing need for primary care-based suicide prevention initiatives and growing acknowledgement of recruitment difficulties and Institutional Review Board (IRB) challenges in suicide research, we are aware of no illustrative examples describing how IRB decisions in the design of a primary care trial can compound recruitment challenges.MethodsThe CDC-funded trial (NCT02986113) of Men and Providers Preventing Suicide aimed to examine the effects of a tailored computer program encourage men with suicidal thoughts (n = 304, ages 35-64) to discuss suicide with a primary care clinician and accept treatment. Before a visit, participants viewed MAPS or a non-tailored control video. Post-visit, both arms were offered telephone collaborative care, as mandated by the institutional review board (IRB). We previously showed that exposure to MAPs led to improvements in communication about suicide in a primary care visit. In this paper, we report data on the study's primary outcome, suicide preparatory behaviors.ResultsAfter screening nearly 4100 men, 48 enrolled. Recruitment challenges, which were exacerabted by an IRB mandate narrowing post-intervention patient management differences between trial arms, limited detection of the effects of MAPS on suicide preparatory behaviors.ConclusionsWhile primary care settings are key sites for suicide prevention trials, issues such as recruitment difficulties and overly restrictive IRB requirements may limit their utility. Methodological innovation to improve recruitment and ethical guidance to inform IRB decision-making are needed.

Background: Care teams are increasingly expected to attend to the needs of patient's personal caregivers (e.g., family members). Improving communication among oncologists, patients with advanced cancer, and their personal caregivers might enhance caregivers' experiences of end-of-life (EoL) cancer care and bereavement outcomes. Objective: To explore the effects of the Values and Options in Cancer Care intervention on caregivers' experiences of EoL care and bereavement outcomes. Design: We developed a brief behavioral intervention to improve communication among oncologists, patients with advanced cancer, and their personal caregivers. The intervention was designed to help patients/caregivers ask questions, express concerns, and help oncologists respond effectively. We randomly assigned oncologists (and their patients/caregivers) to the intervention or usual care. Setting/Subjects: Medical oncologists in NY and CA; patients/personal caregivers with advanced cancer. Measurements: Two months after the patient's death, caregivers completed three instruments assessing their experiences of EoL care. Seven months after the patient's death, caregivers completed the Prolonged Grief Disorder-13 (PG-13; primary prespecified outcome), the Purpose-in-Life scale, and scales assessing mental health function, depression, and anxiety. Results: The intervention did not significantly improve caregivers' scores on the PG-13 (p = 0.21), mental health function, depression, or anxiety, but it did improve purpose-in-life scores (p = 0.018). Cohen's d (95% confidence interval) for all three experiences of EoL care outcomes were promising, ranging from 0.22 (-0.19 to 0.63) to 0.39 (-0.07 to 0.86) although none was statistically significant. Conclusion: Preliminary findings show promise that scalable interventions in cancer care settings may improve caregiver experiences with cancer care and some bereavement outcomes.

BackgroundPatients with advanced, incurable cancer who understand their illness is incurable are more likely to prefer hospice care at the end of life compared with patients who believe their illness is curable. To the authors' knowledge, it is unclear whether patient-caregiver agreement regarding perceived prognosis is associated with hospice enrollment.MethodsThe current study examined the prospective relationship between patient-caregiver agreement concerning perceived prognosis and hospice enrollment in the last 30 days of life. Data were collected during a cluster randomized controlled trial examining a communication intervention for oncologists and patients with advanced cancer and their caregivers. At the time of study entry, patients and caregivers (141 dyads) were categorized as endorsing a "good" prognosis if they: 1) reported a >50% chance of surviving ≥2 years; or if they 2) predicted that the patient's quality of life 3 months into the future would be ≥7 on an 11-point scale.ResultsApproximately one-fifth of dyads agreed on a poor prognosis whereas approximately one-half disagreed regarding prognosis. In approximately one-third of dyads, patients and caregivers both believed the patient's future quality of life would be good (34%) and that the patient would live for ≥2 years (30%). Patients in these dyads were less likely to enroll in hospice compared with patients in dyads who disagreed and those who agreed on a shorter life expectancy and poor future quality of life.ConclusionsDyadic understanding of patients' projected life expectancy and future quality of life appears to be predictive of care received at the end of life. Improving rates of hospice enrollment may be best achieved with dyadic interventions.

ContextAlthough patient and physician characteristics are thought to be predictive of discretionary interventions at the end of life (EoL), few studies have data on both parties.ObjectiveTo test the hypothesis that patient preferences and physician attitudes are both independently associated with discretionary interventions at the EoL.MethodsWe report secondary analyses of data collected prospectively from physicians (n = 38) and patients with advanced cancer (n = 265) in the Values and Options in Cancer Care study. Predictor variables were patient attitudes toward EoL care and physician-reported comfort with medical paternalism, assessed indirectly using a modified version of the Control Preference Scale. We explored whether the magnitude of the physician variable was influenced by the inclusion of particular patient treatment-preference variables (i.e., effect modification). Outcomes were a chemotherapy use score (≤14 days before death [scored 2], 15-31 days before death [scored 1], and >31 days [scored 0]) and an emergency department visit/inpatient admission score (two or more admissions in the last 31 days [scored 2], one admission [1], and 0 admissions [0]) in the last month of life.ResultsChemotherapy scores were nearly 0.25 points higher if patients expressed a preference for experimental treatments with unknown benefit at study entry (0.238 points, 95% CI = 0.047-0.429) or reported an unfavorable attitude toward palliative care (0.247 points, 95% CI = 0.047-0.450). A two-standard deviation difference in physician comfort with medical paternalism corresponded to standardized effects of 0.35 (95% CI = 0.03-0.66) for chemotherapy and 0.33 (95% CI = 0.04-0.61) for emergency department visits/inpatient admissions. There was no evidence of effect modification.ConclusionPatient treatment preferences and physician attitudes are independently associated with higher levels of treatment intensity before death. Greater research, clinical, and policy attention to patient treatment preferences and physician comfort with medical paternalism might lead to improvements in care of patients with advanced disease.

Background and Objectives Home health care supports patient goals for aging in place. Our objective was to determine if home health care use in the last 3 years of life reduces the risk of inpatient death without hospice. Research Design and Methods We analyzed the characteristics of 2,065,300 Medicare beneficiaries who died in 2019 and conducted multinomial logistic regression analyses to evaluate the association between the use and timing of home health care, dementia diagnosis, and place of death. Results Receiving any home health care in the last 3 years of life was associated with a lower probability of inpatient death without hospice (Pr 23.3% vs 31.5%, p  < .001), and this effect was stronger when home health care began prior to versus during the last year of life (Pr 22.5% vs 24.3%, p  < .001). Among all decedents, the probability of death at home with hospice compared to inpatient death with hospice was greater when any home health care was used (Pr 46.0% vs 36.5%, p  < .001), and this association was strongest among beneficiaries with dementia who started home health care at least 1 year prior to death (Pr 55.6%, p  < .001). Discussion and Implications Use of home health care during the last 3 years of life was associated with reduced rates of inpatient death without hospice, and increased rates of home death with hospice. Increasing affordable access to home health care can positively affect end-of-life care outcomes for older Americans and their family caregivers, especially those with dementia. [ABSTRACT FROM AUTHOR]

Introduction: Clinical guidelines and quality improvement initiatives have identified reducing the use of end‐of‐life cancer therapies as an opportunity to improve care. We examined the extent to which oncologists differed in prescribing systemic therapies in the last 30 days of life. Methods: Using Surveillance, Epidemiology, and End Results–Medicare data, we identified patients who died of cancer from 2012 to 2017 (N = 17,609), their treating oncologists (N = 960), and the corresponding physician practice (N = 388). We used multilevel models to estimate oncologists' rates of providing cancer therapy for patients in their last 30 days of life, adjusted for patient characteristics and practice variation. Results: Patients' median age at the time of death was 74 years (interquartile range, 69–79); patients had lung (62%), colorectal (17%), breast (13%), and prostate (8%) cancers. We observed substantial variation across oncologists in their adjusted rate of treating patients in the last 30 days of life: oncologists in the 95th percentile exhibited a 45% adjusted rate of treatment, versus 17% among the 5th percentile. A patient treated by an oncologist with a high end‐of‐life prescribing behavior (top quartile), compared to an oncologist with a low prescribing behavior (bottom quartile), had more than four times greater odds of receiving end‐of‐life cancer therapy (OR, 4.42; 95% CI, 4.00–4.89). Conclusions: Oncologists show substantial variation in end‐of‐life prescribing behavior. Future research should examine why some oncologists more often continue systemic therapy at the end of life than others, the consequences of this for patient and care outcomes, and whether interventions shaping oncologist decision‐making can reduce overuse of end‐of‐life cancer therapies. We examined the extent to which oncologists differed in prescribing systemic therapies to their patients in the last 30 days of life. Results showed substantial variation in end‐of‐life prescribing behavior, with oncologists in the 95th percentile exhibiting a 45% adjusted rate of treatment, compared to just 17% among oncologists in the 5th percentile. [ABSTRACT FROM AUTHOR]

Context: In kidney therapy (KT) decisions, goal-concordant decision-making is recognized to be important, yet alignment with patients' goals during dialysis initiation is not always achieved. Objectives: To explore older patients' and caregivers' hopes, goals, and fears related to KT and communication of these elements with members of their health care team. Methods: The study included patients aged ≥75 years with an estimated glomerular filtration rate ≤25 mL/min/1.73 m2 and their caregivers enrolled in a palliative care intervention for KT decision-making. Patients and caregivers were asked open-ended questions about their hopes, goals, and fears related to KT decisions. A survey assessed if patients shared their goals with members of their health care team. Qualitative data underwent content analysis, supplemented by demographic descriptive statistics. Results: The mean age of patients (n = 26) was 82.7 (±5.7) years, and caregivers (n = 15) had a mean age of 66.4 (±13.7) years. Among the participants, 13 patients and 11 caregivers were women, and 20 patients and 12 caregivers were White. Four themes emerged: (1) Maintaining things as good as they are by avoiding dialysis-related burdens; (2) seeking longevity while avoiding dialysis; (3) avoiding pain, symptoms, and body disfigurement; and (4) deferring decision-making. Patients rarely had shared their goals with the key members of their health care team. Conclusion: Patients and caregivers prioritize maintaining quality of life, deferring decision-making regarding dialysis, and avoiding dialysis-related burdens. These goals are often unshared with their family and health care teams. Given our aging population, urgent action is needed to educate clinicians to actively explore and engage with patient goals in KT decision-making. [ABSTRACT FROM AUTHOR]

ObjectiveTo identify predictors of participation of patients with advanced cancer in clinical encounters with oncologists and to assess the impact of patient and caregiver participation on perceptions of physician support.MethodsThis is a secondary data analysis from the Values and Options in Cancer Care study, a cluster randomized clinical trial of a patient-centered communication intervention. Patients and caregivers completed pre-visit and post-visit health and communication measures. Audio recorded patient-caregiver (when present)-physician encounters were coded for active patient/caregiver participation behaviors (eg, question asking, expressing concern) and for physicians' facilitative communication (eg, partnership-building, support). Mixed linear regression models were used to identify patient, physician, and situational factors predicting patient and patient plus caregiver communication behaviors and post-visit outcomes.ResultsPhysician partnership building predicted greater expressions of concern and more assertive responses from patients and patient-caregiver pairs. Patients' perceptions of greater connectedness with their physician predicted fewer patient expressions of concern. Patient perceptions of physician respect for their autonomy were lower among patients accompanied by caregivers. Caregiver perceptions of physician respect for patient autonomy decreased with increasing patient age and varied by site.ConclusionsIn advanced cancer care, patient and caregiver communication is affected by ecological factors within their consultations. Physicians can support greater patient participation in clinical encounters through facilitative communication such as partnership-building and supportive talk. The presence of a caregiver complicates this environment, but partnership building techniques may help promote patient and caregiver participation during these visits.

Purpose Some research has suggested that discussion of prognosis can disrupt the patient-physician relationship. This study assessed whether physician discussion of prognosis is associated with detrimental changes in measures of the strength of the patient-physician relationship. Methods This was a longitudinal cohort study of 265 adult patients with advanced cancer who visited 38 oncologists within community- and hospital-based cancer clinics in Western New York and Northern California. Prognostic discussion was assessed by coding transcribed audio-recorded visits using the Prognostic and Treatment Choices (PTCC) scale and by patient survey at 3 months after the clinic visit. Changes in the strength of the patient-physician relationship were computed as differences in patient responses to The Human Connection and the Perceived Efficacy in Patient-Physician Interactions scales from baseline to 2 to 7 days and 3 months after the clinic visit. Results Prognostic discussion was not associated with a temporal decline in either measure. Indeed, a one-unit increase in PTCC during the audio-recorded visit was associated with improvement in The Human Connection scale at 2 to 7 days after the visit (parameter estimate, 0.10; 95% CI, -0.02 to 0.23) and 3 months after the visit (parameter estimate, 0.18; 95% CI, 0.02 to 0.35) relative to baseline. Standardized effect sizes (SES) associated with an increase of two standard deviations in the PTCC at each time point were consistent with small beneficial effects (SES, 0.14 [95% CI, -0.02 to 0.29] at 2 to 7 days; SES, 0.24 [95% CI, 0.02 to 0.45] at 3 months), and lower bounds of CIs indicated that substantial detrimental effects of prognostic discussion were unlikely. Conclusion Prognostic discussion is not intrinsically harmful to the patient-physician relationship and may even strengthen the therapeutic alliance between patients and oncologists.

Purpose To build on results of a cluster randomized controlled trial (RCT) of a combined patient-oncologist intervention to improve communication in advanced cancer, we conducted a post hoc analysis of the patient intervention component, a previsit patient coaching session that used a question prompt list (QPL). We hypothesized that intervention-group participants would bring up more QPL-related topics, particularly prognosis-related topics, during the subsequent oncologist visit. Patients and Methods This cluster RCT with 170 patients who had advanced nonhematologic cancer (and their caregivers) recruited from practices of 24 participating oncologists in western New York. Intervention-group oncologists (n = 12) received individualized communication training; up to 10 of their patients (n = 84) received a previsit individualized communication coaching session that incorporated a QPL. Control-group oncologists (n = 12) and patients (n = 86) received no interventions. Topics of interest identified by patients during the coaching session were summarized from coaching notes; one office visit after the coaching session was audio recorded, transcribed, and analyzed by using linear regression modeling for group differences. Results Compared with controls, more than twice as many intervention-group participants brought up QPL-related topics during their office visits (70.2% v 32.6%; P < .001). Patients in the intervention group were nearly three times more likely to ask about prognosis (16.7% v 5.8%; P =.03). Of 262 topics of interest identified during coaching, 158 (60.3%) were QPL related; 20 (12.7%) addressed prognosis. Overall, patients in the intervention group brought up 82.4% of topics of interest during the office visit. Conclusion A combined coaching and QPL intervention was effective to help patients with advanced cancer and their caregivers identify and bring up topics of concern, including prognosis, during their subsequent oncologist visits. Considering that most patients are misinformed about prognosis, more intensive steps are needed to better promote such discussions.

ImportanceObservational studies demonstrate links between patient-centered communication, quality of life (QOL), and aggressive treatments in advanced cancer, yet few randomized clinical trials (RCTs) of communication interventions have been reported.ObjectiveTo determine whether a combined intervention involving oncologists, patients with advanced cancer, and caregivers would promote patient-centered communication, and to estimate intervention effects on shared understanding, patient-physician relationships, QOL, and aggressive treatments in the last 30 days of life.Design, setting, and participantsCluster RCT at community- and hospital-based cancer clinics in Western New York and Northern California; 38 medical oncologists (mean age 44.6 years; 11 (29%) female) and 265 community-dwelling adult patients with advanced nonhematologic cancer participated (mean age, 64.4 years, 146 [55.0%] female, 235 [89%] white; enrolled August 2012 to June 2014; followed for 3 years); 194 patients had participating caregivers.InterventionsOncologists received individualized communication training using standardized patient instructors while patients received question prompt lists and individualized communication coaching to identify issues to address during an upcoming oncologist visit. Both interventions focused on engaging patients in consultations, responding to emotions, informing patients about prognosis and treatment choices, and balanced framing of information. Control participants received no training.Main outcomes and measuresThe prespecified primary outcome was a composite measure of patient-centered communication coded from audio recordings of the first oncologist visit following patient coaching (intervention group) or enrollment (control). Secondary outcomes included the patient-physician relationship, shared understanding of prognosis, QOL, and aggressive treatments and hospice use in the last 30 days of life.ResultsData from 38 oncologists (19 randomized to intervention) and 265 patients (130 intervention) were analyzed. In fully adjusted models, the intervention resulted in clinically and statistically significant improvements in the primary physician-patient communication end point (adjusted intervention effect, 0.34; 95% CI, 0.06-0.62; P = .02). Differences in secondary outcomes were not statistically significant.Conclusions and relevanceA combined intervention that included oncologist communication training and coaching for patients with advanced cancer was effective in improving patient-centered communication but did not affect secondary outcomes.Trial registrationclinicaltrials.gov Identifier: NCT01485627.

While human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) researchers have made remarkable strides in the treatment, management, and prevention of HIV/AIDS, one area of research related to HIV/AIDS remains woefully underrepresented in the scientific literature: suicide prevention. The risk of death by suicide among people living with HIV/AIDS (PLWHA) is 100 times higher compared with that among the general population, and the lifetime prevalence of suicide attempts is similarly elevated. Though there have been many suicide prevention studies worldwide and effective interventions have been identified, few prevention strategies have been tested and implemented among PLWHA. A preliminary review of articles published since 2018 revealed only two behavioral interventions designed to address suicide risk in PLWHA, neither of which were based in the United States. No systematic reviews of behavioral interventions for suicide prevention among PLWHA have been published. In this commentary, we call for research to evaluate the effectiveness of suicide prevention interventions and policies that could decrease suicide rates among PLWHA. [ABSTRACT FROM AUTHOR]

ImportanceEncouraging primary care patients to address depression symptoms and care with clinicians could improve outcomes but may also result in unnecessary treatment.ObjectiveTo determine whether a depression engagement video (DEV) or a tailored interactive multimedia computer program (IMCP) improves initial depression care compared with a control without increasing unnecessary antidepressant prescribing.Design, setting, and participantsRandomized clinical trial comparing DEV, IMCP, and control among 925 adult patients treated by 135 primary care clinicians (603 patients with depression and 322 patients without depression, defined by Patient Health Questionnaire-9 [PHQ-9] score) conducted from June 2010 through March 2012 at 7 primary care clinical sites in California.InterventionsDEV targeted to sex and income, an IMCP tailored to individual patient characteristics, and a sleep hygiene video (control).Main outcomes and measuresAmong depressed patients, superiority assessment of the composite measure of patient-reported antidepressant drug recommendation, mental health referral, or both (primary outcome); depression at 12-week follow-up, measured by the PHQ-8 (secondary outcome). Among nondepressed patients, noninferiority assessment of clinician- and patient-reported antidepressant drug recommendation (primary outcomes) with a noninferiority margin of 3.5%. Analyses were cluster adjusted.ResultsOf the 925 eligible patients, 867 were included in the primary analysis (depressed, 559; nondepressed, 308). Among depressed patients, rates of achieving the primary outcome were 17.5% for DEV, 26% for IMCP, and 16.3% for control (DEV vs control, 1.1 [95% CI, -6.7 to 8.9], P = .79; IMCP vs control, 9.9 [95% CI, 1.6 to 18.2], P = .02). There were no effects on PHQ-8 measured depression score at the 12-week follow-up: DEV vs control, -0.2 (95% CI, -1.2 to 0.8); IMCP vs control,  0.9 (95% CI, -0.1 to 1.9). Among nondepressed patients, clinician-reported antidepressant prescribing in the DEV and IMCP groups was noninferior to control (mean percentage point difference [PPD]: DEV vs control, -2.2 [90% CI, -8.0 to 3.49], P = .0499 for noninferiority; IMCP vs control, -3.3 [90% CI, -9.1 to 2.4], P = .02 for noninferiority); patient-reported antidepressant recommendation did not achieve noninferiority (mean PPD: DEV vs control,  0.9 [90% CI, -4.9 to 6.7], P = .23 for noninferiority; IMCP vs control,  0.3 [90% CI, -5.1 to 5.7], P = .16 for noninferiority).Conclusions and relevanceA tailored IMCP increased clinician recommendations for antidepressant drugs, a mental health referral, or both among depressed patients but had no effect on mental health at the 12-week follow-up. The possibility that the IMCP and DEV increased patient-reported clinician recommendations for an antidepressant drug among nondepressed patients could not be excluded.Trial registrationclinicaltrials.gov Identifier: NCT01144104.

Abstract Background Communication about prognosis and treatment choices is essential for informed decision making in advanced cancer. This article describes an investigation designed to facilitate communication and decision making among oncologists, patients with advanced cancer, and their caregivers. Methods/design The Values and Options in Cancer Care (VOICE) Study is a National Cancer Institute sponsored randomized controlled trial conducted in the Rochester/Buffalo, NY and Sacramento, CA regions. A total of 40 oncologists, approximately 400 patients with advanced cancer, and their family/friend caregivers (one per patient, when available) are expected to enroll in the study. Drawing upon ecological theory, the intervention uses a two-pronged approach: oncologists complete a multifaceted tailored educational intervention involving standardized patient instructors (SPIs), and patients and caregivers complete a coaching intervention to facilitate prioritizing and discussing questions and concerns. Follow-up data will be collected approximately quarterly for up to three years. Discussion The intervention is hypothesized to enhance patient-centered communication, quality of care, and patient outcomes. Analyses will examine the effects of the intervention on key elements of physician-patient-caregiver communication (primary outcomes), the physician-patient relationship, shared understanding of prognosis, patient well-being, and health service utilization (secondary outcomes). Trial registration Clinical Trials Identifier: NCT01485627

Although ecological momentary assessment (EMA) provides an opportunity for the examination of intervention mechanisms in real time, there are few validated tools to assess key treatment mechanisms in EMA studies. Our focus in this study is a potentially critical treatment mechanism, improvement in self-efficacy for managing negative emotions. We examined the psychometric properties of the Patient-Reported Outcomes Measurement Information System (PROMIS) self-efficacy for managing negative emotions scale measured via EMA. Participants (n = 145 college students) in a clinical trial of Dialectical Behavior Therapy skills completed four daily EMAs for 6 weeks (13,153 total responses). Results indicated (a) excellent internal consistency and good factor structure, (b) sufficient variability at both the between- and the within-persons levels, and (c) strong construct and predictive validity. This study supports the validity of an EMA measure of self-efficacy for managing negative emotions that can be used in real time, both in intervention studies and in observational research. [ABSTRACT FROM AUTHOR]