Patient Navigator Intervention to Improve Palliative Care Outcomes for Hispanic Patients With Serious Noncancer Illness: A Randomized Clinical Trial.

Importance: Disparities persist across the trajectory of serious illness, including at the end of life. Patient navigation has been shown to reduce disparities and improve outcomes for underserved populations. Objective: To determine the effectiveness of a lay patient navigator intervention, Apoyo con Cariño, in improving palliative care outcomes among Hispanic patients. Design, Setting, and Participants: This was a multicenter randomized clinical trial that took place across academic, nonprofit, safety-net, and community health care systems in urban, rural, and mountain/frontier regions of Colorado from January 2017 to January 2021. Self-identifying Hispanic adults with serious noncancer medical illness and limited prognosis were recruited. Data were collected and analyzed from July 2022 to July 2023. Interventions: Participants randomized to the intervention group received 5 home visits from a bilingual, bicultural lay patient navigator; participants randomized to control received care as usual. Both groups received culturally tailored educational materials. Investigators/outcome accessors remained blinded to participant assignment. Main Outcomes and Measures: Change in score from baseline to 3 months on the Functional Assessment of Chronic Illness Therapy (FACIT) General quality of life (QOL) scale (primary outcome), Advance Care Planning (ACP) Engagement Survey, Brief Pain Inventory, Edmonton Symptom Assessment Scale, and FACIT Spiritual Well-Being subscale; at 6 months, advance directive (AD) documentation; and at 46 months or death, hospice utilization and length of stay, as well as aggressiveness of care at end of life. Results: Of 209 patients enrolled (mean [SD] age, 63.6 [14.3] years; 108 [51.7%] male), 105 patients were randomized to control and 104 patients to the intervention. There were no statistically significant differences in the change in mean (SD) QOL score between the intervention and control groups (5.0 [16.5] vs 4.3 [15.5]; P = .75). Participants in the intervention group, compared with the control group, had statistically significant greater increases in mean (SD) ACP engagement (0.8 [1.3] vs 0.1 [1.4]; P < .001) and were more likely to have a documented AD (62 of 104 [59.6%] vs 28 of 105 [26.9%]; P < .001). There were no statistically significant differences in mean (SD) change in pain intensity score (0-10) between patients in the intervention group compared with control (-0.4 [2.6] vs -0.5 [2.8]; P = .79), nor pain interference (-0.2 [3.7] vs -0.4 [3.7]; P = .71). Patients receiving the intervention were more likely to be referred to hospice compared with patients receiving control (19 of 43 patients [44.2%] vs 7 of 33 patients [21.2%]; P = .04) and less likely to receive aggressive care at end of life (27 of 42 patients [64.3%] vs 28 of 33 patients [84.8%]; P = .046). Conclusion and Relevance: In this randomized clinical trial, a culturally tailored patient navigator intervention did not improve QOL for patients. However, the intervention did increase ACP engagement, AD documentation, and hospice utilization in Hispanic persons with serious medical illness. Trial Registration: ClinicalTrials.gov Identifier: NCT03181750.

Reality of Family Caregiving for Hispanics With Alzheimer's Disease and Related Dementias: A Qualitative Analysis.

Background: Underserved Hispanic patients often experience unmet palliative care (PC) needs, particularly those with noncancer diagnoses such as Alzheimer's disease and related dementias. Most caregivers for Hispanic patients are family relatives who are less likely to use health care and community resources and experience high caregiver burden. We adapted a culturally tailored patient navigator (PN) intervention to provide support and improve PC outcomes for Hispanics with Alzheimer's disease and related dementias and their family caregivers (FCGs). Objectives: To explore Hispanic FCGs' experiences and perceptions of caregiving for a loved one, and how our PN intervention impacted their needs. Design: Qualitative descriptive. Setting/Subjects: FCG participants (n = 10) from our randomized control trial's intervention group were recruited from academic and safety net hospitals and community-based clinics across urban and rural Colorado in the United States. Measurements: Data obtained from individual, semistructured, 30-minute telephone interviews were recorded, transcribed, translated, and analyzed using NVivo and qualitative thematic analyses. Results: Four major themes emerged: Methods of Support, Cultural Expectations and Varying Family Contributions, Lack of Self-Care, and Awareness. Subthemes highlighted differing definitions of "contributing," role resentment, and interpersonal issues. Varying familial expectations underscore FCG strain when the burden of caregiving is not shared. Participants used various coping strategies as necessary support and gained awareness through education, guidance, and referrals to resources. Conclusions: PNs helped FCGs and patients beyond the intervention's scope. Providing support and awareness to FCGs, and incorporating cultural beliefs, may improve PC access to disparate populations and guide future interventions. Clinical Trial Registration Number NCT03181750.

Perspectives on National Institutes of Health Funding Requirements for Racial and Ethnic Diversity Among Medical Scientist Training Program Leadership.

Importance: Since 1964, the National Institutes of Health (NIH) has funded the Medical Scientist Training Program (MSTP) MD-PhD program at medical schools across the US to support training physician-scientists. Recent studies have suggested that MSTPs have consistently matriculated more students from racial and ethnic backgrounds historically underrepresented in science than MD-PhD programs without NIH funding; however, the underlying basis for the increased diversity seen in NIH-funded MSTPs is poorly understood. Objective: To investigate how administrators and faculty perceive the impact of MSTP status on MD-PhD program matriculant racial and ethnic diversity. Design, Setting, and Participants: This qualitative study used a positive deviance approach to identify 9 high-performing and 3 low-performing MSTPs based on the percentage of students underrepresented in science who matriculated into the program between 2014 and 2018. This study, a subanalysis of a larger study to understand recruitment of students underrepresented in science at MSTPs, focused on in-depth qualitative interviews, conducted from October 26, 2020, to August 31, 2022, of 69 members of MSTP leadership, including program directors, associate and assistant program directors, and program administrators. Main Outcomes and Measures: The association of NIH funding with institutional priorities, programs, and practices related to MD-PhD program matriculant racial and ethnic diversity. Results: The study included 69 participants (mean [SD] age, 53 [10] years; 38 women [55%]; 13 African American or Black participants [19%], 6 Asian participants [9%], 12 Hispanic participants [17%], and 36 non-Hispanic White participants [52%]). A total of 51 participants (74%) were in administrative roles, and 18 (26%) were faculty involved in recruitment. Five themes emerged from the data: (1) by tying MSTP funding to diversity efforts, the NIH created a sense of urgency among MSTP leadership to bolster matriculant diversity; (2) MD-PhD program leadership leveraged the changes to MSTP grant review to secure new institutional investments to promote recruitment of students underrepresented in science; (3) MSTPs increasingly adopted holistic review to evaluate applicants to meet NIH funding requirements; (4) MSTP leadership began to systematically assess the effectiveness of their diversity initiatives and proactively identify opportunities to enhance matriculant diversity; and (5) although all MSTPs were required to respond to NIH criteria, changes made by low-performing programs generally lacked the robustness demonstrated by high-performing programs. Conclusions and Relevance: This study suggests that NIH funding requirements may be a powerful incentive to promote diversity and positively affect representation of students underrepresented in science in the biomedical scientific workforce.

Experiences of caregiving with Alzheimer's disease in the LGBT community.

BACKGROUND: The goal of this paper is to develop a more thorough understanding of the experiences of LGBT older adults living with dementia and their caregivers. METHODS: A phenomenological approach using in-depth interviews with current or former caregivers of LGBT persons living with Alzheimer's disease (AD) was conducted. RESULTS: Participants ranged in age from 44-77 years old; 74% were lesbian, 16% gay, 5% straight, and 5% unknown. Five themes were identified from the analysis: Caregiver tension and isolation; financial stress & security; lack of social support & connection; engineering grief support, and entrapment of past and present stigma and discrimination. CONCLUSIONS: Discrimination related to LGBT status was an important theme over the participants' lives and occurred for several during dementia care. While other themes were similar to prior AD studies, LGBT status affected these other aspects of the caregiving experience. Findings can inform future programs that better meet needs of LGBT people and those who care for them.

Psychometric properties of light touch-pressure somatosensory measures in adults with neurological disorders: A systematic review.

OBJECTIVES: To critically appraise the psychometric properties of light touch-pressure somatosensory assessments to provide guidance for tool selection for research or clinical purposes. DATA SOURCES: MEDLINE, CINAHL, and PsycInfo were searched for research indexed from January 1990-November 2022. English language and human subject filters were applied. "Somatosensation", "psychometric property", and "nervous system-based health condition" search terms were combined. Grey literature and manual searches were conducted to ensure thoroughness. REVIEW METHODS: The reliability, construct validity, and/or measurement error of light touch-pressure assessments was reviewed in adult populations with neurological disorders. Reviewers individually extracted and managed data including patient demographics, assessment characteristics, statistical methods, and psychometric properties. Methodological quality of results was evaluated using an adapted version of the COnsensus-based Standards for the selection of health Measurement INstruments checklist. RESULTS: Thirty-three of 1938 articles were included for review. Fifteen light touch-pressure assessments demonstrated good or excellent reliability. Further, five of those 15 assessments achieved adequate validity and one of the 15 assessments achieved adequate measurement error. Over 80% of the summarized study ratings were determined to be of low or very low quality. CONCLUSION: We recommend using electrical perceptual tests, the Semmes-Weinstein Monofilaments, the Graded and Redefined Assessment of Strength, Sensibility, and Prehension, and the Moving Touch Pressure Test given that they demonstrated good to excellent results in three psychometric properties. No other assessment achieved adequate ratings in more than two psychometric properties. This review highlights a fundamental need to develop sensory assessments that are reliable, valid, and sensitive to change.

Prevalence of adverse childhood experiences and post traumatic stress disorder symptoms in a primary care safety-net population: Implications for healthcare service needs.

OBJECTIVE: We characterized the prevalence and associated characteristics of Adverse Childhood Experiences (ACEs) and Post-traumatic stress disorder (PTSD) in a safety net system and assessed patient preferences for trauma informed care. METHODS: We performed a cross-sectional survey among adult patients attending primary care at three urban federally qualified healthcare centers. We used a method of recruitment that included both convenience and systemic sampling. The survey included the ACEs Questionnaire, the PTSD for DSM 5 (PC-PTSD5), and trauma-informed care preferences. We accessed Electronic Health Records for demographic and clinical data. We used descriptive and multivariable statistical analyses. RESULTS: 303 of 481 (63%) patients that were approached participated. Most participants (81%) had one or more ACEs and 38% had four or more. 88 (29%) patients screened positive for current PTSD. ACEs was associated with a diagnosis of mental illness (p = 0.0125) and substance use disorders (p = 0.01). Patients with ACEs >/=4 or positive PC-PTSD reported stress in attending medical visits and that trauma-informed provider behaviors would make their visits less stressful. CONCLUSIONS: Rates of ACES and current PTSD symptoms were high in this population and support the need for research to evaluate universal trauma-informed care strategies for safety-net healthcare systems.

Transitioning to Remote Recruitment and Intervention: A Tale of Two Palliative Care Research Studies Enrolling Underserved Populations During COVID-19.

CONTEXT: During the COVID-19 pandemic, community-based research studies experienced prolonged shutdowns unless able to pivot to remote study procedures. OBJECTIVES: To describe the revision of two National Institutes of Health funded community-based palliative-focused clinical trials serving underserved populations to accommodate remote subject enrollment and examine its impact. METHODS: Transitioning to remote processes required multiple protocol and procedural changes including: altering informed consent processes; reducing the number of surveys administered; adding internet access as an inclusion criterion. To understand technological challenges, a screening tool was developed for one study to identify potentially eligible subjects' technology abilities and accessibility. RESULTS: Subjects' limited access to the internet and internet-enabled devices and discomfort with technology led to changes in recruitment patterns. Lack of familiarity with technology increased the amount of time it took research team members and subjects to connect remotely. Patients with significant cognitive and/or sensory deficits were at higher risk of experiencing fatigue during remote study visits leading to streamlining of data collection. A researcher-developed technology screening tool found that potential subjects were not comfortable with videoconferencing through Zoom expressing a preference for phone visits. Reduced travel time made scheduling remote study visits more efficient. CONCLUSION: Future community- and home-based palliative care trials must consider the best way to utilize remote recruitment, enrollment, and data collection processes to increase efficiency and reduce costs. Researchers should consider technology accessibility and train staff to ensure the greatest possible opportunity to recruit underserved populations who have traditionally been underrepresented in research studies.

In her own words: understanding the health needs of older lesbians.

This project illuminates the unique struggles and barriers lesbians face. A community advisory board (CAB) was developed and 31 in-depth interviews were conducted with lesbians aged 56-84 in the Rocky Mountain region. Interviews were audio recorded, transcribed, and coded using critical discourse analysis. Themes included: a culture of identity-hiding; lack of recognition and discrimination in health care; channeling passion, fear, and anger into action; concerns about aging; and identified health needs and opportunities. There is a need for innovative and equitable services that understand the barriers and struggles that older lesbian adults face so they can receive high-quality care.

Arm Motor Recovery After Ischemic Stroke: A Focus on Clinically Distinct Trajectory Groups.

BACKGROUND AND PURPOSE: Recovery of arm function poststroke is highly variable with some people experiencing rapid recovery but many experiencing slower or limited functional improvement. Current stroke prediction models provide some guidance for clinicians regarding expected motor outcomes poststroke but do not address recovery rates, complicating discharge planning. This study developed a novel approach to defining recovery groups based on arm motor recovery trajectories poststroke. In addition, between-group differences in baseline characteristics and therapy hours were explored. METHODS: A retrospective cohort analysis was conducted where 40 participants with arm weakness were assessed 1 week, 6 weeks, 3 months, and 6 months after an ischemic stroke. Arm recovery trajectory groups were defined on the basis of timing of changes in the Fugl-Meyer Assessment Upper Extremity (FMA-UE), at least the minimal clinically important difference (MCID), 1 week to 6 weeks or 6 weeks to 6 months. Three recovery trajectory groups were defined: Fast (n = 19), Extended (n = 12), and Limited (n = 9). Between-group differences in baseline characteristics and therapy hours were assessed. Associations between baseline characteristics and group membership were also determined. RESULTS: Three baseline characteristics were associated with trajectory group membership: FMA-UE, NIH Stroke Scale, and Barthel Index. The Fast Recovery group received the least therapy hours 6 weeks to 6 months. No differences in therapy hours were observed between Extended and Limited Recovery groups at any time points. DISCUSSION AND CONCLUSIONS: Three clinically relevant recovery trajectory groups were defined using the FMA-UE MCID. Baseline impairment, overall stroke severity, and dependence in activities of daily living were associated with group membership and therapy hours differed between groups. Stratifying individuals by recovery trajectory early poststroke could offer additional guidance to clinicians in discharge planning.(See Supplemental Digital Content 1 for Video Abstract, available at: http://links.lww.com/JNPT/A337.).

Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Stroke: One-Year Follow-up.

Background. Vagus nerve stimulation (VNS) paired with rehabilitation may improve upper-limb impairment and function after ischemic stroke. Objective. To report 1-year safety, feasibility, adherence, and outcome data from a home exercise program paired with VNS using long-term follow-up data from a randomized double-blind study of rehabilitation therapy paired with Active VNS (n = 8) or Control VNS (n = 9). Methods. All people were implanted with a VNS device and underwent 6 weeks in clinic therapy with Control or Active VNS followed by home exercises through day 90. Thereafter, participants and investigators were unblinded. The Control VNS group then received 6 weeks in-clinic Active VNS (Cross-VNS group). All participants then performed an individualized home exercise program with self-administered Active VNS. Data from this phase are reported here. Outcome measures were Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Wolf Motor Function Test (Functional and Time), Box and Block Test, Nine-Hole Peg Test, Stroke Impact Scale, and Motor Activity Log. Results. There were no VNS treatment-related serious adverse events during the long-term therapy. Two participants discontinued prior to receiving the full crossover VNS. On average, participants performed 200 ± 63 home therapy sessions, representing device use on 57.4% of home exercise days available for each participant. Pooled analysis revealed that 1 year after randomization, the FMA-UE score increased by 9.2 points (95% CI = 4.7 to 13.7; P = .001; n = 15). Other functional measures were also improved at 1 year. Conclusions. VNS combined with rehabilitation is feasible, with good long-term adherence, and may improve arm function after ischemic stroke.

Apoyo con Cariño: A Qualitative Analysis of a Palliative Care-Focused Lay Patient Navigation Intervention for Hispanics With Advanced Cancer.

A lay patient navigator model involving a culturally tailored intervention to improve palliative care outcomes for Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado. Five home visits were delivered over 3 months to 112 patients assigned to the randomized controlled trial's intervention arm. Grounded in core Hispanic values, visits addressed palliative care domains (advance care planning, pain/symptom management, and hospice utilization). To describe the content of patient navigator visits with patients/family caregivers, research team members analyzed 4 patient navigators' field notes comprising 499 visits to 112 patients. Based on previous work, codes were established a priori to identify ways patient navigators help patients/family caregivers. Key words and comments from field notes were classified into themes using ATLAS.ti and additional codes established. Nine common themes and exemplars describing the lay patient navigator role are described: activation/empowerment, advocacy, awareness, access, building rapport, providing support, exploring barriers, symptom screening, and the patient experience. Patient navigators used advocacy, activation, education, and motivational interviewing to address patient/family concerns and reduce barriers to quality palliative care in urban and rural settings. Adapting and implementing this model across cultures has potential to improve palliative care access to underserved populations.

Community-Based Conversations about Advance Care Planning for Underserved Populations Using Lay Patient Navigators.

Background: Widespread community engagement in advance care planning (ACP) is needed to overcome barriers to ACP implementation. Objective: Develop, implement, and evaluate a model for community-based ACP in rural populations with low English language fluency and health care access using lay patient navigators. Design: A statewide initiative to improve ACP setting/subjects-trained in a group session approach, bilingual patient navigators facilitated 1-hour English and Spanish ACP sessions discussing concerns about choosing a surrogate decision maker and completing an advance directive (AD). Participants received bilingual informational materials, including Frequently Asked Questions, an AD in English or Spanish, and Goal Setting worksheet. Measurement: Participants completed a program evaluation and 4-item ACP Engagement Survey (ACP-4) postsession. Results: For 18 months, 74 ACP sessions engaged 1034 participants in urban, rural, and frontier areas of the state; 39% were ethnically diverse, 69% female. A nurse or physician co-facilitated 49% of sessions. Forty-seven percent of participants completed an ACP-4 with 29% planning to name a decision maker in the next 6 months and 21% in the next 30 days; 31% were ready to complete an AD in the next 6 months and 22% in the next 30 days. Evaluations showed 98% were satisfied with sessions. Thematic analysis of interviews with facilitators highlighted barriers to delivering an ACP community-based initiative, strategies used to build community buy-in and engagement, and ways success was measured. Conclusion: Patient navigators effectively engaged underserved and ethnically diverse rural populations in community-based settings. This model can be adapted to improve ACP in other underserved populations.

Puente para cuidar (bridge to caring): A palliative care patient navigator and counseling intervention to improve distress in Latino/as with advanced cancer.

OBJECTIVE: Interventions are needed to improve mental health (ie, depression, anxiety) and palliative care (ie, symptoms, goals of care, and advance care planning) outcomes in Latino/as with advanced cancer. METHODS: An interprofessional study team used the ecological validity model and a participatory approach to adapt an evidence-based counseling intervention for Latino/as and integrate the counseling intervention with an evidence-based patient navigator intervention. Next, a small pilot study was conducted to understand and improve the feasibility of the integrated puente para cuidar intervention. RESULTS: Adaptations were made to language, literacy, and content of the counseling intervention, and video vignettes of the counseling case studies were produced on the recommendation of Latino/a stakeholders. Bicultural, bilingual patient navigators were used as "cultural brokers" between Latino/a patients and the counselor. The pilot study of puente para cuidar demonstrated feasibility based on participant perception of helpfulness and acceptability and nearing goal visit completion rates. CONCLUSIONS: A culturally adapted intervention to address mental health and palliative care needs in Latino/as with advanced cancer was developed from prior evidenced-based interventions using a cultural adaptation model and a participatory approach. The intervention is ready for effectiveness testing.

Mixed method evaluation of Relational Team Development (RELATED) to improve team-based care for complex patients with mental illness in primary care.

BACKGROUND: Patients with mental illness are frequently treated in primary care, where Primary Care Providers (PCPs) report feeling ill-equipped to manage their care. Team-based models of care improve outcomes for patients with mental illness, but multiple barriers limit adoption. Barriers include practical issues and psychosocial factors associated with the reorganization of care. Practice facilitation can improve implementation, but does not directly address the psychosocial factors or gaps in PCP skills in managing mental illness. To address these gaps, we developed Relational Team Development (RELATED). METHODS: RELATED is an implementation strategy combining practice facilitation and psychology clinical supervision methodologies to improve implementation of team-based care. It includes PCP-level clinical coaching and a team-level practice change activity. We performed a preliminary assessment of RELATED with a convergent parallel mixed method study in 2 primary care clinics in an urban Federally Qualified Health Center in Southwest, USA, 2017-2018. Study participants included PCPs, clinic staff, and patient representatives. Clinic staff and patients were recruited for the practice change activity only. Primary outcomes were feasibility and acceptability. Feasibility was assessed as ease of recruitment and implementation. Acceptability was measured in surveys of PCPs and staff and focus groups. We conducted semi-structured focus groups with 3 participant groups in each clinic: PCPs; staff and patients; and leadership. Secondary outcomes were change in pre- post- intervention PCP self-efficacy in mental illness management and team-based care. We conducted qualitative observations to better understand clinic climate. RESULTS: We recruited 18 PCPs, 17 staff members, and 3 patient representatives. We ended recruitment early due to over recruitment. Both clinics developed and implemented practice change activities. The mean acceptability score was 3.7 (SD=0.3) on a 4-point Likert scale. PCPs had a statistically significant increase in their mental illness management self-efficacy [change = 0.9, p-value= <.01]. Focus group comments were largely positive, with PCPs requesting additional coaching. CONCLUSIONS: RELATED was feasible and highly acceptable. It led to positive changes in PCP self-efficacy in Mental Illness Management. If confirmed as an effective implementation strategy, RELATED has the potential to significantly impact implementation of evidence-based interventions for patients with mental illness in primary care.

Designing the relational team development intervention to improve management of mental health in primary care using iterative stakeholder engagement.

BACKGROUND: Team-based models of care are efficacious in improving outcomes for patients with mental and physical illnesses. However, primary care clinics have been slow to adopt these models. We used iterative stakeholder engagement to develop an intervention to improve the implementation of team-based care for this complex population. METHODS: We developed the initial framework for Relational Team Development (RELATED) from a qualitative study of Primary Care Providers' (PCPs') experiences treating mental illness and a literature review of practice facilitation and psychology clinical supervision. Subsequently, we surveyed 900 Colorado PCPs to identify factors associated with PCP self-efficacy in management of mental illness and team-based care. We then conducted two focus groups for feedback on RELATED. Lastly, we convened an expert panel to refine the intervention. RESULTS: We developed RELATED, a two-part intervention delivered by a practice facilitator with a background in clinical psychology. The facilitator observes PCPs during patient visits and provides individualized coaching. Next, the facilitator guides the primary care team through a practice change activity with a focus on relational team dynamics. CONCLUSION: The iterative development of RELATED using stakeholder engagement offers a model for the development of interventions tailored to the needs of these stakeholders. TRIAL REGISTRATION: Not applicable.

Effect of Apoyo con Cariño (Support With Caring) Trial of a Patient Navigator Intervention to Improve Palliative Care Outcomes for Latino Adults With Advanced Cancer: A Randomized Clinical Trial.

Importance: Strategies to increase access to palliative care, particularly for racial/ethnic minorities, must maximize primary palliative care and community-based models to meet the ever-growing need in a culturally sensitive and congruent manner. Objective: To investigate if a culturally tailored patient navigator intervention can improve palliative care outcomes for Latino adults with advanced cancer. Design, Setting, and Participants: The Apoyo con Cariño (Support With Caring) randomized clinical trial was conducted from July 2012 to March 2016. The setting was clinics across the state of Colorado, including an academic National Cancer Institute-designated cancer center, community cancer clinics (urban and rural), and a safety-net cancer center. Participants were adults who self-identified as Latino and were being treated for advanced cancer. Intervention: Culturally tailored patient navigator intervention. Main Outcomes and Measures: Primary outcome measures were advance care planning in the medical record, the Brief Pain Inventory, and hospice use. Secondary outcome measures included the McGill Quality of Life Questionnaire (MQOL), hospice length of stay, and aggressiveness of care at the end of life. This study used an intent-to-treat design. Results: In total, 223 Latino adults enrolled (mean [SD] age, 58.1 [13.6] years; 55.6% female) and were randomized to control (n = 111) or intervention (n = 112) groups. Intervention group patients were more likely to have a documented advance directive compared with control group patients (73 of 112 [65.2%] vs 40 of 111 [36.0%], P < .001). Both groups reported mild pain intensity (mean pain rating of 3 on a scale of 0-10). Intervention group patients had a mean (SD) reported change from baseline in the Brief Pain Inventory pain severity subscale score (range, 0-10) of 0.1 (2.6) vs 0.2 (2.7) in control group patients (P = .88) and a mean (SD) reported change from baseline in the Brief Pain Inventory pain interference subscale score of 0.1 (3.2) vs -0.2 (3.0) in control group patients (P = .66). Hospice use was similar in both groups. Secondary outcomes of overall MQOL score and aggressiveness of care at the end of life showed no significant differences between groups. The MQOL physical subscale showed a mean (SD) significant change from baseline of 1.4 (3.1) in the intervention group vs 0.1 (3.0) in the control group (P = .004). Conclusions and Relevance: The intervention had mixed results. The intervention increased advance care planning and improved physical symptoms; however, it had no effect on pain management and hospice use or overall quality of life. Further research is needed to determine the role and scope of lay navigators in palliative care. Trial Registration: ClinicalTrials.gov identifier: NCT01695382.

Apoyo con Cariño (support with caring): RCT protocol to improve palliative care outcomes for Latinos with advanced medical illness.

Latinos are more likely to experience uncontrolled pain, and institutional death, and are less likely to engage in advance care planning. Efforts to increase access to palliative care must maximize primary palliative care and community based models to meet the ever-growing need in a culturally sensitive and congruent manner. Patient navigator interventions are community-based, culturally tailored models of care that have been successfully implemented to improve disease prevention, early diagnosis, and treatment. We have developed a patient navigation intervention to improve palliative care outcomes for seriously ill Latinos. We describe the protocol for a National Institute of Nursing Research-funded randomized controlled trial designed to determine the effectiveness of the manualized patient navigator intervention. We aim to enroll 240 Latino adults with non-cancer, advanced medical illness from both urban and rural clinical sites. Participants will be randomized to the intervention group (five palliative care patient navigator visits plus bilingual educational materials) or control group (usual care plus bilingual educational materials). Outcomes include quality of life (Functional Assessment of Chronic Illness Therapy), advance care planning (Advance Care Planning Engagement survey), pain (Brief Pain Inventory), symptom management (Edmonton Symptom Assessment Scale-revised), hospice utilization, and cost and utilization of healthcare resources. This culturally tailored, evidence-based, theory-driven, innovative patient navigation intervention has significant potential to improve palliative care for Latinos, and facilitate health equity in palliative and end-of-life care.

Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke.

Background and Purpose- We assessed safety, feasibility, and potential effects of vagus nerve stimulation (VNS) paired with rehabilitation for improving arm function after chronic stroke. Methods- We performed a randomized, multisite, double-blinded, sham-controlled pilot study. All participants were implanted with a VNS device and received 6-week in-clinic rehabilitation followed by a home exercise program. Randomization was to active VNS (n=8) or control VNS (n=9) paired with rehabilitation. Outcomes were assessed at days 1, 30, and 90 post-completion of in-clinic therapy. Results- All participants completed the course of therapy. There were 3 serious adverse events related to surgery. Average FMA-UE scores increased 7.6 with active VNS and 5.3 points with control at day 1 post-in-clinic therapy (difference, 2.3 points; CI, -1.8 to 6.4; P=0.20). At day 90, mean scores increased 9.5 points from baseline with active VNS, and the control scores improved by 3.8 (difference, 5.7 points; CI, -1.4 to 11.5; P=0.055). The clinically meaningful response rate of FMA-UE at day 90 was 88% with active VNS and 33% with control VNS ( P<0.05). Conclusions- VNS paired with rehabilitation was acceptably safe and feasible in participants with upper limb motor deficit after chronic ischemic stroke. A pivotal study of this therapy is justified. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT02243020.

Apoyo con Cariño: Strategies to Promote Recruiting, Enrolling, and Retaining Latinos in a Cancer Clinical Trial.

Background: We present and describe tailored strategies to address known barriers to minority participation in clinical trial research. The strategies used allowed our team to engage communities and successfully recruit, enroll, and retain a diverse underserved population of Latinos with advanced cancer for this clinical trial. Methods: Participants were recruited from 3 urban and 7 rural sites. We identified 4 critical barriers to recruitment for this underserved population: (1) mistrust; (2) language and communication barriers; (3) lack of access to academic cancer center; and (4) inability to participate due to transportation, childcare, or work responsibilities. We developed tailored strategies to engage referring sites and patients to participate in the clinical trial. Results: We identified 318 potentially eligible participants; 34 were found to be ineligible, and 223 consented to participate in the study, representing a 79.0% enrollment rate. All patients (100%) self-identified as Latino, and 47.5% spoke Spanish as their primary language. Patients were socioeconomically disadvantaged: 53.6% had an annual income <$15,000 USD, and 50.2% had less than a high school education. A total of 177 participants completed the 3-month follow-up; 26 died before the 3-month follow interview, and 20 did not complete the follow-up evaluation (9% withdrawal rate). Conclusions: Our community-informed strategies were highly effective for recruiting, enrolling, and retaining an underserved diverse population of Latinos. The barriers we identified and the strategies we used have the potential to inform research to increase minority participation in cancer clinical trials. ClinicalTrials.gov identifier: NCT01695382.