Patient-Centered Framework for Rehabilitation Research in Outpatient Settings.

Conducting high-quality clinical research is dependent on merging scientific rigor with the clinical environment. This is often a complex endeavor that may include numerous barriers and competing interests. Overcoming these challenges and successfully integrating clinical research programs into clinical practice settings serving rehabilitation outpatients is beneficial from both a logistical perspective (eg, supports efficient and successful research procedures) and the establishment of a truly patient-centered research approach. Leveraging our experience with navigating this research-clinical care relationship, this article (1) proposes the Patient-Centered Framework for Rehabilitation Research, a model for integrating patient-centered research in an outpatient clinical setting that incorporates a collaborative, team-based model encompassing patient-centered values, as well as strategies for recruitment and retention, with a focus on populations living with disabilities or chronic diseases; (2) describes application of this framework in a comprehensive specialty multiple sclerosis center with both general strategies and specific examples to guide adaptation and implementation in other settings; and (3) discusses the effect of the framework as a model in 1 center, as well as the need for additional investigation and adaptation for other populations. The 5 interconnected principles incorporated in the Framework and which prioritize patient-centeredness include identifying shared values, partnering with the clinical setting, engaging with the population, building relationships with individuals, and designing accessible procedures. The Patient-Centered Framework for Rehabilitation Research is a model presented as an adaptable roadmap to guide researchers in hopes of not only improving individual patients' experiences but also the quality and relevance of rehabilitation research as a whole. Future investigation is needed to test the Framework in other settings.

Adaptation and study protocol of the evidence-based Make Better Choices (MBC2) multiple diet and activity change intervention for a rural Appalachian population.

BACKGROUND: Rural Appalachian residents experience among the highest prevalence of chronic disease, premature mortality, and decreased life expectancy in the nation. Addressing these growing inequities while avoiding duplicating existing programming necessitates the development of appropriate adaptations of evidence-based lifestyle interventions. Yet few published articles explicate how to accomplish such contextual and cultural adaptation. METHODS: In this paper, we describe the process of adapting the Make Better Choices 2 (MBC2) mHealth diet and activity randomized trial and the revised protocol for intervention implementation in rural Appalachia. Deploying the NIH's Cultural Framework on Health and Aaron's Adaptation framework, the iterative adaptation process included convening focus groups (N = 4, 38 participants), conducting key informant interviews (N = 16), verifying findings with our Community Advisory Board (N = 9), and deploying usability surveys (N = 8), wireframing (N = 8), and pilot testing (N = 9. This intense process resulted in a comprehensive revision of recruitment, retention, assessment, and intervention components. For the main trial, 350 participants will be randomized to receive either the multicomponent MBC2 diet and activity intervention or an active control condition (stress and sleep management). The main outcome is a composite score of four behavioral outcomes: two outcomes related to diet (increased fruits and vegetables and decreased saturated fat intake) and two related to activity (increased moderate vigorous physical activity [MVPA] and decreased time spent on sedentary activities). Secondary outcomes include change in biomarkers, including blood pressure, lipids, A1C, waist circumference, and BMI. DISCUSSION: Adaptation and implementation of evidence-based interventions is necessary to ensure efficacious contextually and culturally appropriate health services and programs, particularly for underserved and vulnerable populations. This article describes the development process of an adapted, community-embedded health intervention and the final protocol created to improve health behavior and, ultimately, advance health equity. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT04309461. The trial was registered on 6/3/2020.

Experiences of Family Caregivers After an Acute Neurological Event.

BACKGROUND: Family of patients hospitalized in an intensive care unit (ICU) often immediately assume the role of caregiver to an individual with significant health care needs. The transition into this caregiver role may be sudden and unexpected; their experiences are not well understood. The purpose of this qualitative study was to explore experiences of family caregivers in the neurocritical care unit in order to identify areas for enhancing patient- and family-centered care. METHODS: This single-center ethnographic study explored the use of systems theory to investigate the perceptions, experiences, and attitudes of family/caregivers regarding their relationships and interactions between the patient, other family, members of the healthcare provider team, and health system after an acute neurological event in Argentina. Field notes from 9 weeks of direct observation together with transcripts from nine semi-structured interviews (transcribed verbatim and translated from Spanish to English) were analyzed using a grounded theory approach. RESULTS: Nine themes emerged based on iterative thematic analysis, including: adjusting to a changed life, managing emotions, changing role, relying on faith, redefining recovery, participating in patient care, depending on clinical experts, el tratohumano, and finding unity in purpose. In the neurocritical care environment, an important intermediary role exists for family/caregivers and the patient, other family, and healthcare providers. CONCLUSIONS: The results demonstrate the potential for family, providers, and the health system to influence family/caregivers' experience with neurocritical care. Involving families as part of the care team could have implications for patient- and family-centered care.

Ethical and Regulatory Considerations for Using Social Media Platforms to Locate and Track Research Participants.

As social media becomes increasingly popular, human subjects researchers are able to use these platforms to locate, track, and communicate with study participants, thereby increasing participant retention and the generalizability and validity of research. The use of social media; however, raises novel ethical and regulatory issues that have received limited attention in the literature and federal regulations. We review research ethics and regulations and outline the implications for maintaining participant privacy, respecting participant autonomy, and promoting researcher transparency when using social media to locate and track participants. We offer a rubric that can be used in future studies to determine ethical and regulation-consistent use of social media platforms and illustrate the rubric using our study team's experience with Facebook. We also offer recommendations for both researchers and institutional review boards that emphasize the importance of well-described procedures for social media use as part of informed consent.

Community engagement through social media: A promising low-cost strategy for rural recruitment?

PURPOSE: For the same reasons that rural telehealth has shown promise for enhancing the provision of care in underserved environments, social media recruitment may facilitate more inclusive research engagement in rural areas. However, little research has examined social media recruitment in the rural context, and few studies have evaluated the feasibility of using a free social media page to build a network of rural community members who may be interested in a research study. Here, we describe the rationale, process, and protocols of developing and implementing a social media approach to recruit rural residents to participate in an mHealth intervention. METHODS: Informed by extensive formative research, we created a study Facebook page emphasizing community engagement in an mHealth behavioral intervention. We distributed the page to local networks and regularly posted recruitment and community messages. We collected data on the reach of the Facebook page, interaction with our messages, and initiations of our study intake survey. FINDINGS: Over 21 weeks, our Facebook page gained 429 followers, and Facebook users interacted with our social media messages 3,080 times. Compared to messages that described desirable study features, messages that described community involvement resulted in higher levels of online interaction. Social media and other recruitment approaches resulted in 225 people initiating our in-take survey, 9 enrolling in our pilot study, and 26 placing their names on a waiting list. CONCLUSIONS: A standalone social media page highlighting community involvement shows promise for recruiting in rural areas.

Nationwide Survey of Trauma Center Screening and Intervention Practices for Posttraumatic Stress Disorder, Firearm Violence, Mental Health, and Substance Use Disorders.

BACKGROUND: Posttraumatic stress disorder (PTSD) symptoms, firearm violence events, alcohol and drug use problems, and major depression and suicidal ideation are endemic among patients admitted to US trauma centers. Despite increasing policy importance, the current availability of screening and intervention services for this constellation of conditions in US trauma centers is unknown. STUDY DESIGN: Trauma program staff at all Level I and Level II trauma centers in the US. (N = 627) were contacted to complete a survey describing screening and intervention procedures for alcohol and drug use problems, PTSD symptoms, depression and suicidality, and firearm violence. Additional questions asked trauma centers about the delivery of peer interventions and information technology capacity for screening and intervention procedures. RESULTS: Fifty-one percent of trauma centers (n = 322) responded to the survey. More than 95% of responding sites endorsed routinely screening and/or intervening for alcohol use problems. Routine services addressing PTSD were less common, with 28% of centers reporting routine screening. More than 50% of sites that screened for PTSD used previously established trauma center alcohol use services. Programmatic screening and intervention for firearm injury sequelae was occurring at 30% of sites. CONCLUSION: Alcohol screening and intervention is occurring frequently at US trauma centers and appears to be responsive to American College of Surgeons Committee on Trauma verification requirements. Routine screening and intervention services for PTSD and firearm injury were occurring less frequently. Regular national surveys may be a key element of tracking progress in national mental health and substance use screening, intervention, and referral policy.

Public health adherence and information-seeking for people with chronic conditions during the early phase of the COVID-19 pandemic.

INTRODUCTION: People with chronic conditions, common among rehabilitation populations, may have risk factors that put them at higher risk for more severe illness due to coronavirus disease 2019 (COVID-19). OBJECTIVE: To describe and compare adherence to public health guidelines, willingness to adhere to public health guidelines (including vaccination), information-seeking, and perceived trustworthiness of information among people with and without chronic conditions during the early stages of the COVID-19 pandemic. DESIGN: National cross-sectional online survey of people with and without chronic health conditions conducted from April through May 2020. PARTICIPANTS: Survey respondents were people with and without chronic conditions, ≥18 years old, able to read English, and in the United States since January 2020. In total, 3109 survey responses were received and 2572 complete unique responses were used in the analysis. METHODS: The survey assessed demographics, adherence to public health measures, information-seeking, and perceived trustworthiness of information sources. Descriptive analyses characterized the sample, and t-tests and nonparametric tests were used to compare those with and without a chronic condition on the public health measures. RESULTS: Participants with a chronic condition reported high adherence to public health recommendations and high willingness to adhere to anticipated recommendations across a wide range of chronic conditions and similar to those without a chronic condition despite advised caution for people with underlying health conditions. Of those with a chronic condition, 70.8% reported a willingness to be vaccinated. Participants reported accessing information from varied sources, with perceived trust highest for the health care providers and lowest for social media. CONCLUSION: Participants reported high adherence to public health measures, regardless of chronic condition status, during the early phase of the COVID-19 pandemic. Knowledge of adherence to public health measures, information-seeking, and trust in information can assist rehabilitation providers and organizations seeking to mitigate disease transmission, particularly for those with chronic conditions.

COVID-19 vaccine hesitancy in adults with multiple sclerosis in the United States: A follow up survey during the initial vaccine rollout in 2021.

BACKGROUND: Multiple sclerosis (MS) organizations have recommended that adults with MS obtain the COVID-19 vaccination. Vaccine hesitancy is a barrier to full COVID-19 inoculation in the general population. Whether vaccine hesitancy is also a barrier towards optimizing vaccination rates in the MS community is unknown. To investigate vaccine hesitancy and inform efforts to increase vaccine uptake in the MS population, we conducted a follow up survey of a national sample of adults with MS living in the United States who completed an initial survey early in the COVID-19 pandemic. The current study aimed to answer questions vital to understanding vaccine hesitancy, specifically: (1) What is the prevalence of COVID-19 vaccine hesitancy in early 2021? (2) What are the reasons for and factors associated with current hesitancy? (3) How has vaccine willingness and hesitancy changed from April/May 2020 to January/February 2021? and (4) Who has changed in their vaccine willingness? METHODS: Adults with MS living in the United States (N = 359) completed two online surveys (the first between 10 April 2020 and 06 May 2020; the second between 11 January 2021 and 08 February 2021) about their willingness and intent to obtain a COVID-19 vaccine. Participants also completed measures to assess factors potentially related to vaccine hesitancy, including demographics, MS variables, influenza vaccine history, vaccine concerns, and contextual factors, including perceived risk for SARS-CoV-2 infection, trust in COVID-19 information source, anxiety, and loneliness. RESULTS: Of the participants who completed the second survey in early 2021, 20.3% were vaccine hesitant, that is, either reporting that they were undecided (13.9%) or not intending to get vaccinated (6.4%). Vaccine hesitancy decreased between the two surveys, with nearly three-fourths (73.8%) of the second sample reporting that they planned to obtain the COVID-19 vaccine. Vaccine hesitancy was associated with having a lower level of education, being non-White, not having a recent flu vaccination, holding a lower perception of one's risk of getting COVID-19, and having lower trust in the Centers for Disease Control and Prevention. Participants who were vaccine hesitant reported concerns about the long-term effects of the vaccine, the vaccine approval process, and the potential impact of the vaccine given their own health conditions/history. Notably, 90% of the undecided group wanted additional information about the vaccine before deciding. Vaccine willingness changed over time, with many of those who were somewhat willing more willing to get the COVID-19 vaccine at survey 2. Individuals who were unwilling at survey 1 were highly likely to remain unwilling at survey 2. CONCLUSION: Overall, COVID-19 vaccine hesitancy decreased during the pandemic, although one in five adults with MS were hesitant in early 2021. Of those who were undecided, most indicated that they wanted additional information about the vaccine before deciding whether to be vaccinated, suggesting additional educational efforts on the vaccine's safety, long-term effects, and potential health implications are still needed. Findings indicate that public health efforts may be best focused on those who are undecided, whose vaccine hesitancy may change over time and, possibly, with appropriate information or intervention.

Willingness to obtain COVID-19 vaccination in adults with multiple sclerosis in the United States.

BACKGROUND: As vaccines for the coronavirus become available, it will be important to know the rate of COVID-19 vaccine acceptability in adults with multiple sclerosis (MS), given that vaccination will be a key strategy for preventing SARS-CoV-2 infections. Using a national sample of adults with MS in the United States obtained early in the COVID-19 pandemic, the current study aimed to: (1) assess willingness to get a COVID-19 vaccine when available; (2) determine demographic, MS, and psychosocial correlates of vaccine willingness; and (3) measure where people with MS get their COVID-19 information and their perceived trustworthiness of such sources, which may influence COVID-19 vaccine willingness. METHODS: Adults with MS (N = 486) living in the United States completed a cross-sectional online survey (between 10 April 2020 and 06 May 2020) about their willingness to receive a COVID-19 vaccination once available. Participants also completed measures to describe the sample and to assess factors potentially related to vaccine willingness, including demographics, MS-specific variables, psychological measures, COVID-19 information sources, and perceived trustworthiness of their information sources. RESULTS: Approximately two-thirds of the participants (66.0%) reported a willingness to obtain a future COVID-19 vaccine, whereas 15.4%of the sample was unwilling. Greater willingness to receive the vaccine was associated with having a higher level of education and holding a higher perception of one's risk of catching COVID-19. Participants reported accessing COVID-19 information from many different sources. Approximately a third (31.6%) of the sample reported getting their information from healthcare providers. Healthcare providers and the National MS Society had the highest perceived trustworthiness for COVID-19 information. The perceived trustworthiness of information sources was highly associated with vaccine willingness. CONCLUSION: Early in the pandemic, willingness to get a COVID-19 vaccine was not universal in this large sample or people living with MS. Vaccine willingness was associated with a few variables including education level, perceived risk for COVID-19 infection, and trust in COVID-19 information sources. These results have important implications for guiding healthcare providers and the MS community as COVID-19 vaccines become widely available.

Distress and risk perception in people living with multiple sclerosis during the early phase of the COVID-19 pandemic.

BACKGROUND: People living with MS during COVID-19 are experiencing the disruptions of the pandemic and concerns that their health status may place them at greater risk for worse COVID-19 outcomes. OBJECTIVE: This study sought to understand how people living with MS in the United States experienced distress and perceived their COVID-19-related risk during the first surge of the pandemic. METHODS: This was a web-based, self-report survey of people with MS who were living in the United States during the early stage of COVID-19. Primary outcomes were depression, anxiety, and positive-affect and well-being. Participants (N = 491) also provided data on demographics, MS-related factors, COVID-19 factors, and psychological coping. RESULTS: Psychological distress was associated with age, psychological coping strategies, and having had symptoms consistent with COVID-19, but not with MS disease-related variables and COVID-19 risk factors. Perception of COVID-19-related risk was associated with age, MS disease severity, COVID-19-related factors, and anxiety. CONCLUSION: This study demonstrated that even during COVID-19, distress and risk perception are primarily driven by psychological factors, experiencing symptoms consistent with COVID-19 and age, with minimal contribution from individual differences in health status, providing an impetus for continued efforts to optimize psychological interventions for people living with MS.

Stepped Collaborative Care Targeting Posttraumatic Stress Disorder Symptoms and Comorbidity for US Trauma Care Systems: A Randomized Clinical Trial.

Importance: To date, few multisite investigations have evaluated early interventions for injured patients with posttraumatic stress disorder (PTSD) symptoms. Objective: To simultaneously assess the effectiveness and implementation of a brief stepped collaborative care intervention targeting PTSD and comorbidity. Design, Setting, and Participants: A stepped-wedge cluster randomized clinical trial was conducted at 25 US level I trauma centers. Participants included hospitalized survivors of physical injury who underwent a 2-step evaluation for PTSD symptoms. Patients reporting high levels of distress on the PTSD Checklist (PCL-C) were randomized (N = 635) per the stepped-wedge protocol to enhanced usual care control (n = 370) or intervention (n = 265) conditions. The study was conducted from January 4, 2016, through November 2018. Data analysis was performed from November 4, 2019, to December 8, 2020. Interventions: The Trauma Survivors Outcomes and Support collaborative care intervention included proactive injury case management that assisted patients transitioning from hospital inpatient to outpatient and community settings. The intervention also integrated evidence-based pharmacotherapy and psychotherapeutic elements targeting PTSD symptoms and comorbidity. Main Outcomes and Measures: The primary study outcome was PTSD symptoms assessed with the PCL-C at baseline in the surgical ward and at 3, 6, and 12 months postinjury. Secondary outcomes included depressive symptoms, alcohol use, and physical function. Subgroup analyses examined the effect of baseline risk factors for enduring PTSD and quality of protocol implementation on study outcomes. Primary statistical analyses were conducted using the intent-to-treat sample. Results: A total of 327 men (51.5%) were included in analysis; mean (SD) age was 39.0 (14.2) years. The investigation attained follow-up of 75% to 80% of the participants at 3 to 12 months. The intervention lasted a mean (SD) of 122 (132) minutes. Mixed model regression analyses revealed statistically significant changes in PCL-C scores for intervention patients compared with control patients at 6 months (difference, -2.57; 95% CI, -5.12 to -0.03; effect size, 0.18; P < .05) but not 12 months (difference, -1.27; 95% CI, -4.26 to 1.73; effect size, 0.08; P = .35). Subgroup analyses revealed larger PTSD treatment effects for patients with 3 or more baseline risk factors for enduring PTSD and for patients, including firearm injury survivors, treated at trauma centers with good or excellent protocol implementation. Intervention effects for secondary outcomes did not attain statistical significance. Conclusions and Relevance: A brief stepped collaborative care intervention was associated with significant 6-month but not 12-month PTSD symptom reductions. Greater baseline PTSD risk and good or excellent trauma center protocol implementation were associated with larger PTSD treatment effects. Orchestrated efforts targeting policy and funding should systematically incorporate the study findings into national trauma center requirements and verification criteria. Trial Registration: ClinicalTrials.gov Identifier: NCT02655354.

Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight.

The implementation of pragmatic clinical trials (PCTs) can be accompanied by unique regulatory challenges. In this paper, we describe the experience and management of regulatory noncompliance during a 25-site acute care PCT. During the trial, the study team conducted a comprehensive audit of all enrollment forms (informed consent and Health Insurance Portability and Accountability Act authorization forms) and related study documentation. A review of 997 participants' enrollment forms identified 138 (13.8%) that required reporting to the institutional review board due to noncompliance. To prevent subsequent noncompliance, the study team developed and introduced a revised participant tracking system, reviewed all enrollment documentation, and retrained sites regarding study procedures. Based on these experiences, we developed a set of recommendations for future PCTs to ensure both operational success and regulatory compliance.