Understanding the impact of the COVID-19 pandemic on U.S. older adults: self-reported pandemic-related concerns and consequences in a cross-sectional survey study.

Background and objectives: The purpose of this study was to explore COVID-19 pandemic-related concerns among a racially and ethnically representative sample of older adults in the U.S. Research design and methods: Participants were 501 English-speaking adults 60 years and older recruited online nationally across the U.S. from Amazon Mechanical Turk (mTurk) and Prolific Research Platforms during June of 2020. Data comes from a larger cross-sectional survey. We content analyzed open-ended responses about pandemic-related concerns and observed responses to a checklist of items created by the research team to assess for specific physical, social, and financial consequences experienced due to the pandemic. Results: A majority of the sample (92%) reported at least one pandemic-related concern, with the highest percentage expressing concerns coded as Concern for Others (28%), Physical Health (27%), Socializing (24%), Finance (15%) and Socio-Political-Economic (14%). Participants reported high concern severity (M = 4.03, SD = 1.04) about their concerns mentioned in response to the open-ended concerns question. When prompted with a checklist of items, participants frequently endorsed disruption in social activities as a consequence of the pandemic (83%), disruptions that could impact physical health (45%), and concern over finances as a consequence of the pandemic (41%). Discussion and implications: Older adults most frequently mentioned concerns about the well-being and behavior of others, one's own physical health, and the impacts of the pandemic and social distancing policies on social activities. Findings align with the Socioemotional Selectivity Theory and point to the importance of supporting older adults to maintain meaningful social engagement under conditions of a pandemic and social distancing policies.

Protocol for a collaborative randomised effectiveness trial of lay-delivered versus clinician-delivered behavioural activation in senior centres.

INTRODUCTION: Depression is common among community-dwelling older adults who make use of senior centre services yet remains undertreated due to a lack of acceptable and available treatments. Emerging evidence suggests that lay health providers can offer psychosocial interventions for mental health disorders experienced by older adults. We developed a streamlined Behavioural Activation intervention (called 'Do More, Feel Better'; DMFB) to be delivered by older adult volunteers and propose to compare its effectiveness to that of clinician-delivered behavioural activation (BA). METHODS AND ANALYSIS: This study is a type I collaborative randomised effectiveness trial testing the effect of DMFB in comparison to BA among 288 senior centre clients (aged 60+). Participant clients will be recruited from 6 Seattle, 6 New York City and 6 Tampa area senior centres serving economically and ethnically diverse communities. Primary outcomes will be increased activity level (target) and decreased depressive symptoms. Secondary outcomes will be functioning and client satisfaction, and an exploratory outcome will be treatment fidelity. ETHICS AND DISSEMINATION: The study received ethics approval from the University of Washington Institutional Review Board (STUDY00011434). Client, volunteer and clinician participants will all provide informed consent for study procedures through in-person or remote contact with investigators. Results of this study will be presented in peer-reviewed journals and at professional conferences. TRIAL REGISTRATION NUMBER: NCT04621877; ClinicalTrials.gov.

Understanding Psychological Distress and Protective Factors Amongst Older Adults During the COVID-19 Pandemic.

OBJECTIVES: This study examined the emotional distress and loneliness during COVID-19 and the roles of resiliency and activities. DESIGN: A cross-sectional national survey. SETTING: Amazon Mechanical Turk (mTurk) and Prolific Research Platforms. PARTICIPANTS: Five hundred and one U.S. dwelling English-speaking adults 60 years old and older. MEASUREMENTS: Participants completed an online survey with the PHQ-9; GAD-7; Short Health Anxiety Inventory; 3-item UCLA Loneliness scale; PROMIS measures of global health, instrumental, and emotional support; 10-item Connor-Davidson Resilience Scale; and COVID-19 needs assessment. RESULTS: Across the sample 13% reported moderate depressive symptoms, 9% reported moderate anxiety symptoms, and 26% endorsed being "lonely." The emotionally distressed group endorsed more loneliness, lower resiliency, less physical exercise, and worse physical health. The low Socio-Economic Status group endorsed less loneliness, less likely to engage in physical exercise and worse physical health.The lonely group endorsed less resilience, less physical exercise, and worse physical health. A multiple logistic regression found that resilience, socioeconomic status, and physical health were significant predictors of loneliness, whereas global health was the best predictor of emotional distress. CONCLUSIONS: Even after prolonged social distancing, older adults in this study did not report greater psychological distress compared to earlier studies of older adults during COVID-19. Older adults with lower SES, worse physical health, and less resiliency, were more likely to report more loneliness. It is this group that should be the focus of intervention.

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.

Pragmatic Quality Assessment of Brief Health Behavior Change Interventions: Evidence for Criterion-Related Validity of the Behavior Change Counseling Index.

BACKGROUND: Healthcare providers frequently engage patients in conversations about health behavior change and are encouraged to use patient-centered approaches, such as Motivational Interviewing. Training in and sustainment of these skills are known to require feedback based on actual or role-played patient encounters. The behavior change counseling index (BECCI) is a pragmatic measure to assess healthcare providers' patient-centered behavior change counseling skills that was developed as an alternative to resource-intensive "gold standard" measures, which are difficult to use in routine practice. We are not aware of any studies that examine the criterion-related validity of this measure using an alternative gold standard measure. We examined the criterion-related validity of the BECCI as rated by a simulated patient actor immediately after a brief behavior change intervention role-play using objective ratings on the motivational interviewing treatment integrity (MITI) scale. METHODS: We conducted a secondary analysis of data from a 25-site clinical trial of screening and intervention for posttraumatic stress disorder and comorbidities with patients at level I trauma centers in the USA. Participants were 64 providers representing diverse professional roles trained to deliver a multi-component intervention with study patients. As part of the training, providers role-played counseling a patient to reduce risky alcohol use with a simulated patient actor. These 20-min role-plays were conducted by telephone and audio recorded. Immediately after the role-play, the simulated patient actor rated the quality of the providers' patient-centered behavior change counseling skills using the BECCI. A third-party expert MITI rater later listened to the audio recordings of the role-plays and rated the quality of the providers' patient-centered behavior change counseling skills using the MITI 3.1.1. RESULTS: All correlations observed were statistically significant. The overall BECCI score correlated strongly (≥ 0.50) with five of the six MITI scores and moderately (0.33) with MITI percent complex reflections. CONCLUSIONS: This study provides evidence of criterion-related validity of the BECCI with a sample of healthcare providers representing a range of professional roles. Simulated patient actor rating using the BECCI is a pragmatic approach to assessing the quality of brief behavior change interventions delivered by healthcare providers.

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.

Evaluation of a Level I trauma center provider training in patient-centered alcohol brief interventions using the Behavior Change Counseling Index rated by standardized patients.

BACKGROUND: Traumatic injury requiring hospitalization is common in the USA and frequently related to alcohol consumption. The American College of Surgeons requires that Level I and II verified trauma centers implement universal alcohol screening and brief intervention for injured patients. We examined whether Level I trauma center provider skill in patient-centered alcohol brief interventions improved after training and whether professional role (eg, nursing, social work) and education were associated with these skills. METHODS: We present evaluation data collected as part of training in alcohol brief interventions embedded within a larger clinical trial of a collaborative care intervention targeting posttraumatic stress disorder and related comorbidities. Sixty-five providers from 25 US Level I trauma centers engaged in a 1-day workshop, with 2 hours dedicated to training in patient-centered alcohol brief interventions followed by 6 months of weekly coaching in a collaborative care model. Providers completed standardized patient role-plays prior to and 6 months after the workshop training. The standardized patient actors rated provider quality of alcohol brief interventions immediately after each role-play using the Behavior Change Counseling Index (BECCI), a pragmatic measure designed to assess the quality of behavior change counseling, an adaptation of motivational interviewing suitable for brief healthcare consultations about behavior change. RESULTS: Seventy-two percent of providers completed both standardized patient role-play assessments. A statistically significant improvement in overall BECCI scores (t(41)=-2.53, p=0.02, Cohen's d=-0.39) was observed among those providers with available pre-post data. Provider professional role was associated with BECCI scores at pre-training (F(3, 58)=11.25, p<0.01) and post-training (F(3, 41)=8.10, p<0.01). DISCUSSION: Findings underscore the need for training in patient-centered alcohol brief interventions and suggest that even a modest training helps providers engage in a more patient-centered way during a role-play assessment. LEVEL OF EVIDENCE: Level V, therapeutic/care management.