Developing the Opioid Rapid Response System™ for Lay Citizen Response to the Opioid Overdose Crisis: a Randomized Controlled Trial.

Emergency responders face challenges in arriving timely to administer naloxone in opioid overdoses. Therefore, interest in having lay citizens administer naloxone nasal spray has emerged. These citizens, however, must be recruited and trained, and be in proximity to the overdose. This study aimed to develop the Opioid Rapid Response System (ORRS)tm to meet this need by developing a system to recruit and train citizen responders and evaluate outcomes in a randomized clinical trial. ORRS recruitment messages and training platform were developed iteratively and then outcomes for each were evaluated in a randomized, unblinded two-arm waitlist-controlled trial. ORRS was field tested in 5 Indiana counties, recruiting adult citizen responders (age 18 or older) who did not self-identity as a certified first responder. Participants were recruited using either personal or communal messages and then randomly assigned to online naloxone training and waitlisted-control conditions. Pre- and post-surveys were administered online to measure the exposure to recruitment messages and training effects on knowledge of opioid overdose, confidence responding, concerns about responding, and intent to respond. Of the 220 randomized participants (114 training, 106 waitlisted-control), 140 were analyzed (59 training, 81 waitlisted-control). Recruited participants more frequently identified with communal appeal than with the personal appeal (chi-square = 53.5; p < 0.0001). Between-group differences for intervention effects were significant for knowledge of overdose signs (Cohen's d = 1.17), knowledge of overdose management (d = 1.72), self-efficacy (d = 1.39), and concerns (d = 1.31), but not for intent (d = 0.17), which suffered from a ceiling effect. ORRS provides stronger support for efficacy than that reported for other training interventions and the digital modality eases rapid dissemination.Trial Registration: NCT04589676.

Peripartum women's perspectives on research study participation in the OneFlorida Clinical Research Consortium during COVID-19 pandemic.

Introduction: The COVID-19 pandemic created an unprecedented need for population-level clinical trials focused on the discovery of life-saving therapies and treatments. However, there is limited information on perception of research participation among perinatal populations, a population of particular interest during the pandemic. Methods: Eligible respondents were 18 years or older, were currently pregnant or had an infant (≤12 months old), and lived in Florida within 50 miles of sites participating in the OneFlorida Clinical Research Consortium. Respondents were recruited via Qualtrics panels between April and September 2020. Respondents completed survey items about barriers and facilitators to participation and answered sociodemographic questions. Results: Of 533 respondents, most were between 25 and 34 years of age (n = 259, 49%) and identified as White (n = 303, 47%) and non-Hispanic (n = 344, 65%). Facebook was the most popular social media platform among our respondents. The most common barriers to research participation included poor explanation of study goals, discomforts to the infant, and time commitment. Recruitment through healthcare providers was perceived as the best way to learn about clinical research studies. When considering research participation, "myself" had the greatest influence, followed by familial ties. Noninvasive biological samples were highly acceptable. Hispanics had higher positive perspectives on willingness to participate in a randomized study (p = 0.009). Education (p = 0.007) had significant effects on willingness to release personal health information. Conclusion: When recruiting women during the pregnancy and postpartum periods for perinatal studies, investigators should consider protocols that account for common barriers and preferred study information sources. Social media-based recruitment is worthy of adoption.

Parental Memorable Messages about Depression: Implications for Perceived Support, Stigma, Relational Satisfaction, and Treatment-Seeking among Young Adults with Depression.

Using a memorable message framework, we explored the content of parental memorable messages about depression and differences in perceptions of parental social support and stigma, relational satisfaction, and depression treatment-seeking among young adults diagnosed with depression (N= 128) based on message type (i.e., content). Thematic analyses revealed seven prominent categories of parental memorable messages about depression (e.g., We will be there, Depression isn't real). Young adult's perceptions of parental support, stigma, and relational satisfaction differed based on message type, though differences in treatment-seeking based on message type were non-significant. Our findings illuminate the significance of parental communication about depression and how the content of messages about depression are linked to perceptions of parental support, stigma, and relational satisfaction among young adult with depression. Theoretical and practical implications, limitations, and future directions are also discussed.

Can virtual human clinicians help close the gap in colorectal cancer screening for rural adults in the United States? The influence of rural identity on perceptions of virtual human clinicians.

Rural adults experience disparities in colorectal cancer screening, a trend even more distinct among rural Black adults. Healthcare disruptions caused by COVID-19 exacerbated inequities, heightening attention on virtual communication strategies to increase screening. Yet little is known about how rural adults perceive virtual human clinicians (VHCs). Given that identifying as rural influences perceived source credibility often through appearance judgments, the goal of this pilot was to explore how to develop VHCs that individuals highly identified with rurality find attractive. Between November 2018 and April 2019, we tested a culturally tailored, VHC-led telehealth intervention delivering evidence-based colorectal cancer prevention education with White and Black adults (N = 2079) in the United States recruited through an online panel who were non-adherent to screening guidelines and between 50 and 73 years of age. Participants were randomized on three factors (VHC race-matching, VHC gender-matching, Intervention type). Ordinal logistic regression models examined VHC appearance ratings. Participants with a high rural identity (AOR = 1.12, CI = [1.02, 1.23], p =.02) rated the VHCs more attractive. High rural belonging influenced VHC attractiveness for Black participants (AOR = 1.22, CI = [1.03, 1.44], p =.02). Also, Black participants interacting with a Black VHC and reporting high rural self-concept rated the VHC as more attractive (AOR = 2.22, CI = [1.27, 3.91], p =.01). Findings suggest adults for whom rural identity is important have more positive impressions of VHC attractiveness. For patients with strong rural identities, enhancing VHC appearance is critical to tailoring colorectal cancer prevention interventions.

Engaging Institutional Stakeholders to Develop and Implement Guidelines for Recruiting Participants in Research Studies Using Social Media: Mixed Methods, Multi-Phase Process.

BACKGROUND: Limited regulatory guidance surrounding the use of social media channels for participant recruitment is an interdisciplinary challenge. Establishing stakeholder-informed procedures is essential for ethical and effective use of social media for participant recruitment. OBJECTIVE: This study aims to provide replicable procedures for developing and implementing guidelines for using social media to recruit participants in research studies. METHODS: Social media use cases at the university were used to identify institutional stakeholders for the initiative. After establishing workflow procedures, a scoping review of web-based materials about recruitment and research on the internet and social media from 19 peer institutions and 2 federal agencies was conducted to inform the structure of the policies and procedures. End users (investigators and study coordinators; N=14) also provided feedback on the policies and procedures and implementation. RESULTS: Representatives (n=7) from 5 institutional offices and 15 subject-matter experts from 5 areas were identified as stakeholders in the development of policies and procedures. Peers with web-based materials (n=16) identified in the scoping review revealed 4 themes that served as a basis for developing our policies and procedures. End user feedback further informed the policies and procedures and implementation. A centrally managed social media account for communicating with participants and hosting advertising campaigns on social media was also established and, when combined with the policies and procedures, resulted in 39 advertising campaigns, and 2846 participants were enrolled in health and clinical research studies. CONCLUSIONS: Our policies and procedures allow research teams to harness the potential of social media to increase study recruitment and participation; the transparent, stakeholder-informed process can be replicated by institutional administrators to establish policies and procedures that meet the interests and needs of their research community.

Perspectives of Pregnant and Breastfeeding Women on Participating in Longitudinal Mother-Baby Studies Involving Electronic Health Records: Qualitative Study.

BACKGROUND: Electronic health records (EHRs) hold great potential for longitudinal mother-baby studies, ranging from assessing study feasibility to facilitating patient recruitment to streamlining study visits and data collection. Existing studies on the perspectives of pregnant and breastfeeding women on EHR use have been limited to the use of EHRs to engage in health care rather than to participate in research. OBJECTIVE: The aim of this study is to explore the perspectives of pregnant and breastfeeding women on releasing their own and their infants' EHR data for longitudinal research to identify factors affecting their willingness to participate in research. METHODS: We conducted semistructured interviews with pregnant or breastfeeding women from Alachua County, Florida. Participants were asked about their familiarity with EHRs and EHR patient portals, their comfort with releasing maternal and infant EHR data to researchers, the length of time of the data release, and whether individual research test results should be included in the EHR. The interviews were transcribed verbatim. Transcripts were organized and coded using the NVivo 12 software (QSR International), and coded data were thematically analyzed using constant comparison. RESULTS: Participants included 29 pregnant or breastfeeding women aged between 22 and 39 years. More than half of the sample had at least an associate degree or higher. Nearly all participants (27/29, 93%) were familiar with EHRs and had experience accessing an EHR patient portal. Less than half of the participants (12/29, 41%) were willing to make EHR data available to researchers for the duration of a study or longer. Participants' concerns about sharing EHRs for research purposes emerged in 3 thematic domains: privacy and confidentiality, transparency by the research team, and surrogate decision-making on behalf of infants. The potential release of sensitive or stigmatizing information, such as mental or sexual health history, was considered in the decisions to release EHRs. Some participants viewed the simultaneous use of their EHRs for both health care and research as potentially beneficial, whereas others expressed concerns about mixing their health care with research. CONCLUSIONS: This exploratory study indicates that pregnant and breastfeeding women may be willing to release EHR data to researchers if researchers adequately address their concerns regarding the study design, communication, and data management. Pregnant and breastfeeding women should be included in EHR-based research as long as researchers are prepared to address their concerns.

Perspectives of pregnant and breastfeeding women on longitudinal clinical studies that require non-invasive biospecimen collection - a qualitative study.

BACKGROUND: Investigation of the microbiome during early life has stimulated an increasing number of cohort studies in pregnant and breastfeeding women that require non-invasive biospecimen collection. The objective of this study was to explore pregnant and breastfeeding women's perspectives on longitudinal clinical studies that require non-invasive biospecimen collection and how they relate to study logistics and research participation. METHODS: We completed in-depth semi-structured interviews with 40 women who were either pregnant (n = 20) or breastfeeding (n = 20) to identify their understanding of longitudinal clinical research, the motivations and barriers to their participation in such research, and their preferences for providing non-invasive biospecimen samples. RESULTS: Perspectives on research participation were focused on breastfeeding and perinatal education. Participants cited direct benefits of research participation that included flexible childcare, lactation support, and incentives and compensation. Healthcare providers, physician offices, and social media were cited as credible sources and channels for recruitment. Participants viewed lengthy study visits and child protection as the primary barriers to research participation. The barriers to biospecimen collection were centered on stool sampling, inadequate instructions, and drop-off convenience. CONCLUSION: Women in this study were interested in participating in clinical studies that require non-invasive biospecimen collection, and motivations to participate center on breastfeeding and the potential to make a scientific contribution that helps others. Effectively recruiting pregnant or breastfeeding participants for longitudinal microbiome studies requires protocols that account for participant interests and consideration for their time.

Measuring health information seeking challenges in chronic disease: A psychometric analysis of a brief scale.

Information seeking is a cornerstone of patient activation in chronic disease self-management. To date, there are few brief and literacy-sensitive tools to measure intrinsic barriers of health information seeking. The Health Information National Trends Survey includes four items from the Information Seeking Experiences scale to measure frustration, effort, concern, and comprehension of information sought during a recent medical/health information search. Limited evidence exists for its construct validity and use in primary data collection in chronic disease. This measurement study examines the psychometric properties of the scale. Qualtrics Panelists with at least one chronic disease (N = 684) participated in an online survey. The average score was M = 12.85 (SD = 3.97), indicating a moderate degree of health information seeking challenges. Confirmatory factor analysis of data collected using this scale supported unidimensionality (RMSEA = .03; CFI/TLI = .99/.99). There was adequate scale (ω = .83) and item (value = .98) reliabilities. Rasch analyses showed optimal measurement error and response predictability with item-fit (values = .80-1.20). Response option "agree" was less likely to be selected than any other response option, although not posing a threat to scale reliability. Results demonstrate that this brief scale has sufficient measurement properties for its use as a measure of intrinsic health information seeking barriers among patients with chronic disease.

Communication strategies for designing Facebook advertising campaigns to recruit rural participants to develop healthcare delivery interventions.

BACKGROUND: Little is known about designing research recruitment campaigns that connect with underserved, geographically isolated rural populations. A theoretically informed process is needed to assist research teams and practitioners in their evaluation of Facebook's feasibility as a recruitment tool and development of online materials for recruiting rural adults into healthcare delivery intervention development studies. METHODS: We drew from research and theory in communication and incorporated process analysis techniques to develop replicable procedures for designing and evaluating Facebook campaigns for rural recruitment. We describe our process and illustrate using two case studies. RESULTS: Campaigns received approximately 1000 link clicks from the target rural demographic and successfully enrolled participants using Facebook as a primary method of recruitment. The rural tobacco intervention development study received a total of 477 link clicks, cost only $155.80, and enrolled three (23%) of its 13 participants from Facebook. The rural mental health intervention development study received a total of 518 link clicks, cost only $233.28, and enrolled 178 participants. CONCLUSIONS: Our process yielded two successful recruitment campaigns. Facebook was an affordable and efficacious strategy for enrolling adults in behavioral research studies on tobacco and mental health. Future work should apply these theoretical techniques to additional study topics and evaluate specific message features associated with recruitment.

A Qualitative Study of Pregnant Women's Perspectives on Antibiotic Use for Mom and Child: Implications for Developing Tailored Health Education Interventions.

The overutilization of antibiotics during pregnancy and early life are associated with adverse health outcomes for mothers and infants. In this study, we explored pregnant women's opinions and concerns of antibiotics and how perceptions may affect their health-related decision-making. We conducted 18 in-depth, semi-structured interviews with pregnant women and used the Health Belief Model (HBM) as a framework to analyze the data. We found that mothers generally understood the benefits of antibiotics and were aware that antibiotics are clinically effective for treating bacterial infections. Importantly, perceived barriers related to antibiotic use included concerns regarding the impact of antibiotics on breastfeeding efficacy, microbial health, and societal factors such as antimicrobial resistance. The prescription of antibiotics by a healthcare provider was a cue to action for women, as they trusted providers to recommend medications that were safe for them and their infants. Overall, mothers shared that receiving education on the effects of antibiotics would improve their self-efficacy and decision-making surrounding the use of antibiotics for treating illness. Implications for tailored perinatal health education interventions to enhance antibiotic use, knowledge, and decision-making are discussed.

Audience segmentation as a strategy for enhancing the use of research registries for recruiting patients into clinical trials.

INTRODUCTION: Health research registries have great potential to increase awareness of research opportunities among diverse patient populations and reduce disparities in clinical trial accrual. However, little research has focused on patients' intentions to participate in clinical trials once they are enrolled in the registry and their intentions to remain in the registry over time. METHODS: Patients (N = 312) enrolled in a university-based health research registry (i.e., Consent2Share) in the southeastern region of the US participated in an online survey. RESULTS: Health research registry knowledge, perceived values, self-efficacy, trust, having chronic health concerns, and consent recall were positively correlated with intentions to remain enrolled in the research registry and participate in future clinical trials. Health research registry consent recall had significant positive associations with registry knowledge, perceived values, trust, registry retention, and participating in future trials. CONCLUSION: The process of consenting patients to the health research registry is important for recruitment, registry retention, and participation in future clinical trials. We identified key points of emphasis to expand participation in research registries as a strategy to increase clinical trial enrollment, such as deploying precision messages and tailored interventions.

A Pilot Study Determining Comprehension and the Acceptability of a Cancer Research Study Website for Cancer Patients and Caregivers.

The purpose of this pilot study was to determine if a cancer research study website increased comprehension among patients and caregivers and if website evaluations differed across patient and caregiver groups. Participants (N = 200) were cancer patients and caregivers living in the USA. Comprehension was determined by the number of correct responses to a series of questions about key characteristics of cancer research studies that are frequently unknown or misinterpreted by patients and/or caregivers. Quantitative and qualitative analyses were conducted to determine participant evaluations across four domains: perceived website credibility, perceived website attractiveness, perceived information effectiveness, and perceived information clarity. Patients and caregivers perceived the website as highly credible and attractive and the information as both easy to understand and moderately effective in helping them make decisions about CCTs. Qualitative feedback underscores the importance of testimonials to website credibility. However, the range in the number of correct responses of certain items across participants coupled with discrepancies in comprehension between patients and caregivers suggests the need for stronger mechanisms evaluating knowledge outcomes.

Characterizing health researcher barriers to sharing results with study participants.

INTRODUCTION: Research participants want to receive results from studies in which they participate. However, health researchers rarely share the results of their studies beyond scientific publication. Little is known about the barriers researchers face in returning study results to participants. METHODS: Using a mixed-methods design, health researchers (N = 414) from more than 40 US universities were asked about barriers to providing results to participants. Respondents were recruited from universities with Clinical and Translational Science Award programs and Prevention Research Centers. RESULTS: Respondents reported the percent of their research where they experienced each of the four barriers to disseminating results to participants: logistical/methodological, financial, systems, and regulatory. A fifth barrier, investigator capacity, emerged from data analysis. Training for research faculty and staff, promotion and tenure incentives, and funding agencies supporting dissemination of results to participants were solutions offered to overcoming barriers. CONCLUSIONS: Study findings add to literature on research dissemination by documenting health researchers' perceived barriers to sharing study results with participants. Implications for policy and practice suggest that additional resources and training could help reduce dissemination barriers and increase the return of results to participants.

Health researchers' experiences, perceptions and barriers related to sharing study results with participants.

BACKGROUND: Although research participants are generally interested in receiving results from studies in which they participate, health researchers rarely communicate study findings to participants. The present study was designed to provide opportunity for a broad group of health researchers to describe their experiences and concerns related to sharing results (i.e. aggregate study findings) with research participants. METHODS: We used a mixed-methods concurrent triangulation design, relying on an online survey to capture health researchers' experiences, perceptions and barriers related to sharing study results with participants. Respondents were health researchers who conduct research that includes the consent of human subjects and hold a current appointment at an accredited academic medical institution within the United States. For quantitative data, the analytic strategy focused on item-level descriptive analyses. For the qualitative data, analyses focused on a priori themes and emergent subthemes. RESULTS: Respondents were 414 researchers from 44 academic medical institutions; 64.5% reported that results should always be shared with participants, yet 60.8% of respondents could identify studies in which they had a leadership role where results were not shared. Emergent subthemes from researchers' reasons why results should be shared included participant ownership of findings and benefits of results sharing to science. Reasons for not sharing included concerns related to participants' health literacy and participants' lack of desire for results. Across all respondents who described barriers to results sharing, the majority described logistical barriers. CONCLUSIONS: Study findings contribute to the literature by documenting researchers' perspectives and experiences about sharing results with research participants, which can inform efforts to improve results sharing. Most respondents indicated that health research results should always be shared with participants, although the extent to which many respondents described barriers to results sharing as well as reported reasons not to share results suggests difficulties with a one-size-fits-all approach to improving results sharing.

Sense-making, Socialization, and Stigma: Exploring Narratives Told in Families About Mental Illness.

Guided by Communicated Narrative Sense-making Theory (CNSM), the current study investigated mental illness (MI) narratives told within families and the lessons younger members learned from these stories. Individual, semi-structured interviews with young adults (N = 24) revealed that family members, mainly parents, share stories about the MIs of individual family members and narratives reflected themes of struggle and caution. Participants reported learning important lessons from these MI narratives (i.e., MI awareness, importance of understanding MI). Findings illuminate the ways family narratives about MI teach younger members lessons and expectations for managing MI despite sometimes reinforcing MI stigma. Limitations, future directions, and implications for narrative interventions are also discussed.

The Perceived Availability of Online Social Support: Exploring the Contributions of Illness and Rural Identities in Adults with Chronic Respiratory Illness.

Joining an online social support group may increase perceived membership to a community, but it does not guarantee that the community will be available when it is needed. This is especially relevant for adults with Chronic Obstructive Pulmonary Disease (COPD), many of whom reside in rural regions and continually negotiate their illness identity. Drawing from social support literature and communication theory of identity, this cross-sectional study explored how COPD illness and geographic identities interact to influence patients' perceived availability of online social support. In April 2018, 575 adults with a history of respiratory symptoms completed an online survey. Patients with a COPD diagnosis reported greater availability of online support. This was partially mediated by a positive degree of COPD illness identity (i.e., being diagnosed with COPD, a history of tobacco use, severe respiratory symptoms, high disease knowledge, and low income but high education). The relationship between COPD illness identity and the availability of online support was strongest among those with low rural identity; however, at lower levels of COPD illness identity, participants with high rural identity reported the greatest degree of available online support. Results have important implications for tailored education approaches across the COPD care continuum by illness and geographic identities.

Evaluating the Efficacy of a Registry linked to a Consent to Re-Contact Program and Communication Strategies for Recruiting and Enrolling Participants into Clinical Trials.

INTRODUCTION: Although registries can rapidly identify clinical study participants, it is unknown which follow up methods for recruiting are most effective. Our goal is to examine the efficacy of three communication strategies for recruiting and enrolling patients who were identified via a contact registry (i.e., registry linked to a consent to re-contact program). METHODS: Patients who met the study criteria were identified via the contact registry and targeted for recruitment. In condition 1, patients established in the university hepatology specialty clinics were contacted one time via phone call by the study coordinator and asked to participate (C1). In condition 2, non-established specialty clinic patients were mailed an IRB-approved letter with study information and instructions for calling the study coordinator to participate (C2). Condition 2A included patients who called within two weeks of receiving the letter (C2A); condition 2B included patients who did not call after receiving the letter but were subsequently contacted via phone call. RESULTS: A registry identified 1,060 patients, of which 661were eligible and targeted for recruiting. All 37 patients were reached in C1 and 17 (45.9%) were recruited. Nineteen of the 624 patients in C2A were reached and 10 were recruited whereas 120 of the 605 patients in C2B were reached and 53 (8.7%) were recruited. Seventy patients enrolled with C2B being the most effective (total, cost) recruitment strategy (n = 50) (p < .001). CONCLUSION: The efficacy of enrolling patients identified via a contact registry into clinical trials varies based on the communication strategies used for recruiting.

A content analysis of Clinical and Translational Science Award (CTSA) strategies for communicating about clinical research participation online.

INTRODUCTION: There is a dearth of literature providing guidance on how to effectively communicate about clinical research (CR). METHODS: Using the transactional model of communication, a content analysis of the investigator (n=62) and participant (n=18) Web sites of institutions funded through the National Institutes of Health Clinical and Translational Science Award (CTSA) was conducted to identify their strategies (e.g., messages) for communicating about CR participation. RESULTS: CTSAs targeted investigators with CR participation content across the main Web sites, although most CTSAs (n=55; 88.7%) also included CR participation content for participants. In total, 18 CTSAs (29%) hosted participant Web sites. Participant sites included 13 message types about CR participation (e.g., registry enrollment) and 5 additional channels (e.g., email, phone number) to communicate about CR. However, many CTSA participant Web sites excluded information explaining the CR process and offered CR content exclusively in English. CONCLUSION: CTSAs should identify their target audience and design strategies (e.g., messages, channels) accordingly.