Communicative Competence for Researchers working with LGBTQ Communities

The ethical principles of respect and justice oblige the use of culturally sensitive approaches when engaging participants in research, however cultural competence training is lacking for researchers who work with LGBTQ populations. The purpose of this study was to explore how researchers can create a welcoming research environment for LGBTQ research participants in the context of historical distrust of medical research as a barrier to research participation among minority populations. Grounded by a framework of communicative competence, this study explored elements of preferred communication during recruitment and informed consent for research involving LGBTQ participants. Grammatical, sociolinguistic, strategic and discourse competence domains aided exploration of the preferences held by participants in LGBTQ sub-groups, as well as the perceived barriers to research. Thirty-six participants, who self-identified as part of the LGBTQ community and were recruited through our community partner, the Center for Health Impact, took part in either focus groups or individual interviews. Preliminary analysis reveals community engagement and building trust are key, particularly in an academic medical center where a patient\u27s clinical experiences may impact their willingness to become a research participant. Participants offered insight into each competence domain, covering: terminology to promote inclusivity, body language to avoid, reducing stigma by being up front and feedback on crafting a more LGBTQ-friendly basic demography questionnaire. These findings will aid in the refinement of an LGBTQ-focused version of our Simulation-based Community-engaged Research Intervention for Informed Consent Protocol Testing and Training (SCRIIPTT) to build communicative competence among clinical researchers

A REDCap-based model for electronic consent (eConsent): Moving toward a more personalized consent

Introduction: The updated common rule, for human subjects research, requires that consents begin with a \u27concise and focused\u27 presentation of the key information that will most likely help someone make a decision about whether to participate in a study (Menikoff, Kaneshiro, Pritchard. The New England Journal of Medicine. 2017; 376(7): 613-615.). We utilized a community-engaged technology development approach to inform feature options within the REDCap software platform centered around collection and storage of electronic consent (eConsent) to address issues of transparency, clinical trial efficiency, and regulatory compliance for informed consent (Harris, et al. Journal of Biomedical Informatics 2009; 42(2): 377-381.). eConsent may also improve recruitment and retention in clinical research studies by addressing: (1) barriers for accessing rural populations by facilitating remote consent and (2) cultural and literacy barriers by including optional explanatory material (e.g., defining terms by hovering over them with the cursor) or the choice of displaying different videos/images based on participant\u27s race, ethnicity, or educational level (Phillippi, et al. Journal of Obstetric, Gynecologic, and Neonatal Nursing. 2018; 47(4): 529-534.). Methods: We developed and pilot tested our eConsent framework to provide a personalized consent experience whereby users are guided through a consent document that utilizes avatars, contextual glossary information supplements, and videos, to facilitate communication of information. Results: The eConsent framework includes a portfolio of eight features, reviewed by community stakeholders, and tested at two academic medical centers. Conclusions: Early adoption and utilization of this eConsent framework have demonstrated acceptability. Next steps will emphasize testing efficacy of features to improve participant engagement with the consent process

Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam- 12 month follow up results: A cluster randomized controlled feasibility trial

INTRODUCTION: Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. The country needs novel, large-scale, and sustainable interventions to improve hypertension control. We report the 12 month follow-up results of a cluster randomized feasibility trial in Hung Yen province, Vietnam, which evaluated the feasibility and acceptability of two community-based interventions to improve hypertension control: a storytelling and a didactic intervention. METHODS: The storytelling intervention included stories in the patients\u27 own words about coping with hypertension and didactic content about the importance of healthy lifestyle behaviors in controlling elevated blood pressure levels. The didactic intervention included only didactic content, which were general recommendations for managing several important risk factors for hypertension and other non-communicable diseases. The storytelling intervention was delivered by two DVDs three months apart; the didactic intervention included only one DVD. The trial was conducted in patients with poorly controlled hypertension from 4 communes (communities), which were equally randomized to the two interventions. RESULTS: The mean age of the 160 patients was 66 years and 54% were men. Between baseline enrollment and the 12 month follow-up, mean systolic blood pressure declined by 10.8 mmHg (95% CI: 6.5-14.9) in the storytelling group and by 5.8 mmHg (95% CI: 1.6-10.0) in the didactic content group. The storytelling group also experienced more improvement in several health behaviors, including increased levels of physical activity and reduced consumption of salt and alcohol. CONCLUSIONS: We observed considerable long-term beneficial effects of both interventions, especially of our storytelling intervention, among patients with inadequately controlled hypertension. A large scale randomized trial should more systematically compare the short and long-term effectiveness of the two interventions in controlling hypertension. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02483780

Conquering hypertension in Vietnam-solutions at grassroots level: study protocol of a cluster randomized controlled trial

BACKGROUND: Vietnam has been experiencing an epidemiologic transition to that of a lower-middle income country with an increasing prevalence of non-communicable diseases. The key risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam, particularly hypertension (HTN). Inasmuch, the burden of CVD will continue to increase in the Vietnamese population unless effective prevention and control measures are put in place. The objectives of the proposed project are to evaluate the implementation and effectiveness of two multi-faceted community and clinic-based strategies on the control of elevated blood pressure (BP) among adults in Vietnam via a cluster randomized trial design. METHODS: Sixteen communities will be randomized to either an intervention (8 communities) or a comparison group (8 communities). Eligible and consenting adult study participants with HTN (n = 680) will be assigned to intervention/comparison status based on the community in which they reside. Both comparison and intervention groups will receive a multi-level intervention modeled after the Vietnam National Hypertension Program including education and practice change modules for health care providers, accessible reading materials for patients, and a multi-media community awareness program. In addition, the intervention group only will receive three carefully selected enhancements integrated into routine clinical care: (1) expanded community health worker services, (2) home BP self-monitoring, and (3) a storytelling intervention, which consists of interactive, literacy-appropriate, and culturally sensitive multi-media storytelling modules for motivating behavior change through the power of patients speaking in their own voices. The storytelling intervention will be delivered by DVDs with serial installments at baseline and at 3, 6, and 9 months after trial enrollment. Changes in BP will be assessed in both groups at several follow-up time points. Implementation outcomes will be assessed as well. DISCUSSION: Results from this full-scale trial will provide health policymakers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam. TRIAL REGISTRATION: ClinicalTrials.gov NCT03590691 . Registered on July 17, 2018. Protocol version: 6. Date: August 15, 2019

Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial

BACKGROUND: Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a storytelling intervention, We Talk about Our Hypertension, and a didactic intervention. METHODS: The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. RESULTS: The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. CONCLUSIONS: Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02483780

COmmuNity-engaged SimULation Training for Blood Pressure Control (CONSULT-BP): A study protocol

BACKGROUND: Healthcare professionals have negative implicit biases toward minority and poor patients. Few communication skills interventions target implicit bias as a factor contributing to disparities in health outcomes. We report the protocol from the COmmuNity-engaged SimULation Training for Blood Pressure Control (CONSULT-BP), a trial evaluating a novel educational and training intervention targeting graduate medical and nursing trainees that is designed to mitigate the effects of implicit bias in clinical encounters. The CONSULT-BP intervention combines knowledge acquisition, bias awareness, and practice of bias mitigating skills in simulation-based communication encounters with racially/ethnically diverse standardized patients. The trial evaluates the effect of this 3-part program on patient BP outcomes, self-reported patient medication adherence, patient-reported quality of provider communication, and trainee bias awareness. METHODS: We are conducting a cluster randomized trial of the intervention among cohorts of internal medicine (IM), family medicine (FM), and nurse practitioner (NP) trainees at a single academic medical center. We are enrolling entire specialty cohorts of IM, FM, and NP trainees over a 3-year period, with each academic year constituting an intervention cycle. There are 3 cycles of implementation corresponding to 3 sequential academic years. Within each academic year, we randomize training times to 1 of 5 start dates using a stepped wedge design. The stepped wedge design compares outcomes within training clusters before and after the intervention, as well as across exposed and unexposed clusters. Primary outcome of blood pressure control is measured at the patient-level for patients clustered within trainees. Eligible patients for outcomes analysis are: English-speaking; non-White racial/ethnic minority; Medicaid recipient (regardless of race/ethnicity); hypertension; not have pregnancy, dementia, schizophrenia, bipolar illness, or other serious comorbidities that would interfere with hypertension self-control; not enrolled in hospice. Secondary outcomes include trainee bias awareness. A unique feature of this trial is the engagement of academic and community stakeholders to design, pilot test and implement a training program addressing healthcare. DISCUSSION: Equipping clinicians with skills to mitigate implicit bias in clinical encounters is crucial to addressing persistent disparities in healthcare outcomes. Our novel, integrated approach may improve patient outcomes. TRIAL REGISTRATION: NCT03375918. PROTOCOL VERSION: 1.0 (November 10, 2020)

Stakeholder-engaged process for refining the design of a clinical trial in home hospice

BACKGROUND: Clinical trials in home hospice settings are important to build the evidence base for practice, but balancing the burden and benefit of clinical trial conduct for clinicians, patients, and family caregivers is challenging. A stakeholder-engaged process can help inform and refine key aspects of home hospice clinical trials. The aim of this study was to describe a stakeholder-engaged process to refine, design, and implement aspects of an educational intervention trial in home hospice, including recommendations for refining intervention content and delivery, recruitment and enrollment strategies, and content and frequency of outcome measurement. METHODS: A panel of interprofessional (1 hospice administrator, 3 nurses, 2 physicians, 2 pharmacists) and 2 former family caregiver stakeholders was systematically selected and invited to participate based on expertise, representing 2 geographically distinct hospices who were participating in the clinical trial. Teleconferences followed a predetermined procedural sequence: 1. pre-meeting materials distribution and review; 2. pre-meeting email solicitation of concerns in response to materials; 3. teleconference with structured and guided discussion; and 4. documentation and distribution of minutes for accuracy review and future meeting guidance. Discussion topics were distinct for each panel meeting. Written reflections on the stakeholder engagement process were collected from panel members to further refine our process. RESULTS: Five initial biweekly teleconferences resulted in recommendations for recruitment strategy, enrollment process, measurement frequency, patient inclusion, and primary care physician notification of the patient\u27s trial involvement. The panel continues to participate in quarterly teleconferences to review progress and unexpected questions and concerns. Panelist reflections reveal personal and professional benefit from participation. CONCLUSIONS: An interprofessional stakeholder process is feasible and invaluable for developing home hospice intervention studies, contributing to better science, successful trial implementation, and relevant, valid outcomes. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03972163 , Registered June 3, 2019

Development of a multi-component intervention to promote participation of Black and Latinx individuals in biomedical research

Introduction: Barriers to research participation by racial and ethnic minority group members are multi-factorial, stem from historical social injustices and occur at participant, research team, and research process levels. The informed consent procedure is a key component of the research process and represents an opportunity to address these barriers. This manuscript describes the development of the Strengthening Translational Research in Diverse Enrollment (STRIDE) intervention, which aims to improve research participation by individuals from underrepresented groups. Methods: We used a community-engaged approach to develop an integrated, culturally, and literacy-sensitive, multi-component intervention that addresses barriers to research participation during the informed consent process. This approach involved having Community Investigators participate in intervention development activities and using community engagement studios and other methods to get feedback from community members on intervention components. Results: The STRIDE intervention has three components: a simulation-based training program directed toward clinical study research assistants that emphasizes cultural competency and communication skills for assisting in the informed consent process, an electronic consent (eConsent) framework designed to improve health-related research material comprehension and relevance, and a storytelling intervention in which prior research participants from diverse backgrounds share their experiences delivered via video vignettes during the consent process. Conclusions: The community engaged development approach resulted in a multi-component intervention that addresses known barriers to research participation and can be integrated into the consent process of research studies. Results of an ongoing study will determine its effectiveness at increasing diversity among research participants

Impact of the COVID-19 pandemic on clinical research activities: Survey of study participants and health care workers participating in a hypertension trial in Vietnam

BACKGROUND: The COVID-19 pandemic has had a profound worldwide impact. Vietnam, a lower middle-income country with limited resources, has successfully slowed this pandemic. The objectives of this report are to explore the impact of the COVID-19 pandemic on the research activities of an ongoing hypertension trial using a storytelling intervention in Vietnam. METHODS: Data were collected in a mixed-methods study among 86 patients and 10 health care workers participating in a clinical trial designed to improve hypertension control. Several questions related to the impact of COVID-19 on patient\u27s daily activities and adherence to the study interventions were included in the follow-up visits. A focus group discussion was conducted among health care workers to discuss the impact of COVID-19 on research related activities. RESULTS: Fewer patients in the intervention group reported that they faced difficulties in adhering to prescribed study interventions, wanted to receive a call from a dedicated hotline, or have a visit from a community health worker as compared with those in the comparison group. Most study patients are willing to participate in future health research studies. When asked about the potential use of mobile phones in health research studies, fewer patients in the intervention group felt comfortable using a mobile phone for the delivery of intervention and interviews compared with those in the comparison condition. Community health workers shared that they visited patient\u27s homes more often than previously due to the pandemic and health care workers had to perform more virus containment activities without a corresponding increase in ancillary staff. CONCLUSIONS: Both patients and health care workers in Vietnam faced difficulties in adhering to recommended trial interventions and procedures. Multiple approaches for intervention delivery and data collection are needed to overcome these difficulties during future health crises and enhance the implementation of future research studies. TRIAL REGISTRATION: ClinicalTrials.gov. Registration number: https://clinicaltrials.gov/ct2/show/NCT03590691 (registration date July 17, 2018)

Stakeholder Engagement in Late-Stage Translation Phase 4 Research for Noncommunicable Diseases in Low- and Middle-Income Countries: What Works and Why-The Vietnam Experience (UMMS-Vietnam Team)

BACKGROUND: Stakeholder engagement is crucial for conducting high-quality implementation research as well as for the incorporation and adoption of health interventions and policies in the community. OBJECTIVES: This study sought to build a mutually rewarding collaboration between stakeholders in Vietnam and investigators in the United States. METHODS: A collaboration was established between investigators from several institutions in Vietnam and the University of Massachusetts Medical School that was built on mutual trust, cross-cultural learning, and shared experiences. This collaborative arrangement has led to sustainable stakeholder engagement in Vietnam. We formed a multidisciplinary transnational research team and maintained regular contact both online and in person. We also conducted a needs assessment study, in which several focus group discussions and in-depth interviews of stakeholders in Vietnam were carried out. RESULTS: The formal collaboration between investigators in Vietnam and the University of Massachusetts Medical School began in 2011 and has strengthened over time. The U.S. team provided expertise in study and intervention design, data collection and analysis, and trial implementation, whereas the team in Vietnam brought a deep understanding of local health care delivery systems and expertise in the delivery of health care interventions at the grassroots level. Our initial partnership has now grown to include committed individuals at the government, academic, and community levels including the Vietnam Ministry of Health, key governmental and nongovernmental research institutions and agencies, medical and public health universities, and communities in rural settings. The needs assessment study found that there are important gaps in the delivery of hypertension management practices in many rural communities in Vietnam and that stakeholders are fully engaged in our ongoing, community-based, hypertension-control project. CONCLUSIONS: Multiple layers of stakeholders and communities in Vietnam are fully engaged with, and have contributed significantly to, our ongoing hypertension control research project in Northern Vietnam