Black patient perceptions of COVID-19 vaccine, treatment, and testing.

Context: The Presence for Racial Justice project leverages the Stanford Presence 5 framework to present anti-racism communication practices that promote clinician trust-building for Black patients in primary care. With the racial/ethnic disparities in COVID-19 infection rates, an assessment of Black patients' perspectives around COVID-19 care is required to promote health equity in current and future health crises. Objective: To compile clinician communication strategies for promotion of patient understanding and agency concerning Black patients' perceptions of COVID-19 vaccine, treatment and testing. Study design: Qualitative study employing inductive and deductive thematic analysis. Setting: Four primary care clinics primarily serving Black patients in Oakland, CA; Rochester, NY; Leeds, AL; and Memphis, TN. Population Studied: 37 Black patients, recruited through convenience sampling by their primary care clinician for 45-minute semi-structured audio-recorded interviews. Outcome Measures: Emergent themes around Black patient perceptions and motivations for seeking/delaying COVID-19 vaccine, treatment, and testing, and their ideal medical guidance on COVID-19 care. Results: Due to historic mistreatment of Black patients within the healthcare system, medicine, and research, there is a high prevalence of mistrust amongst the Black patient interviewees towards the safety, efficacy, and equitable distribution of the COVID-19 vaccine compared to existing vaccines. Patients feared racial discriminatory treatment and intended to wait for the general population, authority figures, and White patients to receive the vaccine first. Many patients believed personal protective behaviors (e.g., mask wearing, staying home, taking supplements) would be more effective than receiving the COVID-19 vaccine. They expressed a preference for receiving COVID-19 medical care in the comfort of their homes due to high costs and risks of maltreatment, death, and loneliness. Conclusion: Black patients hinged their vaccination decisions on having enough time to observe vaccine rollout and discussion with their clinicians. Relating new medical interventions (ie., COVID-19 vaccine) to accept medical approaches (ie., Flu vaccine) and being aware of historical distrust in medicine can inform clinician efforts to empower and provide excellent care for Black patients moving forward.

PPE portraits: patient and clinician experiences at a COVID-19 testing site.

Context: The COVID-19 pandemic mandated personal protective equipment (PPE) in healthcare settings, obscuring clinician faces and expressions, and depersonalizing patient care experiences. PPE Portraits (affixing a clinician's photo to the front of PPE) was first introduced in 2015 during the West Africa Ebola epidemic, and has been shown to help maintain patient-provider connection at times when patients may be fearful, isolated, and unable to identify clinicians caring for them. Objective: To evaluate patient and clinician experiences with PPE Portraits. Study Design: Implementation pilot with mixed methods evaluation. Setting: A drive-thru COVID-19 testing site affiliated with a large academic medical center. Population studied: Patients (n=18) and clinicians (n=6) interviewed in March-April 2020. Clinicians were recruited through convenience sampling. Clinicians answered questions via recorded interviews or email. Patients were interviewed by phone through random sampling stratified by date of service. Patients were sent a post-visit survey. Intervention: Health workers affixed a PPE Portrait in order to connect better with individuals in their care. Outcome Measures: Patient and clinician experiences with PPE Portraits (assessed through inductive coding of qualitative data) and patient experiences with fear (assessed through survey). Results: Patient surveys indicated varying levels of fear, including mild (16%), moderate (66%), and severe (18%). Patients reported that seeing the PPE Portrait was comforting; four patients stated that it did not impact their care because they already trusted the facility. Clinicians corroborated patient sentiments, reporting that the intervention humanized both the testing experience for patients and also the interactions among patients and clinicians. They noted that patients seemed more at ease and that portraits fostered connection and trust, thereby reducing anxiety and fear and signaling to patients that they were being given holistic, optimal care. A majority of clinicians felt this intervention should be replicated, and they recommended having surplus portrait supplies on site to facilitate ad hoc portrait creation. Conclusion: PPE Portraits humanized the COVID-19 testing experiences for patients and clinicians during a time of fear. Clinicians recommended PPE Portraits for other healthcare settings that require PPE. Future research could assess how PPE Portraits promote patient-provider connection and trust.

Presence for racial justice: disrupting racism through physician-patient communication.

Context: Anti-Black racism is firmly rooted in US healthcare, but many clinicians do not have the tools and language to question their biases and address racism in clinical practice, eg biased communication practices such as "non-compliance" in medical documentation. Objective: Presence 5 for Racial Justice (P5RJ) leverages the Presence 5 patient-provider communication framework to identify anti-racism communication practices that support trusting relationships between physicians and Black patients and empower Black individuals in clinical care. Study design: For this multi-phased community-based participatory research (CBPR) overseen by an advisory board of clinicians and patients at four community clinics, we conducted a literature review, interviews with Black patients, clinician small-group discussions, and design thinking interviews with non-medical professionals. We mapped emergent communication practices to Presence 5 domains to create P5RJ. Setting: Four primary care clinics primarily serving Black patients in Oakland CA; Rochester NY; Leeds AL; Memphis TN. Population Studied: Total 113 participants (40 non-medical interviews, 37 Black patients interviewed, 12 advisory board members, 24 clinicians in discussion); 30 reviewed articles. Outcomes: Strategies on how providers, through communication and connection in the clinical visit, can navigate and address structural, institutional, and personally mediated forms of racism faced by Black patients. Results: P5RJ practices included: 1) Prepare with intention by reflecting on identity, bias, and power dynamics; and creating structures to address emergent bias and social determinants of health; 2) Listen intently and completely by using focused interpersonal listening without interruption and deep listening for racism impacts; give patients time and space to tell their story; 3) Agree on what matters most by having explicit conversations about patient goals, treatment comfort, consent, and referral planning; 4) Connect with the patient's story by acknowledging socio-political factors influencing patient health and focusing on positive efforts/events to encourage patient agency; 5) Explore emotional cues by noticing and naming patient emotions and considering how racial trauma might influence these emotions. Conclusion: P5RJ practices offer strategies to reflect on clinician biases, address racism and known gaps in care for Black patients and promote health equity in their clinical care.

Developing best practices for PPE Portraits across 25 sites: a systematic assessment of implementation and spread of adaptations using FRAME.

BACKGROUND: Adaptation, a form of modification that aims to improve an intervention's acceptability and sustainability in each context, is essential to successful implementation in some settings. Due to the COVID-19 pandemic, clinicians have rapidly adapted how they deliver patient care. PPE Portraits are a form of adaptation, whereby health workers affix a postcard size portrait of themselves to the front of their personal protective equipment (PPE) to foster human connection during COVID-19. METHODS: We used the expanded framework for reporting adaptations and modifications to evidence-based interventions (FRAME) method to better understand the reasoning behind and results of each adaptation. We hypothesized that using the FRAME in conjunction with design-thinking would lead to emerging best practices and that we would find adaptation similarities across sites. Throughout multiple implementations across 25 institutions, we piloted, tracked, and analyzed adaptations using FRAME and design thinking. For each adaptation, we assessed the stage of implementation, whether the change was planned, decision makers involved, level of delivery impacted, fidelity to original intervention, and the goal and reasoning for adaptation. We added three crucial components to the FRAME: original purpose of the adaptation, unintended consequences, and alternative adaptations. RESULTS: When implementing PPE Portraits across settings, from a local assisted living center's memory unit to a pediatric emergency department, several requests for adaptations arose during early development stages before implementation. Adaptations primarily related to (1) provider convenience and comfort, (2) patient populations, and (3) scale. Providers preferred smaller portraits and rounded (rather than square) laminated edges that could potentially injure a patient. Affixing the portrait with a magnet was rejected given the potential choking hazard the magnetic strip presented for children. Other adaptations, related to ease of dissemination, included slowing the process down during early development and providing buttons, which could be produced easily at scale. CONCLUSIONS: The FRAME was used to curate the reasoning for each adaptation and to inform future dissemination. We look forward to utilizing FRAME including our additions and design thinking, to build out a range of PPE Portrait best practices with accompanying costs and benefits.

Implementation outcomes of Humanwide: integrated precision health in team-based family practice primary care.

BACKGROUND: Humanwide was precision health embedded in primary care aiming to leverage high-tech and high-touch medicine to promote wellness, predict and prevent illness, and tailor treatment to individual medical and psychosocial needs. METHODS: We conducted a study assessing implementation outcomes to inform spread and scale, using mixed methods of semi-structured interviews with diverse stakeholders and chart reviews. Humanwide included: 1) health coaching; 2) four digital health tools for blood-pressure, weight, glucose, and activity; 3) pharmacogenomic testing; and 4) genetic screening/testing. We examined implementation science constructs: reach/penetration, acceptability, feasibility, and sustainability. Chart reviews captured preliminary clinical outcomes. RESULTS: Fifty of 69 patients (72%) invited by primary care providers participated in the Humanwide pilot. We performed chart reviews for the 50 participating patients. Participants were diverse overall (50% non-white, 66% female). Over half of the participants were obese and 58% had one or more major cardiovascular risk factor: dyslipidemia, hypertension, diabetes. Reach/penetration of Humanwide components varied: pharmacogenomics testing 94%, health coaching 80%, genetic testing 72%, and digital health 64%. Interview participants (n=27) included patients (n=16), providers (n=9), and the 2 staff who were allocated dedicated time for Humanwide patient intake and orientation. Patients and providers reported Humanwide was acceptable; it engaged patients holistically, supported faster medication titration, and strengthened patient-provider relationships. All patients benefited clinically from at least one Humanwide component. Feasibility challenges included: low provider self-efficacy for interpreting genetics and pharmacogenomics; difficulties with data integration; patient technology challenges; and additional staffing needs. Patient financial burden concerns surfaced with respect to sustainability. CONCLUSION: This is the first report of implementation of a multi-component precision health model embedded in team-based primary care. We found acceptance from both patients and providers; however, feasibility barriers must be overcome to enable broad spread and sustainability. We found that barriers to implementation of precision health in a team-based primary care clinic are mundane and straightforward, though not necessarily easy to overcome. Future implementation endeavors should invest in basics: education, workflow, and reflection/evaluation. Strengthening fundamentals will enable healthcare systems to more nimbly accept the responsibility of meeting patients at the crossroads of innovative science and routinized clinical systems.

Building Trust and Partnership with Black Pediatric Patients and their Caregivers.

Systemic racism embedded within the US health care system results in disproportionately worse health outcomes for Black pediatric patients and their caregivers. One meaningful mechanism through which these health disparities persist is through discriminatory treatment and anti-Black bias from clinicians. Strengthening care provided to Black pediatric patients and their caregivers requires that clinicians adopt culturally tailored communication strategies that promote health equity and counter racism. We conducted a scoping review of evidence-based communication practices in the medical literature that improve care for Black pediatric patients. We mapped the specific practices to the Presence 5 for Racial Justice framework and identified cross-cutting themes to describe practices across the five domains. There are three cross-cutting themes that underlie the recommended practices: 1) promote unbiased implementation of clinician communication strategies (eg, providing equitable recommendations for preventive care), 2) tailor care to Black pediatric patients (eg, explore the importance of the family unit), and 3) address racism experienced by Black pediatric patients and their caregivers (eg, acknowledge any previous negative experiences with the health care system). This review highlights communication practices that clinicians can adopt to build trusting relationships, empower Black families, and promote racial justice in clinical care. Future opportunities include expanding to system level change and validating these practices with patients and clinicians.

An initiative to promote value-based stress test selection in primary care and cardiology clinics: A mixed methods evaluation.

OBJECTIVES: Exercise stress echocardiograms (stress echos) are overused, whereas exercise stress electrocardiograms (stress ECGs) can be an appropriate, lower-cost substitute. In this post hoc, mixed methods evaluation, we assessed an initiative promoting value-based, guideline-concordant ordering practices in primary care (PC) and cardiology clinics. METHODS: Change in percent of stress ECGs ordered of all exercise stress tests (stress ECGs and echos) was calculated between three periods: baseline (January 2019-February 2020); Period 1 with reduced stress ECG report turnaround time + PC-targeted education (began June 2020); and Period 2 with the addition of electronic health record-based alternative alert (AA) providing point-of-care clinical decision support. The AA was deployed in two of five PC clinics in July 2020, two additional PC clinics in January 2021, and one of four cardiology clinics in February 2021. Nineteen primary care providers (PCPs) and five cardiologists were interviewed in Period 2. RESULTS: Clinicians reported reducing ECG report turnaround time was crucial for adoption. PCPs specifically reported that value-based education helped change their practice. In PC, the percent of stress ECGs ordered increased by 38% ± 6% (SE) (p < 0.0001) from baseline to Period 1. Most PCPs identified the AA as the most impactful initiative, yet stress ECG ordering did not change (6% ± 6%; p = 0.34) between Periods 1 and 2. In contrast, cardiologists reportedly relied on their expertise rather than AAs, yet their stress ECGs orders increased from Period 1 to 2 to a larger degree in the cardiology clinic with the AA (12% ± 5%; p = 0.01) than clinics without the AA (6% ± 2%; p = 0.01). The percent of stress ECGs ordered was higher in Period 2 than baseline for both specialties (both p < 0.0001). CONCLUSIONS: This initiative influenced ordering behaviour in PC and cardiology clinics. However, clinicians' perceptions of the initiative varied between specialties and did not always align with the observed behaviour change.

Patient and Health Professional Perceptions of Telemonitoring for Hypertension Management: Qualitative Study.

BACKGROUND: Hypertension is the most prevalent and important risk factor for cardiovascular disease, affecting nearly 50% of the US adult population; however, only 30% of these patients achieve controlled blood pressure (BP). Incorporating strategies into primary care that take into consideration individual patient needs, such as remote BP monitoring, may improve hypertension management. OBJECTIVE: From March 2018 to December 2018, Stanford implemented a precision health pilot called Humanwide, which aimed to leverage high-technology and high-touch medicine to tailor individualized care for conditions such as hypertension. We examined multi-stakeholder perceptions of hypertension management in Humanwide to evaluate the program's acceptability, appropriateness, feasibility, and sustainability. METHODS: We conducted semistructured interviews with 16 patients and 15 health professionals to assess their experiences with hypertension management in Humanwide. We transcribed and analyzed the interviews using a hybrid approach of inductive and deductive analysis to identify common themes around hypertension management and consensus methods to ensure reliability and validity. RESULTS: A total of 63% (10/16) of the patients and 40% (6/15) of the health professionals mentioned hypertension in the context of Humanwide. These participants reported that remote BP monitoring improved motivation, BP control, and overall clinic efficiency. The health professionals discussed feasibility challenges, including the time needed to analyze BP data and provide individualized feedback, integration of BP data, technological difficulties with the BP cuff, and decreased patient use of remote BP monitoring over time. CONCLUSIONS: Remote BP monitoring for hypertension management in Humanwide was acceptable to patients and health professionals and appropriate for care. Important challenges need to be addressed to improve the feasibility and sustainability of this approach by leveraging team-based care, engaging patients to sustain remote BP monitoring, standardizing electronic medical record integration of BP measurements, and finding more user-friendly BP cuffs.

Nonmedical Transdisciplinary Perspectives of Black and Racially and Ethnically Diverse Individuals About Antiracism Practices: A Qualitative Study.

Importance: Overwhelming evidence that anti-Black racism is associated with health inequities is driving clinician demand for antiracism practices that promote health equity. Objective: To investigate how nonmedical professionals address personally mediated, institutional, and internalized racism and to adapt these practices for the clinical setting. Design, Setting, and Participants: Using an approach from human-centered design for this qualitative study, virtual qualitative interviews were conducted among 40 professionals from nonmedical fields to investigate antiracism practices used outside of medicine. Inductive thematic analysis was conducted to identify latent themes and practices that may be adaptable to health care, subsequently using an established theoretical framework describing levels of racism to interpret and organize themes. Convenience and purposive sampling was used to recruit participants via email, social media, and electronic flyers. Main Outcomes and Measures: Antiracism practices adapted to medicine. Results: Among 40 professionals from nonmedical fields, most were younger than age 40 years (23 individuals [57.5%]) and there were 20 (50.0%) women; there were 25 Black or African American individuals (62.5%); 4 East Asian, Southeast Asian, or South Asian individuals (10.0%); 3 individuals with Hispanic, Latinx, or Spanish origin (7.5%); and 3 White individuals. Participants described personally mediated, institutional, and internalized antiracism practices that may be adaptable to promote health equity for Black patients. Personally mediated antiracism practices included dialogue and humble inquiry, building trust, and allyship and shared humanity; clinicians may be able to adopt these practices by focusing on patient successes, avoiding stigmatizing language in the electronic health record, and using specific phrases to address racism in the moment. Institutional antiracism practices included education, representation, and mentorship; in the health care setting, clinics may be able to develop staff affiliate groups, focus on improving racial health equity outcomes, and conduct antiracism trainings. Internalized antiracism practices centered on authenticity; clinicians may be able to write positionality statements reflecting their identity and the expertise they bring to clinical encounters. Conclusions and Relevance: This study's findings suggest that antiracism practices from outside the health care sector may offer innovative strategies to promote health equity by addressing personally mediated, institutional, and internalized racism in clinical care.

The Presence 5 for Racial Justice Framework for anti-racist communication with Black patients.

OBJECTIVE: To identify communication practices that clinicians can use to address racism faced by Black patients, build trusting relationships, and empower Black individuals in clinical care. DATA SOURCES: Qualitative data (N = 112 participants, August 2020-March 2021) collected in partnership with clinics primarily serving Black patients in Leeds, AL; Memphis, TN; Oakland, CA; and Rochester, NY. STUDY DESIGN: This multi-phased project was informed by human-centered design thinking and community-based participatory research principles. We mapped emergent communication and trust-building strategies to domains from the Presence 5 framework for fostering meaningful connection in clinical care. DATA COLLECTION METHODS: Interviews and focus group discussions explored anti-racist communication and patient-clinician trust (n = 36 Black patients; n = 40 nonmedical professionals; and n = 24 clinicians of various races and ethnicities). The Presence 5 Virtual National Community Advisory Board guided analysis interpretation. PRINCIPAL FINDINGS: The emergent Presence 5 for Racial Justice (P5RJ) practices include: (1) Prepare with intention by reflecting on identity, bias, and power dynamics; and creating structures to address bias and structural determinants of health; (2) Listen intently and completely without interruption and listen deeply for the potential impact of anti-Black racism on patient health and interactions with health care; (3) Agree on what matters most by having explicit conversations about patient goals, treatment comfort and consent, and referral planning; (4) Connect with the patient's story, acknowledging socioeconomic factors influencing patient health and focusing on positive efforts; (5) Explore emotional cues by noticing and naming patient emotions, and considering how experiences with racism might influence emotions. CONCLUSION: P5RJ provides a framework with actionable communication practices to address pervasive racism experienced by Black patients. Effective implementation necessitates clinician self-reflection, personal commitment, and institutional support that offers time and resources to elicit a patient's story and to address patient needs.

Estudo comparativo de biodisponibilidade relativa entre duas formulações contendo Clozapina 100 mg em pacientes portadores de esquizofrenia / Comparative study of relative bioavailability between two formulations containing Clozapine 100 mg in patients with schizophrenia

Este estudo teve por objetivo avaliar a bioequivalência entre dois produtos contendo Clozapina 100 mg (produto teste: LifalClozapina® da Lifal ? Laboratório Industrial Farmacêutico de Alagoas S/A. O produto referência: Leponex® do Laboratório Novartis Biociências S/A.) em 40 voluntários. O estudo foi aberto, randomizado, do tipo cross-over, em estado de equilíbrio, com dois períodos (duas sequências), nos quais os voluntários receberam, em cada período, a formulação teste ou a formulação referência. A biodisponibilidade relativa das formulações seguidas à administração oral foi avaliada com base em comparações estatísticas de parâmetros farmacocinéticos relevantes obtidos de dados de amostra sanguínea dos voluntários, sendo as amostras coletadas em período de 24h. A concentração de Clozapina foi medida a partir de método analítico apropriado e válido. As medidas farmacocinéticas utilizadas foram: Cmin, Cmax e ASCt. As diferenças médias (± DP) entre referência e teste foram: 0,1615 ± 0,3404 (ng/mL); -0,0969 ± 0,4131 (ng/mL) e 0,9143 ± 3,9941 (ng*h/mL). Os intervalos de confiança para biequivalência média atenderam aos limites determinados pela Agência Nacional de Vigilância Sanitária (ANVISA) de 80 a 125%, sendo os dois medicamentos considerados bioequivalentes. Assim, produtos teste e referência são considerados intercambiáveis.

This study aimed to evaluate the bioequivalence between two products containing Clozapine 100 mg (testing product: LifalClozapina® from Lifal ? Industrial Pharmaceutical Laboratory of Alagoas S/A and the reference product: Leponex® from the Novartis Biociências S/A. Laboratories) in 40 volunteers. The study was open, randomized, crossover type, in a state of equilibrium, with two periods (two sequences) in which volunteers were given, in each period, the testing formulation or the reference formulation. The relative bioavailability of the formulations following oral administration was evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from blood samples in a 24 hours period. The concentration of Clozapine was measured using an appropriate and valid analytical method. The pharmacokinetic measures used were: Cmin and Cmax, and ASCt. The mean differences (± SD) between reference and testing were: 0.1615 ± 0.3404 (ng/mL); -0.0969 ± 0.4131 (ng/mL); and 0.9143 ± 3.9941 (ng*h/ mL). The confidence intervals for medium bioequivalence met the limits determined by the National Agency of Sanitary Surveillance (ANVISA) of 80 to 125%, and both medications were considered bioequivalent. Thus, the testing and reference products are considered interchangeable