Exploring relationships between physician stress, burnout, and diagnostic elements in clinician notes.

OBJECTIVES: To understand the relationship between stressful work environments and patient care by assessing work conditions, burnout, and elements of the diagnostic process. METHODS: Notes and transcripts of audiotaped encounters were assessed for verbal and written documentation related to psychosocial data, differential diagnosis, acknowledgement of uncertainty, and other diagnosis-relevant contextual elements using 5-point Likert scales in seven primary care physicians (PCPs) and 28 patients in urgent care settings. Encounter time spent vs time needed (time pressure) was collected from time stamps and clinician surveys. Study physicians completed surveys on stress, burnout, and work conditions using the Mini-Z survey. RESULTS: Physicians with high stress or burnout were less likely to record psychosocial information in transcripts and notes (psychosocial information noted in 0% of encounters in 4 high stress/burned-out physicians), whereas low stress physicians (n=3) recorded psychosocial information consistently in 67% of encounters. Burned-out physicians discussed a differential diagnosis in only 31% of encounters (low counts concentrated in two physicians) vs. in 73% of non-burned-out doctors' encounters. Burned-out and non-burned-out doctors spent comparable amounts of time with patients (about 25 min). CONCLUSIONS: Key diagnostic elements were seen less often in encounter transcripts and notes in burned-out urgent care physicians.

Mitigating Moral Injury for Palliative Care Clinicians.

Palliative care clinicians (PCCs) in the United States face the combination of increasing burnout and a growing need for their services based on demographic changes and an increasing burden of serious illness. In addition to efforts to increase the number of PCCs and to train other clinicians in "primary palliative skills," we must address the burnout in the field to address the growing gap between need for this care and capacity to provide it. To address burnout in PCCs, we must develop solutions with the unique contributors to burnout in this field in mind. PCCs are particularly susceptible to moral distress and moral injury faced by all clinicians, and these states are inextricably linked to burnout. We propose three solutions to address moral distress and moral injury in PCCs to reduce burnout. These solutions are grounded in the dilemmas particular to palliative care and in best evidence: first, to create space for PCCs to confront moral challenges head-on; second, to integrate ethics consultations into care of some patients cared for by PCCs; and third, to reassess care models for PCCs. These approaches can mitigate burnout and thus address the growing gap in our ability to provide high-quality palliative care for those patients in need.

Trends in Clinician Burnout With Associated Mitigating and Aggravating Factors During the COVID-19 Pandemic.

Importance: The COVID-19 pandemic has affected clinician health and retention. Objective: To describe trends in burnout from 2019 through 2021 with associated mitigating and aggravating factors. Design, Setting, and Participants: Cross-sectional surveys were sent to physicians and advanced practice clinicians throughout 120 large US health care organizations between February 2019 and December 2021. From 56 090 surveys, there were 20 627 respondents. Exposures: Work conditions and COVID-19. Main Outcomes and Measures: Surveys measured time pressure, chaos, work control, teamwork, electronic health record use, values alignment, satisfaction, burnout, intent to leave, and in 2021, feeling valued. Multivariate regressions controlling for gender, race and ethnicity, years in practice, and role determined burnout, satisfaction, and intent-to-leave correlates. Results: Of the 20 627 respondents (median response rate, 58% [IQR, 34%-86%; difference, 52%]), 67% were physicians, 51% female, and 66% White. Burnout was 45% in 2019, 40% to 45% in early 2020, 50% in late 2020, and 60% in late 2021. Intent to leave increased from 24% in 2019 to more than 40% as job satisfaction decreased. Higher burnout was seen in chaotic workplaces (odds ratio [OR], 1.51; 95% CI, 1.38-1.66; P < .001) and with low work control (OR, 2.10; 95% CI, 1.91-2.30; P < .001). Higher burnout was associated with poor teamwork (OR, 2.08; 95% CI, 1.78-2.43; P < .001), while feeling valued was associated with lower burnout (OR, 0.22; 95% CI, 0.18-0.27; P < .001). In time trends, burnout was consistently higher with chaos and poor work control. For example, in the fourth quarter of 2021 burnout was 36% (95% CI, 31%-42%) in calm environments vs 78% (95% CI, 73%-84%) if chaotic (absolute difference, 42%; 95% CI, 34%-49%; P < .001), and 39% (95% CI, 33%-44%) with good work control vs 75% (95% CI, 69%-81%) if poor (absolute difference, 36%; 95% CI, 27%-44%; P < .001). Good teamwork was associated with lower burnout rates (49%; 95% CI, 44%-54%) vs poor teamwork (88%; 95% CI, 80%-97%; absolute difference, 39%; 95% CI, 29%-48%; P < .001), as was feeling valued (37%; 95% CI, 31%-44%) vs not feeling valued (69%; 95% CI, 63%-74%; absolute difference, 32%; 95% CI, 22%-39%; P < .001). Conclusions and Relevance: Results of this survey study show that in 2020 through 2021, burnout and intent to leave gradually increased, rose sharply in late 2021, and varied by chaos, work control, teamwork, and feeling valued. Monitoring these variables could provide mechanisms for worker protection.

Training the next generation of learning health system scientists.

Introduction: The learning health system (LHS) aligns science, informatics, incentives, stakeholders, and culture for continuous improvement and innovation. The Agency for Healthcare Research and Quality and the Patient-Centered Outcomes Research Institute designed a K12 initiative to grow the number of LHS scientists. We describe approaches developed by 11 funded centers of excellence (COEs) to promote partnerships between scholars and health system leaders and to provide mentored research training. Methods: Since 2018, the COEs have enlisted faculty, secured institutional resources, partnered with health systems, developed and implemented curricula, recruited scholars, and provided mentored training. Program directors for each COE provided descriptive data on program context, scholar characteristics, stakeholder engagement, scholar experiences with health system partnerships, roles following program completion, and key training challenges. Results: To date, the 11 COEs have partnered with health systems to train 110 scholars. Nine (82%) programs partner with a Veterans Affairs health system and 9 (82%) partner with safety net providers. Clinically trained scholars (n = 87; 79%) include 70 physicians and 17 scholars in other clinical disciplines. Non-clinicians (n = 29; 26%) represent diverse fields, dominated by population health sciences. Stakeholder engagement helps scholars understand health system and patient/family needs and priorities, enabling opportunities to conduct embedded research, improve outcomes, and grow skills in translating research methods and findings into practice. Challenges include supporting scholars through roadblocks that threaten to derail projects during their limited program time, ranging from delays in access to data to COVID-19-related impediments and shifts in organizational priorities. Conclusions: Four years into this novel training program, there is evidence of scholars' accomplishments, both in traditional academic terms and in terms of moving along career trajectories that hold the potential to lead and accelerate transformational health system change. Future LHS training efforts should focus on sustainability, including organizational support for scholar activities.

Burnout Among Missouri Primary Care Clinicians in 2021: Roadmap for Recovery?

Rates of burnout among clinicians have been exacerbated by the COVID-19 (COVID)pandemic. A survey of Missouri primary care professionals at federally qualified health centers was conducted during a COVID surge in August 2021 to assess burnout, stress, and job satisfaction as well as if respondents had sought assistance for burnout or attended resiliency training. Despite respondents reporting rates of burnout (56%) that exceed those reported nationally (48%), only 17% sought help for burnout. Most (81%) had not attended resiliency training; of those who did, 16% said sessions "make me feel less alone," while an equivalent number found sessions not useful, identifying an absence of resources within their organization. Comments focused on the need for dedicated time to receive support, including time to seek assistance during working hours, time to take breaks, and time for self-care. The data suggest one path forward to remediate burnout: provide the workforce with time to access support.

Designing the careful and kind clinic: an evidence-based approach.

BACKGROUND: There is evidence that creating a 'healthy workplace' can be of profound importance for clinicians, team members and patients. Yet there have been few papers that have proposed mechanisms to take decades of research and translate this into a practical list of options for leaders and managers to take into account when structuring a clinic based on care and kindness to achieve optimal health. EVIDENCE: We bring together 20 years of scholarship linking care of the caregivers with outcomes for caregivers and patients. The data are used to support both structures and cultures that will result in satisfied and thriving healthcare team members, as well as satisfied and healthy patients. RESULTS: The clinic based on care of the caregivers will be structured to address key aspects of worklife that are known to cause either satisfaction or burnout. Aspects of care, such as time pressure, chaotic environments and worker control of their workplace, will be taken into account in clinical design; organisational culture will be supportive and cohesive, emphasising quality, values and communication. Experiences based on gender and race will be measured and continuously improved; and performance will be evaluated in a new, human-centred manner. OUTCOMES: The careful and kind clinic will be a remarkable place to work; in contrast to industrialised healthcare, this will be an environment where health can indeed be optimised, for both workers and patients.

Improving diagnosis: adding context to cognition.

BACKGROUND: The environment in which clinicians provide care and think about their patients is a crucial and undervalued component of the diagnostic process. CONTENT: In this paper, we propose a new conceptual model that links work conditions to clinician responses such as stress and burnout, which in turn impacts the quality of the diagnostic process and finally patient diagnostic outcomes. The mechanism for these interactions critically depends on the relationship between working memory (WM) and long-term memory (LTM), and ways WM and LTM interactions are affected by working conditions. SUMMARY: We propose a conceptual model to guide interventions to improve work conditions, clinician reactions and ultimately diagnostic process, accuracy and outcomes. OUTLOOK: Improving diagnosis can be accomplished if we are able to understand, measure and increase our knowledge of the context of care.

Enrolling people of color to evaluate a practice intervention: lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trial.

BACKGROUND: Trial recruitment of Black, indigenous, and people of color (BIPOC) is key for interventions that interact with socioeconomic factors and cultural norms, preferences, and values. We report on our experience enrolling BIPOC participants into a multicenter trial of a shared decision-making intervention about anticoagulation to prevent strokes, in patients with atrial fibrillation (AF). METHODS: We enrolled patients with AF and their clinicians in 5 healthcare systems (three academic medical centers, an urban/suburban community medical center, and a safety-net inner-city medical center) located in three states (Minnesota, Alabama, and Mississippi) in the United States. Clinical encounters were randomized to usual care with or without a shared decision-making tool about anticoagulation. ANALYSIS: We analyzed BIPOC patient enrollment by site, categorized reasons for non-enrollment, and examined how enrollment of BIPOC patients was promoted across sites. RESULTS: Of 2247 patients assessed, 922 were enrolled of which 147 (16%) were BIPOC patients. Eligible Black participants were significantly less likely (p < .001) to enroll (102, 11%) than trial-eligible White participants (185, 15%). The enrollment rate of BIPOC patients varied by site. The inclusion and prioritization of clinical practices that care for more BIPOC patients contributed to a higher enrollment rate into the trial. Specific efforts to reach BIPOC clinic attendees and prioritize their enrollment had lower yield. CONCLUSIONS: Best practices to optimize the enrollment of BIPOC participants into trials that examined complex and culturally sensitive interventions remain to be developed. This study suggests a high yield from enrolling BIPOC patients from practices that prioritize their care. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02905032).

Childcare Stress, Burnout, and Intent to Reduce Hours or Leave the Job During the COVID-19 Pandemic Among US Health Care Workers.

Importance: Childcare stress (CCS) is high during the COVID-19 pandemic because of remote learning and fear of illness transmission in health care workers (HCWs). Associations between CCS and burnout, intent to reduce (ITR) hours, and intent to leave (ITL) are not known. Objective: To determine associations between CCS, anxiety and depression, burnout, ITR in 1 year, and ITL in 2 years. Design, Setting, and Participants: This survey study, Coping with COVID, a brief work-life and wellness survey of US HCWs, was conducted between April and December 2020, assessing CCS, burnout, anxiety, depression, workload, and work intentions. The survey was distributed to clinicians and staff in participating health care organizations with more than 100 physicians. Data were analyzed from October 2021 to May 2022. Main Outcomes and Measures: The survey asked, "due to…COVID-19, I am experiencing concerns about childcare," and the presence of CCS was considered as a score of 3 or 4 on a scale from 1, not at all, to 4, a great extent. The survey also asked about fear of exposure or transmission, anxiety, depression, workload, and single-item measures of burnout, ITR, and ITL. Results: In 208 organizations, 58 408 HCWs (15 766 physicians [26.9%], 11 409 nurses [19.5%], 39 218 women [67.1%], and 33 817 White participants [57.9%]) responded with a median organizational response rate of 32%. CCS was present in 21% (12 197 respondents) of HCWs. CCS was more frequent among racial and ethnic minority individuals and those not identifying race or ethnicity vs White respondents (5028 respondents [25.2%] vs 6356 respondents [18.8%]; P < .001; proportional difference, -7.1; 95% CI, -7.8 to -6.3) and among women vs men (8281 respondents [21.1%] vs 2573 respondents [17.9%]; odds ratio [OR], 1.22; 95% CI, 1.17 to 1.29). Those with CCS had 115% greater odds of anxiety or depression (OR, 2.15; 95% CI, 2.04-2.26; P < .001), and 80% greater odds of burnout (OR, 1.80; 95% CI, 1.70-1.90; P < .001) vs indidivuals without CCS. High CCS was associated with 91% greater odds of ITR (OR, 1.91; 95% CI, 1.76 to 2.08; P < .001) and 28% greater odds of ITL (OR, 1.28; 95% CI, 1.17 to 1.40; P < .001). Conclusions and Relevance: In this survey study, CCS was disproportionately described across different subgroups of HCWs and was associated with anxiety, depression, burnout, ITR, and ITL. Addressing CCS may improve HCWs' quality of life and HCW retention and work participation.

An Evidence-Based Roadmap for the Provision of More Equitable Telemedicine.

OBJECTIVE: During the coronavirus disease 2019 pandemic, as a safety-net organization with a substantial percentage of patients of color and with limited English proficiency (LEP), we were wary of furthering health disparities in our community. We analyzed gaps in telemedicine (telephone and video) delivery in our communities, quantified the effects of our tests of change, and began the process of accumulating evidence to create a road map for other organizations. METHODS: We leveraged Lean problem-solving strategies to identify modifiable gaps across multiple domains that could inhibit equity in telemedicine. We implemented tests of change across domains of community engagement, technology, education, and access. We observed the proportion of telemedicine encounters across races and languages between April and November, 2020. Regression analyses tested the impact of race and language on telemedicine controlling for age, gender, insurance, and time. RESULTS: Several rounds of changes and enhancements were associated with changes in telemedicine use of +5.5% (p < 0.0001) for Hispanic, +4.0% (p < 0.0001) for Spanish-speaking, -2.1% for Black (p < 0.05), and -4.4% for White patients (p < 0.001). African-American, Hispanic, and non-English-speaking patients had between 2.3 and 4.6 times the odds of preferring telephone to video encounters (p < 0.0001), with increases in preferences for video use over time (p < 0.05). CONCLUSION: Our roadmap to improve equitable delivery of telemedicine was associated with a significant improvement in telemedicine use among certain minority populations. Most populations of color used telephone more often than video. This preference changed over time and with equity-focused changes in telemedicine delivery.

Anatomy of diagnosis in a clinical encounter: how clinicians discuss uncertainty with patients.

BACKGROUND: Studies consider the clinical encounter as linear, comprising six phases (opening, problem presentation, history-taking, physical examination, diagnosis, treatment and closing). This study utilizes formal conversation analysis to explore patient-physician interactions and understanding diagnostic utterances during these phases. METHODS: This study is a qualitative sub-analysis that explores how the diagnosis process, along with diagnostic uncertainty, are addressed during 28 urgent care visits. We analyzed physicians' hypothesis-generation process by focusing on: location of diagnostic utterances during the encounter; whether certain/uncertain diagnostic utterances were revised throughout the encounter; and how physicians tested their hypothesis-generation and managed uncertainty. We recruited 7 primary care physicians (PCPs) and their 28 patients from Brigham and Women's Hospital (BWH) in 3 urgent care settings. Encounters were audiotaped, transcribed, and coded using NVivo12 qualitative data analysis software. Data were analyzed inductively and deductively, using formal content and conversation analysis. RESULTS: We identified 62 diagnostic communication utterances in 12 different clinical situations. In most (24/28, 86%) encounters, the diagnosis process was initiated before the diagnosis phase (57% during history taking and 64% during physical examination). In 17 encounters (61%), a distinct diagnosis phase was not observed. Findings show that the diagnosis process is nonlinear in two ways. First, nonlinearity was observed when diagnostic utterances occurred throughout the encounter, with the six encounter phases overlapping, integrating elements of one phase with another. Second, nonlinearity was noted with respect to the resolution of diagnostic uncertainty, with physicians acknowledging uncertainty when explaining their diagnostic reasoning, even during brief encounters. CONCLUSIONS: Diagnosis is often more interactive and nonlinear, and expressions of diagnostic assessments can occur at any point during an encounter, allowing more flexible and potentially more patient-centered communication. These findings are relevant for physicians' training programs and helping clinicians improve their communication skills in managing uncertain diagnoses.

Longitudinal trajectories of treatment burden: A prospective survey study of adults living with multiple chronic conditions in the midwestern United States.

Objectives: Determine whether there are different longitudinal patterns of treatment burden in people living with multiple chronic conditions (MCC) and, if so, explore predictors that might reveal potential routes of intervention. Methods: We analyzed data from a prospective mailed survey study of 396 adults living with MCC in southeastern Minnesota, USA. Participants completed a measure of treatment burden, the Patient Experience with Treatment and Self-management (PETS), and valid measures of health-related and psycho-social concepts at baseline, 6, 12, and 24 months. Latent class growth mixture modeling (LCGM) determined trajectories of treatment burden in two summary index scores of the PETS: Workload and Impact. Multivariable logistic regressions were used to identify independent predictors of the trajectories. Results: LCGM supported a 2-class model for PETS Workload, including a group of consistently high workload (N = 69) and a group of consistently low workload (N = 311) over time. A 3-class model was supported for PETS Impact, including groups of consistently high impact (N = 62), consistently low impact (N = 278), and increasing impact (N = 51) over time. Logistic regression analyses showed that the following factors were associated with patterns of consistently high or increasing treatment burden over time: lower health literacy, lower self-efficacy, more interpersonal challenges with others, and worse subjective reports of physical and mental health (all p < .05). Conclusions: Different longitudinal patterns of treatment burden exist among people with MCC. Raising health literacy, enhancing self-efficacy, and lessening the effects of negative social interactions might help reduce treatment burden.

A Scoping Review on the Concept of Physician Caring.

BACKGROUND: Physicians' interest in the health and well-being of their patients is a tenet of medical practice. Physicians' ability to act upon this interest by caring for and about their patients is central to high-quality clinical medicine and may affect burnout. To date, a strong theoretical and empirical understanding of physician caring does not exist. To establish a practical, evidence-based approach to improve health care delivery and potentially address physician burnout, we sought to identify and synthesize existing conceptual models, frameworks, and definitions of physician caring. METHODS: We performed a scoping review on physician caring. In November 2019 and September 2020, we searched PubMed MEDLINE, Embase, PsycINFO, CINAHL, and CENTRAL Register of Controlled Trials to identify conceptual models, frameworks, and definitions of physician caring. Eligible articles involved discussion or study of care or caring among medical practitioners. We created a content summary and performed thematic analysis of extracted data. RESULTS: Of 11,776 articles, we reviewed the full text of 297 articles; 61 articles met inclusion criteria. Commonly identified concepts referenced Peabody's "secret of care" and the ethics of care. In bioethics, caring is described as a virtue. Contradictions exist among concepts of caring, such as whether caring is an attitude, emotion, or behavior, and the role of relationship development. Thematic analysis of all concepts and definitions identified six aspects of physician caring: (1) relational aspects, (2) technical aspects, (3) physician attitudes and characteristics, (4) agency, (5) reciprocity, and (6) physician self-care. DISCUSSION: Caring is instrumental to clinical medicine. However, scientific understanding of what constitutes caring from physicians is limited by contradictions across concepts. A unifying concept of physician caring does not yet exist. This review proposes six aspects of physician caring which can be used to develop evidence-based approaches to improve health care delivery and potentially mitigate physician burnout.

Compromised Integrity, Burnout, and Intent to Leave the Job in Critical Care Nurses and Physicians.

To describe relationships between compromised integrity (CI), burnout, and intent-to-leave (ITL) practice in critical care (CC) and noncritical care (non-CC) nurses and physicians. DESIGN: CC nurses (RNs) and physicians (MDs) from the American Medical Association Coping with COVID survey were matched by gender, race, years in practice, and role with non-CC clinicians to determine likelihood of ITL in relation to burnout and CI. SETTING: U.S. Healthcare organizations; July-December 2020. SUBJECTS: One hundred sixty-five CC RNs and 148 CC MDs (n = 313) matched with 165 non-CC RNs and 148 non-CC MDs from 83 healthcare organizations. MEASUREMENTS AND MAIN RESULTS: Burnout was measured with a single, validated question that mainly reflects emotional exhaustion (EE), and CI was determined by asking if respondents worried about doing things that compromised their integrity moderately or to a great extent. ITL included those moderately, likely, or definitely, intending to leave. Burnout correlated strongly with CI (tetrachoric r = 0.704 [0.606-0.803]; P < 0.001). Of 626 subjects, 59% experienced burnout, 24% CI, and 33% ITL. CC RNs experienced burnout more often (76%) than non-CC RNs (62%; P < 0.01) and CC MDs (51%; P < 0.001). CI was more frequent in CC RNs (44%) than non-CC RNs (23%) and CC MDs (16%; P < 0.001). In multivariate regressions, CC clinicians experiencing burnout had 50% greater odds of ITL than non-CC clinicians experiencing burnout; odds of ITL were substantially higher (odds ratio, 2.8-3.2) in those with CI regardless of location or burnout. In the ICU, those feeling valued by their organization had one-third the odds of ITL. CONCLUSIONS: Burnout (EE) is high (>50%) among CC RNs and MDs, which may result in losses of CC clinicians while demand rises. Preventing CI independent of burnout may reduce turnover in all settings and especially in ICUs. Feeling valued may promote staff retention.

Factors associated with patient trust in their clinicians: Results from the Healthy Work Place Study.

BACKGROUND: Patient trust in their clinicians is an important aspect of health care quality, but little evidence exists on what contributes to patient trust. PURPOSE: The aim of this study was to determine workplace, clinician, and patient correlates of patient trust in their clinician. METHODOLOGY/APPROACH: The sample used baseline data from the Healthy Work Place trial, a randomized trial of 34 Midwest and East Coast primary care practices to explore factors associated with patient trust in their clinicians. A multivariate "best subset" regression modeling approach was used, starting with an item pool of 45 potential variables. Over 7 million models were tested, with a best subset of correlates determined using standard methods for scale optimization. Skewed variables were transformed to the fifth power using a Box-Cox algorithm. RESULTS: The final model of nine variables explained 38% of variance in patient trust at the patient level and 49% at the clinician level. Trust was related mainly to several aspects of care variables (including satisfaction with explanations, overall satisfaction with provider, and learning about their medical conditions and their clinician's personal manner), with lesser association with patient characteristics and clinician work conditions. CONCLUSION: Trust appears to be primarily related to what happens between clinicians and patients in the examination room. PRACTICE IMPLICATIONS: System changes such as patient-centered medical homes may have difficulty succeeding if the primacy of physician-patient interactions in inspiring patient trust and satisfaction is not recognized.

Effect of Shared Decision-Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial.

Background Guidelines promote shared decision-making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within-encounter SDM tool to usual care (UC) increases patient involvement in decision-making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. Methods and Results We conducted a multicenter, encounter-level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow-up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. Conclusions In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: clinicaltrials.gov. Identifier: NCT02905032.

Lessons Learned: Recruiting Research Participants from an Underrepresented Patient Population at a Safety Net Hospital.

BACKGROUND: Recruiting participants to clinical research studies is challenging, especially when conducted in safety net settings. We sought to compare the efficacy of different recruitment strategies in an NIH-funded study assessing treatment burden in patients with multiple chronic conditions (MCCs). METHODS: Targeted mailing, in-person table-based recruitment ("tabling") in the waiting room, and telephone calling were used to enroll subjects into one of two studies of treatment burden: a survey study to validate a brief measure of treatment burden for quality assessment (study 1) or a qualitative study to develop a treatment burden clinical communication tool (study 2). RESULTS: Over 50% of subjects in each study were African American or African immigrants. In study 1, the enrollment goal of 200 was reached within 4 months. Tabling enrolled 78.5% of patients, while the remainder (21.5%) were enrolled from phone calls to eligible patients identified through the electronic medical record (EMR). In study 2, 340 eligible patients were identified through the EMR, and 7 (2.1%) were successfully enrolled via mailed invitations and responses. Retention rates (66% in study 1 and 71% in study 2) were reasonable in all groups. CONCLUSIONS: Study recruiting goals in our safety net population were rapidly reached using the tabling method, which had substantively higher enrollment rates than mailings or telephone calls based on EMR reports. Future trials could compare recruitment strategies across settings and clinical populations.