Clinical decision support and electronic interventions to improve care quality in chronic liver diseases and cirrhosis
Significant quality gaps exist in the management of chronic liver diseases and cirrhosis. Clinical decision support (CDS) systems-information-driven tools based in and launched from the electronic health record-are attractive and potentially scalable prospective interventions that could help standardize clinical care in hepatology. Yet, CDS systems have had a mixed record in clinical medicine due to issues with interoperability and compatibility with clinical workflows. In this review, we discuss the conceptual origins of CDS systems, existing applications in liver diseases, issues and challenges with implementation, and emerging strategies to improve their integration in hepatology care.
Effectiveness and Cost-Effectiveness of Team-Based Care for Hypertension: A Meta-Analysis and Simulation Study
BACKGROUND:Team-based care (TBC), a team of ≥2 healthcare professionals working collaboratively toward a shared clinical goal, is a recommended strategy to manage blood pressure (BP). However, the most effective and cost-effective TBC strategy is unknown. METHODS:A meta-analysis of clinical trials in US adults (aged ≥20 years) with uncontrolled hypertension (≥140/90 mm Hg) was performed to estimate the systolic BP reduction for TBC strategies versus usual care at 12 months. TBC strategies were stratified by the inclusion of a nonphysician team member who could titrate antihypertensive medications. The validated BP Control Model-Cardiovascular Disease Policy Model was used to project the expected BP reductions out to 10 years and simulate cardiovascular disease events, direct healthcare costs, quality-adjusted life years, and cost-effectiveness of TBC with physician and nonphysician titration. RESULTS:Among 19 studies comprising 5993 participants, the 12-month systolic BP change versus usual care was -5.0 (95% CI, -7.9 to -2.2) mm Hg for TBC with physician titration and -10.5 (-16.2 to -4.8) mm Hg for TBC with nonphysician titration. Relative to usual care at 10 years, TBC with nonphysician titration was estimated to cost $95 (95% uncertainty interval, -$563 to $664) more per patient and gain 0.022 (0.003-0.042) quality-adjusted life years, costing $4400/quality-adjusted life year gained. TBC with physician titration was estimated to cost more and gain fewer quality-adjusted life years than TBC with nonphysician titration. CONCLUSIONS:TBC with nonphysician titration yields superior hypertension outcomes compared with other strategies and is a cost-effective way to reduce hypertension-related morbidity and mortality in the United States.
Randomized trial protocol for remote monitoring for equity in advancing the control of hypertension in safety net systems (REACH-SNS) study
BACKGROUND:Self-measured blood pressure monitoring (SMBP) is essential to effective management of hypertension. This study aims to evaluate effectiveness and implementation of SMBP that leverages: cellular-enabled home BP monitors without a need for Wi-Fi or Bluetooth; simple communication modalities such as text messaging to support patient engagement; and integration into existing team-based workflows in safety-net clinics. METHODS:This study will be conducted with patients in San Francisco who are treated within a network of safety-net clinics. English and Spanish-speaking patients with diagnosed hypertension will be eligible for the trial if they have recent BP readings ≥140/90 mmHg and do not have co-morbid conditions that make home BP monitoring more complex to manage. This study will implement a three-arm randomized controlled trial to compare varying levels of implementation support: 1) cellular-enabled BP monitors (with minimal implementation support), 2) cellular-enabled BP monitors with protocol-based implementation support (text reminders for patients; aggregated BP summaries sent to primary care providers), and 3) cellular-enabled BP monitors and pharmacist-led support (pharmacist coaching and independent medication adjustments). RESULTS:For the main analysis, we will use mixed effects linear regression to compare the change in primary outcome of systolic BP. Secondary outcomes include BP control (<140/90 mmHg), medication intensification, patient-reported outcomes, and implementation processes (i.e., engagement with the intervention). DISCUSSION:This study will design and test a digital health intervention for use in marginalized populations treated within safety net settings, evaluating both effectiveness and implementation to advance more equitable health outcomes.
A Population Study of Clinical Trial Accrual for Women and Minorities in Neuro-Oncology Following the NIH Revitalization Act
BACKGROUND:The NIH Revitalization Act, implemented 29 years ago, set to improve the representation of women and minorities in clinical trials. In this study, we investigate progress made in all phase therapeutic clinical trials for neuro-epithelial CNS tumors stratified by demographic-specific age-adjusted disease incidence and mortality. Additionally, we identify workforce characteristics associated with clinical trials meeting established accrual benchmarks. METHODS:Registry study of published clinical trials for World Health Organization defined neuro-epithelial CNS tumors between January 2000 and December 2019. Study participants were obtained from PubMed and ClinicalTrials.gov. Population-based data originated from the CBTRUS for incidence analyses. SEER-18 Incidence-Based Mortality data was used for mortality analysis. Descriptive statistics, Fisher exact, and Ï‡2 tests were used for data analysis. RESULTS:Among 662 published clinical trials representing 49,907 participants, 62.5% of participants were men and 37.5% women (P<0.0001) representing a mortality specific over-accrual for men (P=0.001). Whites, Asians, Blacks, and Hispanics represented 91.7%, 1.5%, 2.6%, and 1.7% of trial participants. Compared with mortality, Blacks (47% of expected mortality, P=0.008), Hispanics (17% of expected mortality, P<0.001) and Asians (33% of expected mortality, P<.001) were underrepresented compared with Whites (114% of expected mortality, P<0.001). Clinical trials meeting accrual benchmarks for race included minority authorship. CONCLUSIONS:Following the Revitalization Act, minorities and women remain underrepresented in therapeutic clinical trials for neuroepithelial tumors, relative to disease incidence and mortality. Study accrual has improved with time. This study provides a framework for clinical trial accrual efforts and offers guidance regarding workforce considerations associated with enrollment of underserved patients.
Warfarin Monitoring in Safety-Net Health Systems: Analysis by Race/Ethnicity and Language Preference
BACKGROUND:Racial/ethnic disparities in anticoagulation management are well established. Differences in warfarin monitoring can contribute to these disparities and should be measured. OBJECTIVE:We assessed for differences in international normalized ratio (INR) monitoring by race/ethnicity and language preference across safety-net care systems serving predominantly low-income, ethnically diverse populations. DESIGN/METHODS:Cross-sectional analysis of process and safety data shared from the Safety Promotion Action Research and Knowledge Network (SPARK-Net) initiative, a consortium of five California safety-net hospital systems. PARTICIPANTS/METHODS:Eligible patients were at least 18 years old, received warfarin for at least 56 days during the measurement period from July 2015 to June 2017, and had INR testing in an ambulatory care setting at a participating healthcare system. MAIN MEASURES/METHODS:We conducted a scaled Poisson regression for adjusted rate ratio of having at least one INR checked per 56-day time period for which a patient had a warfarin prescription. Adjusting for age, sex, healthcare system, and insurance status/type, we assessed for racial/ethnic and language disparities in INR monitoring. KEY RESULTS/RESULTS:Of 8129 patients, 3615 (44%) were female; 1470 (18%), Black/African American; 3354 (41%), Hispanic/Latinx; 1210 (15%), Asian; 1643 (20%), White; and 452 (6%), other. Three thousand five hundred forty-nine (45%) were non-English preferring. We did not observe statistically significant disparities in the rate of appropriate INR monitoring by race/ethnicity or language; the primary source of variation was by healthcare network. Older age, female gender, and uninsured patients had a slightly higher rate of appropriate INR monitoring, but differences were not clinically significant. CONCLUSIONS:We did not find a race/ethnicity nor language disparity in INR monitoring; safety-net site was the main source of variation.
Diagnostic Trajectories in Primary Care at 12 Months: An Observational Cohort Study
BACKGROUND:Little is known about the epidemiology of diagnosis in primary care. METHODS:A prospective observational cohort study was conducted of adults presenting between August and December 2018 to primary care clinics across two health systems with an undiagnosed medical problem. Primary outcomes were (1) likelihood of a definitive diagnosis by 12 months and (2) time to diagnosis. Multivariate logistic regression was used to assess for factors associated with the likelihood of reaching a diagnosis, and multivariable Cox regression was used to assess for factors associated with time to diagnosis. Bivariate models were used to explore unadjusted relationships between the cases' organ systems and likelihood of and time to diagnosis. RESULTS:Among 410 cases in a diverse patient population, 206 (50.2%) reached a final diagnosis within 12 months, with a median time to diagnosis of 5 days (interquartile range = 0-46). Among these cases, 32.4% reached a diagnosis within the first month. A majority of cases not diagnosed within a month of the first presentation remained undiagnosed at 12 months. The likelihood of diagnosis and time to diagnosis did not differ by clinician or patient characteristics, clinicians' level of diagnostic uncertainty, chronicity of the medical issue, or visit type. There were no significant associations between organ system and likelihood of time to diagnosis. CONCLUSION/CONCLUSIONS:Patients presenting with new or unresolved problems in ambulatory primary care often remain undiagnosed after a year. There were no provider or patient-level variables associated with such lack of diagnosis. The causes, contributors, and consequences of lack of timely diagnosis and potential solutions require further research.
Comparison of Diagnostic Recommendations from Individual Physicians versus the Collective Intelligence of Multiple Physicians in Ambulatory Cases Referred for Specialist Consultation
BACKGROUND:Studies report higher diagnostic accuracy using the collective intelligence (CI) of multiple clinicians compared with individual clinicians. However, the diagnostic process is iterative, and unexplored is the value of CI in improving clinical recommendations leading to a final diagnosis. METHODS:To compare the appropriateness of diagnostic recommendations advised by individual physicians versus the CI of physicians, we entered actual consultation requests sent by primary care physicians to specialists onto a web-based CI platform capable of collecting diagnostic recommendations (next steps for care) from multiple physicians. We solicited responses to 35 cases (12 endocrinology, 13 gynecology, 10 neurology) from â‰¥3 physicians of any specialty through the CI platform, which aggregated responses into a CI output. The primary outcome was the appropriateness of individual physician recommendations versus the CI output recommendations, using recommendations agreed upon by 2 specialists in the same specialty as a gold standard. The secondary outcome was the recommendations' potential for harm. RESULTS:= 0.11). LIMITATIONS:Cases were from a single institution. CI was solicited using a single algorithm/platform. CONCLUSIONS:When seeking specialist guidance, diagnostic recommendations from the CI of multiple physicians are more appropriate than recommendations from most individual physicians, measured against specialist recommendations. Although CI provides useful recommendations, some have potential for harm. Future research should explore how to use CI to improve diagnosis while limiting harm from inappropriate tests/therapies.
Association of Differences in Treatment Intensification, Missed Visits, and Scheduled Follow-up Interval With Racial or Ethnic Disparities in Blood Pressure Control
Importance:Black patients with hypertension often have the lowest rates of blood pressure (BP) control in clinical settings. It is unknown to what extent variation in health care processes explains this disparity. Objective:To assess whether and to what extent treatment intensification, scheduled follow-up interval, and missed visits are associated with racial and ethnic disparities in BP control. Design, Setting, and Participants:In this cohort study, nested logistic regression models were used to estimate the likelihood of BP control (defined as a systolic BP [SBP] level <140 mm Hg) by race and ethnicity, and a structural equation model was used to assess the association of treatment intensification, scheduled follow-up interval, and missed visits with racial and ethnic disparities in BP control. The study included 16â€¯114 adults aged 20 years or older with hypertension and elevated BP (defined as an SBP level â‰¥140 mm Hg) during at least 1 clinic visit between January 1, 2015, and November 15, 2017. A total of 11 safety-net clinics within the San Francisco Health Network participated in the study. Data were analyzed from November 2019 to October 2020. Main Outcomes and Measures:Blood pressure control was assessed using the patient's most recent BP measurement as of November 15, 2017. Treatment intensification was calculated using the standard-based method, scored on a scale from -1.0 to 1.0, with -1.0 being the least amount of intensification and 1.0 being the most. Scheduled follow-up interval was defined as the mean number of days to the next scheduled visit after an elevated BP measurement. Missed visits measured the number of patients who did not show up for visits during the 4 weeks after an elevated BP measurement. Results:Among 16 114 adults with hypertension, the mean (SD) age was 58.6 (12.1) years, and 8098 patients (50.3%) were female. A total of 4658 patients (28.9%) were Asian, 3743 (23.2%) were Black, 3694 (22.9%) were Latinx, 2906 (18.0%) were White, and 1113 (6.9%) were of other races or ethnicities (including American Indian or Alaska Native [77 patients (0.4%)], Native Hawaiian or Pacific Islander [217 patients (1.3%)], and unknown [819 patients (5.1%)]). Compared with patients from all racial and ethnic groups, Black patients had lower treatment intensification scores (mean [SD], -0.33 [0.26] vs -0.29 [0.25]; Î²â€‰=â€‰-0.03, Pâ€‰<â€‰.001) and missed more visits (mean [SD], 0.8 [1.5] visits vs 0.4 [1.1] visits; Î²â€‰=â€‰0.35; Pâ€‰<â€‰.001). In contrast, Asian patients had higher treatment intensification scores (mean [SD], -0.26 [0.23]; Î²â€‰=â€‰0.02; Pâ€‰<â€‰.001) and fewer missed visits (mean [SD], 0.2 [0.7] visits; Î²â€‰=â€‰-0.20; Pâ€‰<â€‰.001). Black patients were less likely (odds ratio [OR],â€‰0.82; 95% CI, 0.75-0.89; Pâ€‰<â€‰.001) and Asian patients were more likely (OR,â€‰1.13; 95% CI, 1.02-1.25; Pâ€‰<â€‰.001) to achieve BP control than patients from all racial or ethnic groups. Treatment intensification and missed visits accounted for 21% and 14%, respectively, of the total difference in BP control among Black patients and 26% and 13% of the difference among Asian patients. Conclusions and Relevance:This study's findings suggest that racial and ethnic inequities in treatment intensification may be associated with more than 20% of observed racial or ethnic disparities in BP control, and racial and ethnic differences in visit attendance may also play a role. Ensuring more equitable provision of treatment intensification could be a beneficial health care strategy to reduce racial and ethnic disparities in BP control.
Examining Neighborhood Socioeconomic Status as a Mediator of Racial/Ethnic Disparities in Hypertension Control Across Two San Francisco Health Systems
BACKGROUND:A contextual understanding of hypertension control can inform population health management strategies to mitigate cardiovascular disease events. This retrospective cohort study links neighborhood-level data with patients' health records to describe racial/ethnic differences in uncontrolled hypertension and determine if and to what extent these differences are mediated by neighborhood socioeconomic status (nSES). METHODS:We conducted a mediation analysis using a sample of patients with hypertension from 2 health care delivery systems in San Francisco over 2 years (n=47â€‰031). We used generalized structural equation modeling, adjusted for age, sex, and health care system, to estimate the contribution of nSES to disparities in uncontrolled hypertension between White patients and Black, Hispanic/Latino, and Asian patients, respectively. Sensitivity analysis removed adjustment for health care system. RESULTS:Over half the cohort (62%) experienced uncontrolled hypertension during the study period. Racial/ethnic groups showed substantial differences in prevalence of uncontrolled hypertension and distribution of nSES quintiles. Compared with White patients, Black, and Hispanic/Latino patients had higher adjusted odds of uncontrolled hypertension: odds ratio, 1.79 [95% CI, 1.67-1.91] and odds ratio, 1.38 [95% CI, 1.29-1.47], respectively and nSES accounted for 7% of the disparity in both comparisons. Asian patients had slightly lower adjusted odds of uncontrolled hypertension when compared with White patients: odds ratio, 0.95 [95% CI, 0.89-0.99] and the mediating effect of nSES did not change the direction of the relationship. Sensitivity analysis increased the proportion mediated by nSES to 11% between Black and White patients and 13% between Hispanic/Latino and White patients, but did not influence differences between Asian and White patients. CONCLUSIONS:Among patients with hypertension in this study, nSES mediated a small proportion of racial/ethnic disparities in uncontrolled hypertension. Population health management strategies may be most effective by focusing on additional structural and interpersonal pathways such as racism and discrimination in health care settings.
Differences in Hypertension Medication Prescribing for Black Americans and Their Association with Hypertension Outcomes
BACKGROUND:National guidelines recommend different pharmacologic management of hypertension (HTN) without comorbidities for Black/African Americans (BAA) compared with non-BAA. We sought to 1) identify if these recommendations have influenced prescription patterns in BAA and 2) identify the differences in uncontrolled HTN in BAA on different antihypertensive medications. METHODS:We constructed a linked retrospective observational cohort using 2 years of electronic health records data, comprising of patients aged 18 to 85 with HTN on 1- or 2-drug regimens, including angiotensin-converting enzyme inhibitors (ACE), angiotensin receptor blockers (ARB), thiazide diuretics, or calcium channel blockers (CCB). We examined prescribing differences and HTN control in BAA versus non-BAA. RESULTS:< .001). For each drug regimen, there was more variation in HTN control within each group than between BAA and non-BAA. CONCLUSIONS:Providers seem to be following race-based guidelines for HTN, yet HTN control for BAA remains worse than non-BAA. An individualized approach to HTN therapy for all patients may be more important than race-based guidelines.