Using 42 CFR part 2 revisions to integrate substance use disorder treatment information into electronic health records at a safety net health system.

BACKGROUND: Regulations put in place to protect the privacy of individuals receiving substance use disorder (SUD) treatment have resulted in an unintended consequence of siloed SUD treatment and referral information outside of the integrated electronic health record (EHR). Recent revisions to these regulations have opened the door to data integration, which creates opportunities for enhanced patient care and more efficient workflows. We report on the experience of one safety-net hospital system integrating SUD treatment data into the EHR. METHODS: SUD treatment and referral information was integrated from siloed systems into the EHR through the implementation of a referral order, treatment episode definition, and referral and episode-related tools for addiction therapists and other clinicians. Integration was evaluated by monitoring SUD treatment episode characteristics, patient characteristics, referral linkage, and treatment episode retention before and after integration. Satisfaction of end-users with the new tools was evaluated through a survey of addiction therapists. RESULTS: After integration, three more SUD treatment programs were represented in the EHR. This increased the number of patients that could be tracked as initiating SUD treatment by 250%, from 562 before to 1,411 after integration. After integration, overall referral linkage declined (74% vs. 48%) and treatment episode retention at 90-days was higher (45% vs. 74%). Addiction therapists appreciated the efficiency of having all SUD treatment information in the EHR but did not find that the tools provided a large time savings shortly after integration. CONCLUSIONS: Integration of SUD treatment program data into the EHR facilitated both care coordination in patient treatment and quality improvement initiatives for treatment programs. Referral linkage and retention rates were likely modified by a broader capture of patients and changed outcome definition criteria. Greater preparatory workflow analysis may decrease initial end-user burden. Integration of siloed data, made possible given revised regulations, is essential to an efficient hub-and-spoke model of care, which must standardize and coordinate patient care across multiple clinics and departments.

Leveraging Ethnic Backgrounds to Improve Collection of Race, Ethnicity, and Language Data.

INTRODUCTION: Healthcare disparities may be exacerbated by upstream incapacity to collect high-quality and accurate race, ethnicity, and language (REaL) data. There are opportunities to remedy these data barriers. We present the Denver Health (DH) REaL initiative, which was implemented in 2021. METHODS: Denver Health is a large safety net health system. After assessing the state of REaL data at DH, we developed a standard script, implemented training, and adapted our electronic health record to collect this information starting with an individual's ethnic background followed by questions on race, ethnicity, and preferred language. We analyzed the data for completeness after REaL implementation. RESULTS: A total of 207,490 patients who had at least one in-person registration encounter before and after the DH REaL implementation were included in our analysis. There was a significant decline in missing values for race (7.9%-0.5%, p < .001) and for ethnicity (7.6%-0.3%, p < .001) after implementation. Completely of language data also improved (3%-1.6%, p < .001). A year after our implementation, we knew over 99% of our cohort's self-identified race and ethnicity. CONCLUSIONS: Our initiative significantly reduced missing data by successfully leveraging ethnic background as the starting point of our REaL data collection.

No health without access: using a retrospective cohort to model a care continuum for people released from prison at an urban, safety net health system.

BACKGROUND: Release from prison is characterized by discontinuity of healthcare services and results in poor health outcomes, including an increase in mortality. Institutions capable of addressing this gap in care seldom collaborate in comprehensive, data-driven transition of care planning. This study harnesses information from a data exchange between correctional facilities and community-based healthcare agencies in Colorado to model a care continuum after release from prison. METHODS: We merged records from Denver Health (DH), an urban safety-net healthcare system, and the Colorado Department of Corrections (CDOC), for people released from January 1 to June 30, 2021. The study population was either (a) released to the Denver metro area (Denver and its five neighboring counties), or (b) assigned to the DH Regional Accountable Entity, or (c) assigned to the DH medical home based on Colorado Department of Healthcare Policy and Financing attribution methods. Outcomes explored were outpatient, acute care, and inpatient utilization in the first 180 days after release. We used Pearson's chi-squared tests or Fisher exact for univariate comparisons and logistic regression for multivariable analysis. RESULTS: The care continuum describes the healthcare utilization at DH by people released from CDOC. From January 1, 2021, to June 30, 2021, 3242 people were released from CDOC and 2848 were included in the data exchange. 905 individuals of the 2848 were released to the Denver metro area or attributed to DH. In the study population of 905, 78.1% had a chronic medical or psychological condition. Within 180 days of release, 31.1% utilized any health service, 24.5% utilized at least one outpatient service, and 17.1% utilized outpatient services two or more times. 10.1% utilized outpatient services within the first 30 days of release. CONCLUSIONS: This care continuum highlights drop offs in accessing healthcare. It can be used by governmental, correctional, community-based, and healthcare agencies to design and evaluate interventions aimed at improving the health of a population at considerable risk for poor health outcomes and death.

Patient Pill Organization Strategies and Adherence Measured in a Cross-Sectional Study of Hypertension.

Background: The strategies patients use to organize medications (eg, pill dispenser) may be reflected in adherence measured at follow-up. We studied whether medication organization strategies patients use at home are associated with adherence measured using pharmacy-fills, self-report, and pill counts. Design: Secondary analysis of data from a prospective randomized clinical trial. Setting: Eleven US safety-net and community primary care clinics. Patients: Of the 960 enrolled self-identified non-Hispanic Black and White patients prescribed antihypertensive medications, 731 patients reported pill organization strategies and were included. Variable: Patients were asked if they use any of the following medication organization strategies: finish previous refills first; use a pill dispenser; combine same prescriptions; or combine dissimilar prescriptions. Outcomes: Adherence to antihypertensive medications using pill counts (range, 0.0-1.0% of the days covered), pharmacy-fill (proportion of days covered >90%), and self-report (adherent/non-adherent). Results: Of the 731 participants, 38.3% were men, 51.7% were age ≥65, 52.9% self-identified as Black or African American. Of the strategies studied, 51.7% finished previous refills first, 46.5% used a pill dispenser, 38.2% combined same prescriptions and 6.0% combined dissimilar prescriptions. Median (IQR) pill count adherence was 0.65 (0.40-0.87), pharmacy-fill adherence was 75.7%, and self-reported adherence was 63.2%. Those who combined same prescriptions had significantly lower measured pill count adherence than those who did not (0.56 (0.26-0.82) vs 0.70 (0.46-0.90), p<0.01) with no significant difference in pharmacy-fill (78.1% vs 74%, p=0.22) or self-reported adherence (63.0% vs 63.3%, p=0.93). Conclusion: Self-reported medication organization strategies were common. Combining same prescriptions was associated with lower adherence as measured using pill counts but not pharmacy-fills or self-report. Clinicians and researchers should identify the pill organization strategies used by their patients to understand how these strategies may influence measures of patient adherence. Trial Registration: ClinicalTrials.gov NCT03028597; https://clinicaltrials.gov/ct2/show/NCT03028597 (Archived by WebCite at http://www.webcitation.org/72vcZMzAB).

A multimodal strategy to improve race/ethnic group equity in administration of neutralizing monoclonal antibody treatment for COVID-19 outpatients.

Introduction: Racial and ethnic minority groups have higher rates of SARS-CoV-2 infection, severe illness, and death; however, they receive monoclonal antibody (mAb) treatment at lower rates than non-Hispanic White patients. We report data from a systematic approach to improve equitable provision of COVID-19 neutralizing monoclonal antibody treatment. Methods: Treatment was administered at a community health urgent care clinic affiliated with a safety-net urban hospital. The approach included a stable treatment supply, a same-day test and treat model, a referral process, patient outreach, and financial support. We analyzed the race/ethnicity data descriptively and compared proportions using a chi-square test. Results: Over 17 months, 2524 patients received treatment. Compared to the demographics of county COVID-19-positive cases, a greater proportion of patients who received mAb treatment were Hispanic (44.7% treatment vs. 36.5% positive cases, p < 0.001), a lower proportion were White Non-Hispanic (40.7% treatment vs. 46.3% positive cases, p < 0.001), equal proportion were Black (8.2% treatment vs. 7.4% positive cases, P = 0.13), and equal proportion occurred for other race patients. Discussion: Implementation of multiple systematic strategies to administer COVID-19 monoclonal antibodies resulted in an equitable race/ethnic distribution of treatment.

Total cost of care associated with opioid use disorder treatment.

The opioid epidemic in the United States disproportionately affects Medicaid beneficiaries than other groups. This results in a significant financial burden on state Medicaid programs. In this analysis, we investigate the association of medication for opioid use disorder (MOUD) treatment initiation and linkage to ongoing care on overall healthcare costs of Medicaid Fee-for-Service patients. We conducted a retrospective study among adult patients diagnosed with opioid use disorder (OUD) and who had a clinical encounter at a safety-net institution in Denver Colorado in 2020. Three categories of MOUD status of patients were defined: 1) identified with OUD but did not receive MOUD; 2) initiated MOUD but not linked to ongoing treatment and 3) received MOUD and linked to ongoing treatment. Our outcome variable was per-member per-month total healthcare cost. We estimated a multivariable model to test the association between healthcare cost and MOUD status, while controlling for demographic and risk classification variables. We found that in individuals with OUD who initiated MOUD treatment but were not linked to ongoing care had the highest healthcare cost, while those who were linked to ongoing MOUD treatment had the lowest healthcare cost. MOUD treatment is not only effective at addressing the significant morbidity and mortality burden of OUD but also associated with decreased financial cost, which is disproportionately incurred by Medicaid. Additional policy and care delivery changes are needed to focus efforts to improve linkage to ongoing treatment.

Relationship Between Social Vulnerability Indicators and Trial Participant Attrition: Findings From the HYVALUE Trial.

BACKGROUND: Social vulnerability indicators are associated with health care inequities and may similarly impede ongoing participation in research studies. We evaluated the association of social vulnerability indicators and research participant attrition in a trial focused on reducing health disparities. METHODS: Self-identified White or Black adults enrolled in the HYVALUE trial (Hypertension and VALUEs), a randomized trial testing a values-affirmation intervention on medication adherence, from February 2017 to September 2019 were included. The self-reported measures of social vulnerability indicators included: (1) Black race; (2) female gender; (3) no health insurance; (4) unemployment; (5) a high school diploma or less; and (6) financial-resource strain. Full attrition was defined as not completing at least one 3- or 6-month follow-up study visit. Log-binomial regression models adjusted for age, gender, race, medical comorbidities, and the other social vulnerability indicators to estimate the relative risk of each social vulnerability indicator with study attrition. RESULTS: Among 825 participants, the mean age was 63.3 years (±11.7 years), 60% were women, 54% were Black, and 97% reported at least one social vulnerability. Overall, 21% participants had full attrition after study enrollment. After adjustment for all other social vulnerabilities, only financial-resource strain remained consistently associated with full attrition (relative risk, 1.71 [95% CI, 1.28-2.29]). In a secondary analysis of partial attrition (completed only one follow-up visit), financial-resource strain (relative risk, 1.40 [95% CI, 1.09-1.81]) and being uninsured (relative risk, 1.54 [95% CI, 1.01-2.34]) were associated with partial attrition. CONCLUSIONS: In a trial aimed at reducing disparities in medication adherence, participants who reported financial-resource strain had a higher risk of participant attrition independent of race or gender. Our findings suggest that efforts to retain diverse populations in clinical trials should extend beyond race and gender to consider other social vulnerability indicators. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03028597.

Naloxone Co-Dispensing with Opioids: a Cluster Randomized Pragmatic Trial.

BACKGROUND: Although naloxone prevents opioid overdose deaths, few patients prescribed opioids receive naloxone, limiting its effectiveness in real-world settings. Barriers to naloxone prescribing include concerns that naloxone could increase risk behavior and limited time to provide necessary patient education. OBJECTIVE: To determine whether pharmacy-based naloxone co-dispensing affected opioid risk behavior. Secondary objectives were to assess if co-dispensing increased naloxone acquisition, increased patient knowledge about naloxone administration, and affected opioid dose and other substance use. DESIGN: Cluster randomized pragmatic trial of naloxone co-dispensing. SETTING: Safety-net health system in Denver, Colorado, between 2017 and 2020. PARTICIPANTS: Seven pharmacies were randomized. Pharmacy patients (N=768) receiving opioids were followed using automated data for 10 months. Pharmacy patients were also invited to complete surveys at baseline, 4 months, and 8 months; 325 survey participants were enrolled from November 15, 2017, to January 8, 2019. INTERVENTION: Intervention pharmacies implemented workflows to co-dispense naloxone while usual care pharmacies provided usual services. MAIN MEASURES: Survey instruments assessed opioid risk behavior; hazardous drinking; tobacco, cannabis, and other drug use; and knowledge. Naloxone dispensings and opioid dose were evaluated using pharmacy data among pharmacy patients and survey participants. Intention-to-treat analyses were conducted using generalized linear mixed models accounting for clustering at the pharmacy level. KEY RESULTS: Opioid risk behavior did not differ by trial group (P=0.52; 8-month vs. baseline adjusted risk ratio [ARR] 1.07; 95% CI 0.78, 1.47). Compared with usual care pharmacies, naloxone dispensings were higher in intervention pharmacies (ARR 3.38; 95% CI 2.21, 5.15) and participant knowledge increased (P=0.02; 8-month vs. baseline adjusted mean difference 1.05; 95% CI 0.06, 2.04). There was no difference in other substance use by the trial group. CONCLUSION: Co-dispensing naloxone with opioids effectively increased naloxone receipt and knowledge but did not increase self-reported risk behavior. TRIAL REGISTRATION: Registered at ClinicalTrials.gov ; Identifier: NCT03337100.

Health Behavior Theory and Hypertension Management: Comparisons Among Black, White, and American Indian and Alaska Native Patients.

In the United States, hypertension is more common among individuals from racial and ethnic minority groups. Hypertension control rates are also lower for minority group members compared with White Americans. However, little research has employed well-established theoretical perspectives on health behavior, such as the Theory of Planned Behavior (TPB) and the Model of Goal-Directed Behavior (MGB), to better understand racial differences in rates of hypertension control. The present study examines the psychological processes involved in efforts to control blood pressure, through the lens of the TPB augmented by the MGB, in hypertensive patients of three racial groups: American Indian/Alaska Native, Black/African American, and White. Participants completed measures of past efforts to control blood pressure, attitudes, norms, perceived behavioral control, intentions, and anticipated emotions. Analyses employed confirmatory factor analysis and cross-groups path analysis. Measurement of the theoretical constructs and core putative mediators of blood pressure control intentions were largely similar across racial groups. With regard to the patterns of relationships among the constructs, differences among the groups were most apparent in pathways from past efforts to both cognitive and affective theoretical antecedents of intentions. These findings contribute to the sparse literature on factors involved in racial differences in hypertension control rates and may inform future interventions aimed at increasing hypertension control behaviors. Trial Registration ClinicalTrials.gov, NCT03028597, registered 23 January 2017, https://clinicaltrials.gov/ct2/show/NCT03028597; ClinicalTrials.gov, NCT04414982, registered 4 June 2020 (retrospectively registered), https://www.clinicaltrials.gov/ct2/show/NCT04414982.

Effect of Values Affirmation on Reducing Racial Differences in Adherence to Hypertension Medication: The HYVALUE Randomized Clinical Trial.

Importance: Stereotype threat, or the fear of confirming a negative stereotype about one's social group, may contribute to racial differences in adherence to medications by decreasing patient activation to manage chronic conditions. Objective: To examine whether a values affirmation writing exercise improves medication adherence and whether the effect differs by patient race. Design, Setting, and Participants: The Hypertension and Values trial, a patient-level, blinded randomized clinical trial, compared an intervention and a control writing exercise delivered immediately prior to a clinic appointment. Of 20 777 eligible, self-identified non-Hispanic Black and White patients with uncontrolled hypertension who were taking blood pressure (BP) medications, 3891 were approached and 960 enrolled. Block randomization by self-identified race ensured balanced randomization. Patients enrolled between February 1, 2017, and December 31, 2019, at 11 US safety-net and community primary care clinics, with outcomes assessed at 3 and 6 months. Analysis was performed on an intention-to-treat basis. Interventions: From a list of 11 values, intervention patients wrote about their most important values and control patients wrote about their least important values. Main Outcomes and Measures: The primary outcome of adherence to BP medications was measured using pharmacy fill data (proportion of days covered >90%) at baseline, 3 months, and 6 months. The secondary outcome was systolic and diastolic BP. Patient activation to manage their health was also measured. Results: Of 960 patients, 474 (286 women [60.3%]; 256 Black patients [54.0%]; mean [SD] age, 63.4 [11.9] years) were randomly assigned to the intervention group and 486 (288 women [59.3%]; 272 Black patients [56.0%]; mean [SD] age, 62.8 [12.0] years) to the control group. Baseline medication adherence was lower (318 of 482 [66.0%] vs 331 of 412 [80.3%]) and mean (SE) BP higher among Black patients compared with White patients (systolic BP, 140.6 [18.5] vs 137.3 [17.8] mm Hg; diastolic BP, 83.9 [12.6] vs 79.7 [11.3] mm Hg). Compared with baseline, pharmacy fill adherence did not differ between intervention and control groups at 3 months (odds ratio [OR], 0.91 [95% CI, 0.57-1.43]) or at 6 months (OR, 0.86 [95% CI, 0.53-1.38]). There were also no treatment effect differences in pharmacy fill adherence by patient race (Black patients at 3 months: OR, 1.08 [95% CI, 0.61-1.92]; at 6 months: OR, 1.04 [95% CI, 0.58-1.87]; White patients at 3 months: OR, 0.68 [95% CI, 0.33-1.44]; at 6 months: OR, 0.55 [95% CI, 0.24-1.27]). Immediately after the intervention, the median patient activation was higher in intervention patients than in control patients, but this difference was not statistically significant in an unadjusted comparison (75.0 [IQR, 65.5-84.8] vs 72.5 [IQR, 63.1-80.9]; P = .06). In adjusted models, the Patient Activation Measure score immediately after the intervention was significantly higher in the intervention patients than in control patients (mean difference, 2.3 [95% CI, 0.1-4.5]). Conclusions and Relevance: A values affirmation intervention was associated with higher patient activation overall but did not improve adherence or blood pressure among Black and White patients with hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT03028597.

Assessing and Augmenting Predictive Models for Hospital Readmissions With Novel Variables in an Urban Safety-net Population.

BACKGROUND: The performance of existing predictive models of readmissions, such as the LACE, LACE+, and Epic models, is not established in urban safety-net populations. We assessed previously validated predictive models of readmission performance in a socially complex, urban safety-net population, and if augmentation with additional variables such as the Area Deprivation Index, mental health diagnoses, and housing access improves prediction. Through the addition of new variables, we introduce the LACE-social determinants of health (SDH) model. METHODS: This retrospective cohort study included adult admissions from July 1, 2016, to June 30, 2018, at a single urban safety-net health system, assessing the performance of the LACE, LACE+, and Epic models in predicting 30-day, unplanned rehospitalization. The LACE-SDH development is presented through logistic regression. Predictive model performance was compared using C-statistics. RESULTS: A total of 16,540 patients met the inclusion criteria. Within the validation cohort (n=8314), the Epic model performed the best (C-statistic=0.71, P<0.05), compared with LACE-SDH (0.67), LACE (0.65), and LACE+ (0.61). The variables most associated with readmissions were (odds ratio, 95% confidence interval) against medical advice discharge (3.19, 2.28-4.45), mental health diagnosis (2.06, 1.72-2.47), and health care utilization (1.94, 1.47-2.55). CONCLUSIONS: The Epic model performed the best in our sample but requires the use of the Epic Electronic Health Record. The LACE-SDH performed significantly better than the LACE and LACE+ models when applied to a safety-net population, demonstrating the importance of accounting for socioeconomic stressors, mental health, and health care utilization in assessing readmission risk in urban safety-net patients.

Retrospective cohort study of statin prescribing for primary prevention among people living with HIV.

OBJECTIVE: To compare statin prescribing rates between intermediate-risk people living with human immunodeficiency virus (HIV; PLWH) and intermediate-risk patients without a diagnosis of HIV for primary prevention of atherosclerotic cardiovascular disease (ASCVD). METHODS: Retrospective cohort study . Electronic health record data were used to identify a cohort of PLWH aged 40-75 years with a calculated 10-year ASCVD risk between 7.5%-19.9% as determined by the Pooled Cohort Equation (PCE). A matched cohort of primary prevention non-HIV patients was identified. The primary outcome was the proportion of PLWH who were prescribed statin therapy compared to patients who were not living with HIV and were prescribed statin therapy. RESULTS: 81 patients meeting study criteria in the PLWH cohort were matched to 81 non-HIV patients. The proportion of patients prescribed statins was 33.0% and 30.9% in the PLWH and non-HIV cohorts, respectively (p = 0.74).Conclusion and relevance: This study evaluated statin prescribing in PLWH for primary prevention of ASCVD as described in the 2018 AHA/ACC/Multisociety guideline. Rates of statin prescribing were similar, yet overall low, among intermediate-risk primary prevention PLWH compared to those not diagnosed with HIV.

Association Between In-Clinic Opioid Administration and Discharge Opioid Prescription in Urgent Care: a Retrospective Cohort Study.

BACKGROUND: Emergency departments increasingly use nonopioid analgesics to manage acute pain and minimize opioid-related harms. Urgent care centers are expanding to lower costs and provide efficient access to healthcare. General internists increasingly work in these acute care settings. Much is known about opioid prescribing in the primary care, inpatient, and emergency department setting. Little is known about opioid prescribing in the urgent care setting and associated outcomes. OBJECTIVES: To assess the association between in-clinic opioid administration and opioid receipt at clinic discharge and on progression to chronic opioid use among urgent care patients. DESIGN: Retrospective cohort study. PARTICIPANTS: Patients, 20 years or older and not on opioid medications, who presented for care to an urgent care clinic within a safety-net healthcare system from June 1, 2016, to April 30, 2019. MAIN MEASURES: We examined the association between the in-clinic administration of oral or intravenous opioids and opioid receipt at clinic discharge. We also examined the association between in-clinic opioid administration and progression to chronic opioid use after six months. KEY RESULTS: The study sample included 34,978 patients, of which 13.8% (n = 4842) received in-clinic opioids and 86.2% (n = 30,136) did not receive in-clinic opioids. After adjusting for age, gender, race/ethnicity, insurance, and pain diagnosis, patients who received in-clinic opioids were more likely to receive opioids at discharge compared to patients who did not receive in-clinic opioids (aOR = 12.30, 95% CI 11.44-13.23). Among a selected cohort of patients, in-clinic opioid administration was associated with progression to chronic opioid use (aOR = 2.12, 95% CI 1.66-2.71). CONCLUSIONS: In-clinic opioid administration was strongly associated with opioid receipt at discharge and progression to chronic opioid use. Increased use of nonopioid analgesics in urgent care could likely reduce this association and limit opioids available for diversion, overdose, and death.

Improving Atraumatic Chest Pain Evaluation in an Urban, Safety-net Hospital Through Incorporation of a Modified HEART Score.

Atraumatic chest pain is a common emergency department (ED) presentation and the American College of Cardiology and American Heart Association recommends stress testing within 72 hours. The HEART score predicts major adverse cardiac events (MACE) in ED populations and does not require universal stress testing. An evaluation based solely on history, electrocardiography, and biomarkers, therefore, is an attractive approach to risk stratification in resource-limited settings. The HEART score has not been previously evaluated in a safety net hospital setting. We therefore implemented an interdisciplinary clinical care guideline utilizing the HEART score to stratify patients presenting to our inner-city hospital. During a 6-month study period, 1170 patients were evaluated (521 before and 649 after implementation). Among the 998 patients with confirmed follow-up 6-weeks after the index ED encounter, the prevalence of MACE (all-cause mortality, acute myocardial infarction, or coronary revascularization) was 0% [95% confidence interval (CI), 0%-1%] for low, 9% (95% CI, 7%-12%) for moderate, and 52% (95% CI, 39%-65%) for high-risk groups. Guideline implementation significantly increased admissions (+12%, 95% CI, 7%-17%) primarily in the moderate risk group (+38%, 95% CI, 29%-47%), but significantly decreased median ED length of stay (-37 minutes, 95% CI, 17-58). It also led to an increase in stress testing among moderate and high-risk patients (+10%, 95% CI, 0%-19%). In conclusion, the HEART score effectively stratified risk of MACE in a safety net population, improved evaluation consistency, and decreased ED length of stay. However, implementation was associated with an increase in hospitalizations and stress testing. Although the American Heart Association/American College of Cardiology guideline regarding atraumatic chest pain in the ED recommends universal noninvasive testing, the value of this approach, particularly in conjunction with the HEART score is uncertain in safety net hospitals. Further evaluation of the costs and clinical advantages of this approach are warranted.

Using Values Affirmation to Reduce the Effects of Stereotype Threat on Hypertension Disparities: Protocol for the Multicenter Randomized Hypertension and Values (HYVALUE) Trial.

BACKGROUND: Medication nonadherence is a significant, modifiable contributor to uncontrolled hypertension. Stereotype threat may contribute to racial disparities in adherence by hindering a patient's ability to actively engage during a clinical encounter, resulting in reduced activation to adhere to prescribed therapies. OBJECTIVE: The Hypertension and Values (HYVALUE) trial aims to examine whether a values-affirmation intervention improves medication adherence (primary outcome) by targeting racial stereotype threat. METHODS: The HYVALUE trial is a patient-level, blinded randomized controlled trial comparing a brief values-affirmation writing exercise with a control writing exercise among black and white patients with uncontrolled hypertension. We are recruiting patients from 3 large health systems in the United States. The primary outcome is patients' adherence to antihypertensive medications, with secondary outcomes of systolic and diastolic blood pressure over time, time for which blood pressure is under control, and treatment intensification. We are comparing the effects of the intervention among blacks and whites, exploring possible moderators (ie, patients' prior experiences of discrimination and clinician racial bias) and mediators (ie, patient activation) of intervention effects on outcomes. RESULTS: This study was funded by the National Heart, Lung, and Blood Institute. Enrollment and follow-up are ongoing and data analysis is expected to begin in late 2020. Planned enrollment is 1130 patients. On the basis of evidence supporting the effectiveness of values affirmation in educational settings and our pilot work demonstrating improved patient-clinician communication, we hypothesize that values affirmation disrupts the negative effects of stereotype threat on the clinical interaction and can reduce racial disparities in medication adherence and subsequent health outcomes. CONCLUSIONS: The HYVALUE study moves beyond documentation of race-based health disparities toward testing an intervention. We focus on a medical condition-hypertension, which is arguably the greatest contributor to mortality disparities for black patients. If successful, this study will be the first to provide evidence for a low-resource intervention that has the potential to substantially reduce health care disparities across a wide range of health care conditions and populations. TRIAL REGISTRATION: ClinicalTrials.gov NCT03028597; https://clinicaltrials.gov/ct2/show/NCT03028597 (Archived by WebCite at http://www.webcitation.org/72vcZMzAB). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12498.

Novel Opioid Safety Clinic Initiative to Deliver Guideline-Concordant Chronic Opioid Therapy in Primary Care.

OBJECTIVE: To develop and evaluate a novel Opioid Safety Clinic (OSC) initiative to enhance adherence to guidelines on the assessment and monitoring of patients prescribed chronic opioid therapy (COT). PATIENTS AND METHODS: The OSC was developed at an urban Federally Qualified Health Center to provide guideline-concordant care for COT, standardize workflows, and efficiently use clinic staff. We evaluated the OSC using a matched cohort study. Five hundred thirty-nine patients participated in the clinic between July 1, 2014, and March 31, 2016. Of these, 472 clinic participants were matched to 472 nonparticipants by sex and age on the date of the OSC visit. The OSC was evaluated by its completion rates of standardized pain assessments, urine toxicology, and naloxone dispensings. We conducted logistic regression comparing OSC participants to OSC nonparticipants. RESULTS: A total of 539 patients attended an OSC visit, representing approximately 53% of patients in the chronic opioid registry. The OSC participants were more likely than nonparticipants to have completed a pain assessment (adjusted odds ratio [aOR], 169.8; 95% CI, 98.3-293.5), completed a urine toxicology (aOR, 46.1; 95% CI, 30.4-69.9), or had naloxone dispensed (aOR, 2.8; 95% CI, 1.9-4.3) over 12 months of follow-up. CONCLUSION: The OSC model improved adherence to guideline-concordant COT in primary care. Future research is needed to assess the impact of these interventions on pain, quality of life, and adverse events from opioid analgesics.

Identifying Subgroups of Adult Superutilizers in an Urban Safety-Net System Using Latent Class Analysis: Implications for Clinical Practice.

BACKGROUND: Patients with repeated hospitalizations represent a group with potentially avoidable utilization. Recent publications have begun to highlight the heterogeneity of this group. Latent class analysis provides a novel methodological approach to utilizing administrative data to identify clinically meaningful subgroups of patients to inform tailored intervention efforts. OBJECTIVE: The objective of the study was to identify clinically distinct subgroups of adult superutilizers. RESEARCH DESIGN: Retrospective cohort analysis. SUBJECTS: Adult patients who had an admission at an urban safety-net hospital in 2014 and 2 or more admissions within the preceding 12 months. MEASURES: Patient-level medical, mental health (MH) and substance use diagnoses, social characteristics, demographics, utilization and charges were obtained from administrative data. Latent class analyses were used to determine the number and characteristics of latent subgroups that best represented these data. RESULTS: In this cohort (N=1515), a 5-class model was preferred based on model fit indices, clinical interpretability and class size: class 1 (16%) characterized by alcohol use disorder and homelessness; class 2 (14%) characterized by medical conditions, MH/substance use disorders and homelessness; class 3 (25%) characterized primarily by medical conditions; class 4 (13%) characterized by more serious MH disorders, drug use disorder and homelessness; and class 5 (32%) characterized by medical conditions with some MH and substance use. Patient demographics, utilization, charges and mortality also varied by class. CONCLUSIONS: The overall cohort had high rates of multiple chronic medical conditions, MH, substance use disorders, and homelessness. However, the patterns of these conditions were different between subgroups, providing important information for tailoring interventions.

An investigation of associations between clinicians' ethnic or racial bias and hypertension treatment, medication adherence and blood pressure control.

BACKGROUND: Few studies have directly investigated the association of clinicians' implicit (unconscious) bias with health care disparities in clinical settings. OBJECTIVE: To determine if clinicians' implicit ethnic or racial bias is associated with processes and outcomes of treatment for hypertension among black and Latino patients, relative to white patients. RESEARCH DESIGN AND PARTICIPANTS: Primary care clinicians completed Implicit Association Tests of ethnic and racial bias. Electronic medical records were queried for a stratified, random sample of the clinicians' black, Latino and white patients to assess treatment intensification, adherence and control of hypertension. Multilevel random coefficient models assessed the associations between clinicians' implicit biases and ethnic or racial differences in hypertension care and outcomes. MAIN MEASURES: Standard measures of treatment intensification and medication adherence were calculated from pharmacy refills. Hypertension control was assessed by the percentage of time that patients met blood pressure goals recorded during primary care visits. KEY RESULTS: One hundred and thirty-eight primary care clinicians and 4,794 patients with hypertension participated. Black patients received equivalent treatment intensification, but had lower medication adherence and worse hypertension control than white patients; Latino patients received equivalent treatment intensification and had similar hypertension control, but lower medication adherence than white patients. Differences in treatment intensification, medication adherence and hypertension control were unrelated to clinician implicit bias for black patients (P = 0.85, P = 0.06 and P = 0.31, respectively) and for Latino patients (P = 0.55, P = 0.40 and P = 0.79, respectively). An increase in clinician bias from average to strong was associated with a relative change of less than 5 % in all outcomes for black and Latino patients. CONCLUSIONS: Implicit bias did not affect clinicians' provision of care to their minority patients, nor did it affect the patients' outcomes. The identification of health care contexts in which bias does not impact outcomes can assist both patients and clinicians in their efforts to build trust and partnership.