Cumulative environmental stress and emerging cardiometabolic risk during childhood.

OBJECTIVE: To prospectively evaluate the relationship between cumulative environmental stress and cardiometabolic risk in middle childhood, and to examine whether hair cortisol, a measure of hypothalamic pituitary adrenal-axis activity, mediates this relationship. METHODS: In a cohort of children from low-income households (n = 320; 59% Hispanic, 23% Black, body mass index (BMI) percentile >50th at enrollment), environmental stressors including family and neighbourhood factors representing disadvantage/deprivation, and cortisol concentrations from hair samples, were measured over five timepoints beginning when children were 2-4 years old. Cardiometabolic risk factors (i.e., BMI, blood pressure, lipids, blood sugar, C-reactive protein) were measured at the final timepoint when children were 7-11 years of age. RESULTS: In adjusted logistic regression models, greater cumulative environmental stress was associated with a higher likelihood of elevated cardiometabolic risk in middle childhood (p = 0.01). Children from minoritized racial/ethnic groups had a higher prevalence of both stressors and cardiometabolic risk factors. Cumulative environmental stress was associated with higher hair cortisol concentrations (p < 0.01). However, hair cortisol was not directly associated with cardiometabolic risk factors and did not explain the association between environmental stress and cardiometabolic risk in causal mediation analysis. CONCLUSIONS: The influence of cumulative stress on cardiometabolic health can be observed in middle childhood and may contribute to cardiometabolic health disparities, highlighting the importance of public health interventions to mitigate disadvantage.

A CKD Clinical Decision Support System: A Cluster Randomized Clinical Trial in Primary Care Clinics.

Rationale & Objective: The study aimed to develop, implement, and evaluate a clinical decision support (CDS) system for chronic kidney disease (CKD) in a primary care setting, with the goal of improving CKD care in adults. Study Design: This was a cluster randomized trial. Setting & Participants: A total of 32 Midwestern primary care clinics were randomly assigned to either receive usual care or CKD-CDS intervention. Between April 2019 and March 2020, we enrolled 6,420 patients aged 18-75 years with laboratory-defined glomerular filtration rate categories of CKD Stage G3 and G4, and 1 or more of 6 CKD care gaps: absence of a CKD diagnosis, suboptimal blood pressure or glycated hemoglobin levels, indication for angiotensin-converting enzyme inhibitor or angiotensin receptor blocker but not prescribed, a nonsteroidal anti-inflammatory agent on the active medication list, or indication for a nephrology referral. Intervention: The CKD-CDS provided personalized suggestions for CKD care improvement opportunities directed to both patients and clinicians at primary care encounters. Outcomes: We assessed the proportion of patients meeting each of 6 CKD-CDS quality metrics representing care gap resolution after 18 months. Results: The adjusted proportions of patients meeting quality metrics in CKD-CDS versus usual care were as follows: CKD diagnosis documented (26.6% vs 21.8%; risk ratio [RR], 1.17; 95% CI, 0.91-1.51); angiotensin-converting enzyme inhibitor or angiotensin receptor blocker prescribed (15.9% vs 16.1%; RR, 0.95; 95% CI, 0.76-1.18); blood pressure control (20.4% vs 20.2%; RR, 0.98; 95% CI, 0.84-1.15); glycated hemoglobin level control (21.4% vs 22.1%; RR, 1.00; 95% CI, 0.80-1.24); nonsteroidal anti-inflammatory agent not on the active medication list (51.5% vs 50.4%; RR, 1.03; 95% CI, 0.90-1.17); and referral or visit to a nephrologist (38.7% vs 36.1%; RR, 1.02; 95% CI, 0.79-1.32). Limitations: We encountered an overall reduction in expected primary care encounters and obstacles to point-of-care CKD-CDS utilization because of the coronavirus disease 2019 pandemic. Conclusions: The CKD-CDS intervention did not lead to a significant improvement in CKD quality metrics. The challenges to CDS use during the coronavirus disease 2019 pandemic likely influenced these results. Funding: National Institute of Diabetes and Digestive and Kidney Diseases (R18DK118463). Trial Registration: clinicaltrials.gov Identifier: NCT03890588.

This study aimed to improve the management of chronic kidney disease (CKD) through a clinical decision support (CDS) system. It involved 32 primary care clinics and 6,420 patients with CKD who had 1 or more of 6 CKD care improvement opportunities. The CDS provided personalized suggestions to both patients and clinicians about CKD care opportunities during primary care visits. After 18 months, the study found no significant differences between patients in clinics with CKD-CDS compared with usual care in diagnosing CKD, prescribing recommended medications, controlling blood pressure or glycated hemoglobin, nonsteroidal anti-inflammatory agent usage, or nephrology referrals. The coronavirus disease 2019 pandemic may have influenced results by introducing unforeseen implementation challenges, reduced visits, and less than expected CDS exposure.

Differential Effects of an Intervention to Reduce Cardiovascular Risk for Patients With Bipolar Disorder, Schizoaffective Disorder, or Schizophrenia: A Randomized Clinical Trial.

Objective: To measure the impact of a clinical decision support (CDS) tool on total modifiable cardiovascular risk at 12 months separately for outpatients with 3 subtypes of serious mental illness (SMI) identified via ICD-9 and ICD-10 codes: bipolar disorder, schizoaffective disorder, and schizophrenia.Methods: This cluster-randomized pragmatic clinical trial was active from March 2016 to September 2018; data were analyzed from April 2021 to September 2022. Clinicians and patients from 78 primary care clinics participated. All 8,922 adult patients aged 18-75 years with diagnosed SMI, at least 1 cardiovascular risk factor not at goal, and an index and follow-up visit during the study period were included. The CDS tool provided a summary of modifiable cardiovascular risk and personalized treatment recommendations.Results: Intervention patients had 4% relative reduction in total modifiable cardiovascular risk at 12 months compared to controls (relative risk ratio = 0.96; 95% CI, 0.94 to 0.98), with similar intervention benefits for all 3 SMI subtypes. At index, 10-year cardiovascular risk was higher for patients with schizophrenia (mean [SD] = 11.3% [9.2%]) than for patients with bipolar disorder (8.5% [8.9%]) or schizoaffective disorder (9.4% [8.1%]), while 30-year cardiovascular risk was highest for patients with schizoaffective disorder (44% with 2 or more major cardiovascular risk factors, compared to 40% for patients with schizophrenia and 37% for patients with bipolar disorder). Smoking was highly prevalent (47%), and mean (SD) BMI was 32.7 (7.9).Conclusions: This CDS intervention produced a clinically and statistically significant 4% relative reduction in total modifiable cardiovascular risk for intervention patients versus controls at 12 months, an effect observed across all 3 SMI subtypes and attributable to the aggregate impact of small changes in multiple cardiovascular risk factors.Trial Registration: ClinicalTrials.gov Identifier: NCT02451670.

A randomized controlled trial of an intervention to reduce stigma toward people with opioid use disorder among primary care clinicians.

BACKGROUND: Many primary care clinicians (PCCs) hold stigma toward people with opioid use disorder (OUD), which may be a barrier to care. Few interventions exist to address PCC stigma toward people with OUD. This study examined whether an online training incorporating patient narratives reduced PCCs' stigma toward people with OUD (primary) and increased intentions to treat people with OUD compared to an attention-control training (secondary). METHODS: PCCs from 15 primary care clinics were invited to complete a 30 min online training for an electronic health record-embedded clinical decision support (CDS) tool that alerts PCCs to screen, diagnose, and treat people with OUD. PCCs were randomized to receive a stigma-reduction version of the training with patient narrative videos or a control training without patient narratives and were blinded to group assignment. Immediately after the training, PCCs completed surveys of stigma towards people with OUD and intentions and willingness to treat OUD. CDS tool use was monitored for 6 months. Analyses included independent samples t-tests, Pearson correlations, and logistic regression. RESULTS: A total of 162 PCCs were randomized; 88 PCCs (58% female; 68% white) completed the training (Stigma = 48; Control = 40) and were included in analyses. There was no significant difference between intervention and control groups for stigma (t = - 0.48, p = .64, Cohen's d = - 0.11), intention to get waivered (t = 1.11, p = .27, d = 0.26), or intention to prescribe buprenorphine if a waiver were no longer required (t = 0.90, p = 0.37, d = 0.21). PCCs who reported greater stigma reported lower intentions both to get waivered (r = - 0.25, p = 0.03) and to prescribe buprenorphine with no waiver (r = - 0.25, p = 0.03). Intervention group and self-reported stigma were not significantly related to CDS tool use. CONCLUSIONS: Stigma toward people with OUD may require more robust intervention than this brief training was able to accomplish. However, stigma was related to lower intentions to treat people with OUD, suggesting stigma acts as a barrier to care. Future work should identify effective interventions to reduce stigma among PCCs. TRIAL REGISTRATION: ClinicalTrials.gov NCT04867382. Registered 30 April 2021-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04867382.

Design of a pragmatic clinical trial to improve screening and treatment for opioid use disorder in primary care.

BACKGROUND: Opioid-related deaths continue to rise in the U.S. A shared decision-making (SDM) system to help primary care clinicians (PCCs) identify and treat patients with opioid use disorder (OUD) could help address this crisis. METHODS: In this cluster-randomized trial, primary care clinics in three healthcare systems were randomized to receive or not receive access to an OUD-SDM system. The OUD-SDM system alerts PCCs and patients to elevated risk of OUD and supports OUD screening and treatment. It includes guidance on OUD screening and diagnosis, treatment selection, starting and maintaining patients on buprenorphine for waivered clinicians, and screening for common comorbid conditions. The primary study outcome is, of patients at high risk for OUD, the percentage receiving an OUD diagnosis within 30 days of index visit. Additional outcomes are, of patients at high risk for or with a diagnosis of OUD, (a) the percentage receiving a naloxone prescription, or (b) the percentage receiving a medication for OUD (MOUD) prescription or referral to specialty care within 30 days of an index visit, and (c) total days covered by a MOUD prescription within 90 days of an index visit. RESULTS: The intervention started in April 2021 and continues through December 2023. PCCs and patients in 90 clinics are included; study results are expected in 2024. CONCLUSION: This protocol paper describes the design of a multi-site trial to help PCCs recognize and treat OUD. If effective, this OUD-SDM intervention could improve screening of at-risk patients and rates of OUD treatment for people with OUD.

Household Income, Cortisol, and Obesity During Early Childhood: A Prospective Longitudinal Study.

OBJECTIVE: To prospectively evaluate the relationship between household income, children's cortisol, and body mass index (BMI) trajectories over a 3-year period in early childhood. STUDY DESIGN: Household income, child hair cortisol levels, and BMI were measured at baseline, 12-, 24-, and 36-month follow-up visits in the Now Everybody Together for Amazing and Healthful Kids (NET-Works) Study (n = 534, children ages 2-4 years, and household income <$65 000/year at baseline). Relationships were examined between very low household income (<$25 000/year) at baseline, income status over time (remained <$25 000/year or had increasing income), cortisol accumulation from hair samples, and BMI percent of the 95th percentile (BMIp95) trajectories using adjusted linear growth curve modeling. Households with baseline income between $25 000 and $65 000/year were the reference group for all analyses. RESULTS: Children from very low-income households at baseline had annual changes in BMIp95 that were higher (P < .001) than children from reference group households (0.40 vs -0.62 percentage units/year). Annual increases in BMIp95 were also greater among children from households that remained very low income (P < .01, .34 percentage units/year) and among those with increasing income (P = .01, .51 percentage units/year) compared with the reference group (-0.61 percentage units/year). Children from households that remained very low income had higher hair cortisol accumulations (0.22 pg/mg, P = .02) than reference group children, whereas hair cortisol concentrations of children from households with increasing income (0.03 pg/mg) did not differ significantly from the reference group. Cortisol was not related to BMIp95. CONCLUSIONS: The economic circumstances of families may impact children's BMI trajectories and their developing stress systems, but these processes may be independent of one another.

30-year Cardiovascular Disease Risk for Young Adults with Serious Mental Illness.

Objective: To estimate 30-year CVD risk and modifiable risk factors in young adults with serious mental illness (SMI) versus those without, and assess variations in CVD risk by race, ethnicity, and sex. Method: In this cross-sectional study, we estimated and compared the Framingham 30-year CVD risk score and individual modifiable CVD risk factors in young adult (20-39 years) primary care patients with and without SMI at two US healthcare systems (January 2016-Septemeber 2018). Interaction terms assessed whether the SMI-risk association differed across demographic groups. Results: Covariate-adjusted 30-year CVD risk was significantly higher for those with (n=4228) versus those without (n=155,363) SMI (RR 1.28, 95% CI [1.26, 1.30]). Patients with SMI had higher rates of hypertension (OR 2.02 [1.7, 2.39]), diabetes (OR 3.14 [2.59, 3.82]), obesity (OR 1.93 [1.8, 2.07]), and smoking (OR 4.94 [4.6, 5.36]). The increased 30-year CVD risk associated with SMI varied significantly by race and sex: there was an 8% higher risk in Black compared to White patients (RR 1.08, [1.04, 1.12]) and a 9% lower risk in men compared to women (RR 0.91 [0.88, 0.94]). Conclusions: Young adults with SMI are at increased 30-year risk of CVD, and further disparities exist for Black individuals and women.

Clinician perceptions of a clinical decision support system to reduce cardiovascular risk among prediabetes patients in a predominantly rural healthcare system.

BACKGROUND: The early detection and management of uncontrolled cardiovascular risk factors among prediabetes patients can prevent cardiovascular disease (CVD). Prediabetes increases the risk of CVD, which is a leading cause of death in the United States. CVD clinical decision support (CDS) in primary care settings has the potential to reduce cardiovascular risk in patients with prediabetes while potentially saving clinicians time. The objective of this study is to understand primary care clinician (PCC) perceptions of a CDS system designed to reduce CVD risk in adults with prediabetes. METHODS: We administered pre-CDS implementation (6/30/2016 to 8/25/2016) (n = 183, 61% response rate) and post-CDS implementation (6/12/2019 to 8/7/2019) (n = 131, 44.5% response rate) independent cross-sectional electronic surveys to PCCs at 36 randomized primary care clinics participating in a federally funded study of a CVD risk reduction CDS tool. Surveys assessed PCC demographics, experiences in delivering prediabetes care, perceptions of CDS impact on shared decision making, perception of CDS impact on control of major CVD risk factors, and overall perceptions of the CDS tool when managing cardiovascular risk. RESULTS: We found few significant differences when comparing pre- and post-implementation responses across CDS intervention and usual care (UC) clinics. A majority of PCCs felt well-prepared to discuss CVD risk factor control with patients both pre- and post-implementation. About 73% of PCCs at CDS intervention clinics agreed that the CDS helped improve risk control, 68% reported the CDS added value to patient clinic visits, and 72% reported they would recommend use of this CDS system to colleagues. However, most PCCs disagreed that the CDS saves time talking about preventing diabetes or CVD, and most PCCs also did not find the clinical domains useful, nor did PCCs believe that the clinical domains were useful in getting patients to take action. Finally, only about 38% reported they were satisfied with the CDS. CONCLUSIONS: These results improve our understanding of CDS user experience and can be used to guide iterative improvement of the CDS. While most PCCs agreed the CDS improves CVD and diabetes risk factor control, they were generally not satisfied with the CDS. Moreover, only 40-50% agreed that specific suggestions on clinical domains helped patients to take action. In spite of this, an overwhelming majority reported they would recommend the CDS to colleagues, pointing for the need to improve upon the current CDS. TRIAL REGISTRATION: NCT02759055 03/05/2016.

Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial.

BACKGROUND: A team approach is one of the most effective ways to lower blood pressure (BP) in uncontrolled hypertension, but different models for organizing team-based care have not been compared directly. METHODS: A pragmatic, cluster-randomized trial compared 2 interventions in adult patients with moderately severe hypertension (BP≥150/95 mm Hg): (1) clinic-based care using best practices and face-to-face visits with physicians and medical assistants; and (2) telehealth care using best practices and adding home BP telemonitoring with home-based care coordinated by a clinical pharmacist or nurse practitioner. The primary outcome was change in systolic BP over 12 months. Secondary outcomes were change in patient-reported outcomes over 6 months. RESULTS: Participants (N=3071 in 21 primary care clinics) were on average 60 years old, 47% male, and 19% Black. Protocol-specified follow-up within 6 weeks was 32% in clinic-based care and 27% in telehealth care. BP decreased significantly during 12 months of follow-up in both groups, from 157/92 to 139/82 mm Hg in clinic-based care patients (adjusted mean difference -18/-10 mm Hg) and 157/91 to 139/81 mm Hg in telehealth care patients (adjusted mean difference -19/-10 mm Hg), with no significant difference in systolic BP change between groups (-0.8 mm Hg [95% CI, -2.84 to 1.32]). Telehealth care patients were significantly more likely than clinic-based care patients to report frequent home BP measurement, rate their BP care highly, and report that BP care visits were convenient. CONCLUSIONS: Telehealth care that includes extended team care is an effective and safe alternative to clinic-based care for improving patient-centered care for hypertension. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02996565.

Race/ethnicity and age associations with hair cortisol concentrations among children studied longitudinally from early through middle childhood.

A total of 513 children were included in this secondary analysis of data from the NET-Works trial of low income children at risk for obesity. The purpose of the analysis was to examine HCC longitudinally over 5 assessments from early through middle childhood with the goal of i) determining if there were racial/ethnic differences in HCC, and if so, how early in childhood these differences could be observed; and (ii) whether racial/ethnic differences in HCC reflected structural and family-level indicators of disadvantage. The sample consisted of children from diverse racial/ethnic backgrounds: Black, including Hispanic Black (N = 156), non-Hispanic White (N = 67) and Non-Black Hispanic (N = 290) children. As the largest group, the last group was used as the reference group in analyses. Structural and family-level indicators of disadvantage, including the neighborhood child opportunity index (COI), family income, and parent perceived neighborhood safety, were collected at each assessment. The results showed higher HCC among Black children beginning as early as 2-4 years of age than non-Black Hispanic children who did not differ from non-Hispanic White children. Although family income and COI were lower for children from minoritized racial-ethnic backgrounds, entering these measures as covariates did not reduce the difference in HCC between Black children and the other two groups. The results also showed that HCC initially decreased with age and then plateaued, with no evidence that this pattern differed by race/ethnicity. Because of the potential health risks of chronically elevated cortisol concentrations, these data argue for increased attention to the myriad of factors (oppressive structures, systems, and interpersonal experiences) that likely contribute to elevated cortisol levels among Black children.

Comparison of explanatory and pragmatic design choices in a cluster-randomized hypertension trial: effects on enrollment, participant characteristics, and adherence.

BACKGROUND: Explanatory trials are designed to assess intervention efficacy under ideal conditions, while pragmatic trials are designed to assess whether research-proven interventions are effective in "real-world" settings without substantial research support. METHODS: We compared two trials (Hyperlink 1 and 3) that tested a pharmacist-led telehealth intervention in adults with uncontrolled hypertension. We applied PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) scores to describe differences in the way these studies were designed and enrolled study-eligible participants, and the effect of these differences on participant characteristics and adherence to study interventions. RESULTS: PRECIS-2 scores demonstrated that Hyperlink 1 was more explanatory and Hyperlink 3 more pragmatic. Recruitment for Hyperlink 1 was conducted by study staff, and 2.9% of potentially eligible patients enrolled. Enrollees were older, and more likely to be male and White than non-enrollees. Study staff scheduled the initial pharmacist visit and adherence to attending this visit was 98%. Conversely for Hyperlink 3, recruitment was conducted by clinic staff at routine encounters and 81% of eligible patients enrolled. Enrollees were younger, and less likely to be male and White than non-enrollees. Study staff did not assist with scheduling the initial pharmacist visit and adherence to attending this visit was only 27%. Compared to Hyperlink 1, patients in Hyperlink 3 were more likely to be female, and Asian or Black, had lower socioeconomic indicators, and were more likely to have comorbidities. Owing to a lower BP for eligibility in Hyperlink 1 (>140/90 mm Hg) than in Hyperlink 3 (>150/95 mm Hg), mean baseline BP was 148/85 mm Hg in Hyperlink 1 and 158/92 mm Hg in Hyperlink 3. CONCLUSION: The pragmatic design features of Hyperlink 3 substantially increased enrollment of study-eligible patients and of those traditionally under-represented in clinical trials (women, minorities, and patients with less education and lower income), and demonstrated that identification and enrollment of a high proportion of study-eligible subjects could be done by usual primary care clinic staff. However, the trade-off was much lower adherence to the telehealth intervention than in Hyperlink 1, which is likely to reflect uptake under real-word conditions and substantially dilute intervention effect on BP. TRIAL REGISTRATION: The Hyperlink 1 study (NCT00781365) and the Hyperlink 3 study (NCT02996565) are registered at ClinicalTrials.gov.

Depression and cardiovascular risk in primary care patients.

OBJECTIVE: This study assessed the relationship of both depression diagnosis and clinically significant depressive symptoms with individual cardiovascular risk factors and estimated total cardiovascular risk in primary care patients. METHODS: This study used a cross-sectional and retrospective design. Patients who had a primary care encounter between January 2016 and September 2018 and completed depression screening (PHQ-9) during the year prior to their appointment (N = 70,980) were included in this study. Data examining estimated total cardiovascular risk, specific cardiovascular risk factors, and relevant clinical diagnoses (including depression diagnosis) were extracted from the electronic health record. Patients were categorized into three groups: no depression (PHQ-9 < 10 and no depression diagnosis), controlled depression (PHQ-9 < 10 with previous depression diagnosis), and current depression (PHQ-9 ≥ 10). Groups were compared on estimated total risk and specific cardiovascular risk factors (e.g., body mass index [BMI], smoking status, lipids, blood pressure, and glucose). RESULTS: In adjusted analyses, patients with current depression (n = 18,267) demonstrated significantly higher 10-year and 30-year cardiovascular risk compared to patients with controlled depression (n = 33,383; 10-year: b = 0.59 [95% CI = 0.44,0.74]; 30-year: OR = 1.32 [95% CI = 1.26,1.39]) and patients without depression (n = 19,330; 10-year: b = 0.55 [95% CI = 0.37,0.73]; 30-year: OR = 1.56 [95% CI = 1.48,1.65]). Except for low-density lipoprotein (LDL), patients with current depression had the greatest cardiovascular risk across specific risk factors. CONCLUSIONS: Individuals who had a depression diagnosis and clinically significant depressive symptoms had the greatest cardiovascular risk. Pathways to prevent cardiovascular disease in those with depression might focus on treating depressive symptoms as well as specific uncontrolled cardiovascular risk factors.

Cardiovascular Risk for Patients With and Without Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder.

Background To compare estimated 10-year and 30-year cardiovascular risk in primary care patients with and without serious mental illness (SMI; bipolar disorder, schizophrenia, or schizoaffective disorder). Methods and Results All patients aged 18 to 75 years with a primary care visit in January 2016 to September 2018 were included and were grouped into those with and without SMI using diagnosis codes. Ten-year cardiovascular risk was estimated using atherosclerotic cardiovascular disease scores for patients aged 40 to 75 years without cardiovascular disease; 30-year cardiovascular risk was estimated using Framingham risk scores for patients aged 18 to 59 years without cardiovascular disease. Demographic, vital sign, medication, diagnosis, and health insurance data were collected from the electronic health record by a clinical decision support system. Descriptive statistics examined unadjusted differences, while general linear models examined differences for continuous variables and logistic regression models for categorical variables. Models were then adjusted for age, sex, race, ethnicity, and insurance type. A total of 11 333 patients with SMI and 579 924 patients without SMI were included. After covariate adjustment, 10-year cardiovascular risk was significantly higher in patients with SMI (mean, 9.44%; 95% CI, 9.29%-9.60%) compared with patients without SMI (mean, 7.99%; 95% CI, 7.97-8.02). Similarly, 30-year cardiovascular risk was significantly higher in those with SMI (25% of patients with SMI in the highest-risk group compared with 11% of patients without SMI; P<0.001). The individual cardiovascular risk factors contributing most to increased risk for those with SMI were elevated body mass index and smoking. Among SMI subtypes, patients with bipolar disorder had the highest 10-year cardiovascular risk, while patients with schizoaffective disorder had the highest 30-year cardiovascular risk. Conclusions The significantly increased cardiovascular risk associated with SMI is evident even in young adults. This suggests the importance of addressing uncontrolled major cardiovascular risk factors in those with SMI at as early an age as possible. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02451670.

Effect of Clinical Decision Support on Cardiovascular Risk Among Adults With Bipolar Disorder, Schizoaffective Disorder, or Schizophrenia: A Cluster Randomized Clinical Trial.

IMPORTANCE: Adults with schizophrenia, schizoaffective disorder, or bipolar disorder, collectively termed serious mental illness (SMI), have shortened life spans compared with people without SMI. The leading cause of death is cardiovascular (CV) disease. OBJECTIVE: To assess whether a clinical decision support (CDS) system aimed at primary care clinicians improves CV health for adult primary care patients with SMI. DESIGN, SETTING, AND PARTICIPANTS: In this cluster randomized clinical trial conducted from March 2, 2016, to September 19, 2018, restricted randomization assigned 76 primary care clinics in 3 Midwestern health care systems to receive or not receive a CDS system aimed at improving CV health among patients with SMI. Eligible clinics had at least 20 patients with SMI; clinicians and their adult patients with SMI with at least 1 modifiable CV risk factor not at the goal set by the American College of Cardiology/American Heart Association guidelines were included. Statistical analysis was conducted on an intention-to-treat basis from January 10, 2019, to December 29, 2021. INTERVENTION: The CDS system assessed modifiable CV risk factors and provided personalized treatment recommendations to clinicians and patients. MAIN OUTCOMES AND MEASURES: Patient-level change in total modifiable CV risk over 12 months, summed from individual modifiable risk factors (smoking, body mass index, low-density lipoprotein cholesterol level, systolic blood pressure, and hemoglobin A1c level). RESULTS: A total of 80 clinics were randomized; 4 clinics were excluded for having fewer than 20 eligible patients, leaving 42 intervention clinics and 34 control clinics. A total of 8937 patients with SMI (4922 women [55.1%]; mean [SD] age, 48.4 [13.5] years) were enrolled. There was a 4% lower rate of increase in total modifiable CV risk among intervention patients relative to control patients (relative rate ratio [RR], 0.96; 95% CI, 0.94-0.98). The intervention favored patients who were 18 to 29 years of age (RR, 0.89; 95% CI, 0.81-0.98) or 50 to 59 years of age (RR, 0.93; 95% CI, 0.90-0.96), Black (RR, 0.93; 95% CI, 0.88-0.98), or White (RR, 0.96; 95% CI, 0.94-0.98). Men (RR, 0.96; 95% CI, 0.94-0.99) and women (RR, 0.95; 95% CI, 0.92-0.97), as well as patients with any SMI subtype (bipolar disorder: RR, 0.96; 95% CI, 0.94-0.99; schizoaffective disorder: RR, 0.94; 95% CI, 0.90-0.98; schizophrenia: RR, 0.92; 95% CI, 0.85-0.99) also benefited from the intervention. Despite treatment effects favoring the intervention, there were no significant differences in individual modifiable risk factors. CONCLUSIONS AND RELEVANCE: This CDS intervention resulted in a rate of change in total modifiable CV risk that was 4% lower among intervention patients compared with control patients. Results were driven by the cumulative effects of incremental and mostly nonsignificant changes in individual modifiable risk factors. These findings emphasize the value of using CDS to prompt early primary care intervention for adults with SMI. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02451670.

Implementing a prediabetes clinical decision support system in a large primary care system: Design, methods, and pre-implementation results.

BACKGROUND: Early detection of prediabetes and management of cardiovascular (CV) risk factors to prevent CV disease is essential, but clinicians are often slow to address this risk. Clinical decision support (CDS) systems, with appropriate implementation, can potentially improve prediabetes identification and treatment. METHODS/DESIGN: 34 Midwestern primary care clinics were randomized to receive or not receive access to a prediabetes (PreD) CDS tool. Between October 2016 and December 2019, primary care clinicians (PCPs) received Pre-D CDS alerts during visits with adult patients identified with prediabetes and who met minimal inclusion criteria and had at least one CV risk factor not at goal. The PCP Pre-D CDS included a summary of six modifiable CV risk factors and patient-specific treatment recommendations. Study outcomes included total modifiable CV risk, six modifiable CV risk factors, use of CV medications, and referrals. The Consolidated Framework for Implementation Research was used to examine CDS implementation processes. DISCUSSION: This cluster-randomized pragmatic trial allowed PCPs the opportunity to improve CV risk in a timely manner for patients with prediabetes. Effectiveness will be assessed using an intent-to-treat analysis. Implementation processes and outcomes will be assessed through interviews, surveys, and electronic health record data harvested by the CDS tool itself. Pre-implementation interviews and activities identified key strategies to incorporate as part of the Pre-D CDS implementation process to ensure acceptability and high use rates. Analyses are ongoing and trial results are expected in mid-2021.

BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences.

BACKGROUND: State-of-the-art behavioral weight loss treatment (SBT) can lead to clinically meaningful weight loss, but only 30-60% achieve this goal. Developing adaptive interventions that change based on individual progress could increase the number of people who benefit. PURPOSE: Conduct a Sequential Multiple Assignment Randomized Trial (SMART) to determine the optimal time to identify SBT suboptimal responders and whether it is better to switch to portion-controlled meals (PCM) or acceptance-based treatment (ABT). METHOD: The BestFIT trial enrolled 468 adults with obesity who started SBT and were randomized to treatment response assessment at Session 3 (Early TRA) or 7 (Late TRA). Suboptimal responders were re-randomized to PCM or ABT. Responders continued SBT. Primary outcomes were weight change at 6 and 18 months. RESULTS: PCM participants lost more weight at 6 months (-18.4 lbs, 95% CI -20.5, -16.2) than ABT participants (-15.7 lbs, 95% CI: -18.0, -13.4), but this difference was not statistically significant (-2.7 lbs, 95% CI: -5.8, 0.5, p = .09). PCM and ABT participant 18 month weight loss did not differ. Early and Late TRA participants had similar weight losses (p = .96), however, Early TRA PCM participants lost more weight than Late TRA PCM participants (p = .03). CONCLUSIONS: Results suggest adaptive intervention sequences that warrant further research (e.g., identify suboptimal responders at Session 3, use PCMs as second-stage treatment). Utilizing the SMART methodology to develop an adaptive weight loss intervention that would outperform gold standard SBT in a randomized controlled trial is an important next step, but may require additional optimization work. CLINICAL TRIAL INFORMATION: ClinicalTrials.gov identifier; NCT02368002.

Experiences and Perceptions of Patients with Uncontrolled Hypertension Who are Dissatisfied with Their Hypertension Care.

BACKGROUND: Hypertension control has been decreasing recently. We compared the experience and attitudes toward care between patients with uncontrolled hypertension who are more and less satisfied with that care to identify ways to improve their care. METHODS: Baseline survey of 3072 patients with diagnosed hypertension and repeated blood pressure measurements at or above 150/95 mmHg during clinic appointments at 21 primary care clinics of a large Midwestern multi-specialty medical group. Survey questions were about previous hypertension care satisfaction, the degree to which that care was patient-centered, their feelings of self-confidence and treatment burden in managing hypertension, and medication side effects. RESULTS: A total of 1697 patients completed surveys (response rate = 55%). Of the 1697 patients, the 24% who were most dissatisfied (scored 0 to 5 on a 0 to 10 scale of satisfaction) significantly differed from those most satisfied (scored 9 to 10) on all demographic and clinical characteristics as well as on every measure of care experience and health status. After adjusting for those characteristics, reports of patient-centered care, self-confidence, stopping the medication because of side effects, and the burdensomeness of treatment were all significantly worse (P <.01 to P <.001) than for those with a higher rating of their hypertension care. Correlations among these measures were low, so the people with each problem with care seem to be different. CONCLUSIONS: Many patients with uncontrolled hypertension are dissatisfied with their care, but that is associated with different problems for different people. Identifying and attending to these problems may provide opportunities to help them achieve better control.

Pragmatic clinic randomized trial to improve chronic kidney disease care: Design and adaptation due to COVID disruptions.

BACKGROUND: We describe a clinic-randomized trial to improve chronic kidney disease (CKD) care through a CKD-clinical decision support (CKD-CDS) intervention in primary care clinics and the challenges we encountered due to COVID-19 care disruption. METHODS/DESIGN: Primary care clinics (N = 32) were randomized to usual care (UC) or to CKD-CDS. Between April 17, 2019 and March 14, 2020, more than 7000 patients had accrued for analysis by meeting study-eligibility criteria at an index office visit: age 18-75, laboratory criteria for stage 3 or 4 CKD (eGFR 15-59 mL/min/1.73 m2), and one or more opportunities algorithmically identified to improve CKD care such as blood pressure (BP) or glucose control, angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) use, discontinuance of a nonsteroidal anti-inflammatory drug (NSAID), or nephrology referral. At CKD-CDS clinics, CDS provided individualized treatment suggestions that were printed for patients and clinicians at the start of office encounters and were viewable within the electronic health record. By initial design, the impact of the CKD-CDS intervention on care gaps was to be assessed 12 months after the index date, but COVID-19 caused major disruptions to care delivery during the intervention period. In response to disruptions, the intervention was temporarily suspended while we expanded CDS use for telehealth encounters and programmed new criteria for displaying the CKD-CDS to intervention patients due to clinic closures and scheduling changes. DISCUSSION: We describe a NIH-funded pragmatic trial of web-based EHR-integrated CKD-CDS and modifications necessary mid-study to complete the study as intended in the face of COVID-19 pandemic challenges.

A pilot study of the functionality and clinician acceptance of a clinical decision support tool to improve primary care of opioid use disorder.

OBJECTIVE: Most Americans with opioid use disorder (OUD) do not receive indicated medical care. A clinical decision support (CDS) tool for primary care providers (PCPs) could address this treatment gap. Our primary objective was to build OUD-CDS tool and demonstrate its functionality and accuracy. Secondary objectives were to achieve high use and approval rates and improve PCP confidence in diagnosing and treating OUD. METHODS: A convenience sample of 55 PCPs participated. Buprenorphine-waivered PCPs (n = 8) were assigned to the intervention. Non-waivered PCPs (n = 47) were randomized to intervention (n = 24) or control (n = 23). Intervention PCPs received access to the OUD-CDS, which alerted them to patients at potentially increased risk for OUD or overdose and guided diagnosis and treatment. Control PCPs provided care as usual. RESULTS: The OUD-CDS was functional and accurate following extensive multi-phased testing. PCPs used the OUD-CDS in 5% of encounters with at-risk patients, far less than the goal of 60%. OUD screening confidence increased for all intervention PCPs and OUD diagnosis increased for non-waivered intervention PCPs. Most PCPs (65%) would recommend the OUD-CDS and found it helpful with screening for OUD and discussing and prescribing OUD medications. DISCUSSION: PCPs generally liked the OUD-CDS, but use rates were low, suggesting the need to modify CDS design, implementation strategies and integration with existing primary care workflows. CONCLUSION: The OUD-CDS tool was functional and accurate, but PCP use rates were low. Despite low use, the OUD-CDS improved confidence in OUD screening, diagnosis and use of buprenorphine. NIH Trial registration NCT03559179. Date of registration: 06/18/2018. URL: https://clinicaltrials.gov/ct2/show/NCT03559179.

Pragmatic trial design of an intervention to reduce cardiovascular risk in people with serious mental illness.

BACKGROUND: Cardiovascular (CV) disease is the leading cause of death for people with serious mental illness (SMI), but clinicians are often slow to address this risk. METHODS/DESIGN: 78 Midwestern primary care clinics were randomized to receive or not receive access to a clinical decision support (CDS) tool. Between March 2016 and September 2018, primary care clinicians (PCPs) received CDS alerts during visits with adult patients with SMI who met minimal inclusion criteria and had at least one CV risk factor not at goal. The PCP CDS included a summary of six modifiable CV risk factors and patient-specific treatment recommendations. Psychiatrists received CDS alerts during their next visit with an eligible patient with SMI that alerted them to an elevated body mass index or recent weight gain and the presence of an obesogenic SMI medication. Study outcomes include total modifiable CV risk, six modifiable CV risk factors, and use of obesogenic SMI medications. DISCUSSION: This cluster-randomized pragmatic trial allowed PCPs and psychiatrists the opportunity to improve CV risk in a timely manner for patients with SMI. Effectiveness will be assessed using an intent-to-treat analysis, and outcomes will be assessed largely through electronic health record data harvested by the CDS tool itself. In total, 10,347 patients with SMI had an index primary care visit in a randomized clinic, and 8937 patients had at least one follow-up visit. Analyses are ongoing, and trial results are expected in mid-2020. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02451670.