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.

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.

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.

Multicomponent Obesity Prevention Intervention in Low-Income Preschoolers: Primary and Subgroup Analyses of the NET-Works Randomized Clinical Trial, 2012-2017.

OBJECTIVES: To evaluate a multicomponent obesity prevention intervention among diverse, low-income preschoolers. METHODS: Parent-child dyads (n = 534) were randomized to the Now Everybody Together for Amazing and Healthful Kids (NET-Works) intervention or usual care in Minneapolis, MN (2012-2017). The intervention consisted of home visits, parenting classes, and telephone check-ins. The primary outcomes were adjusted 24- and 36-month body mass index (BMI). RESULTS: Compared with usual care, the NET-Works intervention showed no significant difference in BMI change at 24 (-0.12 kg/m2; 95% confidence interval [CI] = -0.44, 0.19) or 36 months (-0.19 kg/m2; 95% CI = -0.64, 0.26). Energy intake was significantly lower in the NET-Works group at 24 (-90 kcal/day; 95% CI = -164, -16) and 36 months (-101 kcal/day; 95% CI = -164, -37). Television viewing was significantly lower in the NET-Works group at 24 (rate ratio = 0.84; 95% CI = 0.75, 0.93) and 36 months (rate ratio = 0.88; 95% CI = 0.78, 0.99). Children with baseline overweight or obesity had lower BMI in the NET-Works group than those in usual care at 36 months (-0.71 kg/m2; 95% CI = -1.30, -0.12). Hispanic children had lower BMI in the NET-Works group than those in usual care at 36 months (-0.59 kg/m2; 95% CI = -1.14, -0.04). CONCLUSIONS: In secondary analyses, NET-Works significantly reduced BMI over 3 years among Hispanic children and children with baseline overweight or obesity. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01606891.

A Statewide Effort to Implement Collaborative Care for Depression: Reach and Impact for All Patients With Depression.

BACKGROUND: Little is known about the reach and impact of collaborative care for depression outside of clinical trials. OBJECTIVE: The objective of this study was to examine the effect of a collaborative care intervention for depression on the rates of depression diagnosis, use of specific depression codes, and treatment intensification. RESEARCH DESIGN: Evaluation of a staggered, multiple baseline implementation initiative. SUBJECTS: Patients receiving depression care in primary care clinics throughout Minnesota from February 2008 through March 2011. MEASURES: Data regarding depression diagnosis rates and codes, and measures of antidepressant intensification were provided by health insurers. RESULTS: Depression Improvement Across Minnesota: Offering a New Direction (DIAMOND) affected neither rates of depression recognition nor use of depression diagnostic codes, and the overall reach of DIAMOND was disappointingly small. Patients in DIAMOND had more episodes of treatment intensification than non-DIAMOND patients, but we were unable to account for depression severity in our analysis. CONCLUSIONS: DIAMOND did not affect depression recognition or diagnostic coding, but may have affected treatment intensification. Our results suggest that even strongly evidence-based interventions may have little contamination effects on patients not enrolled in the new care model.

The effects of patient-centered depression care on patient satisfaction and depression remission.

BACKGROUND: While health systems are striving for patient-centered care, they have little evidence to guide them on how to engage patients in their care, or how this may affect patient experiences and outcomes. OBJECTIVE: To explore which specific patient-centered aspects of care were best associated with depression improvement and care satisfaction. METHODS: Design: observational. SETTING: 83 primary care clinics across Minnesota. SUBJECTS: Primary care patients with new prescriptions for antidepressants for depression were recruited from 2007 to 2009. OUTCOME MEASURES: Patients completed phone surveys regarding demographics and self-rated health status and depression severity at baseline and 6 months. Patient centeredness was assessed via a modified version of the Patient Assessment of Chronic Illness Care. Differences in rates of remission and satisfaction between positive and negative responses for each care process were evaluated using chi-square tests. RESULTS: At 6 months, 37% of 792 patients ages 18-88 achieved depression remission, and 79% rated their care as good-to-excellent. Soliciting patient preferences for care and questions or concerns, providing treatment plans, utilizing depression scales and asking about suicide risk were patient-centered measures that were positively associated with depression remission in the unadjusted model; these associations were mildly weakened after adjustment for depression severity and health status. Nearly all measures of patient centeredness were positively associated with care ratings. CONCLUSION: The patient centeredness of care influences how patients experience and rate their care. This study identified specific actions providers can take to improve patient satisfaction and depression outcomes.

A stepped-wedge evaluation of an initiative to spread the collaborative care model for depression in primary care.

PURPOSE: Scale-up and spread of evidence-based practices is one of the most important challenges facing health care. We tested whether a statewide initiative, Depression Improvement Across Minnesota-Offering a New Direction (DIAMOND), to implement the collaborative care model for depression in 75 primary care clinics resulted in patient outcome improvements corresponding to those reported in randomized controlled trials. METHODS: Health plans provided a new monthly payment to participating clinics after a 6-month intensive training program with ongoing data submission, networking, and consultation. Implementation was staggered, with 5 sequences of 10 to 40 clinics every 6 months. Payers provided weekly contact information for members from participating clinics who were filling antidepressant prescriptions, and we conducted baseline and 6-month surveys of 1,578 patients about their care and outcomes. RESULTS: There were 466 patients in DIAMOND clinics who received usual care before implementation (UCB), 559 who received usual care in DIAMOND clinics after implementation (UCA), 245 who received DIAMOND care after implementation (DCA), and 308 who received usual care in comparison clinics (UC). Patients who received DIAMOND care after implementation reported more collaborative care depression services than the 3 comparison groups (10.9 vs 6.4-6.7, on a scale of 0 of 14, where higher numbers indicate more services; P <.001) and more satisfaction with their care (4.0 vs 3.4 on a scale 1 to 5, in which higher scores indicate higher satisfaction; P ≤.001). Depression remission rates, however, were not significantly different among the 4 groups (36.4% DCA vs 35.8% UCB, 35.0% UCA, 33.9% UC; P = .94). CONCLUSIONS: Despite the incentive of a supporting payment change and intensive training and support for clinics volunteering to participate, no difference in depression outcomes was documented. Specific unmeasured actions present in trials but not present in these clinics may be critical for successful outcome improvement.

Predicting child physical activity and screen time: parental support for physical activity and general parenting styles.

OBJECTIVE: To examine relationships between parenting styles and practices and child moderate-to-vigorous physical activity (MVPA) and screen time. METHODS: Participants were children (6.9 ± 1.8 years) with a body mass index in the 70-95th percentile and their parents (421 dyads). Parent-completed questionnaires assessed parental support for child physical activity (PA), parenting styles and child screen time. Children wore accelerometers to assess MVPA. RESULTS: Parenting style did not predict MVPA, but support for PA did (positive association). The association between support and MVPA, moreover, varied as a function of permissive parenting. For parents high in permissiveness, the association was positive (greater support was related to greater MVPA and therefore protective). For parents low in permissiveness, the association was neutral; support did not matter. Authoritarian and permissive parenting styles were both associated with greater screen time. CONCLUSIONS: Parenting practices and styles should be considered jointly, offering implications for tailored interventions.

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.

Applying Meaning and Self-Determination Theory to the Development of a Web-Based mHealth Physical Activity Intervention: Proof-of-Concept Pilot Study.

BACKGROUND: Meaning in life is positively associated with health, well-being, and longevity, which may be partially explained by engagement in healthier behaviors, including physical activity (PA). However, promoting awareness of meaning is a behavior change strategy that has not been tested in previous PA interventions. OBJECTIVE: This study aims to develop, refine, and pilot-test the Meaningful Activity Program (MAP; MAP to Health), a web-based mobile health PA intervention, theoretically grounded in meaning and self-determination theory, for insufficiently active middle-aged adults. METHODS: Following an iterative user-testing and refinement phase, we used a single-arm double baseline proof-of-concept pilot trial design. Participants included 35 insufficiently active adults in midlife (aged 40-64 years) interested in increasing their PA. After a 4-week baseline period, participants engaged in MAP to Health for 8 weeks. MAP to Health used a web-based assessment and just-in-time SMS text messaging to individualize the intervention; promote meaning salience; support the basic psychological needs of autonomy, competence, and relatedness; and increase PA. Participants completed measures of the hypothesized mechanisms of behavior change, including meaning salience, needs satisfaction, and autonomous motivation at pretest (-4 weeks), baseline (0 weeks), midpoint (4 weeks), and posttest (8 weeks) time points, and wore accelerometers for the study duration. At the end of the intervention, participants completed a qualitative interview. Mixed models compared changes in behavioral mechanisms during the intervention to changes before the intervention. Framework matrix analyses were used to analyze qualitative data. RESULTS: Participants were aged 50.8 (SD 8.2) years on average; predominantly female (27/35, 77%); and 20% (7/35) Asian, 9% (3/35) Black or African American, 66% (23/35) White, and 6% (2/35) other race. Most (32/35, 91%) used MAP to Health for ≥5 of 8 weeks. Participants rated the intervention as easy to use (mean 4.3, SD 0.8 [out of 5.0]) and useful (mean 4.3, SD 0.6). None of the hypothesized mechanisms changed significantly during the preintervention phase (Cohen d values <0.15). However, autonomy (P<.001; Cohen d=0.76), competence (P<.001; Cohen d=0.65), relatedness (P=.004; Cohen d=0.46), autonomous motivation (P<.001; Cohen d=0.37), and meaning salience (P<.001; Cohen d=0.40) increased significantly during the intervention. Comparison of slopes before the intervention versus during the intervention revealed that increases during the intervention were significantly greater for autonomy (P=.002), competence (P<.001), and meaning salience (P=.001); however, slopes were not significantly different for relatedness (P=.10) and autonomous motivation (P=.17). Qualitative themes offered suggestions for improvement. CONCLUSIONS: MAP to Health was acceptable to participants, feasible to deliver, and associated with increases in the target mechanisms of behavior change. This is the first intervention to use meaning as a behavior change strategy in a PA intervention. Future research will test the efficacy of the intervention in increasing PA compared to a control condition.

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.

Designing and implementing research on a statewide quality improvement initiative: the DIAMOND study and initiative.

OBJECTIVE: To demonstrate a rigorous methodology that optimally balanced internal validity with generalizability to evaluate a statewide collaborative that implemented an evidence-based, collaborative care model for depression management in primary care. STUDY DESIGN AND SETTING: Several operational features of the DIAMOND (Depression Improvement Across Minnesota, Offering a New Direction) Initiative suggested that the DIAMOND Study use a staggered implementation design with repeated cross-sections of patients across clinical settings. A multilevel recruitment strategy elicited virtually complete study participation from the medical groups, clinics, and health plans that coordinated efforts to deliver and reimburse DIAMOND care. Patient identification capitalized on large health plan claims databases to rapidly identify the population of patients newly treated for depression in DIAMOND clinics. RESULTS: The staggered implementation design and multilevel recruitment strategy made it possible to evaluate DIAMOND by holding confounding factors constant and accurately identifying an intent-to-treat population of patients treated for depression without intruding on or requiring effort from their clinics. CONCLUSIONS: Recruitment and data collection from health plans, medical groups and clinics, and patients ensured a representative, intent-to-treat sample of study-enrolled patients. Separating patient identification from care delivery reduced threats of selection bias and enabled comparisons between the treated population and study sample. A key challenge is that intent-to-treat patients may not be exposed to DIAMOND which dilutes the effect size but offers realistic expectations of the impact of quality improvement in a population of treated patients.

Enhancing long-term weight loss maintenance: 2 year results from the Keep It Off randomized controlled trial.

OBJECTIVE: The Keep It Off trial evaluated the efficacy of a phone-based weight loss maintenance intervention among adults who had recently lost weight in Minnesota (2007-2010). METHODS: 419 adults who had recently lost ≥ 10% of their body weight were randomized to the "Guided" or "Self-Directed" intervention. Guided participants received a 10 session workbook, 10 biweekly, eight monthly and six bimonthly phone coaching calls, bimonthly weight graphs and tailored letters based on self-reported weights. Self-Directed participants received the workbook and two calls. Primary outcomes are weight change and maintenance (regain of <2.5% of baseline body weight). RESULTS: Mixed model repeated-measures analysis examining weight change revealed a significant time by treatment group interaction (p<0.0085). Guided participants regained significantly less weight than the Self-Directed participants at 12 and 24 months. The odds of 24 month maintenance were 1.37 (95% CI: 0.97-2.03) times greater in the Guided than in the Self-Directed group. When maintenance rates were compared across all follow-ups, there was a consistently higher maintenance rate for Guided participants (HR 1.31, 95% CI: 1.12-1.54). CONCLUSIONS: A sustained, supportive phone- and mail-based intervention promotes weight loss maintenance relative to a brief intervention for participants who have recently lost weight.

Medical home transformation: a gradual process and a continuum of attainment.

PURPOSE: The patient-centered medical home is often discussed as though there exist either traditional practices or medical homes, with marked differences between them. We analyzed data from an evaluation of certified medical homes in Minnesota to study this topic. METHODS: We obtained publicly reported composite measures for quality of care outcomes pertaining to diabetes and vascular disease for all clinics in Minnesota from 2008 to 2010. The extent of and change in practice systems over that same time period for the first 120 clinics serving adults certified as health care homes (HCHs) was measured by the Physician Practice Connections Research Survey (PPC-RS), a self-report tool similar to the National Committee for Quality Assurance standards for patient-centered medical homes. Measures were compared between these clinics and 518 non-HCH clinics in the state. RESULTS: Among the 102 clinics for which we had precertification and postcertification scores for both the PPC-RS and either diabetes or vascular disease measures, the mean increase in systems score over 3 years was an absolute 29.1% (SD = 16.7%) from a baseline score of 38.8% (SD = 16.5%, P ≤.001). The proportion of clinics in which all patients had optimal diabetes measures improved by an absolute 2.1% (SD = 5.5%, P ≤.001) and the proportion in which all had optimal cardiovascular disease measures by 4.4% (SD = 7.5%, P ≤.001), but all measures varied widely among clinics. Mean performance rates of HCH clinics were higher than those of non-HCH clinics, but there was extensive overlap, and neither group changed much over this time period. CONCLUSIONS: The extensive variation among HCH clinics, their overlap with non-HCH clinics, and the small change in performance over time suggest that medical homes are not similar, that change in outcomes is slow, and that there is a continuum of transformation.

Relationships between the Survey of Organizational Research Climate (SORC) and self-reported research practices.

The Survey of Organizational Research Climate (SORC) is a validated tool to facilitate promotion of research integrity and research best practices. This work uses the SORC to assess shared and individual perceptions of the research climate in universities and academic departments and relate these perceptions to desirable and undesirable research practices. An anonymous web- and mail-based survey was administered to randomly selected biomedical and social science faculty and postdoctoral fellows in the United States. Respondents reported their perceptions of the research climates at their universities and primary departments, and the frequency with which they engaged in desirable and undesirable research practices. More positive individual perceptions of the research climate in one's university or department were associated with higher likelihoods of desirable, and lower likelihoods of undesirable, research practices. Shared perceptions of the research climate tended to be similarly predictive of both desirable and undesirable research practices as individuals' deviations from these shared perceptions. Study results supported the central prediction that more positive SORC-measured perceptions of the research climate were associated with more positive reports of research practices. There were differences with respect to whether shared or individual climate perceptions were related to desirable or undesirable practices but the general pattern of results provide empirical evidence that the SORC is predictive of self-reported research behavior.

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.

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.

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.

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.

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.