Protocol of a patient randomized clinical trial to improve medication adherence in primary care.

BACKGROUND: Enhanced awareness of poor medication adherence could improve patient care. This article describes the original and adapted protocols of a randomized trial to improve medication adherence for cardiometabolic conditions. METHODS: The original protocol entailed a cluster randomized trial of 28 primary care clinics allocated to either (i) medication adherence enhanced chronic disease care clinical decision support (eCDC-CDS) integrated within the electronic health record (EHR) or (ii) usual care (non-enhanced CDC-CDS). Enhancements comprised (a) electronic interfaces printed for patients and clinicians at primary care encounters that encouraged discussion about specific medication adherence issues that were identified, and (b) pharmacist phone outreach. Study subjects were individuals who at an index visit were aged 18-74 years and not at evidence-based care goals for hypertension (HTN), diabetes mellitus (DM), or lipid management, along with low medication adherence (proportion of days covered [PDC] <80%) for a corresponding medication. The primary study outcomes were improved medication adherence and clinical outcomes (BP and A1C) at 12 months. Protocol adaptation became imperative in response to major implementation challenges: (a) the availability of EHR system-wide PDC calculations that superseded our ability to limit PDC adherence information solely to intervention clinics; (b) the unforeseen closure of pharmacies committed to conducting the pharmacist outreach; and (c) disruptions and clinic closures due to the Covid-19 pandemic. CONCLUSION: This manuscript details the protocol of a study to assess whether enhanced awareness of medication adherence issues in primary care settings could improve patient outcomes. The need for protocol adaptation arose in response to multiple implementation challenges.

Does Clinical Decision Support Increase Appropriate Medication Prescribing for Cardiovascular Risk Reduction?

PURPOSE: To assess the impact of a clinical decision support (CDS) system's recommendations on prescribing patterns targeting cardiovascular disease (CVD) when the recommendations are prioritized in order from greatest to least benefit toward overall CVD risk reduction. METHODS: Secondary analysis of trial data from September 20, 2018, to March 15, 2020, where 70 community health center clinics were cluster-randomized to the CDS intervention (42 clinics; 8 organizations) or control group (28 clinics; 7 organizations). Included patients were medication-naïve and aged 40 to 75 years with ≥1 uncontrolled cardiovascular disease risk factor, with known diabetes or cardiovascular disease, or ≥10% 10-year reversible CVD risk. RESULTS: Among eligible encounters with 29,771 patients, the probability of prescribing a medication targeting hypertension was greater at intervention clinic encounters when CDS was used (34.9% [95% CI, 31.5 to 38.3]) versus dismissed (29.6% [95% CI, 26.7 to 32.6]; P < .001), but not when compared with control clinic encounters (34.9% [95% CI, 31.1 to 38.7]; P = .998). Prescribing for dyslipidemia was significantly higher at intervention encounters where the CDS system was used (11.3% [95% CI, 9.3 to 13.3]) compared with dismissed (7.7% [95% CI, 6.1 to 9.3]; P = .003) and to control encounters (8.7% [95% CI, 7.0 to 10.4]; P = .044); smoking cessation medication showed a similar pattern. Except for dyslipidemia, prescribing rates increased according to their prioritization. CONCLUSIONS: Use of this CDS system was associated with significantly higher prescribing targeting most cardiovascular risk factors. These results highlight how displaying prioritized actions to reduce reversible CVD risk could improve risk management. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03001713, https://clinicaltrials.gov/.

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.

Adoption of shared decision-making and clinical decision support for reducing cardiovascular disease risk in community health centers.

Objective: Electronic health record (EHR)-based shared decision-making (SDM) and clinical decision support (CDS) systems can improve cardiovascular disease (CVD) care quality and risk factor management. Use of the CV Wizard system showed a beneficial effect on high-risk community health center (CHC) patients' CVD risk within an effectiveness trial, but system adoption was low overall. We assessed which multi-level characteristics were associated with system use. Materials and Methods: Analyses included 80 195 encounters with 17 931 patients with high CVD risk and/or uncontrolled risk factors at 42 clinics in September 2018-March 2020. Data came from the CV Wizard repository and EHR data, and a survey of 44 clinic providers. Adjusted, mixed-effects multivariate Poisson regression analyses assessed factors associated with system use. We included clinic- and provider-level clustering as random effects to account for nested data. Results: Likelihood of system use was significantly higher in encounters with patients with higher CVD risk and at longer encounters, and lower when providers were >10 minutes behind schedule, among other factors. Survey participants reported generally high satisfaction with the system but were less likely to use it when there were time constraints or when rooming staff did not print the system output for the provider. Discussion: CHC providers prioritize using this system for patients with the greatest CVD risk, when time permits, and when rooming staff make the information readily available. CHCs' financial constraints create substantial challenges to addressing barriers to improved system use, with health equity implications. Conclusion: Research is needed on improving SDM and CDS adoption in CHCs. Trial Registration: ClinicalTrials.gov, NCT03001713, https://clinicaltrials.gov/.

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.

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.

Impact of the COVID-19 Pandemic on Type 2 Diabetes Care Delivery.

The coronavirus disease 2019 (COVID-19) pandemic instigated major changes in care delivery, but our understanding of how the rapid transition from in-person to telehealth encounters affected the care of patients with chronic conditions such as type 2 diabetes remains incomplete. This study examined changes in primary care encounters, A1C testing rates, and the likelihood of meeting A1C guidelines before and during the first 9 months of the COVID-19 pandemic in a large health care system. It found significant decreases in utilization and testing rates and the likelihood of meeting A1C guidelines, primarily driven by missing A1C tests. Patients who had all telehealth encounters or no encounters, who identified as racial or ethnic minorities, or had Medicaid or no insurance were significantly more likely to miss A1C tests.

Bolstering the Business Case for Adoption of Shared Decision-Making Systems in Primary Care: Randomized Controlled Trial.

BACKGROUND: Limited budgets may often constrain the ability of health care delivery systems to adopt shared decision-making (SDM) systems designed to improve clinical encounters with patients and quality of care. OBJECTIVE: This study aimed to assess the impact of an SDM system shown to improve diabetes and cardiovascular patient outcomes on factors affecting revenue generation in primary care clinics. METHODS: As part of a large multisite clinic randomized controlled trial (RCT), we explored the differences in 1 care system between clinics randomized to use an SDM intervention (n=8) versus control clinics (n=9) regarding the (1) likelihood of diagnostic coding for cardiometabolic conditions using the 10th Revision of the International Classification of Diseases (ICD-10) and (2) current procedural terminology (CPT) billing codes. RESULTS: At all 24,138 encounters with care gaps targeted by the SDM system, the proportion assigned high-complexity CPT codes for level of service 5 was significantly higher at the intervention clinics (6.1%) compared to that in the control clinics (2.9%), with P<.001 and adjusted odds ratio (OR) 1.64 (95% CI 1.02-2.61). This was consistently observed across the following specific care gaps: diabetes with glycated hemoglobin A1c (HbA1c)>8% (n=8463), 7.2% vs 3.4%, P<.001, and adjusted OR 1.93 (95% CI 1.01-3.67); blood pressure above goal (n=8515), 6.5% vs 3.7%, P<.001, and adjusted OR 1.42 (95% CI 0.72-2.79); suboptimal statin management (n=17,765), 5.8% vs 3%, P<.001, and adjusted OR 1.41 (95% CI 0.76-2.61); tobacco dependency (n=7449), 7.5% vs. 3.4%, P<.001, and adjusted OR 2.14 (95% CI 1.31-3.51); BMI >30 kg/m2 (n=19,838), 6.2% vs 2.9%, P<.001, and adjusted OR 1.45 (95% CI 0.75-2.8). Compared to control clinics, intervention clinics assigned ICD-10 diagnosis codes more often for observed cardiometabolic conditions with care gaps, although the difference did not reach statistical significance. CONCLUSIONS: In this randomized study, use of a clinically effective SDM system at encounters with care gaps significantly increased the proportion of encounters assigned high-complexity (level 5) CPT codes, and it was associated with a nonsignificant increase in assigning ICD-10 codes for observed cardiometabolic conditions. TRIAL REGISTRATION: ClinicalTrials.gov NCT02451670; https://clinicaltrials.gov/ct2/show/NCT02451670.

Association of an Automated Blood Pressure Measurement Quality Improvement Program With Terminal Digit Preference and Recorded Mean Blood Pressure in 11 Clinics.

Importance: Terminal digit preference has been shown to be associated with inaccurate blood pressure (BP) recording. Objective: To evaluate whether converting from manual BP measurement with aneroid sphygmomanometers to automated BP measurement was associated with terminal digit preference, mean levels of recorded BP, and the rate at which hypertension was diagnosed. Design, Setting, and Participants: This quality improvement study was conducted from May 9, 2021, to March 24, 2022, using interrupted time series analysis of medical record data from 11 primary care clinics in a single health care system from April 2008 to April 2015. The study population was patients aged 18 to 75 years who had their BP measured and recorded at least once during the study period. Exposures: Manual BP measurement before April 2012 vs automated BP measurement with the Omron HEM-907XL monitor from May 2012 to April 2015. Main Outcomes and Measures: The main outcome was the distribution of terminal digits and mean systolic BP (SBP) values obtained during 4 years of manual measurement vs 3 years of automated measurement, assessed using a generalized linear mixed regression model with a random intercept for clinic and adjusted for seasonal fluctuations and patient demographic and clinical characteristics. Results: The study included 1 541 227 BP measurements from 225 504 unique patients during the entire study period, with 849 978 BP measurements from 165 137 patients (mean [SD] age, 47.1 [15.2] years; 58.2% female) during the manual measurement period and 691 249 measurements from 149 080 patients (mean [SD] age, 48.4 [15.3] years; 56.3% female) during the automated measurement period. With manual measurement, 32.8% of SBP terminal digits were 0 (20% was the expected value because nursing staff was instructed to record BP to the nearest even digit). This proportion decreased to 12.4% during the automated measurement period (expected value, 10%) when both even and odd digits were to be recorded. After automated measurement was implemented, the mean SBP estimated with statistical modeling increased by 5.09 mm Hg (95% CI, 4.98-5.19 mm Hg). Fewer BP values recorded during the automated than the manual measurement period were below 140/90 mm Hg (69.9% vs 84.3%; difference, -14.5%; 95% CI, -14.6% to -14.3%) and below 130/80 mm Hg (42.1% vs 60.0%; difference, -17.9%; 95% CI, -18.0% to -17.7%). The proportion of patients with a diagnosis of hypertension was 4.3 percentage points higher (23.4% vs 19.1%) during the automated measurement period. Conclusions and Relevance: In this quality improvement study, automated BP measurement was associated with decreased terminal digit preference and significantly higher mean BP levels. The method of BP measurement was also associated with the rate at which hypertension was diagnosed. These findings may have implications for pay-for-performance programs, which may create an incentive to record BP levels that meet a particular goal and a disincentive to adopt automated measurement of BP.

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.

Human Papillomavirus vaccination clinical decision support for young adults in an upper midwestern healthcare system: a clinic cluster-randomized control trial.

INTRODUCTION: Human papillomavirus (HPV) vaccination rates are low in young adults. Clinical decision support (CDS) in primary care may increase HPV vaccination. We tested the treatment effect of algorithm-driven, web-based, and electronic health record-linked CDS with or without shared decision-making tools (SDMT) on HPV vaccination rates compared to usual care (UC). METHODS: In a clinic cluster-randomized control trial conducted in a healthcare system serving a largely rural population, we randomized 34 primary care clinic clusters (with three clinics sharing clinicians randomized together) to: CDS; CDS+SDMT; UC. The sample included young adults aged 18-26 due for HPV vaccination with a study index visit from 08/01/2018-03/15/2019 in a study clinic. Generalized linear mixed models tested differences in HPV vaccination status 12 months after index visits by study arm. RESULTS: Among 10,253 patients, 6,876 (65.2%) were due for HPV vaccination, and 5,054 met study eligibility criteria. In adjusted analyses, the HPV vaccination series was completed by 12 months in 2.3% (95% CI: 1.6%-3.2%) of CDS, 1.6% (95% CI: 1.1%-2.3%) of CDS+SDMT, and 2.2% (95% CI: 1.6%-3.0%) of UC patients, and at least one HPV vaccine was received by 12 months in 13.1% (95% CI: 10.6%-16.1%) of CDS, 9.2% (95% CI: 7.3%-11.6%) of CDS+SDMT, and 11.2% (95% CI: 9.1%-13.7%) of UC patients. Differences were not significant between arms. Females, those with prior HPV vaccinations, and those seen at urban clinics had significantly higher odds of HPV vaccination in adjusted models. DISCUSSION: CDS may require optimization for young adults to significantly impact HPV vaccination. TRIAL REGISTRATION: clinicaltrials.gov NCT02986230, 12/6/2016.

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.

Effect of Clinical Decision Support at Community Health Centers on the Risk of Cardiovascular Disease: A Cluster Randomized Clinical Trial.

Importance: Management of cardiovascular disease (CVD) risk in socioeconomically vulnerable patients is suboptimal; better risk factor control could improve CVD outcomes. Objective: To evaluate the impact of a clinical decision support system (CDSS) targeting CVD risk in community health centers (CHCs). Design, Setting, and Participants: This cluster randomized clinical trial included 70 CHC clinics randomized to an intervention group (42 clinics; 8 organizations) or a control group that received no intervention (28 clinics; 7 organizations) from September 20, 2018, to March 15, 2020. Randomization was by CHC organization accounting for organization size. Patients aged 40 to 75 years with (1) diabetes or atherosclerotic CVD and at least 1 uncontrolled major risk factor for CVD or (2) total reversible CVD risk of at least 10% were the population targeted by the CDSS intervention. Interventions: A point-of-care CDSS displaying real-time CVD risk factor control data and personalized, prioritized evidence-based care recommendations. Main Outcomes and Measures: One-year change in total CVD risk and reversible CVD risk (ie, the reduction in 10-year CVD risk that was considered achievable if 6 key risk factors reached evidence-based levels of control). Results: Among the 18 578 eligible patients (9490 [51.1%] women; mean [SD] age, 58.7 [8.8] years), patients seen in control clinics (n = 7419) had higher mean (SD) baseline CVD risk (16.6% [12.8%]) than patients seen in intervention clinics (n = 11 159) (15.6% [12.3%]; P < .001); baseline reversible CVD risk was similarly higher among patients seen in control clinics. The CDSS was used at 19.8% of 91 988 eligible intervention clinic encounters. No population-level reduction in CVD risk was seen in patients in control or intervention clinics; mean reversible risk improved significantly more among patients in control (-0.1% [95% CI, -0.3% to -0.02%]) than intervention clinics (0.4% [95% CI, 0.3% to 0.5%]; P < .001). However, when the CDSS was used, both risk measures decreased more among patients with high baseline risk in intervention than control clinics; notably, mean reversible risk decreased by an absolute 4.4% (95% CI, -5.2% to -3.7%) among patients in intervention clinics compared with 2.7% (95% CI, -3.4% to -1.9%) among patients in control clinics (P = .001). Conclusions and Relevance: The CDSS had low use rates and failed to improve CVD risk in the overall population but appeared to have a benefit on CVD risk when it was consistently used for patients with high baseline risk treated in CHCs. Despite some limitations, these results provide preliminary evidence that this technology has the potential to improve clinical care in socioeconomically vulnerable patients with high CVD risk. Trial Registration: ClinicalTrials.gov Identifier: NCT03001713.

Clinical Decision Support with or without Shared Decision Making to Improve Preventive Cancer Care: A Cluster-Randomized Trial.

BACKGROUND: Innovative interventions are needed to address gaps in preventive cancer care, especially in rural areas. This study evaluated the impact of clinical decision support (CDS) with and without shared decision making (SDM) on cancer-screening completion. METHODS: In this 3-arm, parallel-group, cluster-randomized trial conducted at a predominantly rural medical group, 34 primary care clinics were randomized to clinical decision support (CDS), CDS plus shared decision making (CDS+SDM), or usual care (UC). The CDS applied web-based clinical algorithms identifying patients overdue for United States Preventive Services Task Force-recommended preventive cancer care and presented evidence-based recommendations to patients and providers on printouts and on the electronic health record interface. Patients in the CDS+SDM clinic also received shared decision-making tools (SDMTs). The primary outcome was a composite indicator of the proportion of patients overdue for breast, cervical, or colorectal cancer screening at index who were up to date on these 1 y later. RESULTS: From August 1, 2018, to March 15, 2019, 69,405 patients aged 21 to 74 y had visits at study clinics and 25,198 were overdue for 1 or more cancer screening tests at an index visit. At 12-mo follow-up, 9,543 of these (37.9%) were up to date on the composite endpoint. The adjusted, model-derived percentage of patients up to date was 36.5% (95% confidence interval [CI]: 34.0-39.1) in the UC group, 38.1% (95% CI: 35.5-40.9) in the CDS group, and 34.4% (95% CI: 31.8-37.2) in the CDS+SDM group. For all comparisons, the screening rates were higher than UC in the CDS group and lower than UC in the CDS+SDM group, although these differences did not reach statistical significance. CONCLUSION: The CDS did not significantly increase cancer-screening rates. Exploratory analyses suggest a deeper understanding of how SDM and CDS interact to affect cancer prevention decisions is needed. Trial registration: ClinicalTrials.gov ID: NCT02986230, December 6, 2016.

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.

Assessing the implementation of a clinical decision support tool in primary care for diabetes prevention: a qualitative interview study using the Consolidated Framework for Implementation Science.

BACKGROUND: In this paper we describe the use of the Consolidated Framework for Implementation Research (CFIR) to study implementation of a web-based, point-of-care, EHR-linked clinical decision support (CDS) tool designed to identify and provide care recommendations for adults with prediabetes (Pre-D CDS). METHODS: As part of a large NIH-funded clinic-randomized trial, we identified a convenience sample of interview participants from 22 primary care clinics in Minnesota, North Dakota, and Wisconsin that were randomly allocated to receive or not receive a web-based EHR-integrated prediabetes CDS intervention. Participants included 11 clinicians, 6 rooming staff, and 7 nurse or clinic managers recruited by study staff to participate in telephone interviews conducted by an expert in qualitative methods. Interviews were recorded and transcribed, and data analysis was conducted using a constructivist version of grounded theory. RESULTS: Implementing a prediabetes CDS tool into primary care clinics was useful and well received. The intervention was integrated with clinic workflows, supported primary care clinicians in clearly communicating prediabetes risk and management options with patients, and in identifying actionable care opportunities. The main barriers to CDS use were time and competing priorities. Finally, while the implementation process worked well, opportunities remain in engaging the care team more broadly in CDS use. CONCLUSIONS: The use of CDS tools for engaging patients and providers in care improvement opportunities for prediabetes is a promising and potentially effective strategy in primary care settings. A workflow that incorporates the whole care team in the use of such tools may optimize the implementation of CDS tools like these in primary care settings. Trial registration Name of the registry: Clinicaltrial.gov. TRIAL REGISTRATION NUMBER: NCT02759055. Date of registration: 05/03/2016. URL of trial registry record: https://clinicaltrials.gov/ct2/show/NCT02759055 Prospectively registered.

Patient Perceptions of Using Clinical Decision Support for Cancer Screening and Prevention: "I wouldn't have thought about getting screened without it."

PURPOSE: We sought to gain an understanding of cancer prevention and screening perspectives among patients exposed to a clinical decision support (CDS) tool because they were due or overdue for certain cancer screenings or prevention. METHODS: Semi-structured qualitative interviews were conducted with 37 adult patients due or overdue for cancer prevention services in 10 primary care clinics within the same health system. Data were thematically segmented and coded using qualitative content analysis. RESULTS: We identified three themes: 1) The CDS tool had more strengths than weaknesses, with areas for improvement; 2) Many facilitators and barriers to cancer prevention and screening exist; and 3) Discussions and decision-making varied by type of cancer prevention and screening. Almost all participants made positive comments regarding the CDS. Some participants learned new information, reporting the CDS helped them make a decision they otherwise would not have made. Participants who used the tool with their provider had higher self-reported rates of deciding to be screened than those who did not. CONCLUSIONS: Learning about patients' perceptions of a CDS tool may increase understanding of how patient-tailored CDS impacts cancer screening and prevention rates. Participants found a personalized CDS tool for cancer screening and prevention in primary care useful and a welcome addition to their visit. However, many providers were not using the tool with eligible patients.

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.