COPD Population in US Primary Care: Data From the Optimum Patient Care DARTNet Research Database and the Advancing the Patient Experience in COPD Registry.

PURPOSE: To describe demographic and clinical characteristics of chronic obstructive pulmonary disease patients managed in US primary care. METHODS: This was an observational registry study using data from the Chronic Obstructive Pulmonary Disease (COPD) Optimum Patient Care DARTNet Research Database from which the Advancing the Patient Experience COPD registry is derived. Registry patients were aged ≥35 years at diagnosis. Electronic health record data were collected from both registries, supplemented with patient-reported information/outcomes from the Advancing the Patient Experience registry from 5 primary care groups in Texas, Ohio, Colorado, New York, and North Carolina (June 2019 through November 2020). RESULTS: Of 17,192 patients included, 1,354 were also in the Advancing the Patient Experience registry. Patients were predominantly female (56%; 9,689/17,192), White (64%; 9,732/15,225), current/ex-smokers (80%; 13,784/17,192), and overweight/obese (69%; 11,628/16,849). The most commonly prescribed maintenance treatments were inhaled corticosteroid with a long-acting ß2-agonist (30%) and inhaled corticosteroid with a long-acting muscarinic antagonist (27%). Although 3% (565/17,192) of patitents were untreated, 9% (1,587/17,192) were on short-acting bronchodilator monotherapy, and 4% (756/17,192) were on inhaled corticosteroid monotherapy. Despite treatment, 38% (6,579/17,192) of patients experienced 1 or more exacerbations in the last 12 months. These findings were mirrored in the Advancing Patient Experience registry with many patients reporting high or very high impact of disease on their health (43%; 580/1,322), a breathlessness score 2 or more (45%; 588/1,315), and 1 or more exacerbation in the last 12 months (50%; 646/1,294). CONCLUSIONS: Our findings highlight the high exacerbation, symptom, and treatment burdens experienced by COPD patients managed in US primary care, and the need for more real-life effectiveness trials to support decision making at the primary care level.

Variation in Demographic and Clinical Characteristics of Patients with COPD Receiving Care in US Primary Care: Data from the Advancing the Patient EXperience (APEX) in COPD Registry.

Introduction: Little is known about the variability in chronic obstructive pulmonary disease (COPD) management and how it may be affected by patient characteristics across different healthcare systems in the US. This study aims to describe demographic and clinical characteristics of people with COPD and compare management across five primary care medical groups in the US. Methods: This is a retrospective observational registry study utilizing electronic health records stored in the Advancing the Patient Experience (APEX) COPD registry. The APEX registry contains data from five US healthcare organizations located in Texas, Ohio, Colorado, New York, and North Carolina. Data on demographic and clinical characteristics of primary care patients with COPD between December 2019 and January 2020 were extracted and compared. Results: A total of 17,192 patients with COPD were included in analysis: Texas (n = 811), Ohio (n = 8722), Colorado (n = 472), New York (n = 1149) and North Carolina (n = 6038). The majority of patients at each location were female (>54%) and overweight/obese (>60%). Inter-location variabilities were noted in terms of age, race/ethnicity, exacerbation frequency, treatment pattern, and prevalence of comorbid conditions. Patients from the Colorado site experienced the lowest number of exacerbations per year while those from the New York site reported the highest number. Hypertension was the most common co-morbidity at 4 of 5 sites with the highest prevalence in New York. Depression was the most common co-morbidity in Ohio. Treatment patterns also varied by site; Colorado had the highest proportion of patients not on any treatment. ICS/LABA was the most commonly prescribed treatment except in Ohio, where ICS/LABA/LAMA was most common. Conclusions and Relevance: Our data show heterogeneity in demographic, clinical, and treatment characteristics of patients diagnosed with COPD who are managed in primary care across different healthcare organizations in the US.

Dynamic-ETL: a hybrid approach for health data extraction, transformation and loading.

BACKGROUND: Electronic health records (EHRs) contain detailed clinical data stored in proprietary formats with non-standard codes and structures. Participating in multi-site clinical research networks requires EHR data to be restructured and transformed into a common format and standard terminologies, and optimally linked to other data sources. The expertise and scalable solutions needed to transform data to conform to network requirements are beyond the scope of many health care organizations and there is a need for practical tools that lower the barriers of data contribution to clinical research networks. METHODS: We designed and implemented a health data transformation and loading approach, which we refer to as Dynamic ETL (Extraction, Transformation and Loading) (D-ETL), that automates part of the process through use of scalable, reusable and customizable code, while retaining manual aspects of the process that requires knowledge of complex coding syntax. This approach provides the flexibility required for the ETL of heterogeneous data, variations in semantic expertise, and transparency of transformation logic that are essential to implement ETL conventions across clinical research sharing networks. Processing workflows are directed by the ETL specifications guideline, developed by ETL designers with extensive knowledge of the structure and semantics of health data (i.e., "health data domain experts") and target common data model. RESULTS: D-ETL was implemented to perform ETL operations that load data from various sources with different database schema structures into the Observational Medical Outcome Partnership (OMOP) common data model. The results showed that ETL rule composition methods and the D-ETL engine offer a scalable solution for health data transformation via automatic query generation to harmonize source datasets. CONCLUSIONS: D-ETL supports a flexible and transparent process to transform and load health data into a target data model. This approach offers a solution that lowers technical barriers that prevent data partners from participating in research data networks, and therefore, promotes the advancement of comparative effectiveness research using secondary electronic health data.

Adoption of a Portal for the Primary Care Management of Pediatric Asthma: A Mixed-Methods Implementation Study.

BACKGROUND: Patient portals may improve communication between families of children with asthma and their primary care providers and improve outcomes. However, the feasibility of using portals to collect patient-reported outcomes from families and the barriers and facilitators of portal implementation across diverse pediatric primary care settings have not been established. OBJECTIVE: We evaluated the feasibility of using a patient portal for pediatric asthma in primary care, its impact on management, and barriers and facilitators of implementation success. METHODS: We conducted a mixed-methods implementation study in 20 practices (11 states). Using the portal, parents of children with asthma aged 6-12 years completed monthly surveys to communicate treatment concerns, treatment goals, symptom control, medication use, and side effects. We used logistic regression to evaluate the association of portal use with child characteristics and changes to asthma management. Ten clinician focus groups and 22 semistructured parent interviews explored barriers and facilitators of use in the context of an evidence-based implementation framework. RESULTS: We invited 9133 families to enroll and 237 (2.59%) used the portal (range by practice, 0.6%-13.6%). Children of parents or guardians who used the portal were significantly more likely than nonusers to be aged 6-9 years (vs 10-12, P=.02), have mild or moderate/severe persistent asthma (P=.009 and P=.04), have a prescription of a controller medication (P<.001), and have private insurance (P=.002). Portal users with uncontrolled asthma had significantly more medication changes and primary care asthma visits after using the portal relative to the year earlier (increases of 14% and 16%, respectively). Qualitative results revealed the importance of practice organization (coordinated workflows) as well as family (asthma severity) and innovation (facilitated communication and ease of use) characteristics for implementation success. CONCLUSIONS: Although use was associated with higher treatment engagement, our results suggest that achieving widespread portal adoption is unlikely in the short term. Implementation efforts should include workflow redesign and prioritize enrollment of symptomatic children. CLINICALTRIAL: Clinicaltrials.gov NCT01966068; https://clinicaltrials.gov/ct2/show/NCT01966068 (Archived by WebCite at http://www.webcitation.org/6i9iSQkm3).

Monitoring suicidal patients in primary care using electronic health records.

INTRODUCTION: Patients at risk for suicide often come into contact with primary care providers, many of whom use electronic health records (EHRs) for charting. It is not known, however, how often suicide ideation or attempts are documented in EHRs. METHODS: We used retrospective analyses of de-identified EHR data from a distributed health network of primary care organizations to estimate the frequency of using diagnostic codes to record suicidal ideation and attempts. Data came from 3 sources: a clinician notes field processed using natural language processing; a suicidal ideation item on a patient-reported depression severity instrument (9-item Patient Health Questionnaire [PHQ-9]); and diagnostic codes from the EHR. RESULTS: Only 3% of patients with an indication of suicidal ideation in the notes field had a corresponding International Classification of Diseases, 9th Revision (ICD-9), code (κ = 0.036). Agreement between an indication of suicidal ideation from item 9 of the PHQ-9 and an ICD-9 code was slightly higher (κ = 0.068). Suicide attempt indicated in the notes field was more likely to be recorded using an ICD-9 code (19%; κ = 0.18). CONCLUSIONS: Few cases of suicidal ideation and attempt were documented in patients' EHRs using diagnostic codes. Increased documentation of suicidal ideation and behaviors in patients' EHRs may improve their monitoring in the health care system.

Do professional development programs for Maintenance of Certification (MOC) affect quality of patient care?

OBJECTIVE: The objective of this study was to examine the relationship between physicians' completion of American Board of Family Medicine (ABFM) Maintenance of Certification (MOC) modules and the quality of medical care delivered. METHODS: Physicians from the Electronic National Quality Improvement and Research Network (eNQUIRENet) were enrolled. Data from their electronic health records were compared before and after they completed one or more MOC modules for family physicians (Self-Assessment Module [Part II MOC] and Performance in Practice Module [Part IV MOC]; SAM/PPM). Process data and other quantitative clinical measures for all adult patients with a diagnosis of type 2 diabetes were gathered from each study physician. General linear mixed effects models were used to analyze data before and after the MOC modules, adjusting for clustering of patients within physicians. RESULTS: Physicians participating in SAM/PPM activities demonstrated greater improvements over time in 11 of 24 measures in process and intermediate outcome measures related to type 2 diabetes care compared with non-SAM/PPM participants. All groups demonstrated improvements over time. CONCLUSION: Participation in SAM/PPM activities is associated with greater improvements in care, but the association between activity undertaken and specific improvements is difficult to demonstrate.

Risk-adjusted comparison of blood pressure and low-density lipoprotein (LDL) noncontrol in primary care offices.

OBJECTIVES: Population-level control of modifiable cardiovascular disease (CVD) risk factors is suboptimal. The objectives of this study were (1) to demonstrate the use of electronically downloaded electronic health record (EHR) data to assess guideline concordance in a large cohort of primary care patients, (2) to provide a contemporary assessment of blood pressure (BP) and low-density lipoprotein (LDL) noncontrol in primary care, and (3) to demonstrate the effect of risk adjustment of rates of noncontrol of BP and LDL for differences in patient mix on these clinic-level performance measures. METHODS: This was an observational comparative effectiveness study that included 232,172 adult patients ≥18 years old with ≥1 visit within 2 years in 33 primary care clinics with EHRs. The main measures were rates of BP and LDL noncontrol based on current guidelines and were calculated from electronically downloaded EHR data. Rates of noncontrol were risk-adjusted using multivariable models of patient-level variables. RESULTS: Overall, 16.0% of the 227,122 patients with known BP and 14.9% of the 136,771 patients with known LDL were uncontrolled. Clinic-level, risk-adjusted BP noncontrol ranged from 7.7% to 26.5%, whereas that for LDL ranged from 5.8% to 23.6%. Rates of noncontrol exceeded an achievable benchmark for 85% (n = 28) and 79% (n = 26) of the 33 clinics for BP and LDL, respectively. Risk adjustment significantly influences clinic rank order for rate of noncontrol. CONCLUSIONS: We demonstrated that the use of electronic collection of data from a large cohort of patients from fee-for-service primary care clinics is feasible for the audit of and feedback on BP and LDL noncontrol. Rates of noncontrol for most clinics are substantially higher than those achievable. Risk adjustment of noncontrol rates results in a rank-order of clinics very different from that achieved with nonadjusted data.

Scalable Architecture for Federated Translational Inquiries Network (SAFTINet) Technology Infrastructure for a Distributed Data Network.

INTRODUCTION: Distributed Data Networks (DDNs) offer infrastructure solutions for sharing electronic health data from across disparate data sources to support comparative effectiveness research. Data sharing mechanisms must address technical and governance concerns stemming from network security and data disclosure laws and best practices, such as HIPAA. METHODS: The Scalable Architecture for Federated Translational Inquiries Network (SAFTINet) deploys TRIAD grid technology, a common data model, detailed technical documentation, and custom software for data harmonization to facilitate data sharing in collaboration with stakeholders in the care of safety net populations. Data sharing partners host TRIAD grid nodes containing harmonized clinical data within their internal or hosted network environments. Authorized users can use a central web-based query system to request analytic data sets. DISCUSSION: SAFTINet DDN infrastructure achieved a number of data sharing objectives, including scalable and sustainable systems for ensuring harmonized data structures and terminologies and secure distributed queries. Initial implementation challenges were resolved through iterative discussions, development and implementation of technical documentation, governance, and technology solutions.

Enhancing electronic health record measurement of depression severity and suicide ideation: a Distributed Ambulatory Research in Therapeutics Network (DARTNet) study.

BACKGROUND: Depression is a leading cause of morbidity worldwide. The majority of treatment for depression occurs in primary care, but effective care remains elusive. Clinical decision making and comparative studies of real-world antidepressant effectiveness are limited by the absence of clinical measures of severity of illness and suicidality. METHODS: The Distributed Ambulatory Research in Therapeutics Network (DARTNet) was engaged to systematically collect data using the 9-item Patient Health Questionnaire (PHQ-9) at the point of care. We used electronic health records (EHRs) and the PHQ-9 to capture, describe, and compare data on both baseline severity of illness and suicidality and response and suicidality after diagnosis for depressed patients in participating DARTNet practices. RESULTS: EHR data were obtained for 81,028 episodes of depression (61,464 patients) from 14 clinical organizations. Over 9 months, data for 4900 PHQ-9s were collected from 2969 patients in DARTNet practices (this included 1892 PHQ-9s for 1019 adults and adolescents who had at least one depression diagnosis). Only 8.3% of episodes identified in our depression cohort had severity of illness information available in the EHR. For these episodes, considerable variation existed in both severity of illness (32.05% with no depression, 26.89% with minimal, 19.54% with mild, 12.04% with moderate, and 9.47% with severe depression) and suicidality (69.43% with a score of 0, 22.58% with a score of 1, 4.97% with a score of 2, and 3.02% with a score of 3 on item 9 of the PHQ-9). Patients with an EHR diagnosis of depression and a PHQ-9 (n = 1019) had similar severity but slightly higher suicidality levels compared with all patients for which PHQ-9 data were available. The PHQ-9 showed higher sensitivity for identifying depression response and emergent (after diagnosis) severity and suicidality; 25% to 30% of subjects had some degree of suicidal thought at some point in time according to the PHQ-9. CONCLUSIONS: This study demonstrated the value of adding PHQ-9 data and prescription fulfillment data to EHRs to improve diagnosis and management of depression in primary care and to enable more robust comparative effectiveness research on antidepressants.

Improving the management of skin and soft tissue infections in primary care: a report from State Networks of Colorado Ambulatory Practices and Partners (SNOCAP-USA) and the Distributed Ambulatory Research in Therapeutics Network (DARTNet).

BACKGROUND: Purulent skin and soft tissue infections (SSTIs) requiring medical attention are often managed in primary care. The prevalence of SSTIs caused by community-acquired Methicillin-resistant Staphylococcus aureus (CA-MRSA) has been increasing rapidly, including in otherwise healthy individuals. The Centers for Disease Control and Prevention (CDC) issued guidelines to improve the management of SSTIs in primary care. PURPOSE: In primary care settings, to assess the prevalence of CA-MRSA using an electronic chart audit and then evaluate SSTI management strategies consistent with CDC guidelines. METHODS: A practical intervention that compared a historical cohort to an intervention cohort of patients seen for SSTI in 16 primary care practices in two health care systems. The intervention included a ready-made kit for I & D procedures, MRSA information for clinicians, a patient information handout, provider education, and patient follow-up. RESULTS: A total of 3112 SSTI cases (cellulitis or purulent) were observed during the preintervention period and 1406 cases during the intervention. For purulent infections in the intervention period (n = 148), univariate and multivariate analyses showed no significant improvement in the rate of I & D procedures or cultures obtained but showed increased use of antibiotics overall and agents that typically cover MRSA strains (OR, 2.183; 95% CI, 1.443 to 3.303 and 2.624; 95% CI, 1.500 to 4.604, respectively). For infections that were cellulitis with or without purulence (n = 1258), overall rates in the use of antibiotics and those that cover MRSA increased significantly, but secular trends could not be ruled out as an explanation for this increase. CONCLUSION: In SSTIs, this intervention resulted in increased use of antibiotics, including antibiotics that typically cover MRSA strains, but did not demonstrate increased rates of recommended drainage procedures. It is replicable and portable, and may improve antibiotic selection in other settings.

Comparative effectiveness research in DARTNet primary care practices: point of care data collection on hypoglycemia and over-the-counter and herbal use among patients diagnosed with diabetes.

BACKGROUND: The Distributed Ambulatory Research in Therapeutics Network (DARTNet) is a federated network of electronic health record (EHR) data, designed as a platform for next-generation comparative effectiveness research in real-world settings. DARTNet links information from nonintegrated primary care clinics that use EHRs to deliver ambulatory care to overcome limitations with traditional observational research. OBJECTIVE: Test the ability to conduct a remote, electronic point of care study in DARTNet practices by prompting clinic staff to obtain specific information during a patient encounter. RESEARCH DESIGN: Prospective survey of patients identified through queries of clinical data repositories in federated network organizations. On patient visit, survey is triggered and data are relinked to the EHR, de-identified, and copied for evaluation. SUBJECTS: Adult patients diagnosed with diabetes mellitus that scheduled a clinic visit for any reason in a 2-week period in DARTNet primary care practices. MEASURES: Survey on hypoglycemic events (past month) and over-the-counter and herbal supplement use. RESULTS: DARTNet facilitated point of care data collection triggered by an electronic prompt for additional information at a patient visit. More than one-third of respondents (33% response rate) reported either mild (45%) or severe hypoglycemic events (5%) in the month before the survey; only 3 of those were also coded using the ICD-9 (a significant difference in detection rates 37% vs. 1%). Nearly one-quarter of patients reported taking an OTC/herbal, 4% specifically for the treatment of symptoms of diabetes. CONCLUSIONS: Prospective data collection is feasible in DARTNet and can enable comparative effectiveness and safety research.

An electronic practice-based network for observational comparative effectiveness research.

The Distributed Ambulatory Research in Therapeutics Network (DARTNet) is a federated network of electronic health data from 8 organizations representing more than 500 clinicians and more than 400 000 patients. DARTNet was designed to increase knowledge of the comparative effectiveness of prescription medications and medical devices. Traditional observational comparative effectiveness research is conducted using large data sets, such as claims databases. Such databases do not provide important clinical information that is critical to understanding comparative effectiveness. By linking electronic health records, laboratory and imaging data, and administrative data from diverse and geographically disparate patients, DARTNet provides important new insight into the comparative effectiveness of oral diabetes medications, and it is ready for expansion to further enable effectiveness research.

Practice-based research network studies and institutional review boards: two new issues.

BACKGROUND: Practice-based research network (PBRN) study investigators must interface with multiple Institutional Review Boards (IRBs), many of which are unfamiliar with PBRN research. OBJECTIVE: To present 2 IRB-related issues that have not appeared in the literature but occurred during the course of a large 5-year PBRN study involving 32 sites dispersed around the United States. RESULTS: Our study required IRB approval from a total of 19 local, hospital, academic center, and professional organization-based IRBs that reviewed a protocol of postpartum depression screening and follow-up completed in English or Spanish. Initial approval of the protocol and consent forms proceeded with only the usual barriers of submitting 19 different forms, and no protocol amendments were required. However, 2 unanticipated IRB issues provided significant additional work for the study team and the local practice sites. First, several IRBs required staff to repeat human subjects training every 1 to 2 years, resulting in 92 practicing physicians, residents, and members of the nursing staff spending time completing the exact same human subjects' training at least twice during the course of this study. Second, 17 of the 19 IRBs required that the patient be given consent forms that were newly stamped and dated each year, requiring the central site to reprint and replace consent forms yearly. Because not all IRBs returned the newly stamped and dated forms in a timely fashion, study enrollment with valid consent forms was interrupted in 4 sites for periods of 2 to 13 weeks. CONCLUSIONS: IRB requirements not directly responsive to federal regulations can add significant costs, frustrations, and burdens to PBRN studies. Non-federally mandated IRB requirements should be based on an identified need with evidence to support the solution.

Barriers and motivators for making error reports from family medicine offices: a report from the American Academy of Family Physicians National Research Network (AAFP NRN).

CONTEXT: Reporting of medical errors is a widely recognized mechanism for initiating patient safety improvement, yet we know little about the feasibility of error reporting in physician offices, where the majority of medical care in the United States is rendered. OBJECTIVE: To identify barriers and motivators for error reporting by family physicians and their office staff based on the experiences of those participating in a testing process error reporting study. DESIGN: Qualitative focus group study, analyzed using the editing method. SETTING: Eight volunteer practices of the American Academy of Family Physicians National Research Network. PARTICIPANTS: 139 physicians, nurse practitioners, physician assistants, nurses, and staff who took part in 18 focus groups. INSTRUMENT: Interview questions asked about making reports, what prevents more reports from being made, and decisions about when to make reports. RESULTS: Four factors were seen as central to making error reports: the burden of effort to report, clarity regarding the information requested in an error report, the perceived benefit to the reporter, and properties of the error (eg, severity, responsibility). The most commonly mentioned barriers were related to the high burden of effort to report and lack of clarity regarding the requested information. The most commonly mentioned motivator was perceived benefit. CONCLUSION: Successful error reporting systems for physicians' offices will need to have low reporting burden, have great clarity regarding the information requested, provide direct benefit through feedback useful to reporters, and take into account error severity and personal responsibility.