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There are limited data evaluating chronic nonsteroidal anti-inflammatory drug (NSAID) exposure and decline in kidney function in primary care practice where rates of NSAID prescribing are high (1,2). The majority of published observational studies have evaluated the association of prescription NSAID use with AKI using claims data in focused geographic areas outside of the United States (1). It is estimated that >36 million Americans use over-the-counter (OTC) NSAIDs and data suggest that many users, regardless of age, exceed the recommended dose (1,3,4). Education materials for prescription ( e.g ., Food and Drug Administration Medication Guide) and OTC (label) NSAIDs have also been noted to have content that is not aligned with the universal precautions for health literacy. Poor literacy around NSAID education materials has been documented among primary care patients with CKD (5). This study sought to evaluate eGFR changes associated with chronic NSAID exposure in a large, geographically vast, primary care cohort using data from the DARTNet Practice Performance Registry receiving prescription and OTC NSAIDs (6). This project was determined to not require oversight by the University of Michigan Institutional Review Board. This determination was based on the fact that the data set analyzed had no protected health information. Eligible patients were ≥18 years old and had at least two eGFR measurements (between 29 ml/min per 1.73 m2) at least 3 months apart. Baseline was defined as the first qualifying eGFR during the study period of January 1, …

The Advancing the Patient Experience (APEX) in Chronic Obstructive Pulmonary Disease (COPD) registry (https://www.apexcopd.org/) is the first primary care health system-based COPD registry in the United States. While its ultimate goal is to improve the care of patients diagnosed with COPD, the registry is also designed to describe real-life experiences of people with COPD, track key outcomes longitudinally, and assess the effectiveness of interventions. It will retrospectively and prospectively collect information from 3000 patients enrolled in 5 health care organizations. Information will be obtained from electronic health records, and from extended annual and brief questionnaires completed by patients before clinic visits. Core variables to be collected into the APEX COPD registry were agreed on by Delphi consensus and fall into 3 domains: demographics, COPD monitoring, and treatment. Main strengths of the registry include: 1) its size and scope (in terms of patient numbers, geographic spread and use of multiple information sources including patient-reported information); 2) collection of variables which are clinically relevant and practical to collect within primary care; 3) use of electronic data capture systems to ensure high-quality data and minimization of data-entry requirements; 4) inclusion of clinical, database development, management and communication experts; 5) regular sharing of key findings, both at international/national congresses and in peer-reviewed publications; and 6) a robust organizational structure to ensure continuance of the registry, and that research outputs are ethical, relevant and continue to bring value to both patients and physicians.

Background: Chronic obstructive pulmonary disease (COPD) is commonly managed by family physicians, but little is known about specifics of management and how this may be improved. The Advancing the Patient Experience in COPD (APEX COPD) registry will be the first U.S. primary care, health system-based registry following patients diagnosed with COPD longitudinally, using a standardized set of variables to investigate how patients are managed in real life and assess outcomes of various management strategies.Objective: Gaining expert consensus on a standardized list of variables to capture in the APEX COPD registry.Methods: A modified, Delphi process was used to reach consensus on which data to collect in the registry from electronic health records (EHRs), patient-reported information (PRI) and patient-reported outcomes (PRO), and by physicians during subsequent office visits. The Delphi panel comprised 14 primary care and specialty COPD experts from the United States and internationally. The process consisted of 3 iterative rounds. Responses were collected electronically.Results: Of the initial 195 variables considered, consensus was reached to include up to 115 EHR variables, 34 PRI/PRO variables and 5 office-visit variables in the APEX COPD registry. These should include information on symptom burden, diagnosis, COPD exacerbations, lung function, quality of life, comorbidities, smoking status/history, treatment specifics (including side effects), inhaler management, and patient education/self-management.Conclusion: COPD experts agreed upon the core variables to collect from EHR data and from patients to populate the APEX COPD registry. Data will eventually be integrated, standardized and stored in the APEX COPD database and used for approved COPD-related research.

Background: Despite the current evidence of preventive screening effectiveness, rates of breast, cervical, and colorectal cancer in the United States fall below national targets. We evaluated the efficacy and feasibility of combining practice facilitation and academic detailing quality improvement (QI) strategies to help primary care practices increase breast, cervical, and colorectal cancer screening among patients. Methods: Practices received a 1-hour academic detailing session addressing current cancer screening guidelines and best practices, followed by 6 months of practice facilitation to implement evidence-based interventions aimed at increasing patient screening. One-way repeated measures analysis of variance compared screening rates before and after the intervention, provider surveys, and TRANSLATE model scores. Qualitative data were gathered via participant focus groups and interviews. Results: Twenty-three practices enrolled in the project: 4 federally qualified health centers, 10 practices affiliated with larger health systems, 4 physician-owned practices, 4 university hospital clinics, and 1 nonprofit clinic. Average screening rates for breast cancer increased by 13% (P = .001), and rates for colorectal cancer increased by 5.6% (P = .001). Practices implemented a mix of electronic health record data cleaning workflows, provider audits and feedback, reminder systems streamlining, and patient education and outreach interventions. Practice facilitators assisted practices in tailoring interventions to practice-specific priorities and constraints and in connecting with community resources. Practices with resource constraints benefited from the engagement of all levels of staff in the quality improvement processes and from team-based adaptations to office workflows and policies. Many practices aligned quality improvement interventions in this project with patient-centered medical home and other regulatory reporting targets. Conclusions: Combining practice facilitation and academic detailing is 1 method through which primary care practices can achieve systems-level changes to better manage patient population health.

Introduction: As chronic kidney disease (CKD) is among the most prevalent chronic diseases in the world with various rate of progression among patients, identifying its phenotypic subtypes is important for improving risk stratification and providing more targeted therapy and specific treatments for patients having different trajectories of the disease progression.Problem Definition and Data: The rapid growth and adoption of electronic health records (EHR) technology has created a unique opportunity to leverage the abundant clinical data, available as EHRs, to find meaningful phenotypic subtypes for CKD. In this study, we focus on extracting disease severity profiles for CKD while accounting for other confounding factors.Probabilistic Subtyping Model: We employ a probabilistic model to identify precise phenotypes from EHR data of patients who have chronic kidney disease. Using this model, patient’s eGFR trajectory is decomposed as a combination of four different components including disease subtype effect, covariate effect, individual long-term effect and individual short-term effect.Experimental Results: The discovered disease subtypes obtained by Probabilistic Subtyping Model for CKD are presented and their clinical relevance is analyzed.Discussion: Several clinical health markers that were found associated with disease subtypes are presented with suggestion for further investigation on their use as risk predictors. Several assumptions in the study are also clarified and discussed.Conclusion: The large dataset of EHRs can be used to identify deep phenotypes retrospectively. Directions for further expansion of the model are also discussed.

We examined the use of automated voice recognition (AVR) messages targeting smokers from primary care practices located in underserved urban and rural communities to promote smoking cessation. We partnered with urban and rural primary care medical offices (n = 7) interested in offering this service to patients. Current smokers, 18 years and older, who had completed an office visit within the previous 12 months, from these sites were used to create a smoker's registry. Smokers were recruited within an eight county region of western New York State between June 2012 and August 2013. Participants were contacted over six month intervals using the AVR system. Among 5812 smokers accrued 1899 (32%) were reached through the AVR system and 55% (n = 1049) continued to receive calls. Smokers with race other than white or African American were less likely to be reached (OR = 0.71, 0.57–0.90), while smokers ages 40 and over were more likely to be reached. Females (OR = 0.78, 0.65–0.95) and persons over age 40 years were less likely to opt out, while rural smokers were more likely to opt out (OR = 3.84, 3.01–4.90). Among those receiving AVR calls, 30% reported smoke free (self-reported abstinence over a 24 h period) at last contact; smokers from rural areas were more likely to report being smoke free (OR = 1.41, 1.01–1.97). An AVR-based smoking cessation intervention provided added value beyond typical tobacco cessation efforts available in these primary care offices. This intervention required no additional clinical staff time and served to satisfy a component of patient center medical home requirements for practices.

Background: Primary care physicians (PCPs) are optimally situated to identify and manage early stage chronic kidney disease (CKD). Nonetheless, studies have documented suboptimal PCP understanding, awareness, and management of early CKD. The TRANSLATE CKD study is an ongoing national, mixed-methods, cluster randomized control trial that examines the implementation of evidence-based guidelines for CKD into primary care practice. Methods: As part of the mixed-methods process evaluation, semistructured interviews were conducted by phone with 27 providers participating in the study. Interviews were audio-taped and transcribed. Thematic content analysis was used to identify themes. Themes were categorized according to the 4 domains of Normalization Process Theory (NPT). Results: Identified themes illuminated the complex work undertaken to manage CKD in primary care practices. Barriers to guideline implementation were identified in each of the 4 NPT domains, including (1) lack of knowledge and understanding around CKD (coherence), (2) difficulties engaging providers and patients in CKD management (cognitive participation), (3) limited time and competing demands (collective action), and (4) challenges obtaining and using data to monitor progress (reflexive monitoring). Conclusions: Addressing the barriers to implementation with concrete interventions at the levels at which they occur, informed by NPT, will ultimately improve the quality of CKD patient care.

While health information technology (HIT) efforts are beginning to yield measurable clinical benefits, more is needed to meet the needs of patients and clinicians. Primary care researchers are uniquely positioned to inform the evidence-based design and use of technology. Research strategies to ensure success include engaging patient and clinician stakeholders, working with existing practice-based research networks, and using established methods from other fields such as human factors engineering and implementation science. Policies are needed to help support primary care researchers in evaluating and implementing HIT into everyday practice, including expanded research funding, strengthened partnerships with vendors, open access to information systems, and support for the Primary Care Extension Program. Through these efforts, the goal of improved outcomes through HIT can be achieved.

Objective This study explored the self-management strategies and treatment burden experienced by low-income US primary care patients with chronic kidney disease. Methods Semi-structured interviews were conducted with 34 patients from two primary care practices on Buffalo’s East Side, a low-income community. Qualitative analysis was undertaken using an inductive thematic content analysis approach. We applied normalization process theory (NPT) to the concept of treatment burden to interpret and categorize our findings. Results The sample was predominantly African-American (79%) and female (59%). Most patients (79%) had a diagnosis of stage 3 CKD. Four major themes were identified corresponding to NPT and treatment burden: (1) coherence—making sense of CKD; (2) cognitive participation—enlisting support and organizing personal resources; (3) collective action—self-management work; and (4) reflexive monitoring—further refining chronic illness self-care in the context of CKD. For each component, we identified barriers hindering patients' ability to accomplish the necessary tasks. Conclusions Our findings highlight the substantial treatment burden faced by inner-city primary care patients self-managing CKD in combination with other chronic illnesses. Health care providers’ awareness of treatment burden can inform the development of person-centered care plans that can help patients to better manage their chronic illnesses.

The National Institute of Diabetes and Digestive and Kidney Diseases–supported Kidney Research National Dialogue asked the scientific community to formulate and prioritize research objectives that would enhance understanding of kidney function and disease and improve clinical outcomes. An engaged and growing group of investigators working in type 2 translation (from clinical evidence to implementation in the community) identified barriers to improving patient care in CKD and suggested research priorities to test translational strategies that have been effective for other chronic diseases.

Purpose To test the effect of office-based motivational interviewing (MI) on prescription opioid adherence in older adults with chronic pain. Design and Methods Pre- and post-design was used. Thirty chronic pain patients participated in a 4-week MI in two outpatient settings. Findings Participants demonstrated a significantly reduced risk of prescription opioid misuse, decreased substance use, increased self-efficacy, increased motivation to change, and decreased depression at both the post-test and 1-month follow-up. Practice Implication MI can be effectively delivered in outpatient settings for older adults who are at risk for opioid misuse. Clinicians could incorporate MI techniques to enhance prescription opioid adherence.

Inequities in smoking behaviors continue to exist with higher rates among persons with limited formal education and for those living below the poverty level. This report describes the scope of tobacco cessation services delivered to low socio-economic status (SES) patients in several primary care medical offices, considered as "safety-net" sources of health care. Using a cross-sectional design, a random sample of records were reviewed for 922 smokers from 4 medical offices. The primary outcome variable was the delivery of smoking cessation services as documented in medical records; information on patient demographics and number of visits during the past 12 months was also abstracted. Smoking status was assessed during the last office visit for 65 % of smokers, 59 % were advised to quit, readiness to quit was assessed for 24 %, 2 % indicated a willingness to quit within the next 30 days and a quit date was established for 1 %. Among smokers not yet ready to quit, few were counseled on the "5 R's" (Relevance, Risks, Rewards, Roadblocks, Repetition). These results expand our understanding of the unfortunately limited scope of cessation services delivered to persons seen in safety-net medical offices and call attention to the need to redouble efforts to more effectively address smoking cessation among diverse, low SES patients served by safety-net primary care clinics.

Background. Smoking rates are higher among those living at or below poverty and among persons with lower levels of education. We report on a formative research project examining patient perceptions of tobacco cessation strategies among diverse, low socioeconomic, urban smokers cared for in community-based primary care medical offices. Method. We conducted 10 focus groups among low socioeconomic status participants recruited from urban primary care medical offices in Buffalo and Niagara Falls, New York. Participants included current or former smokers, who were stratified by age-group (18-39 years and 40+ years). The focus groups discussed perceptions of tobacco cessation strategies, previous quit attempts, and use/attitudes regarding technology and social media as potential platforms for cessation support. Results. Participants ( n = 96) included predominantly African Americans ( n = 62, 65%) and European Americans ( n = 16, 16%); 56% were older than 40 years and 92% were low income. Most participants were supportive of cessation message delivery via phone; however, the age-groups varied in their attitudes on quitting smoking, desired frequency of phone contacts, and social media usage. Participants aged 18 to 39 years reported more Internet use, greater use of text messaging, and were more open to health information via social media. Conclusions. Based on significant variation between younger and older smokers’ perceptions of tobacco addiction and use of communication technologies, it appears reasonable to stratify the content and platform of health messaging by the target age-group.

Practice‐based research networks (PBRNs) can function as a platform for delivery of patient‐centered care consistent with the Patient Protection and Affordable Care Act. Patient‐centered (centric) clinical studies encourage the patient to be an integral part of study design and outcome. The patient’s electronic health record contributes to the shared national health care data set. PBRNs integrate health care data in real time at the point of care and reflectthefullcontextoftheperson’shealth.PBRNsdesignedundertheprinciplesofgoodclinicalpractice(GCP)validatestudiesrelatedtocomparative effectiveness research and drug development. PBRNs can generate large amounts of data from known patient histories so that side effects can be assessed in their totality. The larger and more diverse number of patients recruited suggests that point‐of‐care‐data, where both provider and patient participate in the treatment, may be more robust in that side effects, drug–drug interactions and number of concomitant medications used may be identified earlier in the development process. The GCP PBRN concept affords continuous patient information for both care and research purposes. Theseallcontributetoanethicalapproachforthepharmaceuticalindustrytogenerateclinicalresearchdataforregulatorysubmissionandtocontribute to a HIPAA‐compliant national database that could contribute to improved health care delivery and pharmacovigilance.

The Patient-Centered Outcomes Research Institute (PCORI), created and funded by the Affordable Care Act, is charged with bringing the patient perspective to clinical research design and the outcomes that are studied. However, there is no consensus definition of "patient-centeredness" or "patient-centricity." This paper distinguishes between the terms and describes an infrastructure for supporting the concept of patient-centricity. The patient's role needs to be described in a way that makes it feasible to implement health care delivery and support parameters to conduct clinical research over a sustained period of time. The authors propose the use of a structured Practice-Based Clinical Research Network to perform patient-centered outcomes research consistent with the requirements of the pharmaceutical sector in a safe, ethical, and effective manner and congruent with the principles of Good Clinical Practice (GCP).

Aims: The objective of this analysis was to examine the association between complex multidimensional factors and walking ability among older adults. Methods: In total, 200 patients completed literature-validated questionnaires to assess depressive symptoms, psychosocial stress and chronic pain. Previous medical diagnoses and medication usage were also recorded. BMI was calculated and walking ability was estimated using the Six-Minute Walk Test. Multiple regression was performed to ascertain the contribution of the predictor variables on distance walked. Results: The overall model accounted for 61.2% of the variance in walking ability. Age, number of medications used and number of comorbid conditions were predictive of distance walked along with chronic pain, depressive symptoms and BMI (p < 0.05). Conclusion: These findings indicate that walking ability is influenced by complex multidimensional factors, many of which can be managed. Comprehensive intervention should focus on ameliorating depressive symptoms and chronic pain, and preventing excess weight gain in older adults.

Objectives: This study explores the perceptions, attitudes, and beliefs that inform how people live with diabetes in a high poverty, ethnically diverse neighborhood with a growing population of refugees. The specific research objective was to examine participants’ explanations of how their diabetes began, understandings about the illness, description of symptoms, as well as physical and emotional reactions to the diagnosis. Methods: Qualitative design using semi-structured interviews. The transcripts were analyzed using an immersion–crystallization approach. Results: Thirty four individuals diagnosed with diabetes for at least 1 year participated. The sample included 14 refugees (from Somalia, Sudan, Burma, or Cuba), eight Puerto Ricans, six non-Hispanic Caucasians, six African-Americans, and two Native Americans. Three broad themes were identified across ethnic groups: (a) the diagnosis of diabetes was unexpected; (b) emotional responses to diabetes were similar to Kubler-Ross’s stages of grief; (c) patients’ understanding of diabetes focused on symptoms and diet. Conclusions: Patients were frequently stunned by the diagnosis of diabetes, and expressed emotions associated with the stages of grief including denial, anger, bargaining, depression, and acceptance. Our findings suggest that clinicians might consider addressing the patients’ emotions or grief reaction as an early priority to promote acceptance as a first step to self-management.

An arteriovenous fistula (AVF) is the optimal vascular access for hemodialysis (HD), because it is associated with prolonged survival, fewer infections, lower hospitalization rates, and reduced costs. The AVF First breakthrough initiative (FFBI) has made dramatic progress, effectively promoting the increase in the national AVF prevalence since the program's inception from 32% in May 2003 to nearly 60% in 2011. Central venous catheter (CVC) use has stabilized and recently decreased slightly for prevalent patients (treated more than 90 days), while CVC usage in the first 90 days remains unacceptably high at nearly 80%. This high prevalence of CVC utilization suggests important specific improvement goals for FFBI. In addition to the current 66% AVF goal, the initiative should include specific CVC usage target(s), based on the KDOQI goal of less than 10% in patients undergoing HD for more than 90 days, and a substantially improved initial target from the current CVC proportion. These specific CVC targets would be disseminated through the ESRD networks to individual dialysis facilities, further emphasizing CVC avoidance in the transition from advanced CKD to chronic kidney failure, while continuing to decrease CVC by prompt conversion of CVC-based hemodialysis patients to permanent vascular access, utilizing an AVF whenever feasible.

Individuals with serious mental illnesses (SMI) represent a high-risk health disparities population disproportionately affected by diabetes and obesity. Objectives: This paper describes a community-based participatory research (CBPR) approach to adapting a well-known evidence-based behavioral change protocol, the Diabetes Prevention Program (DPP) lifestyle intervention, for individuals with diabetes and SMI in the community setting. Methods: A committee composed of university researchers and representatives from the recovery community modified the DPP following three criteria: Person centeredness, practicality, and empowerment. Lessons Learned: Major modifications to the DPP were made in light of barriers and challenges faced by individuals with diabetes and SMI. Conclusions: The adaptations made to the DPP, and the process through which the modifications were made, may be used by physicians, mental health practitioners, and health educators to engage individuals confronting self-management of diabetes and mental illness.

Purpose The purpose of the study was to examine the impact of incorporating certified diabetes educator trainees into medical practices on patient diabetes outcomes. Methods This was a mixed methods practice-based evaluation study undertaken in 2 primary care practices in high-poverty neighborhoods in Buffalo, New York. The evaluation entailed a physician-referred patient cohort with pre- and postanalysis of chart review data corresponding to the American Diabetes Association’s diabetes indicators. Patient charts were reviewed at baseline and 12 months. A brief survey was administered to the providers and staff to ascertain the extent to which the certified diabetes educator trainees were perceived as useful as part of the medical practice team. Results Among 74 patients enrolled in diabetes classes, A1C levels decreased from a mean of 8.8% to 8.3%. Among a subset of patients (35%) with poorly controlled diabetes at baseline (A1C ≥ 9), there was a 15% decrease in A1C levels. Overall improvement in A1C was observed among 219 patients seen by a diabetes educator, in either a diabetes education class or a one-on-one visit. Conclusions Results suggest that having a certified diabetes educator trainee as part of the primary care practice team may advance diabetes care, as evidenced by improvements in glucose control. Responses from providers and staff suggest that the certified diabetes educator trainees were well integrated into the practices and were perceived as instrumental in educating patients to better manage their diabetes.

To examine the prevalence and treatment of typical and subsyndromal bipolar disorder (BD) in depressed primary care patients.Patients with a diagnosis of a mood disorder being treated with antidepressants in 2 academic family practice clinics underwent a structured diagnostic interview (Mini International Neuropsychiatric Inventory) for manic and hypomanic symptoms.Of 58 patients evaluated, 19% met full criteria for bipolar I disorder and 8.6% for bipolar II disorder; 31% had subsyndromal BD (ie, persistent elation or irritability accompanied by additional symptoms of hypomania but not enough symptoms to meet full criteria for bipolar I or II disorder). Only 5 patients with BD were receiving mood stabilizers, which had not been instituted in any patient by the primary care physician.The high prevalence of patients meeting full criteria for BD and the low rate of identification of BD in primary care patients are consistent with estimates using self-administered questionnaires, but the interview revealed a substantial additional population that could be considered to have subsyndromal BD. Because subsyndromal forms of BD are associated with significant impairment and comorbidity as well as progression to frank BD, recognition of both full and subthreshold BD in primary care practice should be improved.

Purpose The purpose of this study was to explore the issues and challenges faced by certified diabetes educator (CDE) trainees in providing diabetes self-management education to patients in safety-net practices. Methods Semi-structured interviews were conducted with CDE trainees and a CDE mentor in 2 primary care practices. Transcripts were analyzed using a content-driven immersioncrystallization approach to identify major themes. Results Four major themes emerged from the qualitative interview data: (1) patient recruitment approaches, (2) patient barriers to attending diabetes education classes, (3) teaching challenges, and (4) CDE integration into the practices. Conclusions This study underscores the need for diabetes educators and other health education professionals to be creative and flexible in delivering self-management education to patients in underserved settings. The complexity of diabetes care and the self-care responsibilities placed on the patient reinforce the need for a team approach such as that proposed in the medical home model and should include certified diabetes educators.

The asymptomatic nature of chronic kidney disease (CKD) makes explicit screening strategies for individuals at risk as the only means of early detection. This will allow more time for interventions to alter the natural history of the disease by delaying or preventing kidney disease progression and its complications. Patient awareness of CKD remains low. Utilization of CKD tests for patients at risk and interpretation of those tests to detect CKD by primary care physicians remain suboptimal. There is insufficient evidence to support general population screening. Diabetes, hypertension, and age 60 or greater are the primary CKD screening target conditions, based on assessments representative of the general populations in America and Norway. Although cardiovascular disease, family history of CKD, and ethnic and racial minorities are important predictors of CKD risk, they do not contribute significantly beyond the scope of diabetes, hypertension, and older age. Challenges remain to define the roles in the community of the primary physician and nephrologist to implement intensive blood pressure control, use of renin-angiotensin system blockers for proteinuric patients and nephrology referral as indicated. The electronic medical record holds the most promise in CKD screening through improvements in the flow of information and application of clinical decision support.

Background: With the prevalence of chronic kidney disease (CKD) in the United States rising from 10% to 13%, implementation of the evidence-based Kidney Disease Outcomes Quality Initiative guidelines, which were developed for the delay of progression of CKD, is of increasing importance in primary care offices. Previous studies have shown limited knowledge and uptake of Kidney Disease Outcomes Quality Initiative guidelines by primary care physicians. CKD and its complications are still largely under-diagnosed and under-treated. A multifaceted quality improvement study was undertaken to test if these guidelines could be implemented to improve CKD care in underserved practices. Methods: Using a combination of practice enhancement assistants, computer decision-making support, and academic detailing, we sought to increase physician awareness and care of CKD in 2 inner-city practices. Using these 3 modalities, a rapid-cycle quality improvement process was implemented. Results: One hundred eighty-one patients met the inclusion criteria of having a glomerular filtration rate

Objectives: To determine the prevalence of self-reported depression symptoms among diabetic individuals enrolled in Gold Choice, a Medicaid managed care organization specifically for people with mental health and/or substance abuse diagnoses; and to assess the sensitivity and specificity of individuals' self-report with encounter data. Methods: The 9-item depression scale of the Patient Health Questionnaire (PHQ-9) was mailed to 454 Gold Choice members in Western New York diagnosed with diabetes; and 249 completed PHQ-9 forms were returned (55% response rate). The PHQ-9 forms were compared to primary care encounter data to determine whether the respondents had been diagnosed with depression. Descriptive and inferential statistical analysis was undertaken. Results: The majority (56%) of individuals in the sample screened positive for depression (PHQ-9 ≥ 10), and half (49%) did not have evidence of a diagnosis in their encounter data. The percentage of those diagnosed with depression rose with increasing PHQ-9 severity levels, with 63% of individuals with the most severe depression (PHQ-9 ≥ 20) having a diagnosis. This trend was statistically significant, confirmed by independent sample t-tests and chi-square tests. The sensitivity of the PHQ-9 was moderate (66%), as was the specificity (52%). Conclusions: The results of this study suggest that depressive disorders may be under-recognized and under-treated amongst individuals with diabetes in the primary care setting. Half (51%) of those with PHQ-9 scores ≥ 10 had depression diagnoses, suggesting poor compliance rates and/or a need for therapy reassessment.

BACKGROUND. Failure to obtain the requisite follow-up of patients with abnormal mammograms may delay cancer diagnosis and impact outcome. Up to 20% of women do not receive timely recommended follow-up. The current study tested the accuracy of the linkage of payer claims and clinical data to identify the appropriate treatment for patients with abnormal mammograms. METHODS. Electronic medical records in a staff model practice that was affiliated with a single health payer were scanned to identify the Breast Imaging Reporting and Data System (BI-RADS®) code for all mammograms. For each woman with a BI-RADS code 0, 3, 4, or 5 mammogram, the payer claims were searched for follow-up breast procedures (imaging, biopsy, and surgery) occurring within 2 months for BI-RADS code 0, 4, and 5 mammograms and within 8 months for BI-RADS code 3 mammograms. For women with >1 abnormal mammogram during the study period, only follow-up for the first abnormal mammogram was examined. The medical records of cases defined by claims as not having recommended follow-up care were reviewed to determine the accuracy of claims analyses. RESULTS. A total of 17,329 women underwent 23,721 mammograms between January 1, 2001 and December 31, 2003. BI-RADS codes 0, 3, 4, or 5 occurred in 1490 mammograms (6.3%). Among 1206 women with a first abnormal mammogram who were eligible for claims follow-up, 16% did not receive recommended follow-up care. Medical record review demonstrated that the claims search accurately identified follow-up care in 97% of these cases. CONCLUSIONS. Administrative claims supplemented with BI-RADS data were found to accurately identify the follow-up care of patients with abnormal mammograms. Case management using this method may assist physicians in ensuring that all patients receive appropriate care. Cancer 2007. © 2007 American Cancer Society.

This study applies qualitative research methods to explore perspectives on cessation among smokers/former smokers recruited from an area of Northern Appalachia. Six focus groups, stratified by age group (18-39 years old and 40 years and older), were conducted among participants (n = 54) recruited from community settings. Participants described varied interest in and challenges with quitting smoking. Smokers 40 years and older more readily endorsed the health risks of smoking and had greater interest in quitting assistance. Participants expressed frustration with the US government for allowing a harmful product (e.g., cigarettes) to be promoted with minimal regulation. Use of social media was robust among both age groups; participants expressed limited interest in various social media/technology platforms for promoting smoking cessation. Findings from this understudied area of northern Appalachia reflect the heterogeneity of this region and contribute novel information about the beliefs, attitudes, and experiences of current and formers smokers with regard to cessation.

Objective This report assesses the impact of a series of education sessions delivered to office staff on the delivery of smoking cessation services among patients seeking care at a community-based women’s health center. Methods A quasi-experimental design was used to examine the delivery of smoking cessation services to patients in a medical office before and after office staff attended a series of 3 educational sessions intended to increase their knowledge and self-efficacy to address cessation. Delivery of smoking cessation services was documented through a systematic review of medical records using a structured abstraction form. Results While nearly all smokers (93%) were asked about smoking status at their last office visit, few smokers at baseline or follow-up were assessed for interest in setting a quit date or offered pharmacotherapy. Referrals to the smokers quit line increased from

Patient safety and medical errors in ambulatory primary care are receiving increasing attention from policy makers, accreditation bodies and researchers, as well as by practising family physicians and their patients. While a great deal of progress has been made in understanding errors in hospital settings, it is important to recognise that ambulatory settings pose a very large and different set of challenges and that the types of hazards that exist and the strategies required to reduce them are very different. What is needed is a logical theoretical model for understanding the causes of errors in primary care, the role of healthcare systems in contributing to errors, the propagation of errors through complex systems and, importantly, for understanding ambulatory primary care in the context of the larger healthcare system. The authors have developed such a model using a formal 'systems engineering' approach borrowed from the management sciences and engineering. This approach has not previously been formally described in the medical literature.This paper outlines the formal systems approach, presents our visual model of the system, and describes some experiences with and potential applications of the model for monitoring and improving safety. Applications include providing a framework to help focus research efforts, creation of new (visual) error reporting and taxonomy systems, furnishing a common and unambiguous vision for the healthcare team, and facilitating retrospective and prospective analyses of errors and adverse events. It is aimed at system redesign for safety improvement through a computer-based patient-centred safety enhancement and monitoring instrument (SEMI-P). This model can be integrated with electronic medical records (EMRs).

The shift in care for individuals with psychiatric disabilities from the psychiatric hospital to the community has been accompanied by an increased emphasis on the measurement of quality of life (QOL) for these clients. It is the goal of this paper to measure the impact of a voluntary outpatient wellness program on individuals' self-reports of QOL over time. QOL for 49 wellness center participants was assessed at baseline, three months, and six months. There was a significant increase in QOL over the assessment period, particularly for those participants who used the center's services more frequently. Limitations and future directions are discussed.

Context: Care continuity during transitions between the hospital and home requires reliable communication between providers and settings and an understanding of social determinants that influence recovery.Case Description: The coordinating transitions intervention uses real time alerts, delivered directly to the primary care practice for complex chronically ill patients discharged from an acute care setting, to facilitate nurse care coordinator led telephone outreach. The intervention incorporates claims-based risk stratification to prioritize patients for follow-up and an assessment of social determinants of health using the Patient-centered Assessment Method (PCAM). Results from transitional care are stored and transmitted to qualified healthcare providers across the continuum.Findings: Reliance on tools that incorporated interoperability standards facilitated exchange of health information between the hospital and primary care. The PCAM was incorporated into both the clinical and informational workflow through the collaboration of clinical, industry, and academic partners. Health outcomes improved at the study practice over their baseline and in comparison with control practices and the regional Medicaid population.Major Themes: Current research supports the potential impact of systems approaches to care coordination in improving utilization value after discharge. The project demonstrated that flexibility in developing the informational and clinical workflow was critical in developing a solution that improved continuity during transitions. There is additional work needed in developing managerial continuity across settings such as shared comprehensive care plans.Conclusions: New clinical and informational workflows which incorporate social determinant of health data into standard practice transformed clinical practice and improved outcomes for patients.

Purpose of the Study: While smoking represents the leading preventable cause of premature morbidity and mortality in the U.S., research has demonstrated that only a limited scope of cessation services are delivered to patients in many medical offices. We examined the use of an automated voice recognition (AVR) messaging intervention among smokers from primary care practices located in underserved urban and rural communities as a strategy to promote smoking cessation. Methods: We utilized community-based participatory research (CBPR) involving smokers as a foundation for creating AVR messaging and partnered with urban and rural primary care medical office sites (n=7), including community clinics and federally qualified health centers. Current smokers, 18 years and older, who had an office visit within the previous 12 months, from these sites were used to create a smoker's registry (n=5,872). Between 2012 and 2014 participants were contacted over six month intervals using the AVR system. Smoker's registry data including demographic variables, medical office, and phone contact information. AVR results from each practice were aggregated and analyzed to assess cessation outcomes. Results: Of the seven practice sites, a total of 5,872 smokers were accrued of whom 1,899 (32%) were reached through the AVR system. The average number of calls to smokers was 44 (median 51). 28% of the smokers reached were African American, 79% were age 40 and over, and 57% were female. Self-reported quit rates among reached smokers were 30%; quit rates were variable across selected variables. Conclusions: An AVR based smoking cessation intervention provided added value beyond typical tobacco cessation efforts available in these primary care offices. This intervention required no additional clinical staff time and served to satisfy a component of patient center medical home requirements for many of these practices. Building partnerships with primary care medical offices can aid in the development and testing of community-based interventions such as smoking cessation delivered to medically underserved and diverse patient populations. Citation Format: Frances G. Saad-Harfouche, Elisa M. Rodriguez, Annamaria Masucci Twarozek, Christy A. Widman, Deborah O. Erwin, Willie Underwood, III, Chester Fox, Martin C. Mahoney. Leveraging technology to promote smoking cessation in primary care medical offices. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr A08.

Background: There is increased interest nationally in multicenter clinical trials to answer questions about clinical effectiveness, comparative effectiveness, and safety in real-world community settings. Primary care practice-based research networks (PBRNs), comprising community- and/or academically affiliated practices committed to improving medical care for a range of health problems, offer ideal settings for these trials, especially pragmatic clinical trials. However, many researchers are not familiar with working with PBRNs. Methods: Experts in practice-based research identified solutions to challenges that researchers and PBRN personnel experience when collaborating on clinical trials in PBRNs. These were organized as frequently asked questions in a draft document presented at a 2013 Agency for Health care Research and Quality PBRN conference workshop, revised based on participant feedback, then shared with additional experts from the DARTNet Institute, Clinical Translational Science Award PBRN, and North American Primary Care Research Group PBRN workgroups for further input and modification. Results: The “Toolkit for Developing and Conducting Multi-site Clinical Trials in Practice-Based Research Networks” offers guidance in the areas of recruiting and engaging practices, budgeting, project management, and communication, as well as templates and examples of tools important in developing and conducting clinical trials. Conclusion: Ensuring the successful development and conduct of clinical trials in PBRNs requires a highly collaborative approach between academic research and PBRN teams.

Context: Clinical data research networks require large investments in infrastructure support to maintain their abilities to extract, transform, and load data from varied data sources, expand electronic data sources and develop learning communities.Case Description: This paper outlines a sustainable business model of ongoing infrastructure support for clinical data research activities. The DARTNet Institute is a not-for-profit 501(c)(3) organization that serves as a support entity for multiple practice-based research networks. Several clinical data research networks working closely with a professional society began collaborating to support shared goals in 2008. This loose affiliation called itself the “DARTNet Collaborative.” In 2011, the DARTNet Institute incorporated as an independent, not-for-profit entity. The business structure allows DARTNet to advocate for all partners without operating its own practice-based research network, serve as a legal voice for activities that overlap multiple partners, share personnel resources through service contracts between partners, and purchase low-cost (nonprofit rate) software.Major Themes: DARTNet’s business model relies upon four diverse sources of revenue: (1) DARTNet licenses and provides access to a propriety software system that extracts, transforms, and loads data from all major electronic health records (EHRs) utilized in the United States, and which also provides clinical decision support for research studies; (2) DARTNet operates a recognized, national professional-society-quality improvement registry that enables organizations to fulfill Meaningful Use 2 criteria; (3) DARTNet provides access to data for research activities that are funded by direct research dollars, provided at prices that generate excess revenue; and (4) DARTNet provides access to large primary care datasets for observational studies and pregrant analyses such as for sample size development. The ability of the system to support pragmatic trials will be described.Conclusion: The DARTNet model facilitates the use of direct grant dollars to generate revenue to support the overall enterprise through a purchased services arrangement. Other services provided through subcontracting provide facilities and administration fees as well as direct dollars to support the system. The flexibility of the business model overcomes the complicated financial arrangements and governance requirements of many professional associations and academic medical centers.

CKD is associated with significant morbidity, mortality, and financial burden. Practice guidelines outlining CKD management exist, but there is limited application of these guidelines. Interventions to improve CKD guideline adherence have been limited. This study evaluated a new CKD checklist (a tool outlining management guidelines for CKD) to determine whether implementation in an academic primary care clinic improved adherence to guidelines.During a 1-year period (August 2012-August 2013), a prospective study was conducted among 13 primary care providers (PCPs), four of whom were assigned to use a CKD checklist incorporated into the electronic medical record during visits with patients with CKD stages 1-4. All providers received education regarding CKD guidelines. The intervention and control groups consisted of 105 and 263 patients, respectively. Adherence to CKD management guidelines was measured.A random-effects logistic regression analysis was performed to account for intra-group correlation by PCP assignment and adjusted for age and CKD stage. CKD care improved among patients whose PCPs were assigned to the checklist intervention compared with controls. Patients in the CKD checklist group were more likely than controls to have appropriate annual laboratory testing for albuminuria (odds ratio [OR], 7.9; 95% confidence interval [95% CI], 3.6 to 17.2), phosphate (OR, 3.5; 95% CI, 1.5 to 8.3), and parathyroid hormone (OR, 8.1; 95% CI, 4.8 to 13.7) (P0.001 in all cases). Patients in the CKD checklist group had higher rates of achieving a hemoglobin A1c target7% (OR, 2.7; 95% CI, 1.4 to 5.1), use of an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker (OR, 2.1; 95% CI, 1.0 to 4.2), documentation of avoidance of nonsteroidal anti-inflammatory drugs (OR, 41.7; 95% CI, 17.8 to 100.0), and vaccination for annual influenza (OR, 2.1; 95% CI, 1.1 to 4.0) and pneumococcus (OR, 4.7; 95% CI, 2.6 to 8.6) (P0.001 in all cases).Implementation of a CKD checklist significantly improved adherence to CKD management guidelines and delivery of CKD care.

PURPOSE Guideline implementation in primary care has proven difficult. Although external assistance through performance feedback, academic detailing, practice facilitation (PF), and learning collaboratives seems to help, the best combination of interventions has not been determined. METHODS In a cluster randomized trial, we compared the independent and combined effectiveness of PF and local learning collaboratives (LLCs), combined with performance feedback and academic detailing, with performance feedback and academic detailing alone on implementation of the National Heart, Lung and Blood Institute’s Asthma Guidelines. The study was conducted in 3 primary care practice-based research networks. Medical records of patients with asthma seen during pre- and postintervention periods were abstracted to determine adherence to 6 guideline recommendations. McNemar’s test and multivariate modeling were used to evaluate the impact of the interventions. RESULTS Across 43 practices, 1,016 patients met inclusion criteria. Overall, adherence to all 6 recommendations increased (P ≤.002). Examination of improvement by study arm in unadjusted analyses showed that practices in the control arm significantly improved adherence to 2 of 6 recommendations, whereas practices in the PF arm improved in 3, practices in the LLCs improved in 4, and practices in the PF + LLC arm improved in 5 of 6 recommendations. In multivariate modeling, PF practices significantly improved assessment of asthma severity (odds ratio [OR] = 2.5, 95% CI, 1.7–3.8) and assessment of asthma level of control (OR = 2.3, 95% CI, 1.5–3.5) compared with control practices. Practices assigned to LLCs did not improve significantly more than control practices for any recommendation. CONCLUSIONS Addition of PF to performance feedback and academic detailing was helpful to practices attempting to improve adherence to asthma guidelines.

Background Four practice-based research networks (PBRNs) participated in a study to determine whether networks could increase dissemination, implementation, and diffusion of evidence-based treatment guidelines for chronic kidney disease by leveraging early adopter practices. Methods Motivated practices from four PBRNs received baseline and periodic performance feedback, academic detailing, and weekly practice facilitation for 6 months during wave I of the study. Each wave I practice then recruited two additional practices (wave II), which received performance feedback and academic detailing and participated in monthly local learning collaboratives led by the wave I clinicians. They received only monthly practice facilitation. The primary outcomes were adherence to primary care-relevant process-of-care recommendations from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative Guidelines. Performance was determined retrospectively by medical records abstraction. Practice priority, change capacity, and care process content were measured before and after the interventions. Results Following the intervention, wave I practices increased the use of ACEIs/ARBs, discontinuation of NSAIDs, testing for anemia, and testing and/or treatment for vitamin D deficiency. Most were able to recruit two additional practices for wave II, and wave II practices also increased their use of ACEIs/ARBs and testing and/or treatment of vitamin D deficiency. Conclusions With some assistance, early adopter practices can facilitate the diffusion of evidence-based approaches to other practices. PBRNs are well-positioned to replicate this process for other evidence-based innovations. Electronic supplementary material The online version of this article (doi:10.1186/s13012-014-0169-x) contains supplementary material, which is available to authorized users.

To test the effect of office-based motivational interviewing (MI) on prescription opioid adherence in older adults with chronic pain.Pre- and post-design was used. Thirty chronic pain patients participated in a 4-week MI in two outpatient settings.Participants demonstrated a significantly reduced risk of prescription opioid misuse, decreased substance use, increased self-efficacy, increased motivation to change, and decreased depression at both the post-test and 1-month follow-up.MI can be effectively delivered in outpatient settings for older adults who are at risk for opioid misuse. Clinicians could incorporate MI techniques to enhance prescription opioid adherence.

Background: Gold Choice, a Medicaid managed care organization for individuals with mental health and/or substance abuse diagnoses, uses telephonic case management to link members with primary care providers (PCPs). This study assessed the effectiveness of this approach. Methods: The number of new members without a PCP at baseline were compared with primary care encounter data documenting first PCP visits from 2003 to 2006. Paired t tests compared the mean number of new Gold Choice members linked to primary care who received telephonic case management. Results: During the 4 years, 52% of new members without a PCP at baseline were linked to a provider within 12 months. Paired sample t tests comparing the mean number of members linked to a PCP from baseline to 12 months for each of the 4 years yielded statistically significant results. Conclusion: More than 50% of members who indicated at baseline that they had not seen a PCP were linked to primary care during the first 12 months of their enrollment in Gold Choice, suggesting that that telephonic case management may be an effective approach to linking mentally ill and/or chemically dependent patients to primary care.

The National Kidney Foundation–Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) guideline for evaluation, classification, and stratification of chronic kidney disease (CKD) was published in 2002. The KDOQI guideline was well accepted by the medical and public health communities, but concerns and criticisms arose as new evidence became available since the publication of the original guidelines. KDIGO (Kidney Disease: Improving Global Outcomes) recently published an updated guideline to clarify the definition and classification of CKD and to update recommendations for the evaluation and management of individuals with CKD based on new evidence published since 2002. The primary recommendations were to retain the current definition of CKD based on decreased glomerular filtration rate or markers of kidney damage for 3 months or more and to include the cause of kidney disease and level of albuminuria, as well as level of glomerular filtration rate, for CKD classification. NKF-KDOQI convened a work group to write a commentary on the KDIGO guideline in order to assist US practitioners in interpreting the KDIGO guideline and determining its applicability within their own practices. Overall, the commentary work group agreed with most of the recommendations contained in the KDIGO guidelines, particularly the recommendations regarding the definition and classification of CKD. However, there were some concerns about incorporating the cause of disease into CKD classification, in addition to certain recommendations for evaluation and management.

This US, multicenter, observational study assessed the CKD prevalence in adult patients with type-2 diabetes mellitus (T2DM) and characterized the proportion of detected and undiagnosed CKD in the primary care setting using the following: a clinician survey; a patient physical exam and medical history; a single blood draw for estimated glomerular filtration rate (eGFR) and glycosolated hemoglobin (HbA1c); urine dipstick for protein; urine albumin-creatinine ratio (ACR); two patient quality of life questionnaires; and a 15-month medical record review. The study consisted of 9339 adults with T2DM and 466 investigator sites. Of the 9339 enrolled, 9307 had complete data collection for analysis. The 15-month retrospective review showed urine protein, urine ACR, and eGFR testing were not performed in 51.4%, 52.9% and 15.2% of individuals, respectively. Of the 9307 patients, 5036 (54.1%) had Stage 1–5 CKD based on eGFR and albuminuria; however, only 607 (12.1%) of those patients were identified as having CKD by their clinicians. Clinicians were more successful in diagnosing patients with Stage 3–5 CKD than Stages 1 and 2. There were no differences in clinicians’ likelihood of identification of CKD based on practice setting, number of years in practice, or self-reported patients seen per week. Awareness or patient self-reported CKD was 81.1% with practitioner detection versus 2.6% in the absence of diagnosis. Primary care of T2DM demonstrates recommended urine CKD testing is underutilized, and CKD is significantly under-diagnosed. This is the first study to show CKD detection is associated with awareness.

Background Chronic kidney disease (CKD) and end stage renal disease (ESRD) are steadily increasing in prevalence in the United States. While there is reasonable evidence that specific activities can be implemented by primary care physicians (PCPs) to delay CKD progression and reduce mortality, CKD is under-recognized and undertreated in primary care offices, and PCPs are generally not familiar with treatment guidelines. The current study addresses the question of whether the facilitated TRANSLATE model compared to computer decision support (CDS) alone will lead to improved evidence-based care for CKD in primary care offices. Methods/Design This protocol consists of a cluster randomized controlled trial (CRCT) followed by a process and cost analysis. Only practices providing ambulatory primary care as their principal function, located in non-hospital settings, employing at least one primary care physician, with a minimum of 2,000 patients seen in the prior year, are eligible. The intervention will occur at the cluster level and consists of providing CKD-specific CDS versus CKD-specific CDS plus practice facilitation for all elements of the TRANSLATE model. Patient-level data will be collected from each participating practice to examine adherence to guideline-concordant care, progression of CKD and all-cause mortality. Patients are considered to meet stage three CKD criteria if at least two consecutive estimated glomerular filtration rate (eGFR) measurements at least three months apart fall below 60 ml/min. The process evaluation (cluster level) will determine through qualitative methods the fidelity of the facilitated TRANSLATE program and find the challenges and enablers of the implementation process. The cost-effectiveness analysis will compare the benefit of the intervention of CDS alone against the intervention of CDS plus TRANSLATE (practice facilitation) in relationship to overall cost per quality adjusted years of life. Discussion This study has three major innovations. First, this study adapts the TRANSLATE method, proven effective in diabetes care, to CKD. Second, we are creating a generalizable CDS specific to the Kidney Disease Outcome Quality Initiative (KDOQI) guidelines for CKD. Additionally, this study will evaluate the effects of CDS versus CDS with facilitation and answer key questions regarding the cost-effectiveness of a facilitated model for improving CKD outcomes. The study is testing virtual facilitation and Academic detailing making the findings generalizable to any area of the country. Trial registration Registered as NCT01767883 on clinicaltrials.gov NCT01767883