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1.  A comparison of chronic illness care quality in US and UK family medicine practices prior to pay-for-performance initiatives 
Family Practice  2009;26(6):510-516.
Background. The Quality and Outcomes Framework (QOF) has contributed to modest improvements in chronic illness care in the UK. US policymakers have proposed similar pay-for-performance (P4P) approaches to improve care. Since previous studies have not compared chronic illness care quality in US and UK primary care practices prior to the QOF, the relative preparedness of practices to respond to P4P incentives is unknown.
Objective. To compare US and UK practices on P4P measures prior to program implementation.
Methods. We analysed medical record data collected before QOF implementation from randomly selected patients with diabetes or coronary artery disease (CAD) in 42 UK and 55 US family medicine practices. We compared care processes and intermediate outcomes using hierarchical logistic regression.
Results. While we found gaps in chronic illness care quality across both samples, variation was lower in UK practices. UK patients were more likely to receive recommended care processes for diabetes [odds ratio (OR), 8.94; 95% confidence interval (CI), 4.26–18.74] and CAD (OR, 9.18; 95% CI, 5.22–16.17) but less likely to achieve intermediate diabetes outcome targets (OR, 0.50; 95% CI, 0.39–0.64).
Conclusions. Following National Health Service (NHS) investment in primary care preparedness, but prior to the QOF, UK practices provided more standardized care but did not achieve better intermediate outcomes than a sample of typical US practices. US policymakers should focus on reducing variation in care documentation to ensure the effectiveness of P4P efforts while the NHS should focus on moving from process documentation to better patient outcomes.
PMCID: PMC2791043  PMID: 19748914
Coronary artery disease; diabetes mellitus; health policy; primary health care; quality of health care
2.  Electronic Health Record Impact on Work Burden in Small, Unaffiliated, Community-Based Primary Care Practices 
The use of electronic health records (EHR) is widely recommended as a means to improve the quality, safety and efficiency of US healthcare. Relatively little is known, however, about how implementation and use of this technology affects the work of clinicians and support staff who provide primary health care in small, independent practices.
To study the impact of EHR use on clinician and staff work burden in small, community-based primary care practices.
We conducted in-depth field research in seven community-based primary care practices. A team of field researchers spent 9–14 days over a 4–8 week period observing work in each practice, following patients through the practices, conducting interviews with key informants, and collecting documents and photographs. Field research data were coded and analyzed by a multidisciplinary research team, using a grounded theory approach.
All practice members and selected patients in seven community-based primary care practices in the Northeastern US.
The impact of EHR use on work burden differed for clinicians compared to support staff. EHR use reduced both clerical and clinical staff work burden by improving how they check in and room patients, how they chart their work, and how they communicate with both patients and providers. In contrast, EHR use reduced some clinician work (i.e., prescribing, some lab-related tasks, and communication within the office), while increasing other work (i.e., charting, chronic disease and preventive care tasks, and some lab-related tasks). Thoughtful implementation and strategic workflow redesign can mitigate the disproportionate EHR-related work burden for clinicians, as well as facilitate population-based care.
The complex needs of the primary care clinician should be understood and considered as the next iteration of EHR systems are developed and implemented.
PMCID: PMC3539023  PMID: 22926633
electronic health records; primary care; work burden; qualitative research
3.  Predictors of Mortality Over 8 Years in Type 2 Diabetic Patients 
Diabetes Care  2012;35(6):1301-1309.
To examine demographic, socioeconomic, and biological risk factors for all-cause, cardiovascular, and noncardiovascular mortality in patients with type 2 diabetes over 8 years and to construct mortality prediction equations.
Beginning in 2000, survey and medical record information was obtained from 8,334 participants in Translating Research Into Action for Diabetes (TRIAD), a multicenter prospective observational study of diabetes care in managed care. The National Death Index was searched annually to obtain data on deaths over an 8-year follow-up period (2000–2007). Predictors examined included age, sex, race, education, income, smoking, age at diagnosis of diabetes, duration and treatment of diabetes, BMI, complications, comorbidities, and medication use.
There were 1,616 (19%) deaths over the 8-year period. In the most parsimonious equation, the predictors of all-cause mortality included older age, male sex, white race, lower income, smoking, insulin treatment, nephropathy, history of dyslipidemia, higher LDL cholesterol, angina/myocardial infarction/other coronary disease/coronary angioplasty/bypass, congestive heart failure, aspirin, β-blocker, and diuretic use, and higher Charlson Index.
Risk of death can be predicted in people with type 2 diabetes using simple demographic, socioeconomic, and biological risk factors with fair reliability. Such prediction equations are essential for computer simulation models of diabetes progression and may, with further validation, be useful for patient management.
PMCID: PMC3357242  PMID: 22432119
5.  Getting Under the Skin of Clinical Inertia in Insulin Initiation: The Translating Research Into Action for Diabetes (TRIAD) Insulin Starts Project 
The Diabetes educator  2012;38(1):94-100.
The purpose of this cross-sectional study is to explore primary care providers’ (PCPs) perceptions about barriers to initiating insulin among patients. Studies suggest that many patients with poorly controlled type 2 diabetes do not receive insulin initiation by PCPs.
As part of the TRIAD study, we conducted structured interviews in health systems in Indiana, New Jersey, and California, asking PCPs about the importance of insulin initiation and factors affecting this decision. We calculated proportions choosing each multiple-choice response option and listed the most frequently offered open-ended response categories.
Among 83 PCPs, 45% were women, 60% were Caucasian, and they averaged 13.4 years in practice. Four-fifths of PCPs endorsed guideline-concordant glycemic targets, but 54% individualized targets based on patient age, life expectancy, medical co-morbidities, self-management capacity, and willingness. Most (64%) reported that many patients were resistant to new oral or insulin therapies due to fears about the therapy and what it meant about their disease progression. Two-thirds (64%) cited patient resistance as a barrier to insulin initiation, and 43% cited problems with patient self-management, including cognitive or mental health issues, dexterity, or ability to adhere.† Eighty percent felt that patient non-adherence would dissuade them from initiating insulin at least some of the time.
PCPs perceived that patient resistance and poor self-management skills were significant barriers to initiating insulin. Future studies should investigate whether systems-level interventions to improve patient-provider communication about insulin and enhance providers’ perceptions of patient self-management capacity can increase guideline-concordant, patient-centered insulin initiation.
PMCID: PMC3557962  PMID: 22222513
diabetes; insulin therapy; clinical inertia; clinical decision-making
6.  Thiazolidinediones, Cardiovascular Disease and Cardiovascular Mortality: Translating Research Into Action For Diabetes (TRIAD) 
Studies have associated thiazolidinedione (TZD) treatment with cardiovascular disease (CVD) and questioned whether the two available TZDs, rosiglitazone and pioglitazone, have different CVD risks. We compared CVD incidence, cardiovascular (CV) and all-cause mortality in type 2 diabetic patients treated with rosiglitazone or pioglitazone as their only TZD.
We analyzed survey, medical record, administrative, and National Death Index (NDI) data from 1999 through 2003 from Translating Research Into Action for Diabetes (TRIAD), a prospective observational study of diabetes care in managed care. Medications, CV procedures, and CVD were determined from health plan (HP) administrative data, and mortality was from NDI. Adjusted hazard rates (AHR) were derived from Cox proportional hazard models adjusted for age, sex, race/ethnicity, income, history of diabetic nephropathy, history of CVD, insulin use, and HP.
Across TRIAD’s ten HPs, 1,815 patients (24%) filled prescriptions for a TZD, 773 (10%) for only rosiglitazone, 711 (10%) for only pioglitazone, and 331 (4%) for multiple TZDs. In the seven HPs using both TZDs, 1,159 patients (33%) filled a prescription for a TZD, 564 (16%) for only rosiglitazone, 334 (10%) for only pioglitazone, and 261 (7%) for multiple TZDs. For all CV events, CV and all-cause mortality, we found no significant difference between rosiglitazone and pioglitazone.
In this relatively small, prospective, observational study, we found no statistically significant differences in CV outcomes for rosiglitazone- compared to pioglitazone-treated patients. There does not appear to be a pattern of clinically meaningful differences in CV outcomes for rosiglitazone- versus pioglitazone-treated patients.
PMCID: PMC3548906  PMID: 20583206
Thiazolidinediones; rosiglitazone; pioglitazone; diabetes
7.  Evaluation of risk equations for prediction of short-term coronary heart disease events in patients with long-standing type 2 diabetes: the Translating Research into Action for Diabetes (TRIAD) study 
To evaluate the U.K. Prospective Diabetes Study (UKPDS) and Framingham risk equations for predicting short-term risk of coronary heart disease (CHD) events among adults with long-standing type 2 diabetes, including those with and without preexisting CHD.
Prospective cohort of U.S. managed care enrollees aged ≥ 18 years and mean diabetes duration of more than 10 years, participating in the Translating Research into Action for Diabetes (TRIAD) study, was followed for the first occurrence of CHD events from 2000 to 2003. The UKPDS and Framingham risk equations were evaluated for discriminating power and calibration.
A total of 8303 TRIAD participants, were identified to evaluate the UKPDS (n = 5914, 120 events), Framingham-initial (n = 5914, 218 events) and Framingham-secondary (n = 2389, 374 events) risk equations, according to their prior CHD history. All of these equations exhibited low discriminating power with Harrell’s c-index <0.65. All except the Framingham-initial equation for women and the Framingham-secondary equation for men had low levels of calibration. After adjsusting for the average values of predictors and event rates in the TRIAD population, the calibration of these equations greatly improved.
The UKPDS and Framingham risk equations may be inappropriate for predicting the short-term risk of CHD events in patients with long-standing type 2 diabetes, partly due to changes in medications used by patients with diabetes and other improvements in clinical care since the Frmaingham and UKPDS studies were conducted. Refinement of these equations to reflect contemporary CHD profiles, diagnostics and therapies are needed to provide reliable risk estimates to inform effective treatment.
PMCID: PMC3433369  PMID: 22776317
8.  Temporal Trends in Recording of Diabetes on Death Certificates 
Diabetes Care  2011;34(7):1529-1533.
To determine the frequency that diabetes is reported on death certificates of decedents with known diabetes and describe trends in reporting over 8 years.
Data were obtained from 11,927 participants with diabetes who were enrolled in Translating Research into Action for Diabetes, a multicenter prospective observational study of diabetes care in managed care. Data on decedents (N = 2,261) were obtained from the National Death Index from 1 January 2000 through 31 December 2007. The primary dependent variables were the presence of the ICD-10 codes for diabetes listed anywhere on the death certificate or as the underlying cause of death.
Diabetes was recorded on 41% of death certificates and as the underlying cause of death for 13% of decedents with diabetes. Diabetes was significantly more likely to be reported on the death certificate of decedents dying of cardiovascular disease than all other causes. There was a statistically significant trend of increased reporting of diabetes as the underlying cause of death over time (P < 0.001), which persisted after controlling for duration of diabetes at death. The increase in reporting of diabetes as the underlying cause of death was associated with a decrease in the reporting of cardiovascular disease as the underlying cause of death (P < 0.001).
Death certificates continue to underestimate the prevalence of diabetes among decedents. The increase in reporting of diabetes as the underlying cause of death over the past 8 years will likely impact estimates of the burden of diabetes in the U.S.
PMCID: PMC3120163  PMID: 21709292
9.  Electronic medical records are not associated with improved documentation in community primary care practices 
The adoption of electronic medical records (EMRs) in ambulatory settings has been widely recommended. It is hoped that EMRs will improve care; however, little is known about the effect of EMR use on care quality in this setting. This study compares EMR versus paper medical record documentation of basic health history and preventive service indicators in 47 community-based practices. Differences in practice level documentation rates between EMR- and non EMR-using practices were examined using the Kruskal-Wallis non-parametric test and robust regression, adjusting for practice level covariates. Frequencies of documentation of health history and preventive service indicator items were similar in the two groups of practices. While EMRs provide the capacity for more robust record keeping, the community-based practices here are not using EMRs to their full capacity. EMR usage does not guarantee more systematic record keeping and thus may not lead to improved quality in the community practice setting.
PMCID: PMC3137715  PMID: 21266596
10.  Barriers to Insulin Initiation 
Diabetes Care  2010;33(4):733-735.
Reasons for failing to initiate prescribed insulin (primary nonadherence) are poorly understood. We investigated barriers to insulin initiation following a new prescription.
We surveyed insulin-naïve patients with poorly controlled type 2 diabetes, already treated with two or more oral agents who were recently prescribed insulin. We compared responses for respondents prescribed, but never initiating, insulin (n = 69) with those dispensed insulin (n = 100).
Subjects failing to initiate prescribed insulin commonly reported misconceptions regarding insulin risk (35% believed that insulin causes blindness, renal failure, amputations, heart attacks, strokes, or early death), plans to instead work harder on behavioral goals, sense of personal failure, low self-efficacy, injection phobia, hypoglycemia concerns, negative impact on social life and job, inadequate health literacy, health care provider inadequately explaining risks/benefits, and limited insulin self-management training.
Primary adherence for insulin may be improved through better provider communication regarding risks, shared decision making, and insulin self-management training.
PMCID: PMC2845015  PMID: 20086256
11.  Self-report versus Medical Records for Assessing Cancer-Preventive Services Delivery 
Accurate measurement of cancer-preventive behaviors is important for quality improvement, research studies, and public health surveillance. Findings differ, however, depending on whether patient self-report or medical records are used as the data source. We evaluated concordance between patient self-report and medical records on risk factors, cancer screening, and behavioral counseling among primary care patients. Data from patient surveys and medical records were compared from 742 patients in 25 New Jersey primary care practices participating at baseline in SCOPE (supporting colorectal cancer outcomes through participatory enhancements), an intervention trial to improve colorectal cancer screening in primary care offices. Sensitivity, specificity, and rates of agreement describe concordance between self-report and medical records for risk factors (personal or family history of cancer, smoking), cancer screening (breast, cervical, colorectal, prostate), and counseling (cancer screening recommendations, diet or weight loss, exercise, smoking cessation). Rates of agreement ranged from 41% (smoking cessation counseling) to 96% (personal history of cancer). Cancer screening agreement ranged from 61% (Pap and prostate-specific antigen) to 83% (colorectal endoscopy) with self-report rates greater than medical record rates. Counseling was also reported more frequently by self-report (83% by patient self-report versus 34% by medical record for smoking cessation counseling). Deciding which data source to use will depend on the outcome of interest, whether the data is used for clinical decision making, performance tracking, or population surveillance; the availability of resources; and whether a false positive or a false negative is of more concern.
PMCID: PMC2962564  PMID: 18990740
12.  Predictors and Impact of Intensification of Antihyperglycemic Therapy in Type 2 Diabetes 
Diabetes Care  2009;32(6):971-976.
The purpose of this study was to examine the predictors of intensification of antihyperglycemic therapy in patients with type 2 diabetes; its impact on A1C, body weight, symptoms of anxiety/depression, and health status; and patient characteristics associated with improvement in A1C.
We analyzed survey, medical record, and health plan administrative data collected in Translating Research into Action for Diabetes (TRIAD). We examined patients who were using diet/exercise or oral antihyperglycemic medications at baseline, had A1C >7.2%, and stayed with the same therapy or intensified therapy (initiated or increased the number of classes of oral antihyperglycemic medications or began insulin) over 18 months.
Of 1,093 patients, 520 intensified therapy with oral medications or insulin. Patients intensifying therapy were aged 58 ± 12 years, had diabetes duration of 11 ± 9 years, and had A1C of 9.1 ± 1.5%. Younger age and higher A1C were associated with therapy intensification. Compared with patients who did not intensify therapy, those who intensified therapy experienced a 0.49% reduction in A1C (P < 0.0001), a 3-pound increase in weight (P = 0.003), and no change in anxiety/depression (P = 0.5) or health status (P = 0.2). Among those who intensified therapy, improvement in A1C was associated with higher baseline A1C, older age, black race/ethnicity, lower income, and more physician visits.
Treatment intensification improved glycemic control with no worsening of anxiety/depression or health status, especially in elderly, lower-income, and minority patients with type 2 diabetes. Interventions are needed to overcome clinical inertia when patients might benefit from treatment intensification and improved glycemic control.
PMCID: PMC2681018  PMID: 19228862
13.  Perceptions of Standards-based Electronic Prescribing Systems as Implemented in Outpatient Primary Care: A Physician Survey 
To compare the experiences of e-prescribing users and nonusers regarding prescription safety and workload and to assess the use of information from two e-prescribing standards (for medication history and formulary and benefit information), as they are implemented.
Cross-sectional survey of physicians who either had installed or were awaiting installation of one of two commercial e-prescribing systems.
Perceptions about medication history and formulary and benefit information among all respondents, and among e-prescribing users, experiences with system usability, job performance impact, and amount of e-prescribing.
Of 395 eligible physicians, 228 (58%) completed the survey. E-prescribers (n = 139) were more likely than non-e-prescribers (n = 89) to perceive that they could identify clinically important drug–drug interactions (83 versus 67%, p = 0.004) but not that they could identify prescriptions from other providers (65 versus 60%, p = 0.49). They also perceived no significant difference in calls about drug coverage problems (76 versus 71% reported getting 10 or fewer such calls per week; p = 0.43). Most e-prescribers reported high satisfaction with their systems, but 17% had stopped using the system and another 46% said they sometimes reverted to handwriting for prescriptions that they could write electronically. The volume of e-prescribing was correlated with perceptions that it enhanced job performance, whereas quitting was associated with perceptions of poor usability.
E-prescribing users reported patient safety benefits but they did not perceive the enhanced benefits expected from using standardized medication history or formulary and benefit information. Additional work is needed for these standards to have the desired effects.
PMCID: PMC2705252  PMID: 19390106
14.  Variation in Electronic Prescribing Implementation Among Twelve Ambulatory Practices 
Electronic prescribing has been advocated as an important tool for improving the safety and quality of medication use in ambulatory settings. However, widespread adoption of e-prescribing in ambulatory settings has yet to be realized. The determinants of successful implementation and use in these settings are not well understood.
To describe the practice characteristics associated with implementation and use of e-prescribing in ambulatory settings.
Multi-method qualitative case study of ambulatory practices before and after e-prescribing implementation.
Sixteen physicians and 31 staff members working in 12 practices scheduled for implementation of an e-prescribing program and purposively sampled to ensure a mix of practice size and physician specialty.
Field researchers used observational and interview techniques to collect data on prescription-related clinical workflow, information technology experience, and expectations.
Five practices fully implemented e-prescribing, 3 installed but with only some prescribers or staff members using the program, 2 installed and then discontinued use, 2 failed to install. Compared to practice members in other groups, members of successful practices exhibited greater familiarity with the capabilities of health information technologies and had more modest expectations about the benefits likely to accrue from e-prescribing. Members of unsuccessful practices reported limited understanding of e-prescribing capabilities, expected that the program would increase the speed of clinical care and reported difficulties with technical aspects of the implementation and insufficient technical support.
Practice leaders should plan implementation carefully, ensuring that practice members prepare for the effective integration of this technology into clinical workflow.
PMCID: PMC2359528  PMID: 18373131
electronic prescribing; medical informatics; qualitative research; health services research
15.  Evaluating the Technical Adequacy of Electronic Prescribing Standards: Results of an Expert Panel Process 
To support more informed prescribing decisions, e-prescribing systems need data on patients’ medication histories and their drug-specific insurance coverage. We used an expert panel process to evaluate the technical adequacy of two standards for delivering this information, the Medication History function of the NCPDP SCRIPT Standard and the NCPDP Formulary and Benefit Standard.
We convened a panel representing 14 organizations that had experience with these standards. Experts within each organization submitted narrative responses and ratings assessing the standards in 6 domains, including data quality, completeness, usability, and interoperability. Areas of disagreement were discussed in recorded teleconferences. Narrative was analyzed using a grounded-theory approach.
Panelists agreed that the structure of the Medication History Standard was adequate for delivering accurate and complete information but implementation problems made the data difficult to use for decision support. The panel also agreed that the Formulary and Benefit Standard was adequate to deliver formulary status lists, but other parts of the standard were not used consistently and group-level variations in coverage were not represented. A common problem for both standards was the lack of unambiguous drug identifiers; panelists agreed that RxNorm deserves further evaluation as a solution to this problem.
A panel of industry experts found the basic structure of these two standards to be technically adequate, but to enable benefits for patient care, improvements are needed in the standards’ implementation.
PMCID: PMC2656071  PMID: 18999287

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