JoAnn Sperl-Hillen

Effect of Home Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure Control: A Cluster Randomized Clinical Trial

IMPORTANCE Only about half of patients with high blood pressure (BP) in the United States have their BP controlled. Practical, robust, and sustainable models are needed to improve BP control in patients with uncontrolled hypertension. OBJECTIVES To determine whether an intervention combining home BP telemonitoring with pharmacist case management improves BP control compared with usual care and to determine whether BP control is maintained after the intervention is stopped. DESIGN, SETTING, AND PATIENTS A cluster randomized clinical trial of 450 adults with uncontrolled BP recruited from 14,692 patients with electronic medical records across 16 primary care clinics in an integrated health system in Minneapolis-St Paul, Minnesota, with 12 months of intervention and 6 months of postintervention follow-up. INTERVENTIONS Eight clinics were randomized to provide usual care to patients (n = 222) and 8 clinics were randomized to provide a telemonitoring intervention (n = 228). Intervention patients received home BP telemonitors and transmitted BP data to pharmacists who adjusted antihypertensive therapy accordingly. MAIN OUTCOMES AND MEASURES Control of systolic BP to less than 140 mm Hg and diastolic BP to less than 90 mm Hg (<130/80 mm Hg in patients with diabetes or chronic kidney disease) at 6 and 12 months. Secondary outcomes were change in BP, patient satisfaction, and BP control at 18 months (6 months after intervention stopped). RESULTS At baseline, enrollees were 45% women, 82% white, mean (SD) age was 61.1 (12.0) years, and mean systolic BP was 148 mm Hg and diastolic BP was 85 mm Hg. Blood pressure was controlled at both 6 and 12 months in 57.2% (95% CI, 44.8% to 68.7%) of patients in the telemonitoring intervention group vs 30.0% (95% CI, 23.2% to 37.8%) of patients in the usual care group (P = .001). At 18 months (6 months of postintervention follow-up), BP was controlled in 71.8% (95% CI, 65.0% to 77.8%) of patients in the telemonitoring intervention group vs 57.1% (95% CI, 51.5% to 62.6%) of patients in the usual care group (P = .003). Compared with the usual care group, systolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-10.7 mm Hg [95% CI, -14.3 to -7.3 mm Hg]; P<.001), at 12 months (-9.7 mm Hg [95% CI, -13.4 to -6.0 mm Hg]; P<.001), and at 18 months (-6.6 mm Hg [95% CI, -10.7 to -2.5 mm Hg]; P = .004). Compared with the usual care group, diastolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-6.0 mm Hg [95% CI, -8.6 to -3.4 mm Hg]; P<.001), at 12 months (-5.1 mm Hg [95% CI, -7.4 to -2.8 mm Hg]; P<.001), and at 18 months (-3.0 mm Hg [95% CI, -6.3 to 0.3 mm Hg]; P = .07). CONCLUSIONS AND RELEVANCE Home BP telemonitoring and pharmacist case management achieved better BP control compared with usual care during 12 months of intervention that persisted during 6 months of postintervention follow-up. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00781365.

Challenges of Change: A Qualitative Study of Chronic Care Model Implementation

PURPOSE The Chronic Care Model (CCM) provides a conceptual framework for transforming health care for patients with chronic conditions; however, little is known about how to best design and implement its specifics. One large health care organization that tried to implement the CCM in primary care provided an opportunity to study these issues. METHODS We conducted a qualitative, comparative case study of 5 of 18 group clinics 18 to 23 months after the implementation began. Built on knowledge of the clinics from a previous study of advanced access implementation, data included in-depth interviews with organizational leaders and varied clinic personnel, observation of clinic care processes, and review of written materials. RESULTS Relatively small and highly variable care process changes were made during the study period. The change process underwent several marked shifts in strategy when initial efforts failed to achieve much and bore little resemblance to the change process used in the previously successful large-scale implementation of advanced access scheduling. Many barriers were identified, including too many competing priorities, a lack of specificity and agreement about the care process changes desired, and little engagement of physicians. CONCLUSION These findings highlight specific organizational challenges with health care transformation in the absence of a blueprint more specific than the CCM. Effective models of organizational change and detailed examples of proven, feasible care changes still need to be demonstrated if we are to transform care as called for by the Institute of Medicine.

Impact of an Electronic Medical Record on Diabetes Quality of Care

PURPOSE This study was designed to evaluate the impact of electronic medical record (EMR) implementation on quality of diabetes care. METHODS We conducted a 5-year longitudinal study of 122 adults with diabetes mellitus at an intervention (EMR) clinic and a comparison (non-EMR) clinic. Clinics had similarly trained primary care physicians, similar patient populations, and used a common diabetes care guideline that emphasized the importance of glucose control. The EMR provided basic decision support, including prompts and reminders for diabetes care. Preintervention and postintervention frequency of testing for glycated hemoglobin (HbA1c) and low-density lipoprotein (LDL) levels were compared with and without adjustment for patient age, sex, comorbidity, and baseline HbA1c level. RESULTS Frequency of HbA1c tests increased at the EMR clinic compared with the frequency at the non-EMR clinic (P <.001). HbA1c levels improved in both clinics (P <.05) with no significant differences between clinics 2 years (P = .10) or 4 years (P = .27) after EMR implementation. Similar results were observed for LDL levels. CONCLUSIONS In this controlled study, EMR use led to an increased number of HbA1c and LDL tests but not to better metabolic control. If EMRs are to fulfill their promise as care improvement tools, improved implementation strategies and more sophisticated clinical decision support may be needed.

Are Claims Data Accurate Enough to Identify Patients for Performance Measures or Quality Improvement? The Case of Diabetes, Heart Disease, and Depression

The objective of this study was to demonstrate a method to accurately identify patients with specific conditions from claims data for care improvement or performance measurement. In an iterative process of trial case definitions followed by review of repeated random samples of 10 to 20 cases for diabetes, heart disease, or newly treated depression, a final identification algorithm was created from claims files of health plan members. A final sample was used to calculate the positive predictive value (PPV). Each condition had unacceptably low PPVs (0.20, 0.60, and 0.65) when cases were identified on the basis of only 1 International Classification of Diseases, ninth revision, code per year. Requiring 2 outpatient codes or 1 inpatient code within 12 months (plus consideration of medication data for diabetes and extra criteria for depression) resulted in PPVs of 0.97, 0.95, and 0.95. This approach is feasible and necessary for those wanting to use administrative data for case identification for performance measurement or quality improvement.

Comparative effectiveness of patient education methods for type 2 diabetes: a randomized controlled trial.

BACKGROUND Group education for patients with suboptimally controlled diabetes has not been rigorously studied. METHODS A total of 623 adults from Minnesota and New Mexico with type 2 diabetes and glycosylated hemoglobin (HbA(1c)) concentrations of 7% or higher were randomized to (1) group education (using the US Diabetes Conversation Map program), (2) individual education, or (3) usual care (UC; ie, no assigned education). Both education methods covered content as needed to meet national standards for diabetes self-management education and were delivered through accredited programs from 2008 to 2009. General linear mixed-model methods assessed patient-level changes between treatment groups in mean HbA(1c) levels from baseline to follow-up at 6.8 months. Secondary outcomes included mean change in general health status (Medical Outcomes Study 12-Item Short Form Health Survey [SF-12]), Problem Areas in Diabetes (PAID), Diabetes Self-Efficacy (DES-SF), Recommended Food Score (RFS), and Physical Activity (PA, min/wk). RESULTS Mean HbA(1c) concentration decreased in all groups but significantly more with individual (-0.51%) than group education (-0.27%) (P = .01) and UC (-0.24%) (P = .01). The proportion of subjects with follow-up HbA(1c) concentration lower than 7% was greater for individual education (21.2%) than for group (13.9%) and UC (12.8%) (P = .03). Compared with UC, individual education (but not group) improved SF-12 physical component score (+1.88) (P = .04), PA (+42.95 min/wk) (P = .03), and RFS (+0.63) (P = .05). Compared with group education, individual education reduced PAID (-3.62) (P = .02) and increased self-efficacy (+0.1) (P = .04). CONCLUSIONS Individual education for patients with established suboptimally controlled diabetes resulted in better glucose control outcomes than did group education using Conversation Maps. There was also a trend toward better psychosocial and behavioral outcomes with individual education. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00652509.

Care Quality and Implementation of the Chronic Care Model: A Quantitative Study

PURPOSE We wanted to test whether improvements in care quality were correlated with changes in the Chronic Care Model (CCM) in a large medical group that attempted to implement the CCM. METHODS The leaders of 17 primary care clinics in this medical group completed the Assessing Chronic Illness Care (ACIC) survey measure of CCM implementation before and after care system changes were made. We used administrative data to measure care quality changes for yearly samples of patients with diabetes, coronary heart disease, or depression. RESULTS The total ACIC score for the CCM increased by an overall average of 1.4 points (from 5.8 to 7.2 on a scale of 1 to 11, P = .02) and significant increases occurred for 3 of the 6 components of the CCM. During this time, patients experienced a significant increase in the proportion meeting a composite outcome measure for low-density lipoprotein (LDL) and glycated hemoglobin levels (from 15.7% to 25.5%, P = .001). Heart disease patients meeting a composite measure for LDL values increased from 46.8% to 57.8%, and the percentage of patients with 1 or more cardiac events dropped from 17.2% to 11.4% (P = .001 for each). Persistent use of new antidepressants did not change, but more of these patients had follow-up visits (P = .02). Only the diabetes measure was significantly correlated with 2 CCM elements—clinical information systems and decision support. CONCLUSION Despite implementation of the CCM and improvements in quality measures for 3 chronic diseases, there were few significant correlations between these changes. Showing such a relationship may require larger changes, a larger number of clinics, changes in other CCM elements, or a more-sensitive measurement tool.

Do All Components of the Chronic Care Model Contribute Equally to Quality Improvement

BACKGROUND The Chronic Care Model (CCM) is a widely used conceptual model for improving chronic illness care, but there is limited evidence to support the validity of this model. Seventeen clinics in a single medical group used the CCM in a diabetes improvement initiative, and the study tested which CCM components at the clinic level were associated with improved glycohemoglobin (A1C) and low-density (LDL) outcomes for patients with diabetes. DESIGN Three leaders from each of 17 clinics completed a survey in 2002 that assessed the presence of CCM components in their clinics. Clinic scores from this survey were correlated with change in clinic-level measures of the quality of care for their diabetes patients (A1C and LDL outcomes) during the preceding year. RESULTS Delivery system design (DSD) scores were positively correlated with improvements in A1C and lipid test rates and levels at these clinics (r = 0.49-0.57, p < .05). Self-management support and clinical information systems demonstrated associations that may have substantive significance but did not reach p < 05. CONCLUSIONS These data suggest that delivery system design is associated with improved A1C and LDL outcomes for people with diabetes. Additional studies are necessary to determine the association of other CCM components with improved outcomes.

Reversibility of Fenofibrate Therapy–Induced Renal Function Impairment in ACCORD Type 2 Diabetic Participants

OBJECTIVE To assess the reversibility of the elevation of serum creatinine levels in patients with diabetes after 5 years of continuous on-trial fenofibrate therapy. RESEARCH DESIGN AND METHODS An on-drug/off-drug ancillary study to the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid Trial to investigate posttrial changes in serum creatinine and cystatin C. Eligible participants were recruited into a prospective, nested, three-group study based on retrospective on-trial serum creatinine levels: fenofibrate case subjects (n = 321, ≥20% increase after 3 months of therapy); fenofibrate control subjects (n = 175, ≤2% increase); and placebo control subjects (n = 565). Serum creatinine and cystatin C were measured at trial end and 6–8 weeks after discontinuation of trial therapy. RESULTS At trial end, case subjects had the highest adjusted serum creatinine (± SE) mg/dL (1.11 ± 0.02) and the lowest adjusted estimated glomerular filtration rate (eGFR) (± SE) mL/min/1.73 m2 (68.4 ± 1.0) versus control subjects (1.01 ± 0.02; 74.8 ± 1.3) and placebo subjects (0.98 ± 0.01; 77.8 ± 0.7). After 51 days off-drug, serum creatinine in case subjects was still higher (0.97 ± 0.02) and eGFR still lower (77.8 ± 1.0) than control subjects (0.90 ± 0.02; 81.8 ± 1.3) but not different from placebo subjects (0.99 ± 0.01; 76.6 ± 0.7). Changes in serum cystatin C recapitulated the serum creatinine changes. CONCLUSIONS Participants with significant initial on-trial increases in serum creatinine (≥20%) returned to the same level of renal function as participants receiving placebo while participants who had ≤2% increase in serum creatinine had net preservation of renal function compared with the same unselected placebo reference group. The fenofibrate-associated on-trial increases in serum creatinine were reversible, and the reversal was complete after 51 days off-drug. The similarity of the cystatin C results suggests that the mechanism of this change is not specific for serum creatinine.

Transforming Medical Care: Case Study of an Exemplary, Small Medical Group

PURPOSE Most published descriptions of organizations providing or improving quality of care concern large medical groups or systems; however, 90% of the medical care in the United States is provided by groups of no more than 20 physicians. We studied one such group to determine the organizational and cultural attributes that seem related to its achievements in care quality. METHODS A 15–family physician medical group was identified from comparative public performance scores of 27 medical groups providing most of the primary care in our metropolitan area. Semistructured interviews were conducted with diverse personnel in this group, operations were observed, and written documents were reviewed. Four primary care physician researchers and a consultant then reviewed transcriptions, field notes, and materials during semistructured sessions to identify the main attributes of this group and their probable origins. RESULTS This medical group ranked first in a composite measure of preventive services and fourth and sixth, respectively, in composite scores for coronary artery disease and diabetes care. Our analysis identified 12 attributes of this group that seemed to be associated with its good care quality, with patient-centeredness being the foundational attribute for most of the others. Historical factors important to most of these attributes included small size, physician ownership, and a high value on practice consistency among the clinicians in the group. CONCLUSIONS The identified 12 attributes of this medical group seem to be associated with its superior care quality, and most of them might be replicable by other small groups if they choose to work toward that end.

Key Issues in Transforming Health Care Organizations for Quality: The Case of Advanced Access

BACKGROUND The 2001 Institute of Medicine (IOM) report highlighted the need for transformation of the U.S. health care system. This rigorous qualitative evaluation of transformational change for patient access in one large multispecialty group practice identifies the major issues facing organizations addressing the IOM challenge. METHODS Semistructured depth interviews were conducted with the medical and administrative leaders at all levels, physicians, and nurses from 17 primary care clinics in one integrated medical group two years after they began to transform their approach to primary care patient appointment access. RESULTS The mean time to third-next-available appointment was reduced by 76% during one year, from 17.8 days to 4.2 days. Nine important issues related to the change process were identified from clinic interviews. When combined with issues identified by central leaders, 13 themes stood out as lessons in transformational change. A major issue is the tension between physician autonomy and both effective organizational function and putting patients first. Physician autonomy is also diminished by the need to standardize and systematize care. CONCLUSIONS Transformational change in care delivery is possible in large and complex group practices. Changes that directly affect care delivery and physician autonomy present particular challenges to physicians that need to be attended to if the changes are to be successful.