Skip to main content
Journal of General Internal Medicine logoLink to Journal of General Internal Medicine
. 2009 Oct 28;24(12):1303–1310. doi: 10.1007/s11606-009-1147-x

The Vermont Diabetes Information System: A Cluster Randomized Trial of a Population Based Decision Support System

Charles D MacLean 1,, Michael Gagnon 2, Peter Callas 3, Benjamin Littenberg 1,4
PMCID: PMC2787948  PMID: 19862578

Abstract

BACKGROUND

Optimal care for patients with diabetes is difficult to achieve in clinical practice.

OBJECTIVE

To evaluate the impact of a registry and decision support system on processes of care, and physiologic control.

PARTICIPANTS

Randomized trial with clustering at the practice level, involving 7,412 adults with diabetes in 64 primary care practices in the Northeast.

INTERVENTIONS

Provider decision support (reminders for overdue diabetes tests, alerts regarding abnormal results, and quarterly population reports with peer comparisons) and patient decision support (reminders and alerts).

MEASUREMENTS AND MAIN RESULTS

Process and physiologic outcomes were evaluated in all subjects. Functional status was evaluated in a random patient sample via questionnaire. We used multiple logistic regression to quantify the effect, adjusting for clustering and potential confounders. Intervention subjects were significantly more likely to receive guideline-appropriate testing for cholesterol (OR = 1.39; [95%CI 1.07, 1.80] P = 0.012), creatinine (OR = 1.40; [95%CI 1.06, 1.84] P = 0.018), and proteinuria (OR = 1.74; [95%CI 1.13, 1.69] P = 0.012), but not A1C (OR = 1.17; [95% CI 0.80, 1.72] P = 0.43). Rates of control of A1C and LDL cholesterol were similar in the two groups. There were no differences in blood pressure, body mass index, or functional status.

CONCLUSIONS

A chronic disease registry and decision support system based on easily obtainable laboratory data was feasible and acceptable to patients and providers. This system improved the process of laboratory monitoring in primary care, but not physiologic control.

KEY WORDS: diabetes mellitus; decision support systems, clinical; patient care management; chronic disease; health services research; primary health care; human; randomized controlled trial; adult

BACKGROUND

Optimal diabetes care can improve outcomes and costs1. Although physiologic results have improved in the US, care remains suboptimal2,3. The Chronic Care Model highlights the importance of a population-based approach; involving community, patients and providers; and information technology46. Various combinations of population management, practice support, and patient outreach have been used for diabetes care in a variety of settings with mixed results716.

Many practice interventions for diabetes have been carried out in academic and urban centers. However, much primary care occurs in small private practices; half of visits in the US are to practices with two or fewer physicians17. These practices are less likely to have electronic systems with decision support for chronic illness care18.

The Vermont Diabetes Information System (VDIS) is a registry and decision support system based on the Chronic Care Model that targets both providers and patients, and was designed for easy integration into primary care offices with or without electronic medical records. We sought to determine its effect on processes of diabetes care (guideline-based laboratory testing), and physiologic outcomes (glycemic and lipid control) in a largely rural, community, primary care setting.

METHODS

A full description of the decision support system, the study design, and the recruitment strategy has been reported19,20. In brief, VDIS is a laboratory-based registry defined by: use of the Chronic Care Model as an organizing framework, daily data feeds from otherwise independent laboratories, automatic test interpretation using guideline-based algorithms, use of fax and mail to report to providers and patients not easily reached by electronic networks, and report formats that are accessible and useful to patients and providers. The system collects pertinent laboratory results (hemoglobin A1C, cholesterol, creatinine, and urine protein) and provides five types of reports: accurate and timely faxed laboratory result flow sheets to providers, faxed reminders of overdue laboratory tests to providers, mailed reminders to patients overdue for testing, mailed alerts to patients with elevated test results, and mailed population reports to providers summarizing their entire diabetes roster19,20.

Subjects

We identified 13 hospital-based clinical laboratories in Vermont and adjacent New York State that provided services to community practices. Two were excluded because they could not establish reliable data feeds. Eleven completed business associate agreements in accordance with the Health Insurance Portability and Accountability Act21.

We recruited 141 internal medicine or family medicine practices that used the participating laboratories (Fig. 1). Twenty-two were ineligible because they extensively used point-of-care testing (9); were participating in conflicting quality improvement activities (6); were undergoing a major transition such as a new practice or retiring provider (4); did not provide diabetes care (2); or used an electronic medical record that included reminders and decision support (1). We recruited from the 119 remaining practices until we met our target of 64.

Figure 1.

Figure 1

Vermont diabetes information system practice and patient recruitment.

The practice was chosen as the unit of randomization because of the sharing of patients and systems of care among primary care providers (PCPs) in the same office20. We randomized practices in blocks by hospital lab to balance the number of practices in each arm in each region. Participation required informed consent and a business associate agreement. Intervention practices received VDIS services while control practices received usual care. Orientation of the intervention practices to the system typically consisted of a one hour orientation session for the providers and staff and approximately 30 minutes of provider time to review patient rosters.

Clustering of patients within practices reduces statistical power in proportion to the degree that subjects within each cluster are similar. Therefore, we modeled sample size using methods which require an estimate of the intraclass correlation coefficient to use in a variance inflation factor2224. Preliminary data indicated a standard deviation of A1C of 1.4%, an intra-class correlation of 0.02, and 125 subjects per practice20. Using alpha = 0.05 and a power of 80%, we estimated that 22 practices per arm would allow the detection of a difference of 0.2 percentage points of A1C. To accommodate drop-out and unanticipated problems, we enrolled 64 practices. The observed intra-class correlation for A1C was higher than estimated (0.055)25 providing power to detect a change of 0.3 points of A1C. Practices were enrolled between June 2003 and January 2005 and followed until all had at least 24 months of observation.

Once a practice was enrolled, a list of patients with an A1C result in the previous two years was generated by the lab. PCPs confirmed those who had diabetes using chart review. Exclusion criteria were age under 18 years, patient receiving most diabetes care in another practice, or cognitive impairment that would limit the understanding of reminders, per the judgment of the PCP. We did not distinguish between Type 1 and Type 2 diabetes because national consensus guidelines do not differ substantially regarding testing frequency or therapeutic goals26, and because, in practice, it is often unclear which type is present. Patients were censored from the study when they died (526); were no longer with a participating practice because they moved or because of a practice change (1673); or at the end of the planned observation period. Three practices closed during the intervention period and two ended early to participate in other projects.

In order to more fully assess the study population, we conducted a home-based survey of subjects20. Randomly selected patients from each practice were invited by phone to participate until we had recruited approximately 12.5% of the study population (N = 929). This target was chosen to allow for some attrition over the observation period while maintaining adequate sample size to include important covariates in modeling. Ninety percent of the baseline interviews were completed within 3 months of study start. The same patients were re-surveyed at the end of the observation period within 6 months of study completion. The surveyed population was slightly older (64.7 vs. 62.7 years, p = 0.001), more likely to be female (54.3% vs. 50.5%, p = 0.04), and more likely to be on time for A1C testing at study baseline (63.0% vs. 56.2%, p = 0.001), though the mean A1C was not significantly different (7.12% vs. 7.07%, p = 0.36).

Patients were enrolled with a passive consent (“opt-out”) procedure20,21, with a patient refusal rate of 2%. The study was approved by the University of Vermont Committee on Human Research.

Measurements

The primary outcome was glycemic control measured by mean A1C and by the proportion of patients with A1C < 7%. Secondary outcomes included mean LDL, proportion with LDL < 100 mg/dl, and timeliness of testing. For A1C, on-time was defined as testing within 6 months if A1C < 7% and 3 months otherwise; for lipid testing, annually if LDL < 100 mg/dl, 6 months if LDL 100–129 mg/dl, and 3 months otherwise; for serum creatinine, annually; and for urine microalbumin testing, annually unless previous testing was abnormal, after which further testing was not required26.

Date of birth and sex were reported by the hospital laboratory. Other measures were obtained from the patient survey: self-reported race was categorized as “white” or other; education was classified as high school graduate or less; marital status was classified as “Married or living together as married” or other; household income was dichotomized as “<$30,000 per year” or “≥$30,000 per year.” Patients completed the SF-12 functional status measure27, the Diabetes Self Care Survey28, the Short Test of Functional Health Literacy29 (dichotomized at the median), the Self-administered Comorbidity Questionnaire30 and the Audit of Diabetes-Dependant Quality of Life (ADDQOL), a continuous measure of the impact of diabetes on quality of life (QOL) with lower scores representing lower QOL (possible range −9 to +9)31. We measured height, weight and determined the mean of three separate blood pressure readings using an automated sphygmomanometer.

At the follow-up survey, we asked patients to recall healthcare utilization in the past year32. We used visit costs from the Medical Expenditure Panel Survey (PCP $121; Specialist $235; ER $560;33,34; Hospital day $2,14735) multiplied by the number of uses recalled by the patient to estimate total cost per patient.

Statistical Approach

We used a general linear mixed model for outcomes with normally distributed residual errors, or a generalized linear mixed model for outcomes with a binomial distribution for residual errors36. Standard errors were adjusted for clustering within practice37. Intervention was a fixed effect in these models, while practice and patients nested within practice were random effects. To control for possible confounding, we adjusted for patient and practice characteristics that varied at baseline. For the analysis of on-time testing and physiologic control, we adjusted for the patient’s baseline value of the outcome, and the mean practice value at baseline. For utilization, we controlled for age, sex, marital status, education, health literacy, race, insulin use, comorbidity, and nominal variables representing the subject’s community and hospital. Baseline estimates of utilization were not available. Because the data were skewed, we also compared the unadjusted distributions in the two groups with the nonparametric Wilcoxon rank sum test. For functional status, quality of life, and self-care activities, we controlled for baseline patient values, age, sex, marital status, education, health literacy, race, insulin use and comorbidity.

The intervention induced testing in the active group compared to the control group, possibly generating bias from asymmetric observation38. To minimize this, after censoring we mailed letters to overdue control subjects to stimulate testing and collected data for another 90 days. Tests done after censoring were used to assess physiologic control, but not the proportion on-time. Because of the asymmetric ascertainment of the final lab values, we performed an additional analysis using multiple imputation by chained equations39,40. This method imputes missing data using known information about each case with multiple simulations, and then combines the results into a single imputed result. Variables used in the imputation were age, sex, baseline test results, on-time status of the four target tests at baseline and censoring, residence (NY, VT, or other), vital status at censoring, treatment group (active or control), duration of participation, date of enrollment, and indicator variables for each practice and hospital. Five imputations of 10 cycles each were combined for the final analysis.

Asymmetry also occurred in ascertainment of death, with 301 deaths recorded in the intervention arm (7.7%) and 222 in the control arm (6.4%) (P = 0.27). We learned about intervention subject deaths through returned mail or interactions with PCP offices over the 32 months of observation. In the control arm, there was no communication with the subjects until study conclusion when we asked the PCPs to review their patient rosters to note any subjects known to have died. We also searched the Social Security Death Index for deceased subjects41,42. Deaths in the intervention group were reviewed to assure that no death was attributable to the intervention.

We analyzed all data on an intention-to-treat basis and had complete data for on-time testing at censoring for every subject. We used imputation to estimate the final A1C value for those patients who had no result recorded within 9 months before or 3 months after censoring, and the final LDL value if no result was recorded within 18 months before or 3 months after censoring according to our pre-specified analytic plan. Analyses were performed with Stata 10 (Stata Corporation, College Station, TX).

RESULTS

Patients were observed for a mean of 32 months (range, 1 day to 47 months; Table 1). Demographic characteristics were similar to the population of Vermont43,44. The results of the SF-12 Physical and Mental Component Summaries were similar to national samples of patients with diabetes27. Only 2% of the subjects were uninsured, reflecting regional characteristics and recruitment of subjects who were receiving care.

Table 1.

Baseline Characteristics of the Patient Population

Characteristic N Control Intervention Pa
Registry data
  Number of patients 7,412 3,526 3,886
  Age in years, mean (range) 7,412 62.4 (19–99) 63.5 (18–97) 0.29
  Female, proportion 7,412 52% 50% 0.58
  A1C testing on-time at baseline 7,412 59% 56% 0.30
  Lipids testing on-time at baseline 7,412 79% 75% 0.23
  Creatinine testing on-time at baseline 7,412 86% 85% 0.55
  Microalbumin testing on-time at baseline 7,412 30% 25% 0.22
  A1C, mean (SD) 7,412 7.03 (1.45) 7.11 (1.43) 0.46
  A1C in excellent control (<7%) 7,412 58% 55% 0.45
  LDL-cholesterol, mean (SD) 6,630 107 (34) 106 (33) 0.67
  Lipids in controlb 6,697 44% 45% 0.86
  Creatinine normal (<1.5 mg/dl) 7,181 89% 90% 0.69
  Microalbuminuria present (≥30 mg/gm) 3,083 29% 33% 0.10
Field survey data
  Number of patients 928 499 (14%) 429 (11%) 0.15
  Race (white) 925 97% 97% 0.57
  Education (high school graduate) 920 76% 76% 0.94
  Married or living as married 925 64% 60% 0.26
  Current smoker 927 16% 18% 0.52
  High health literacy (STOFHLA>34) c 923 45% 44% 0.69
  Income (<$30,000/y) 853 57% 59% 0.62
  Body mass index in kg/m2, mean (SD) 915 34.0 (7.2) 33.3 (7.2) 0.13
  Excellent blood pressure (≤130/80) 921 26% 23% 0.45
  Poor blood pressure (≥140/90 mmHg) 921 49% 51% 0.69
  SF-12 Physical Component Summary, mean (SD) 908 41.2 (12.6) 41.7 (12.2) 0.61
  SF-12 Mental Component Summary, mean (SD) 908 49.1 (11.3) 50.6 (9.9) 0.06
  Duration of diabetes in years, mean (range) 885 10.4 (0.03–61.0) 10.0 (0.02–62.0) 0.64
  Self-administered Comorbidity Questionnaire, mean (range) 928 3.5 (0–25) 3.8 (0–25) 0.42
  Insulin user 929 18% 20% 0.32

aLinear regression for continuous variables; logistic regression for proportions; adjusted for clustering within practices in all cases

bLipids in control = LDL <100 mg/dl and triglycerides <400 mg/dl

cSTOFHLA = Short Test of Functional Health Literacy in Adults

Subjects received care in small practices: 31 solo practices and 33 practices of two to six providers (65 Family Medicine physicians, 35 Internists, 18 nurse practitioners, and 14 physician assistants). The mean number of patients per PCP was 101 (median 82; range 1–395). No significant differences were observed between the two groups at baseline (Table 1).

At censoring, intervention subjects were more likely to receive guideline-appropriate testing than those randomized to control (Table 2). After adjusting for baseline differences and for clustering within practices, the differences were significant for lipids (OR = 1.39), creatinine (OR = 1.40), and urine protein (OR = 1.74). The improvement in A1C testing (OR = 1.17) was not statistically significant.

Table 2.

Effects of VDIS Intervention on Laboratory Outcomes at Censoring

Outcome Control Intervention Unadjusted effecta Adjusted effect (CI)b Pb
On-time testing (complete data; n = 7,412)
A1C 55% 56% OR = 1.06 1.17 (0.80, 1.72) 0.43
Lipids 71% 74% OR = 1.17 1.39 (1.08, 1.80) 0.012
Creatinine 80% 84% OR = 1.26 1.40 (1.06, 1.84) 0.018
Urine protein 32% 40% OR = 1.41 1.74 (1.13, 2.69) 0.012
Physiologic control (non-imputed; n = 4,998 for A1C; n = 5,450 for LDL)
Mean A1C (%) 7.01 7.16 AD = +0.16 +0.12 (−0.01, +0.25) 0.08
Mean LDL (mg/dl) 93.4 93.5 AD = −0.1 +0.4 (−2.2, +3.1) 0.74
A1C <7% 59% 54% OR = 0.82 0.84 (0.66, 1.08) 0.18
LDL <100 mg/dl 63% 64% OR = 1.04 1.04 (0.87, 1.23) 0.68
Physiologic control (imputed data; n = 7,412)
Mean A1C (%) 7.10 7.25 AD = +0.15 +0.10 (−0.05, +0.24) 0.17
Mean LDL (mg/dl) 95.8 95.0 AD = −0.8 +0.2 (−2.5, +3.0) 0.86
A1C <7% 59% 54% OR = 0.82 0.84 (0.66, 1.08) 0.18
LDL <100 mg/dl 63% 64% OR = 1.07 1.04 (0.88, 1.23) 0.65

aOR = odds ratio; AD = absolute difference (Intervention–Control)

bLogistic or linear regression adjusted for baseline patient value, baseline practice performance, and clustering within practices, with 95% confidence intervals

Cholesterol and A1C levels were similar in the two groups at censoring (Table 2). Adjustment for baseline test results, practice performance, and clustering revealed no significant differences. Missing laboratory results occurred more frequently in the control group (A1C: 34% vs. 32%, P = 0.09; LDL: 23% vs. 20%, P < 0.001). Analyses using imputed data were similar (Table 2).

At the follow-up survey no significant differences were seen in blood pressure, body mass, functional status, quality of life, or self-care, except for an improvement in exercise habits (Table 3). Recalled utilization was significantly lower in the VDIS group (Table 4). After adjustment, estimated total costs of care per person in the year prior to censoring were $2,426 lower in the intervention group than the control group (95% CI = [−4,647, −$205] P = 0.03 by multivariate linear regression; P = 0.03 by unadjusted Wilcoxon rank-sum test).

Table 3.

Patient Status at Follow-up Survey

Outcome Control Intervention Unadjusted effect Adjusted effect (CI)a Pa
Physical status (n = 672)
Systolic BP (mmHg) 138.4 137.4 −1.0 −1.7 (−4.0, +0.6) 0.14
Diastolic BP (mmHg) 76.4 76.3 −0.1 0.0 (−1.2, +1.3) 0.94
Body Mass Index (kg/m2) 33.7 33.7 0.0 −0.1 (−0.5, +0.3) 0.52
Functional status (n = 688)
SF-12 Physical (0–100) 40.6 40.8 +0.2 +0.2 (−0.9, +1.3) 0.68
SF-12 Mental (0–100) 50.5 50.7 +0.3 −0.4 (−1.6, +0.8) 0.50
Self-care activity (n = 564)
General diet (0–100) 61.0 59.2 −1.8 −2.7 (−6.9, +1.6) 0.22
Specific diet (0–100) 51.9 54.4 +2.5 +1.7 (−2.0, +5.4) 0.35
Exercise (0–100) 33.5 39.4 +5.9 +5.0 (+0.9, +9.1) 0.017
Blood testing (0–100) 63.4 55.4 −8.1 −5.5 (−11.7, +0.6) 0.08
Foot care (0–100) 52.9 48.8 −4.0 −2.5 (−7.0, +2.0) 0.28
Quality of Life (n = 658)
ADDQOLb (−9 to +9) −1.4 −1.2 +0.23 +0.12 (−0.04, +0.28) 0.13

aLinear regression adjusted for baseline patient value, age, sex, marital status, education, health literacy, race, insulin use, comorbidity, and clustering within practices, with 95% confidence intervals

bADDQOL = Audit of Diabetes Dependant Quality of Life

Table 4.

Service Utilization at Follow-up Survey (n = 704)

Outcome Control Intervention Unadjusted effect Adjusted effect (CI)a Pa
Hospital days/y 1.89 1.18 −0.71 −1.01 (−2.02, −0.01) 0.047
ER visits/y 0.72 0.55 −0.18 −0.23 (−0.42, −0.04) 0.020
Primary care visits/y 2.86 2.04 −0.82 −0.81 (−1.42, −0.20) 0.010
Specialty visits/y 0.23 0.15 −0.07 −0.08 (−0.15, −0.002) 0.044
Costs $/y 4937 3202 −1736 −2426 (−4647, −205) 0.033

aLinear regression adjusted for age, sex, marital status, education, health literacy, race, insulin use, comorbidity, hospital, and clustering within practices, with 95% confidence intervals

The system integrated into clinical workflow with minimal disruption. Fax volume averaged 4/practice/day. Ongoing support required less than 1 hour of information technology professional support per month.

DISCUSSION

In this large-scale, randomized controlled trial, the VDIS resulted in significant improvements in test ordering with no change in physiologic control or functional status. In order to be generalizable to typical primary care practices with minimal disruption to workflow, VDIS does not require added personnel, hardware, or software.

A similar diabetes decision support intervention targeted at both providers and patients in a large multispecialty group found no improvement in laboratory outcomes and a negative impact on timeliness of test ordering47. However, the decision support was not delivered at the point of care and may have been as much as 6 weeks out of date. These negative findings highlight the importance of delivering decision support information that is both timely and actionable. Another study in 24 practices in Minnesota, which included a case manager function, showed improvements in both process and outcome15. Other interventions have resulted in improvement in process but not laboratory outcomes8,10,16.

Systematic reviews suggest that quality improvement strategies in diabetes care produce modest results45,46. VDIS uses 5 of the 11 recommended strategies for improving care46: audit and feedback, electronic registry, clinician reminders, patient reminders, and abbreviated patient education (in the form of alert letters when results are significantly out of range). This approach led to improvements in patient testing without changing physiologic outcomes.

There are several possible explanations for the failure of improved testing to lead to improved control in our study. The level of control at baseline was very good—the mean A1C was 7.1% with 55% of subjects below 7%, compared to 7.7% and 42% for a national sample2, suggesting a possible “ceiling effect”48. This is supported by the observation that the strongest effect was on nephropathy testing, which had the poorest baseline performance. It is unknown if VDIS would improve outcomes in a population with a poorer baseline level of control.

Perhaps some patients without diabetes were included in the study population despite being confirmed by their PCP. However, 92% of all subjects had at least one A1C > 6% at some time during the study, suggesting well-controlled diabetes at baseline rather than over-diagnosis.

It is possible that VDIS alone is not a sufficiently intensive approach49,50. Interventions that add personnel15,45,46 or more intensive behavioral interventions51 have been somewhat successful, though not uniformly52. The US health care payment structure is currently not supportive of a coordinated, team-based approach to chronic illness53,54, though initiatives such as the Patient Centered Medical Home are underway55. Our study findings support the idea that practices interested in population-based chronic disease management may consider a laboratory-based registry and decision support system as a transition to a more fully integrated future including a broader team and improved electronic systems.

It was the generally accepted basis of this experiment that improved monitoring would lead to improved physiologic control which would, in turn, lead to fewer complications, better quality of life, and lower costs. The failure of improved monitoring to influence physiologic control in this study does not suggest that monitoring is unimportant. Measurement is an essential step in any quality improvement process56. The challenge remains in designing interventions that appropriately balance clinical impact and ease of dissemination and use. Subsequent work has shown us that VDIS can serve as platform to support other systems improvements such as automatic pre-ordering of tests, planned diabetes visits, specialty referral, and added personnel for health behavior coaching or case management57.

The strengths of this study are the large sample, rigorous design, and long follow-up in small, independent, community practices (without sophisticated electronic systems) representative of how most primary care is delivered today. While the subjects were less racially diverse than the rest of the country, more rural, and less likely to have access to specialty care, they are similar to other Americans with diabetes in regard to age, income, sex, comorbid conditions, tobacco use, functional status, and other social and demographic characteristics. The cost data in this study are based on patient recall of clinical events, rather than review of clinical or administrative records. However, patient recall of hospitalizations and emergency room use is generally good32 and any error would apply to both control and intervention groups. We recently analyzed data from another population using actual insurance claims and found a similar magnitude of cost reduction58. Because VDIS includes several components directed at both providers and patients, it is difficult to tell which parts led to the improvements in testing.

CONCLUSIONS

A chronic disease registry and decision support system based on easily obtainable laboratory data was feasible and acceptable to patients and providers. It improved the process of laboratory monitoring in primary care, but not physiologic control. Utilization was lower among patients provided the service with no adverse impact on functional status.

Acknowledgments

The authors are grateful for the generous contributions made by the patients, providers, and staffs of the participating practices and hospitals.

Funded by the National Institute of Diabetes and Digestive and Kidney Diseases (R01 DK61167 and K24 DK068380).

Conflict of Interest Drs. MacLean and Littenberg, and Mr. Gagnon are principals of Vermedx, Inc., which distributes clinical decision support systems based on this work.

Footnotes

Clinical Trials Registration Number: ClinicalTrials.gov—NCT00109369

References

  • 1.Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003;348(5):383–93. [DOI] [PubMed]
  • 2.Saaddine JB, Cadwell B, Gregg EW, et al. Improvements in diabetes processes of care and intermediate outcomes: United States, 1988–2002. Ann Intern Med. 2006;144(7):465–74. [DOI] [PubMed]
  • 3.Saydah SH, Fradkin J, Cowie CC. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. Jama. 2004;291(3):335–42. [DOI] [PubMed]
  • 4.Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. Jama. 2002;288(15):1909–14. [DOI] [PubMed]
  • 5.Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness. Jama. 2002;288(14):1775–9. [DOI] [PubMed]
  • 6.Wagner EH, Glasgow RE, Davis C, et al. Quality improvement in chronic illness care: a collaborative approach. Jt Comm J Qual Improv. 2001;27(2):63–80. [DOI] [PubMed]
  • 7.Pearson ML, Wu S, Schaefer J, et al. Assessing the implementation of the chronic care model in quality improvement collaboratives. Health Serv Res. 2005;40(4):978–96. [DOI] [PMC free article] [PubMed]
  • 8.Grant RW, Cagliero E, Sullivan CM, et al. A controlled trial of population management: diabetes mellitus: putting evidence into practice (DM-PEP). Diabetes Care. 2004;27(10):2299–305. [DOI] [PubMed]
  • 9.Maddigan SL, Majumdar SR, Guirguis LM, et al. Improvements in patient-reported outcomes associated with an intervention to enhance quality of care for rural patients with type 2 diabetes: results of a controlled trial. Diabetes Care. 2004;27(6):1306–12. [DOI] [PubMed]
  • 10.Glasgow RE, Nutting PA, King DK, et al. Randomized effectiveness trial of a computer-assisted intervention to improve diabetes care. Diabetes Care. 2005;28(1):33–9. [DOI] [PubMed]
  • 11.Montori VM, Dinneen SF, Gorman CA, et al. The impact of planned care and a diabetes electronic management system on community-based diabetes care: the Mayo Health System Diabetes Translation Project. Diabetes Care. 2002;25(11):1952–7. [DOI] [PubMed]
  • 12.O'Connor PJ, Desai J, Solberg LI, et al. Randomized trial of quality improvement intervention to improve diabetes care in primary care settings. Diabetes Care. 2005;28(8):1890–7. [DOI] [PubMed]
  • 13.Sequist TD, Gandhi TK, Karson AS, et al. A randomized trial of electronic clinical reminders to improve quality of care for diabetes and coronary artery disease. J Am Med Inform Assoc. 2005;12(4):431–7. [DOI] [PMC free article] [PubMed]
  • 14.Piatt GA, Orchard TJ, Emerson S, et al. Translating the chronic care model into the community: results from a randomized controlled trial of a multifaceted diabetes care intervention. Diabetes Care. 2006;29(4):811–7. [DOI] [PubMed]
  • 15.Peterson KA, Radosevich DM, O'Connor PJ, et al. Improving diabetes care in practice: findings from the TRANSLATE trial. Diabetes Care. 2008;31(12):2238–43. [DOI] [PMC free article] [PubMed]
  • 16.Cleveringa FG, Gorter KJ, van den Donk M, Rutten GE. Combined task delegation, computerized decision support, and feedback improve cardiovascular risk for type 2 diabetic patients: a cluster randomized trial in primary care. Diabetes Care. 2008;31(12):2273–5. [DOI] [PMC free article] [PubMed]
  • 17.Cherry DK, Hing E, Woodwell DA, Rechtsteiner EA. National ambulatory medical care survey: 2006 summary. Natl Health Stat Report. 2008;(3):1–39. [PubMed]
  • 18.DesRoches CM, Campbell EG, Rao SR, et al. Electronic health records in ambulatory care-a national survey of physicians. N Engl J Med. 2008;359(1):50–60. [DOI] [PubMed]
  • 19.MacLean CD, Littenberg B, Gagnon M. Diabetes decision support: initial experience with the Vermont diabetes information system. Am J Public Health. 2006;96(4):593–5. [DOI] [PMC free article] [PubMed]
  • 20.MacLean CD, Littenberg B, Gagnon MS, Reardon M, Turner PD, Jordan C. The Vermont Diabetes Information System (VDIS): study design and subject recruitment for a cluster randomized trial of a decision support system in a regional sample of primary care practices. Clinical Trials. 2004;1:532–44. [DOI] [PMC free article] [PubMed]
  • 21.Littenberg B, Maclean CD. Passive consent for clinical research in the age of HIPAA. J Gen Intern Med. 2006;21(3):207–11. [DOI] [PMC free article] [PubMed]
  • 22.Donner A, Birkett N, Buck C. Randomization by cluster. Sample size requirements and analysis. Am J Epidemiol. 1981;114(6):906–14. [DOI] [PubMed]
  • 23.Donner A, Klar N. Pitfalls of and controversies in cluster randomization trials. Am J Public Health. 2004;94(3):416–22. [DOI] [PMC free article] [PubMed]
  • 24.Koepsell TD, Wagner EH, Cheadle AD, et al. Selected methodological issues in evaluating community-based health promotion and disease prevention programs. Annu Rev Publ Health. 1992;13:31–57. [DOI] [PubMed]
  • 25.Littenberg B, Maclean CD. Intra-cluster correlation coefficients in adults with diabetes in primary care practices: the Vermont Diabetes Information System Field Survey. BMC Med Res Methodol. 2006;6(1):20. [DOI] [PMC free article] [PubMed]
  • 26.ADA. Standards of medical care in diabetes-2006. Diabetes Care. 2006;29(Suppl 1):S4–42. [PubMed]
  • 27.Ware JE, Kosinski M, Turner-Bowker DM, Gandek B. How to Score Version 2 of the SF-12 Health Survey. Lincoln: QualityMetric Inc.; 2003.
  • 28.Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000;23(7):943–50. [DOI] [PubMed]
  • 29.Baker DW, Williams MV, Parker RM, Gazmararian JA, Nurss J. Development of a brief test to measure functional health literacy. Patient Educ Couns. 1999;38(1):33–42. [DOI] [PubMed]
  • 30.Sangha O, Stucki G, Liang MH, Fossel AH, Katz JN. The self-administered comorbidity questionnaire: a new method to assess comorbidity for clinical and health services research. Arthritis Rheum. 2003;49(2):156–63. [DOI] [PubMed]
  • 31.Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R. The development of an individualized questionnaire measure of perceived impact of diabetes on quality of life: the ADDQoL. Qual Life Res. 1999;8(1–2):79–91. [DOI] [PubMed]
  • 32.Ritter PL, Stewart AL, Kaymaz H, Sobel DS, Block DA, Lorig KR. Self-reports of health care utilization compared to provider records. J Clin Epidemiol. 2001;54(2):136–41. [DOI] [PubMed]
  • 33.Machlin CR, Carper K. Expenses for a hospital emergency room visit, 2003. AHRQ statistical brief #111. http://www.meps.ahrq.gov/mepsweb/datafiles/publications/st111/stat111.pdf. Accessed September 29, 2009.
  • 34.Machlin CR, Carper K. Expenses for office-based physician visits by specialty, 2004. http://www.meps.ahrq.gov/mepsweb/datafiles/publications/st166/stat166.pdf. Accessed September 29, 2009.
  • 35.Medical Expenditure Panel Survey. 2005 Hospital Inpatient Stays, 2007. (October 2007). http://www.meps.ahrq.gov/mepsweb/datastats/downloaddatafilesdetail.jsp?cboPufNumber=HC-094D. Accessed September 29, 2009.
  • 36.Brown H, Prescott R. Applied mixed models in medicine. 2nd ed. Chichester, England; Hoboken, NJ: John Wiley; 2006.
  • 37.Murray DM. Design and analysis of group-randomized trials. New York: Oxford University Press; 1998.
  • 38.Piantadosi S. Clinical Trials: A Methodologic Perspective. New York: Wiley-Interscience; 1997.
  • 39.Royston P. Multiple imputation of missing values: update. Stata Journal. 2005;5(2):188–201.
  • 40.Ambler G, Omar RZ, Royston P. A comparison of imputation techniques for handling missing predictor values in a risk model with a binary outcome. Stat Methods Med Res. 2007;16(3):277–98. [DOI] [PubMed]
  • 41.Calle EE, Terrell DD. Utility of the National Death Index for ascertainment of mortality among cancer prevention study II participants. Am J Epidemiol. 1993;137(2):235–41. [DOI] [PubMed]
  • 42.Lash TL, Silliman RA. A comparison of the National Death Index and Social Security Administration databases to ascertain vital status. Epidemiology. 2001;12(2):259–61. [DOI] [PubMed]
  • 43.US Census. Income, Poverty, and Health Insurance Coverage in the United States:2003. http://www.census.gov/prod/2004pubs/p60-226.pdf. Accessed September 29, 2009.
  • 44.US Census. Health Insurance Coverage Status and Type of Coverage by State and Age for All People:2004. http://pubdb3.census.gov/macro/032005/health/h05000.htm. Accessed September 29, 2009.
  • 45.Renders CM, Valk GD, Griffin S, Wagner EH, Eijk JT, Assendelft WJ. Interventions to improve the management of diabetes mellitus in primary care, outpatient and community settings. Cochrane Database Syst Rev. 2001(1):CD001481. [DOI] [PMC free article] [PubMed]
  • 46.Shojania KG, Ranji SR, McDonald KM, et al. Effects of quality improvement strategies for type 2 diabetes on glycemic control: a meta-regression analysis. Jama. 2006;296(4):427–40. [DOI] [PubMed]
  • 47.O'Conner PJ, Sperl-Hillen J, Johnson PE, Rush WA, Crain AL. Customized feedback to patients and providers failed to improve safety or quality of diabetes care: a randomized trial. Diabetes Care. 2009;32:1158–63. [DOI] [PMC free article] [PubMed]
  • 48.Rosenthal MB, Frank RG, Li Z, Epstein AM. Early experience with pay-for-performance: from concept to practice. Jama. 2005;294(14):1788–93. [DOI] [PubMed]
  • 49.Phillips LS, Branch WT, Cook CB, et al. Clinical inertia. Ann Intern Med. 2001;135(9):825–34. [DOI] [PubMed]
  • 50.Parchman ML, Pugh JA, Romero RL, Bowers KW. Competing demands or clinical inertia: the case of elevated glycosylated hemoglobin. Ann Fam Med. 2007;5(3):196–201. [DOI] [PMC free article] [PubMed]
  • 51.Gary TL, Genkinger JM, Guallar E, Peyrot M, Brancati FL. Meta-analysis of randomized educational and behavioral interventions in type 2 diabetes. Diabetes Educ. 2003;29(3):488–501. [DOI] [PubMed]
  • 52.Krein SL, Klamerus ML, Vijan S, et al. Case management for patients with poorly controlled diabetes: a randomized trial. Am J Med. 2004;116(11):732–9. [DOI] [PubMed]
  • 53.Davis K, Schoenbaum SC, Audet AM. A 2020 vision of patient-centered primary care. J Gen Intern Med. 2005;20(10):953–7. [DOI] [PMC free article] [PubMed]
  • 54.Bodenheimer T. Coordinating care-a perilous journey through the health care system. N Engl J Med. 2008;358(10):1064–71. [DOI] [PubMed]
  • 55.American Academy of Family Physicians, American Academy of Pediatrics, American College of Physicians, American Osteopathic Association. Joint Principles of the Patient-Centered Medical Home. March 2007. http://www.acponline.org/advocacy/wherewestand/medicalhome/approvejp.pdf. Accessed September 29, 2009.
  • 56.Batalden PB, Godfrey MM, Nelson EC. Quality by Design: A Clinical Microsystems Approach1st ed. San Francisco: Jossey-Bass; 2007.
  • 57.MacLean CD, Littenberg B. Patient assignment in a diabetes decision support system: implications for population management and pay for performance. Society of General Internal Medicine. Pittsburgh; 2008.
  • 58.Littenberg B, MacLean CD, Zygarowski K, Drapola BH, Duncan JA, Frank CR. The Vermedx Diabetes Information System reduces healthcare utilization. Am J Manag Care. 2009;15(3):166–70. [PubMed]

Articles from Journal of General Internal Medicine are provided here courtesy of Society of General Internal Medicine

RESOURCES