Santanu K. Datta

Medical Clinics Versus Usual Care for Patients With Both Diabetes and Hypertension: A Randomized Trial

BACKGROUND Group medical clinics (GMCs) are widely used in the management of diabetes and hypertension, but data on their effectiveness are limited. OBJECTIVE To test the effectiveness of GMCs in the management of comorbid diabetes and hypertension. DESIGN Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00286741) SETTING 2 Veterans Affairs Medical Centers in North Carolina and Virginia. PATIENTS 239 patients with poorly controlled diabetes (hemoglobin A(1c) [HbA(1c)] level > or =7.5%) and hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg). INTERVENTION Patients were randomly assigned within each center to either attend a GMC or receive usual care. Clinics comprised 7 to 8 patients and a care team that consisted of a primary care general internist, a pharmacist, and a nurse or other certified diabetes educator. Each session included structured group interactions moderated by the educator. The pharmacist and physician adjusted medication to manage each patients HbA(1c) level and blood pressure. MEASUREMENTS Hemoglobin A(1c) level and systolic blood pressure, measured by blinded research personnel at baseline, study midpoint (median, 6.8 months), and study completion (median follow-up, 12.8 months). Linear mixed models, adjusted for clustering within GMCs, were used to compare HbA(1c) levels and systolic blood pressure between the intervention and control groups. RESULTS Mean baseline systolic blood pressure and HbA(1c) level were 152.9 mm Hg (SD, 14.2) and 9.2% (SD, 1.4), respectively. At the end of the study, mean systolic blood pressure improved by 13.7 mm Hg in the GMC group and 6.4 mm Hg in the usual care group (P = 0.011 by linear mixed model), whereas mean HbA(1c) level improved by 0.8% in the GMC group and 0.5% in the usual care group (P = 0.159). LIMITATION Measurements of effectiveness may have been limited by concomitant improvements in the usual care group that were due to co-intervention. CONCLUSION Group medical clinics are a potent strategy for improving blood pressure but not HbA(1c) level in diabetic patients. PRIMARY FUNDING SOURCE U.S. Department of Veterans Affairs Health Services Research and Development Service.

Setting the target for a better cervical screening test: characteristics of a cost-effective test for cervical neoplasia screening.

Objective To determine the potential effects on costs and outcomes of changes in sensitivity and specificity with new screening methods for cervical cancer. Methods Using a Markov model of the natural history of cervical cancer, we estimated the effects of sensitivity, specificity, and screening frequency on cost-effectiveness. Our estimates of conventional Papanicolaou test sensitivity of 51% and specificity of 97% were obtained from a meta-analysis. We estimated the effect of reducing false-negative rates from 40–90% and increasing false-positive rates by up to 20%, independently and jointly. We varied the marginal cost of improving sensitivity from

Patient education and provider decision support to control blood pressure in primary care: a cluster randomized trial.

0 to

Teledermatology's Impact on Time to Intervention among Referrals to a Dermatology Consult Service

15. Results When specificity was held constant, increasing sensitivity of the Papanicolaou test increased life expectancy and costs. When sensitivity was held constant, decreasing specificity of the Papanicolaou test increased costs, an effect that was more dramatic at more frequent intervals. Decreased specificity had a substantial effect on cost-effectiveness estimates of improved Papanicolaou test sensitivity. Most of those effects are related to the cost of evaluation and treatment of low-grade lesions. Conclusion Policies or technologies that increased sensitivity of cervical cytologic screening increased overall costs, even if the cost of the technology was identical to that of conventional Papanicolaou smears. These effects appear to be caused by relatively high prevalence of low-grade lesions and are magnified at frequent screening intervals. Efficient cervical cancer screening requires methods with greater ability to detect lesions that are most likely to become cancerous.

An economic analysis of a store and forward teledermatology consult system.

BACKGROUND Less than one third of the 65 million Americans with hypertension have adequate blood pressure (BP) control. This study examined the effectiveness of 2 interventions for improving patient BP control. METHODS This was a 2-level (primary care provider and patient) cluster randomized trial with 2-year follow-up occurring among patients with hypertension enrolled from a Veterans Affairs Medical Center primary care clinic. Primary care providers (n = 17) in the intervention received computer-generated decision support designed to improve guideline concordant medical therapy at each visit; control providers (n = 15) received a reminder at each visit. Patients received usual care or a bimonthly tailored nurse-delivered behavioral telephone intervention to improve hypertension treatment. The primary outcome was proportion of patients who achieved a BP <140/90 mm Hg (<130/85 for diabetic patients) over the 24-month intervention. RESULTS Of the 816 eligible patients contacted, 190 refused and 38 were excluded. The 588 enrolled patients had a mean age of 63 years, 43% had adequate baseline BP control, and 482 (82%) completed the 24-month follow-up. There were no significant differences in amount of change in BP control in the 3 intervention groups as compared to the hypertension reminder control group. In secondary analyses, rates of BP control for all patients receiving the patient behavioral intervention (n = 294) improved from 40.1% to 54.4% at 24 months (P = .03); patients in the nonbehavioral intervention group improved from 38.2% to 43.9% (P = .38), but there was no between-group differences at the end of the study. CONCLUSION The brief behavioral intervention showed improved outcomes over time, but there were not significant between group differences.

Telephone-based self-management of osteoarthritis: A randomized trial.

The aim of this study was to determine if a teledermatology consult system, using store-and-forward digital imaging technology, results in patients achieving a shorter time from referral date to date of initial definitive intervention when compared to a traditional referral process. Patients being referred to the dermatology consult service from the primary care clinics at the Durham VA Medical Center were randomized to either a teledermatology consultation or usual care. A usual care consultation consisted of a text-based electronic consult request. A teledermatology consultation included digital images and a standardized history, in addition to the text-based electronic consult. Time to initial definitive intervention was defined as the time between referral date and the date the patient was scheduled for a clinic visit for those patients that the consultant requested a clinic-based evaluation, or the time between referral date and the date the consult was answered by the consultant if a clinic visit was not required. Patients in the teledermatology arm of the study reached a time to initial definitive intervention significantly sooner than did those patients randomized to usual care (median 41 days versus 127 days, p = 0.0001, log-rank test). Additionally, 18.5% of patients in the teledermatology arm avoided the need for a dermatology clinic-based visit compared to zero patients avoiding a dermatology clinic visit in the usual care arm of the study (p < 0.001, z-test). Teledermatology consult systems can result in significantly shorter times to initial definitive intervention for patients compared to traditional consult modalities, and, in some cases, the need for a clinic-based visit can be avoided.

Implementation of Lung Cancer Screening in the Veterans Health Administration

Our objective was to assess the economic impact of store-and-forward teledermatology in a United States Department of Veterans Affairs (VA) health care setting. Patients being referred to the Dermatology Consult Service from the Primary Care Clinics at the Durham, North Carolina VA Medical Center were randomized either to usual care or to a teledermatology consultation. Fixed and variable costs for both consult modalities were identified using a microcosting approach. The observed clinical outcomes from the randomized trial generated probability and effectiveness measures that were inserted into a decision model. A cost analysis and a cost-effectiveness analysis that compared the two consult modalities was performed. Teledermatology was not cost saving when compared to usual care using observed costs and outcomes. Sensitivity analyses indicated that teledermatology has the potential to be cost saving if clinic visit costs, travel costs, or averted clinic visits were higher than observed in the study. Teledermatology was cost-effective for decreasing the time required for patients to reach a point of initial definitive care. Cost-effectiveness ratios ranged from

Cost Minimization Analysis of a Store-and-Forward Teledermatology Consult System

0.12-0.17 (U.S.) per patient per day of time to initial intervention.

Effect of Store and Forward Teledermatology on Quality of Life: A Randomized Controlled Trial

BACKGROUND Osteoarthritis is a leading cause of pain and disability, and self-management behaviors for osteoarthritis are underutilized. OBJECTIVE To examine the effectiveness of a telephone-based self-management intervention for hip or knee osteoarthritis in a primary care setting. DESIGN Randomized clinical trial with equal assignment to osteoarthritis self-management, health education (attention control), and usual care control groups. (ClinicalTrials.gov registration number: NCT00288912) SETTING Primary care clinics in a Veterans Affairs Medical Center. PATIENTS 515 patients with symptomatic hip or knee osteoarthritis. INTERVENTION The osteoarthritis self-management intervention involved educational materials and 12 monthly telephone calls to support individualized goals and action plans. The health education intervention involved nonosteoarthritis educational materials and 12 monthly telephone calls related to general health screening topics. MEASUREMENTS The primary outcome was score on the Arthritis Impact Measurement Scales-2 pain subscale (range, 0 to 10). Pain was also assessed with a 10-cm visual analog scale. Measurements were collected at baseline and 12 months. RESULTS 461 participants (90%) completed the 12-month assessment. The mean Arthritis Impact Measurement Scales-2 pain score in the osteoarthritis self-management group was 0.4 point lower (95% CI, -0.8 to 0.1 point; P = 0.105) than in the usual care group and 0.6 point lower (CI, -1.0 to -0.2 point; P = 0.007) than in the health education group at 12 months. The mean visual analog scale pain score in the osteoarthritis self-management group was 1.1 points lower (CI, -1.6 to -0.6 point; P < 0.001) than in the usual care group and 1.0 point lower (CI, -1.5 to -0.5 point; P < 0.001) than in the health education group. Health care use did not differ across the groups. LIMITATION The study was conducted at 1 Veterans Affairs Medical Center, and the sample consisted primarily of men. CONCLUSION A telephone-based osteoarthritis self-management program produced moderate improvements in pain, particularly compared with a health education control group. PRIMARY FUNDING SOURCE U.S. Department of Veterans Affairs Health Services Research and Development Service.

Economic analysis of a tailored behavioral intervention to improve blood pressure control for primary care patients

Importance The US Preventive Services Task Force recommends annual lung cancer screening (LCS) with low-dose computed tomography for current and former heavy smokers aged 55 to 80 years. There is little published experience regarding implementing this recommendation in clinical practice. Objectives To describe organizational- and patient-level experiences with implementing an LCS program in selected Veterans Health Administration (VHA) hospitals and to estimate the number of VHA patients who may be candidates for LCS. Design, Setting, and Participants This clinical demonstration project was conducted at 8 academic VHA hospitals among 93 033 primary care patients who were assessed on screening criteria; 2106 patients underwent LCS between July 1, 2013, and June 30, 2015. Interventions Implementation Guide and support, full-time LCS coordinators, electronic tools, tracking database, patient education materials, and radiologic and nodule follow-up guidelines. Main Outcomes and Measures Description of implementation processes; percentages of patients who agreed to undergo LCS, had positive findings on results of low-dose computed tomographic scans (nodules to be tracked or suspicious findings), were found to have lung cancer, or had incidental findings; and estimated number of VHA patients who met the criteria for LCS. Results Of the 4246 patients who met the criteria for LCS, 2452 (57.7%) agreed to undergo screening and 2106 (2028 men and 78 women; mean [SD] age, 64.9 [5.1] years) underwent LCS. Wide variation in processes and patient experiences occurred among the 8 sites. Of the 2106 patients screened, 1257 (59.7%) had nodules; 1184 of these patients (56.2%) required tracking, 42 (2.0%) required further evaluation but the findings were not cancer, and 31 (1.5%) had lung cancer. A variety of incidental findings, such as emphysema, other pulmonary abnormalities, and coronary artery calcification, were noted on the scans of 857 patients (40.7%). Conclusions and Relevance It is estimated that nearly 900 000 of a population of 6.7 million VHA patients met the criteria for LCS. Implementation of LCS in the VHA will likely lead to large numbers of patients eligible for LCS and will require substantial clinical effort for both patients and staff.