Justin Starren

A Randomized Trial Comparing Telemedicine Case Management with Usual Care in Older, Ethnically Diverse, Medically Underserved Patients with Diabetes Mellitus

BACKGROUND Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions who experience barriers to access to care or a high burden of illness. METHODS The authors conducted a randomized, controlled trial comparing telemedicine case management to usual care, with blinding of those obtaining outcome data, in 1,665 Medicare recipients with diabetes, aged 55 years or greater, and living in federally designated medically underserved areas of New York State. The primary endpoints were HgbA1c, blood pressure, and low-density lipoprotein (LDL) cholesterol levels. RESULTS In the intervention group (n = 844), mean HgbA1c improved over one year from 7.35% to 6.97% and from 8.35% to 7.42% in the subgroup with baseline HgbA1c > or =7% (n = 353). In the usual care group (n = 821) mean HgbA1c improved over one year from 7.42% to 7.17%. Adjusted net reductions (one-year minus baseline mean values in each group, compared between groups) favoring the intervention were as follows: HgbA1c, 0.18% (p = 0.006), systolic and diastolic blood pressure, 3.4 (p = 0.001) and 1.9 mm Hg (p < 0.001), and LDL cholesterol, 9.5 mg/dL (p < 0.001). In the subgroup with baseline HgbA1c > or =7%, net adjusted reduction in HgbA1c favoring the intervention group was 0.32% (p = 0.002). Mean LDL cholesterol level in the intervention group at one year was 95.7 mg/dL. The intervention effects were similar in magnitude in the subgroups living in New York City and upstate New York. CONCLUSION Telemedicine case management improved glycemic control, blood pressure levels, and total and LDL cholesterol levels at one year of follow-up.

A Randomized Trial Comparing Telemedicine Case Management with Usual Care in Older, Ethnically Diverse, Medically Underserved Patients with Diabetes Mellitus: 5 Year Results of the IDEATel Study

CONTEXT Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions and lower access to care. OBJECTIVES To examine the effectiveness of a telemedicine intervention to achieve clinical management goals in older, ethnically diverse, medically underserved patients with diabetes. DESIGN, Setting, and Patients A randomized controlled trial was conducted, comparing telemedicine case management to usual care, with blinded outcome evaluation, in 1,665 Medicare recipients with diabetes, aged >/= 55 years, residing in federally designated medically underserved areas of New York State. Interventions Home telemedicine unit with nurse case management versus usual care. Main Outcome Measures The primary endpoints assessed over 5 years of follow-up were hemoglobin A1c (HgbA1c), low density lipoprotein (LDL) cholesterol, and blood pressure levels. RESULTS Intention-to-treat mixed models showed that telemedicine achieved net overall reductions over five years of follow-up in the primary endpoints (HgbA1c, p = 0.001; LDL, p < 0.001; systolic and diastolic blood pressure, p = 0.024; p < 0.001). Estimated differences (95% CI) in year 5 were 0.29 (0.12, 0.46)% for HgbA1c, 3.84 (-0.08, 7.77) mg/dL for LDL cholesterol, and 4.32 (1.93, 6.72) mm Hg for systolic and 2.64 (1.53, 3.74) mm Hg for diastolic blood pressure. There were 176 deaths in the intervention group and 169 in the usual care group (hazard ratio 1.01 [0.82, 1.24]). CONCLUSIONS Telemedicine case management resulted in net improvements in HgbA1c, LDL-cholesterol and blood pressure levels over 5 years in medically underserved Medicare beneficiaries. Mortality was not different between the groups, although power was limited. Trial Registration http://clinicaltrials.gov Identifier: NCT00271739.

Frequency of serum creatinine changes in the absence of iodinated contrast material: Implications for studies of contrast nephrotoxicity

OBJECTIVE Most studies of contrast-induced nephropathy lack controls to distinguish it from nephropathy from other causes. We assessed the frequency and magnitude of serum creatinine changes in patients not receiving iodinated contrast material to compare with creatinine changes in publications regarding contrast nephropathy. MATERIALS AND METHODS From the electronic medical records of an academic medical center, adults with creatinine determinations on five consecutive days who had not received contrast material during the previous 10 days were identified. The first creatinine level was compared with those on subsequent days. We calculated the frequency with which these levels exceeded thresholds used to identify contrast nephropathy in previous publications. RESULTS Among 32,161 patients, more than half showed a change of at least 25% and more than two fifths, a change of at least 0.4 mg/dL. Among patients with baseline creatinine levels of 0.6-1.2 mg/dL, increases of at least 25%, 33%, and 50% occurred in 27%, 19%, and 11% of patients, respectively. Increases of 0.4, 0.6, and 1.0 mg/dL occurred in 13%, 7%, and 3% of patients. Among patients with baseline creatinine levels greater than 2.0 mg/dL, increases of at least 25%, 33%, and 50% occurred in 16%, 12%, and 7%. Increases of 0.4, 0.6, and 1.0 mg/dL occurred in 33%, 26%, and 18%. These increases were not different from the incidences of contrast nephropathy previously published. CONCLUSION The creatinine level increases in patients who are not receiving contrast material as often as it does in published series of patients who are receiving contrast material. The role of contrast material in nephropathy may have been overestimated.

Usability in the real world: assessing medical information technologies in patient's homes

OBJECTIVE This paper presents an approach to usability evaluation of computer-based health care systems designed for patient use in their homes. Although such devices are becoming more prevalent, there is very little known about their usability. DESIGN The theoretical foundations for the methods are discussed. The approach incorporates a cognitive walkthrough usability evaluation and new methods for usability testing that can be conducted in patients homes. The method was applied to the IDEATel intervention, a multi-institution randomized controlled trial of the feasibility, acceptability, and clinical utility of a home-based telemedicine system for diabetic Medicare population. The usability study was designed to assess barriers to optimal use of the system. The focus was both on dimensions of the interface and on dimensions of patient skills and competency. The usability field research involved testing 25 patients in their homes using the system. The analysis included a range of video-analytic methods of varying levels of granularity. RESULTS The usability evaluation revealed aspects of the interface that were sub-optimal and impeded the performance of certain tasks. It also found a range of patient-related factors such as numeracy and psychomotor skills that constituted barriers to productive use. CONCLUSIONS A multifaceted usability approach provided important insight regarding use of technology by an elderly chronic-care patient population and more generally, for understanding how home health initiatives can more effectively use such technology.

Columbia University's Informatics for Diabetes Education and Telemedicine (IDEATel) Project: rationale and design.

The Columbia University Informatics for Diabetes Education and Telemedicine (IDEATel) Project is a four-year demonstration project funded by the Centers for Medicare and Medicaid Services with the overall goals of evaluating the feasibility, acceptability, effectiveness, and cost-effectiveness of telemedicine in the management of older patients with diabetes. The study is designed as a randomized controlled trial and is being conducted by a state-wide consortium in New York. Eligibility requires that participants have diabetes, are Medicare beneficiaries, and reside in federally designated medically underserved areas. A total of 1,500 participants will be randomized, half in New York City and half in other areas of the state. Intervention participants receive a home telemedicine unit that provides synchronous videoconferencing with a project-based nurse, electronic transmission of home fingerstick glucose and blood pressure data, and Web access to a project Web site. End points include glycosylated hemoglobin, blood pressure, and lipid levels; patient satisfaction; health care service utilization; and costs. The project is intended to provide data to help inform regulatory and reimbursement policies for electronically delivered health care services.

Anticipating and addressing the unintended consequences of health IT and policy: a report from the AMIA 2009 Health Policy Meeting

Federal legislation (Health Information Technology for Economic and Clinical Health (HITECH) Act) has provided funds to support an unprecedented increase in health information technology (HIT) adoption for healthcare provider organizations and professionals throughout the U.S. While recognizing the promise that widespread HIT adoption and meaningful use can bring to efforts to improve the quality, safety, and efficiency of healthcare, the American Medical Informatics Association devoted its 2009 Annual Health Policy Meeting to consideration of unanticipated consequences that could result with the increased implementation of HIT. Conference participants focused on possible unintended and unanticipated, as well as undesirable, consequences of HIT implementation. They employed an input-output model to guide discussion on occurrence of these consequences in four domains: technical, human/cognitive, organizational, and fiscal/policy and regulation. The authors outline the conferences recommendations: (1) an enhanced research agenda to guide study into the causes, manifestations, and mitigation of unintended consequences resulting from HIT implementations; (2) creation of a framework to promote sharing of HIT implementation experiences and the development of best practices that minimize unintended consequences; and (3) recognition of the key role of the Federal Government in providing leadership and oversight in analyzing the effects of HIT-related implementations and policies.

Automating Content Extraction of HTML Documents

Abstract Web pages often contain clutter (such as unnecessary images and extraneous links) around the body of an article that distracts a user from actual content. Extraction of “useful and relevant” content from web pages has many applications, including cell phone and PDA browsing, speech rendering for the visually impaired, and text summarization. Most approaches to making content more readable involve changing font size or removing HTML and data components such as images, which takes away from a webpage’s inherent look and feel. Unlike “Content Reformatting,” which aims to reproduce the entire webpage in a more convenient form, our solution directly addresses “Content Extraction.” We have developed a framework that employs an easily extensible set of techniques. It incorporates advantages of previous work on content extraction. Our key insight is to work with DOM trees, a W3C specified interface that allows programs to dynamically access document structure, rather than with raw HTML markup. We have implemented our approach in a publicly available Web proxy to extract content from HTML web pages. This proxy can be used both centrally, administered for groups of users, as well as by individuals for personal browsers. We have also, after receiving feedback from users about the proxy, created a revised version with improved performance and accessibility in mind.

Telemedical Diagnosis of Retinopathy of Prematurity: Intraphysician Agreement between Ophthalmoscopic Examination and Image-Based Interpretation

OBJECTIVE To evaluate the intraphysician agreement between ophthalmoscopic examination and image-based telemedical interpretation for retinopathy of prematurity (ROP) diagnosis, when performed by the same expert physician grader. DESIGN Prospective, nonrandomized, comparative study. PARTICIPANTS Sixty-seven consecutive premature infants who underwent ROP examination at a major university medical center whose parents consented for participation. METHODS Infants underwent standard dilated ophthalmoscopy by one of two pediatric ophthalmologists, followed by retinal imaging with a commercially available wide-angle fundus camera by a trained neonatal nurse. Study examinations were performed at 31 to 33 weeks postmenstrual age (PMA) and/or 35 to 37 weeks PMA. Images were uploaded to a Web-based telemedicine system developed by the authors. After a 4- to 12-month period, telemedical interpretations were performed in which each physician graded images from infants upon whom he had initially performed ophthalmoscopic examinations. Diagnoses were classified using an ordinal scale: no ROP, mild ROP, type 2 prethreshold ROP, and treatment-requiring ROP. MAIN OUTCOME MEASURES Absolute intraphysician agreement and kappa statistic between ophthalmoscopic examination and telemedical interpretation were calculated by eye. All intraphysician discrepancies were reviewed, and underlying causes were classified by eye as no ROP identified by ophthalmoscopic examination, no ROP identified by telemedical interpretation, discrepancy about presence of zone 1 ROP, discrepancy about presence of plus disease, or other discrepancy in classification of ROP stage. RESULTS Absolute intraphysician agreement between ophthalmoscopic examination and telemedical interpretation was 86.3%. The kappa statistic for intraphysician agreement between examinations ranged from 0.657 (substantial agreement) for diagnosis of treatment-requiring ROP to 0.854 (near-perfect agreement) for diagnosis of mild or worse ROP. Among 206 eye examinations (103 infant examinations), there were 28 (13.6%) intraphysician discrepancies in diagnosis, 8 of which resulted from uncertainty about presence of zone 1 disease and 4 from uncertainty about presence of plus disease. CONCLUSIONS Intraphysician agreement between ophthalmoscopic examination and telemedical interpretation for ROP was very high. Neither examination modality appeared to have a systematic tendency to overdiagnose or underdiagnose ROP. Diagnosis of zone 1 disease and plus disease were major sources of clinically significant discrepancies.

Breaking the translational barriers: the value of integrating biomedical informatics and translational research.

The conduct of translational health research has become a vital national enterprise. However, multiple barriers prevent the effective translation of basic science discoveries into clinical and community practice. New information technology (IT) applications could help address these barriers. Unfortunately, owing to a combination of organizational, technical, and social factors, neither physician-investigators and research staff nor their clinical and community counterparts have harnessed such applications. Recently, at the request of the Institute of Medicines Clinical Research Roundtable, a qualitative study of these factors was conducted at several leading academic medical centers. We explore the current status of IT in the translational research domain, describe the qualitative results, and conclude with a proposed set of initiatives to further increase the integration of IT into translational research.

Importance of multi-modal approaches to effectively identify cataract cases from electronic health records

OBJECTIVE There is increasing interest in using electronic health records (EHRs) to identify subjects for genomic association studies, due in part to the availability of large amounts of clinical data and the expected cost efficiencies of subject identification. We describe the construction and validation of an EHR-based algorithm to identify subjects with age-related cataracts. MATERIALS AND METHODS We used a multi-modal strategy consisting of structured database querying, natural language processing on free-text documents, and optical character recognition on scanned clinical images to identify cataract subjects and related cataract attributes. Extensive validation on 3657 subjects compared the multi-modal results to manual chart review. The algorithm was also implemented at participating electronic MEdical Records and GEnomics (eMERGE) institutions. RESULTS An EHR-based cataract phenotyping algorithm was successfully developed and validated, resulting in positive predictive values (PPVs) >95%. The multi-modal approach increased the identification of cataract subject attributes by a factor of three compared to single-mode approaches while maintaining high PPV. Components of the cataract algorithm were successfully deployed at three other institutions with similar accuracy. DISCUSSION A multi-modal strategy incorporating optical character recognition and natural language processing may increase the number of cases identified while maintaining similar PPVs. Such algorithms, however, require that the needed information be embedded within clinical documents. CONCLUSION We have demonstrated that algorithms to identify and characterize cataracts can be developed utilizing data collected via the EHR. These algorithms provide a high level of accuracy even when implemented across multiple EHRs and institutional boundaries.