Faculty Bibliography

Geriatric syndromes are common in hospitalized elders with heart failure (HF), but association with clinical outcomes is not well characterized. The purpose of this study (N = 289) was to assess presence of geriatric syndromes using Joint Commission-mandated measures, the Braden Scale (BS) and Morse Fall Scale (MFS), and to explore prognostic utility in hospitalized HF patients. Data extracted from the electronic medical record included sociodemographics, medications, clinical data, comorbid conditions, and the BS and MFS. The primary outcome of mortality was assessed using Social Security Death Master File. Statistical analysis included Cox proportional hazards models to assess association between BS and MFS scores and all-cause mortality with adjustment for known clinical prognostic factors. Higher risk BS and MFS scores were common in hospitalized HF patients, but were not independent predictors of survival. Further study of the clinical utility of these scores and other measures of geriatric syndromes in HF is warranted.

BACKGROUND: Heart failure (HF) is the leading cause of hospitalization among US adults, significant increasing mortality and reducing quality of life. Most importantly, prognosis following HF is dismal, being worse than that for most cancers. This population-based observational study evaluates the mortality outcomes for individuals hospitalized for incident heart failure and elucidates the impact of co-existing clinical conditions on mortality. METHODS: We identified participants admitted for heart failure from the NHEFS cohort of 14,407 adults. They were followed from their initial interview (1971-1975) until their last interview in 1992. Information regarding cardiovascular disease risk factors was collected at each interview. Health care facility stay data was used to identify hospitalizations and diagnosis of incident HF. Mortality before last interview was determined using information from the National Death Index-linked mortality file. The relationship between comorbidities and mortality was evaluated using: a) median survival time (with 95% confidence intervals [CI])) from life table analyses for the unadjusted analyses, and b) hazard ratios (with 95% CI) from Cox proportional-hazards models that adjusted for age, sex, race, and education. All analyses incorporated the complex sampling design (strata, cluster, and weight variables) to provide population estimates. RESULTS: Our analysis focused on the sample of 1080 participants who survived their incident CHF-related event. Their median age was 72.2 years (interquartile range 64.6-78.1), 506 (46.8%) participants were male, 89.3% were white, and 37.2% did not complete high school. Median follow-up time was 14.96 years. Diabetes mellitus (DM) was present in 23.5%, hypertension (HTN) in 14.4%, hyperlipidemia in 45.0%, and prior myocardial infarction (MI) in 23.6%. Median survival time (with 95% CI) was lower for individuals with DM [0.73 (0.48-1.07) years with DM vs. 2.04 (1.46-2.58) years without DM, p = 0.002] and prior MI [1.42 (0.79-2.16) with prior MI vs. 1.64 (1.25- 2.30) without MI, p = 0.004]. There was no significant difference in median survival time for hypertension [0.96 (0.69-1.60) with HTN vs. 1.67 (1.39- 2.19) without HTN, p = 0.833] or hyperlipidemia [1.37 (1.00-2.03) with hyperlipidemia vs. 1.62 (1.30-2.41) without hyperlipidemia, p = 0.321]. Participants with DM (HR = 1.82 (1.39-2.37), p < .0001), hypertension (HR = 1.45 (1.05-2.15), p = 0.028) and hyperlipidemia (HR = 1.37 (1.06- 1.77), p = 0.015) were at very high risk for mortality using multivariable Cox models adjusting for age, sex, race, and education. CONCLUSIONS: Participants with diabetes had the highest mortality after incident HF. In both adjusted and unadjusted analyses, patients with diabetes had significantly worse outcomes than those with other conditions. Patients with diabetes should be targeted for HF prevention and if HF develops, they should be the focus of intense monitoring and treatment

BACKGROUND: United States Veterans are at excess risk for Type 2 diabetes and early mortality. Our objective is to determine the impact of prediabetes and related risk factors on the occurrence of diabetes and mortality in this at-risk population. METHODS: At the primary care practices of the VA New York Harbor (VA NYHHS) during 2004-2014, we identified 15,173 diabetes-free Veterans, among those who received 2 or more hemoglobin A1c tests (HbA1c). Among these participants, we identified 14,361 veterans with HbA1c values below the diabetic range (i.e., <6.5% HbA1c) and characterized these individuals with respect to selected risk factors. We followed these individuals through 2014 for incident diabetes and all-cause mortality. Cox proportional hazard regression was used to relate HbA1c levels, age, sex, race/ethnicity, anthropometric measures, and comorbid cardiovascular conditions (ischemic heart disease, cerebral vascular accident, congestive heart failure and peripheral vascular disease) to incident diabetes and all-cause mortality (Hazard Ratio [HR] and 95% confidence intervals). RESULTS: Among 8,145 Veterans with prediabetes (HbA1c 5.7-6.4%), 1,170 (14.4%) developed diabetes and 1,139 (14%) died during the course of follow-up. Compared to 5,292 normoglycemic Veterans (HbA1c: 5.0-5.6%), 4,207 prediabetics in the moderate risk group (HbA1c 5.7-5.9%) had a greater than 2-fold increased risk of incident diabetes (HR 2.46 [2.08-2.92]), and those 3,938 in the prediabetic high risk group (HbA1c 6.0-6.4%) had a greater than 5-fold risk (HR 5.70 [4.88-6.65]). Furthermore, all-cause mortality was increased in 924 participants with low glycemia (HbA1c <5.0%: HR 1.40 [1.17- 1.68]) and among those 812 in the diabetes risk range (HbA1c >6.5%:HR 1.44 [1.22-1.71]) compared with the normoglycemic group. Excess all-cause mortality was not observed among the prediabetic group, compared to the normoglycemic group. CONCLUSIONS: Among Veterans, prospective risk of transition to Type 2 diabetes ranged from 2.5-fold to 5.7-fold among prediabetics, depending on HbA1c level. Patients with HbA1c < 5.0 and those in the diabetic range had increased risks of all-cause mortality, while prediabetics showed no excess mortality. The higher risk population (HbA1c 6.0-6.4%) is an important group to target with diabetes prevention efforts

BACKGROUND: In order to generate valid results in RCTs, it is important to collect unbiased data. Behavioral intervention trials are more difficult to blind than pharmacologic trials. In our ongoing behavioral trial, PATRIOT, which aims to prevent foot complications in diabetes through improved self-care, we are intervening both face-to-face as well as remotely. Consequently blinding is more difficult. Here we illustrate the different blinding processes used. METHODS: In the PATRIOT trial, following randomization during the baseline visit, the intervention group receives computer-based education and demonstration on how to use a special foot thermometer. Following that, intervention participants receive a comprehensive intervention that includes regular telephone counseling and tailored mailings. The control group receives health prevention strategies not related to foot care. For this complex intervention, we needed to develop new strategies to maintain blinding at the participant, research assistant (RA), counselor, outcome adjudicator and data analyst levels. We created a "Blinding Tracker" to identify unblinded and blinded staff so that participants pass from unblinded to blinded staff so that only blinded staff collect data. The integrity of the study is maintained by careful monitoring of blinding with any break in blinding being contained. RESULTS: To date, we have enrolled 221 participants. While participants know the arm to which they are randomized, we needed to make sure that the staff collecting data are blinded. Participants are educated throughout the whole study process by the telephone counselors about the importance of blinding using non-scientific descriptions. Though the counselors know their participant's treatment assignment, they do not know their foot photography results and other outcomes. The RA's, who conduct study visits and collect data, are blinded to treatment assignment. To improve efficiency and preserve blinding, we have different RAs for different phases of a participant's progress. Initially, RAs are initially blinded, but by the end of their involvement with a particular subject, when data collection is done, they become unblinded so they can show the educational videos and demonstrate foot thermometer use. However, RA's can also become unblinded prematurely. To date, out of 96 six-month visits, there have been 26 such instances. RAs are subsequently transitioned off a particular subject to be replaced by a blinded RA. We will also control for RA blinding in the analysis. The adjudicators who read the foot photographs to determine outcomes and the statisticians are blinded to treatment assignment. CONCLUSIONS: Novel techniques have been used to achieve and maintain blinding, but it is resource intensive. While conducting complex trials, vigilance and responsiveness are needed. Finally, blinding information should be incorporated in the analysis in order to get the most valid results

BACKGROUND: Diabetes patients are usually started on a low dose of insulin and their dose is adjusted or "titrated" according to their blood glucose levels. Insulin titration administered through face-to-face visits with a clinician can be time consuming and logistically burdensome for patients, especially those of low socioeconomic status (SES). Given the wide use of mobile phones among this population, there is the potential to use short message service (SMS) text messaging and phone calls to perform insulin titration remotely. OBJECTIVE: The goals of this pilot study were to (1) evaluate if our Mobile Insulin Titration Intervention (MITI) intervention using text messaging and phone calls was effective in helping patients reach their optimal insulin glargine dose within 12 weeks, (2) assess the feasibility of the intervention within our clinic setting and patient population, (3) collect data on the cost savings associated with the intervention, and (4) measure patient satisfaction with the intervention. METHODS: This was a pilot study evaluating an intervention for patients requiring insulin glargine titration in the outpatient medical clinic of Bellevue Hospital Center in New York City. Patients in the intervention arm received weekday SMS text messages from a health management platform requesting their fasting blood glucose values. The clinic's diabetes nurse educator monitored the texted responses on the platform website each weekday for alarm values. Once a week, the nurse reviewed the glucose values, consulted the MITI titration algorithm, and called patients to adjust their insulin dose. Patients in the usual care arm continued to receive their standard clinic care for insulin titration. The primary outcome was whether a patient reached his/her optimal insulin glargine dose within 12 weeks. RESULTS: A total of 61 patients consented and were randomized into the study. A significantly greater proportion of patients in the intervention arm reached their optimal insulin glargine dose than patients in the usual care arm (88%, 29/33 vs 37%, 10/27; P<.001). Patients responded to 84.3% (420/498) of the SMS text messages requesting their blood glucose values. The nurse reached patients within 2 attempts or by voicemail 91% of the time (90/99 assigned calls). When patients traveled to the clinic, they spent a median of 45 minutes (IQR 30-60) on travel and 39 minutes (IQR 30-64) waiting prior to appointments. A total of 61% (37/61) of patients had appointment copays. After participating in the study, patients in the intervention arm reported higher treatment satisfaction than those in the usual care arm. CONCLUSIONS: MITI is an effective way to help low-SES patients reach their optimal insulin glargine dose using basic SMS text messaging and phone calls. The intervention was feasible and patients were highly satisfied with their treatment. The intervention was cost saving in terms of time for patients, who were able to have their insulin titrated without multiple clinic appointments. Similar interventions should be explored to improve care for low-SES patients managing chronic disease. TRIAL REGISTRATION: Clinicaltrials.gov NCT01879579; https://clinicaltrials.gov/ct2/show/NCT01879579 (Archived by WebCite at http://www.webcitation.org/6YZik33L3).