New York University Medical School
Division of Internal Medicine
VOLUNTEER RESEARCH OPPORTUNITY
Our externally funded multidisciplinary research team has positions available for summer interns. We are looking for highly responsible, organized psychology major or pre-med students who are interested in pursuing careers in medicine, psychology, clinical research, and related fields.
The individual would be responsible for assisting in recruitment and data management in ongoing research studies evaluating different behavioral approaches to improve cardiovascular risk factor control. The intern would also participate in organization of study materials, administrative duties, and literature searches. The individual will have opportunities to aid in patient recruitment, to observe patient intake and baseline interviews, and to participate in research team meetings. As part of the position, they will be involved in academic deliberations involving a multidisciplinary group that includes individuals with expertise in medicine, psychology, epidemiology, statistics, health education, economics, etc. The interns are able to join in conducting the research, and in preparing for presentation and publication. As such, the intern can expect to be named as coauthors on any material to which they make a substantial contribution. For example, at the NYU Medicine Research Day in May 2009, four of our interns presented abstracts at the meeting. They have also been coauthors of abstracts at large national meetings.
The applicant must be a rising sophomore, junior, or senior undergraduate in college, and should be pursuing a psychology major, nutrition major, pre-med concentration, or something of a similar nature. Research experience and completion of a Research Methods or Statistics course are preferred, but not necessary. The position requires that the applicant be available for at least 20 hours a week during business hours over the summer, negotiable depending on their availability and our need. Interns are also highly encouraged to continue into the fall semester for at least 10 hours a week during business hours. The position, which is an un paid position at the VA Medical Center, would start in May or early June. This is an excellent research opportunity for students planning on applying to graduate programs in Clinical/Health Psychology or medical school.
To apply, please send a cover letter and resume before March 29th, 2010 to sundar.natarajan@med.nyu.edu [Sundar Natarajan, MD, MSc] or to Jennifer.Friedberg@med.nyu.edu [Jennifer Friedberg, PhD]. Interviews will be conducted once all applications are received. Candidates will be notified mid-late April.
A BEHAVIORAL INTERVENTION TO IMPROVE HYPERTENSION CONTROL
BACKGROUND/RATIONALE:
High blood pressure (BP) is the most common chronic condition among patients. It greatly increases their risk for cardiovascular disease (CVD) and kidney failure. Diet, exercise and medications are primary therapy with the target BP being < 140/90 mm Hg. Though the effectiveness of hypertension control (Systolic BP [SBP] < 140 mm Hg and diastolic BP [DBP] <90 mm Hg) in preventing CVD is well established, a significant gap exists between ideal control rates and what is actually achieved. Insufficient treatment adherence contributes to poor BP control, and clinicians are faced with the difficult challenge of motivating their patients to exercise, diet, and take drugs as prescribed. Despite the relative ease and low cost of treating high BP, and despite being prescribed treatment, many patients remain non adherent and have uncontrolled hypertension. This proposal is a direct consequence of a previous pilot project targeted at optimizing hypertension control in patients and builds on previous research that demonstrates the feasibility of this approach. We propose a randomized controlled trial (RCT) at 2 Medical Centers to evaluate the effect of a telephone-delivered Transtheoretical stage-matched intervention to improve hypertension control in patients with uncontrolled BP. The study addresses three important healthcare priority areas: 1) Telemedicine, 2) Patient-Centered Care, and 3) Implementation of clinical practice guidelines while targeting a chronic condition of enormous importance, hypertension.
OBJECTIVE(S):
The specific aims of the study are: 1) To determine whether a stage-matched intervention (SMI) will lower BP at 6 months compared to usual care (UC) or a health education intervention (HE1) in patients with uncontrolled hypertension 2) To evaluate whether the SMI is effective in improving adherence to exercise, diet, or medications at 6 months in participants who receive the SMI compared to participants who receive UC or HEI 3) To assess whether patients randomized to the SMI achieve sustained benefit to significantly lower BP and improve adherence 6 months after intervention completion (i.e., 12 months after randomization) compared to those on UC or HEI. 4) To examine the effect of SMI on patient’s health-related quality of life, satisfaction, and acceptability. 5) To determine the cost-effectiveness of the SMI
METHODS:
Patients with uncontrolled hypertension will be randomized equally to 3 groups: 1) The Stage-Matched Intervention (SMI) will use the Transtheoretical model (TTM) as the overall study framework (constructs: stages of change, decisional balance, and self-efficacy), while also incorporating key aspects of Bandura’s social cognitive theory, behavioral self-management and the skills model of adherence. Delivery of the behavioral intervention will be by phone. Patients in this group will receive TTM stage-matched counseling for exercise, diet, and medications via monthly telephone counseling sessions based on current stage. A counselor will assess each participant’s current stage for each behavior and use a previously developed and tested computerized system to deliver the appropriate standardized SMI. The SMI will be based on the processes of change tailored to each patients responses to the stage of change, decisional balance and self-efficacy. 2) The Health Education Intervention (HEI) group receives monthly telephone calls by a counselor during which they will receive education about hypertension management, and 3) The Usual Care (UC) group participates in all the in-person visits but does not receive monthly calls. The randomized participants will be followed for a total of 12 months. There will be an initial 6-month active intervention phase following which the intervention will be stopped and patients will be followed for another 6 months to assess sustainability of the intervention. Participants will make in-person visits at baseline and at 3, 6, and 12 months. BP, the primary outcome, will be measured from several BP readings (at least 5 mm apart), and analyzed as categorical (controlled or not) or continuous. Secondary outcomes include adherence to diet, exercise and medications; quality of life; satisfaction; acceptability; cost and cost-effectiveness. In order to preserve the benefits of randomization and guard against bias, the study will be analyzed using longitudinal data analysis methods using an “intention to treat” strategy.
FINDINGS/RESULTS:
This study has started enrolling patients and enrollment will be complete by April, 2009 with additional follow-up until October, 2009. Final results will be reported after all the data have been collected and analyzed. Baseline analyses are being conducted.
IMPACT:
This project builds on previous research to test the effect of SMI in lowering BP by improving adherence to antihypertensive therapy (medication, exercise, and diet). It may provide the scientific rationale, not only for using such interventions to improve BP control, but also for other conditions where sustained adherence is a problem. This could be an efficient and cost-effective way to enhance treatment adherence and improve outcomes- among patients living at a distance. This research may also influence future health behavior studies in patients to achieve better clinical outcomes.
PUBLICATIONS:
Several abstracts have been presented at national meetings, 1 paper is in press and several others are under review.
Targeting Adherence to Cholesterol-lowering Treatment to Improve Control Study (TACTICS)
Background: This is a randomized controlled trial (RCT) of two novel behavioral interventions to enhance treatment adherence and improve low-density lipoprotein cholesterol (LDL) in diabetes. Among adults with diabetes, high LDL greatly increases their risk for cardiovascular disease (CVD). Despite the proven efficacy of LDL control (<100 mg/dL) in preventing CVD, the control rate is low. Poor adherence to treatment (diet, exercise and medication) is the main reason for this poor control.
Aims: This study will test two telephone-delivered interventions, a Transtheoretical stage-matched intervention (SMI) and a prospect theory-based framing effects intervention (FEI). We hypothesize that both SMI and FEI will be more effective in
improving LDL control than an attention placebo intervention (API) at 6 months. SMI and FEI will also be more effective in increasing adherence to medications, diet and exercise than API at 6 months. Methods: We will recruit 246 adults with diabetes and high LDL despite being on medications. Key outcomes are adherence to diet, exercise and medication, and LDL control. The interventions will be standardized and fidelity of intervention maintained. Using a blinded RCT we will test the effect of SMI and FEI compared to API on LDL control and adherence. All analyses will be intent to treat. Significance: This project will provide important information to improve diabetes-related behavior and lead to the implementation of novel interventions for lowering LDL in primary care settings among adults with diabetes. It may also provide the scientific rationale to use such approaches to control other risk factors in diabetes.
The PREVENTS Trial: Preventing Recurrent Events in Veterans Navigating TIA or Stroke Trial
National recommendations state that patients with a history of transient ischemic attack (TIA) or ischemic stroke should receive hypertension treatment, including antihypertensive medication and lifestyle modification, with a goal of reducing blood pressure (BP) to <120 mm Hg systolic BP and <80 mm Hg diastolic BP. Statin treatment and lifestyle modification is also recommended for post-stroke and post-TIA patients with elevated cholesterol levels or a history of stroke or TIA with an atherosclerotic cause. Despite the clear benefits of secondary stroke prevention, there is a gap between evidence and implementation in clinical practice. By a randomized controlled trial, we will test whether a tailored, telephone-delivered behavioral intervention will improve adherence to treatment in veterans with a history of TIA or stroke, thereby leading to better control of BP and cholesterol levels, as compared to an attention placebo. The primary specific aims of this project are to: 1) determine whether a behaviorally tailored intervention (TI) can effectively lower BP after 6 months of counseling as compared to an attention placebo (AP) in veterans with a history of stroke or TIA; and 2) assess whether the TI is effective in improving adherence to diet after 6 months of counseling in veterans with a history of stroke or TIA. Secondary aims are to a) assess whether the TI is effective in improving cholesterol levels in post-stroke veterans after 6 months; b) evaluate whether the TI is effective in improving adherence to antihypertensive and lipid-lowering medications after 6 months of counseling in veterans with a history of stroke or TIA; and c) determine whether the TI is effective in improving adherence to exercise recommendations after 6 months. To answer this, veterans with a history of stroke or TIA will be randomized equally to the TI, which will use the transtheoretical model framework to provide 6 monthly counseling phone sessions about adherence to diet, medication, and exercise recommendations, and the AP, in which 6 monthly counseling phone sessions about non-stroke-related health topics will be provided. Participants will make in-person visits at baseline and 6 months. BP and dietary sodium are the primary outcomes, while secondary outcomes will be total cholesterol/high density lipoprotein ratio, adherence to antihypertensive and lipid lowering drugs, and exercise adherence.
VALOR in Heart Failure Study
Heart failure (HF) greatly increases mortality and lowers quality of life (QOL). HF is the most common indication for readmission in older adults and the most frequent reason for 30-day readmission. Medications and restriction of dietary sodium constitute crucial therapy to lower HF recurrence. However, adherence to medications and dietary recommendations is low in HF patients. Non adherence is often due to an interaction among the environment, the patient and providers.
In the VALOR in Heart Failure Study, we will assess a novel intervention to improve HF care using a pretest-posttest design. This interdisciplinary theory-based prospective experimental study will target improving HF treatment using patient-based behavioral and checklist intervention, as well as provider and system-targeted checklists and treatment defaults (posttest or intervention phase); this will be compared to current best practice evaluated in the pretest (pretest or pre-intervention) phase. It is hypothesized that the QIP, which intervenes on patient, provider and system levels, will lower HF recurrence compared to CBP. The primary specific aims are 1) To test the effect of QIP on the 30 day post-discharge HF readmission rate, and 2) To evaluate the effect of QIP on the rate of 30 day emergency room visits. Secondary specific aims are to: 1) determine the impact of QIP on quality of life, 2) evaluate the effect of QIP on medication adherence at 3 months, 3) examine the effect of QIP on diet adherence at 3 months, 4) evaluate the effect of QIP on satisfaction, and 5) assess the effect of QIP on intervention acceptability. We will also seek to determine the impact of QIP at 3 months on keeping routine outpatient visits, health-care utilization, exercise capacity, weight, perceived stress, depression, cardiovascular events and deaths. We will enroll 518 patients being discharged from the hospital with a diagnosis of HF. Patients enrolled in the pretest phase (1-4.5 months of the study) will receive the HF management based on current best practice (CBP). Patients enrolled in the posttest phase (4.5-8 months of the study) will receive comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients’ self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients. Data, including quality of life (QOL), medication adherence, and dietary adherence, will be collected from patients at baseline (prior to hospital discharge) and 3 months. Hospital readmissions, emergency room visits, and healthcare utilization will also be tracked for 3 months. If, as expected, there are no differences in demographic or other confounders (EF, comorbidities, etc), the pretest and posttest groups will be compared by the Fisher’s Exact test for discrete outcomes (30-day readmissions or ER visits). For the secondary outcomes and for the exploratory aims, we will use the Student's t-test (two-tailed) for normally distributed outcomes and the Wilcoxon rank-sum test for categorical variables and continuous variables not normally distributed. This study will inform and enhance quality improvement efforts in heart failure care. It will also provide data for a rigorous effectiveness trial to test this promising intervention that could reduce HF recurrence and improve QOL in HF. If this promising theory-driven approach can work in a clinical setting where improvements in HF care are so urgent, it will be an important scientific contribution.
