Educational videos to reduce racial disparities in ICD therapy via innovative designs (VIVID): a randomized clinical trial.

BACKGROUND: Black individuals eligible for an implantable cardioverter/defibrillator (ICD) are considerably less likely than white individuals to receive one. This disparity may, in part, be explained by racial differences in patient preferences. We hypothesized that a targeted patient-centered educational video could improve knowledge of sudden cardiac arrest (SCA) and ICDs and reduce racial differences in ICD preferences. We conducted a pilot study to assess the feasibility of testing this hypothesis in a randomized trial. METHODS: We created a video that included animation, physician commentary, and patient testimonials on SCA and ICDs. The primary outcome was the decision to have an ICD implanted as a function of race and intervention. Between January 1, 2011, and December 31, 2011, 59 patients (37 white and 22 black) were randomized to the video or health care provider counseling/usual care. RESULTS: Relative to white patients, black patients were younger (median age, 55 vs 68 years) and more likely to have attended college or technical school. Baseline SCA and ICD knowledge was similar and improved significantly in both racial groups after the intervention. Black patients viewing the video were as likely as white patients to want an ICD (60.0% vs 79.2%, P = .20); and among those in the usual care arm, black patients were less likely than white patients to want an ICD (42.9% vs 84.6% P = .05). CONCLUSION: Among individuals eligible for an ICD, a video decision aid increased patient knowledge and reduced racial differences in patient preference for an ICD.

Depression and antidepressant use after stroke and transient ischemic attack.

BACKGROUND AND PURPOSE: Patients with stroke and transient ischemic attack (TIA) often have comparable comorbidities, but it is unclear whether they have similar rates of depression or antidepressant use. METHODS: This study was a secondary analysis of a prospective cohort registry that enrolled subjects from 2006 to 2008 in the United States. Depression (defined by the Patient Health Questionnaire-8 score ≥ 10) and medication use were prospectively assessed 3 and 12 months after hospitalization in 1450 subjects with ischemic stroke and 397 subjects with TIA. RESULTS: The proportional frequency of depression after stroke and TIA was similar at 3 months (17.9% versus 14.3%, P=0.09) and at 12 months (16.4% versus 12.8%, P=0.08). The rates of newly identified depression between 3 and 12 months were also similar (8.7% versus 6.2%, P=0.12). Persistent depression (defined as Patient Health Questionnaire-8 score ≥ 10 at both 3 and 12 months) was present in 134 (9.2%) of those with stroke and in 30 (7.6%) of those with TIA. Younger age, greater stroke-related disability, and inability to work at 3 months were associated with persistent depression in subjects with stroke. Among subjects with persistent depression, 67.9% of those with stroke and 70.0% of those with TIA were not using antidepressants at either time point (P=0.920). CONCLUSIONS: Stroke and TIA subjects had a similar frequency of depression at 3 and 12 months after hospitalization and similar rates of newly identified depression between 3 and 12 months. A high proportion of those with persistent depression was untreated.

Is heart failure guideline adherence being underestimated? The impact of therapeutic contraindications.

BACKGROUND: Several studies based on claims data have reported underutilization of evidence-based heart failure (HF) therapies. The degree to which these estimates fail to account for therapeutic contraindications is unclear. METHODS: We identified patients with HF and left ventricular ejection fraction ≤45% seen between January 1, 2010, and July 1, 2010, at a tertiary care Veterans Affairs Medical Center. Medical records were abstracted to evaluate utilization of and contraindications to ß-blocker, angiotensin-converting enzyme inhibitor, aldosterone antagonist, anticoagulation for atrial fibrillation, implantable cardioverter-defibrillator, and cardiac resynchronization therapies. RESULTS: Of the 178 patients with HF and an ejection fraction ≤45%, 78 (44%) received every guideline-recommended therapy. After accounting for medical contraindications, 77 (72%) of 107 patients received every guideline-recommended therapy. Adherence to recommendations for ß-blocker (98%), angiotensin-converting enzyme inhibitor/angiotensin blocker (95%), and anticoagulation (97%) were better than adherence to implantable cardioverter-defibrillator (82%), cardiac resynchronization therapy (59%), or aldosterone antagonist (51%) recommendations. In adjusted analysis, lower New York Heart Association functional class and care by a cardiologist were associated with improved guideline adherence (P < .001). CONCLUSIONS: Many patients with HF have therapeutic contraindications, and a failure to account for these may lead to a large underestimation of the true guideline adherence rates.

Medication coaching program for patients with minor stroke or TIA: a pilot study.

BACKGROUND: Patients who are hospitalized with a first or recurrent stroke often are discharged with new medications or adjustment to the doses of pre-admission medications, which can be confusing and pose safety issues if misunderstood. The purpose of this pilot study was to assess the feasibility of medication coaching via telephone after discharge in patients with stroke. METHODS: Two-arm pilot study of a medication coaching program with 30 patients (20 intervention, 10 control). Consecutive patients admitted with stroke or TIA with at least 2 medications changed between admission and discharge were included. The medication coach contacted intervention arm patients post-discharge via phone call to discuss risk factors, review medications and triage patients' questions to a stroke nurse and/or pharmacist. Intervention and control participants were contacted at 3 months for outcomes. The main outcomes were feasibility (appropriateness of script, ability to reach participants, and provide requested information) and participant evaluation of medication coaching. RESULTS: The median lengths of the coaching and follow-up calls with requested answers to these questions were 27 minutes and 12 minutes, respectively, and participant evaluations of the coaching were positive. The intervention participants were more likely to have seen their primary care provider than were control participants by 3 months post discharge. CONCLUSIONS: This medication coaching study executed early after discharge demonstrated feasibility of coaching and educating stroke patients with a trained coach. Results from our small pilot showed a possible trend towards improved appointment-keeping with primary care providers in those who received coaching.

Do physicians' attitudes toward implantable cardioverter defibrillator therapy vary by patient age, gender, or race?

BACKGROUND: Implantable cardioverter defibrillator (ICD) therapy improves survival of patients with systolic heart failure. We assessed whether physicians' recommendation for ICD therapy varies as a function of patient age, gender, race, and physician's specialty. METHODS: We surveyed a random sample (n = 9969) of U.S. physicians who are active members of the American College of Cardiology (ACC). We asked participants about their likelihood to recommend ICD therapy in 4 clinical scenarios that randomly varied patient age, gender, race, and ICD indication (guideline Class I, Class IIa, Class III, and Class I in a noncompliant patient). RESULTS: Responses were received from 1210 physicians (response rate 12%), of whom 1127 met the study inclusion criteria. Responders and nonresponders had similar demographics. In responding to hypothetical clinical scenarios, physicians were less likely to recommend an ICD to older patients (≥80 vs 50 years) (P < 0.01) but were unaffected by gender or race for all class indications. Compared with non-electrophysiologists (EPs), EPs were significantly more likely to recommend an ICD for a Class I indication (92.4% vs 81.4%; P < 0.01), but they were not more likely to offer an ICD for a Class III indication (0.4% vs 0.6%; P = 0.95). CONCLUSIONS: Based on survey responses, physicians were equally willing to offer an ICD to men and women and to whites and blacks, but were less likely to offer an ICD to an older patient even when indicated by practice guidelines. Electrophysiologists (EPs) more often adhered to practice guideline recommendations on ICD therapy compared with non-EPs.

A phase II randomized trial of amphotericin B alone or combined with fluconazole in the treatment of HIV-associated cryptococcal meningitis.

BACKGROUND: Cryptococcosis is a life-threatening infection among patients with human immunodeficientcy virus (HIV) infection. Therapeutic options for the treatment of central nervous system cryptococcosis are limited, especially in resource-limited settings. METHODS: We conducted a randomized, open-label, phase II trial in Thailand and the United States that compared the safety and efficacy of intravenous amphotericin B deoxycholate (AmB) 0.7 mg/kg (the standard therapy) with that of AmB 0.7 mg/kg plus fluconazole 400 mg (the low-dosage combination) or AmB 0.7 mg/kg plus fluconazole 800 mg (the high-dosage combination) administered daily for 14 days, followed by fluconazole alone at the randomized dosage (400 or 800 mg per day) for 56 days. The primary safety end point was the number of severe or life-threatening treatment-related toxicities; the primary efficacy end point was a composite of survival, neurologic stability, and negative cerebrospinal fluid culture results after 14 days of therapy. RESULTS: A total of 143 patients were enrolled. There were no differences in treatment-related toxicities among the 3 arms. Toxicity was predictable and was most often related to AmB, and it included electrolyte abnormalities, anemia, nephrotoxicity, and infusion-related events. At day 14, 41%, 27%, and 54% of patients in the standard therapy, low-dosage combination, and high-dosage combination therapy arms, respectively, demonstrated successful outcomes. A trend towards better outcomes in the combination therapy arms was seen at days 42 and 70. CONCLUSIONS: AmB plus fluconazole administered at a dosage of 800 mg for 14 days, followed by fluconazole administered at a dosage of 800 mg daily for 56 days, is well-tolerated and efficacious among HIV-positive patients with central nervous system cryptococcosis. These results have significant treatment implications and should be validated in a randomized phase III trial.

Development and initial testing of the stroke rapid-treatment readiness tool.

No instruments are currently available to help health systems identify target areas for reducing door-to-needle times for the administration of intravenous tissue plasminogen activator to eligible patients with ischemic stroke. A 67-item Likert-scale survey was administered by telephone to stroke personnel at 252 U.S. hospitals participating in the "Get With The Guidelines-Stroke" quality improvement program. Factor analysis was used to refine the instrument to a four-factor 29-item instrument that can be used by hospitals to assess their readiness to administer intravenous tissue plasminogen activator within 60 minutes of patient hospital arrival.

An evaluation of stroke education in AVAIL registry hospitals.

The purpose of this study is to explore factors associated with recall of medication education and satisfaction with healthcare provider communication in patients with acute stroke or transient ischemic attack. This is an analysis of data from the AVAIL (Adherence Evaluation of Acute Ischemic Stroke Longitudinal) study. At 3 months after discharge, 2,219 stroke patients from 99 sites were interviewed and asked about their perceptions of education and communication with their healthcare providers as well as their current medication use and knowledge. Results show that less than 2% of the respondents reported not understanding how to take their medications, 4% did not know how to refill their medications, and 5% did not know the reason they were taking them. A vast majority (92%) of participants reported high levels of satisfaction in their communications with healthcare providers after discharge. Although overall understanding and satisfaction was high, older subjects were less likely to recall receiving medication information at discharge or to understand their medications. Similarly, African Americans and patients discharged from an academic hospital were less likely to report receiving a written medication list. This report highlights the success of education efforts and potential areas for additional improvement.

Similar secondary stroke prevention and medication persistence rates among rural and urban patients.

PURPOSE: Rural residents are less likely to obtain optimal care for many serious conditions and have poorer health outcomes than those residing in more urban areas. We determined whether rural vs urban residence affected postdischarge medication persistence and 1 year outcomes after stroke. METHODS: The Adherence eValuation After Ischemic Stroke-Longitudinal (AVAIL) study is a multicenter registry of stroke patients enrolled in 101 hospitals nationwide. Medications were recorded at hospital discharge and again after 3 and 12 months. Persistence was defined as continuation of prescribed discharge medications. Participants were categorized as living in rural or urban settings by cross-referencing home ZIP code with metropolitan statistical area (MSA) designation. FINDINGS: Rural patients were younger, more likely to be white, married, smokers, and less likely to be college graduates. There was no difference in stroke type or working status compared to urban patients, and there were minor differences in comorbid conditions. There were no differences based on rural vs urban residence in medication persistence at 3 or 12 months postdischarge and no differences in outcomes of recurrent stroke or rehospitalization at 12 months. CONCLUSION: Despite differences in patient characteristics, there was no difference in medication persistence or outcomes between rural and urban dwellers after hospitalization for ischemic stroke or transient ischemic attack (TIA).

A qualitative assessment of practices associated with shorter door-to-needle time for thrombolytic therapy in acute ischemic stroke.

Early treatment with intravenous (IV) recombinant tissue plasminogen activator/alteplase (tPA) is associated with improved outcomes for patients with an acute ischemic stroke. Thus, rapid triage and treatment of stroke patients are essential, with a goal of door-to-needle time of no more than 60 minutes. We sought to identify best practices associated with faster treatment among hospitals participating in Get With the Guidelines--Stroke. Qualitative telephone interviews were conducted to elicit strategies being used by these centers to assess, treat, and monitor stroke patients treated with IV tPA. We sequentially carried out these interviews until we no longer identified novel factors. Interviews were conducted with 13 personnel at 7 top-performing U.S. hospitals. With the use of a hermeneutic-phenomenological framework, 5 distinct domains associated with rapid IV tPA delivery were identified. These included (a) communication and teamwork, (b) process, (c) organizational culture, (d) performance monitoring and feedback, and (e) overcoming barriers.

Extent of and reasons for nonuse of implantable cardioverter defibrillator devices in clinical practice among eligible patients with left ventricular systolic dysfunction.

BACKGROUND: Several studies that used claims and registry data have reported that 40% to 80% of patients eligible for an implantable cardioverter defibrillator (ICD) fail to receive one in clinical practice, and the rates are especially high among women and blacks. The extent and documented reasons for nonuse of ICDs among patients with left ventricular systolic dysfunction are unknown. METHODS AND RESULTS: Using hospital claims and clinical data, we identified patients hospitalized with a heart failure diagnosis and left ventricular ejection fraction ≤30% between January 1, 2007, and August 30, 2007, at a tertiary-care center. Using claims data, we determined placement of an ICD or cardiac resynchronization therapy with defibrillation device at any time up to 1 year after hospitalization. Medical records for patients without an ICD were abstracted to determine reasons for nonuse. Patients with an ICD were compared with patients without an ICD and also with patients without an ICD who did not have any contraindication for an ICD as identified through chart abstraction. Of the 542 potentially eligible patients identified, 224 (41%) did not have an ICD. In the initial adjusted analysis, female sex (odds ratio=1.90; 95% CI, 1.28 to 2.81) and increasing age (odds ratio=1.07; 95% CI, 1.04 to 1.11) were associated with a higher likelihood of not having an ICD. After detailed chart review, of the 224 patients without an ICD, 117 (52%) were ineligible for the device and 38 (17%) patients refused the device, resulting in only 69 (13%) patients eligible for an ICD who failed to receive one. In this subsequent adjusted analysis, remaining factors associated with a higher likelihood of not having an ICD were absence of ventricular arrhythmias (odds ratio=4.93; 95% CI, 2.56 to 9.50), noncardiology hospital service (odds ratio=3.73; 95% CI, 1.98 to 7.04), and lack of health insurance (odds ratio=3.10; 95% CI, 1.48 to 6.46). CONCLUSIONS: On the basis of a detailed chart review, the true rate of ICD underuse may be substantially lower than previous estimates. In addition, after accounting for ICD eligibility criteria, patient sex and age disparities in ICD therapy were no longer present.

Persistence with stroke prevention medications 3 months after hospitalization.

OBJECTIVE: To measure longitudinal use of stroke prevention medications following stroke hospital discharge. We hypothesized that a combination of patient-, provider-, and system-level factors influence medication-taking behavior. DESIGN: Observational cohort design. SETTING: One hundred six US hospitals participating in the American Heart Association Get With The Guidelines-Stroke program. PATIENTS: Two thousand eight hundred eighty-eight patients 18 years or older admitted with ischemic stroke or transient ischemic attack. MAIN OUTCOME MEASURE: Regimen persistence, including use of antiplatelet therapies, warfarin, antihypertensive therapies, lipid-lowering therapies, or diabetes medications, from discharge to 3 months. Reasons for nonpersistence were also ascertained. RESULTS: Two thousand five hundred ninety-eight patients (90.0%) were eligible for analysis. At 3 months, 75.5% of subjects continued taking all secondary prevention medications prescribed at discharge. Persistence at 3 months was associated with decreasing number of medication classes prescribed, increasing age, medical history, less severe stroke disability, having insurance, working status, understanding why medications are prescribed and how to refill them, increased quality of life, financial hardship, geographic region, and hospital size. CONCLUSIONS: One-quarter of stroke patients reported discontinuing 1 or more of their prescribed regimen of secondary prevention medications within 3 months of hospitalization for an acute stroke. Several modifiable factors associated with regimen persistence were identified and could be targets for improving long-term secondary stroke prevention.