Michele M. Pelter

A Randomized Clinical Trial to Reduce Patient Prehospital Delay to Treatment in Acute Coronary Syndrome

Background—Delay from onset of acute coronary syndrome (ACS) symptoms to hospital admission continues to be prolonged. To date, community education campaigns on the topic have had disappointing results. Therefore, we conducted a clinical randomized trial to test whether an intervention tailored specifically for patients with ACS and delivered one-on-one would reduce prehospital delay time. Methods and Results—Participants (n=3522) with documented coronary heart disease were randomized to experimental (n=1777) or control (n=1745) groups. Experimental patients received education and counseling about ACS symptoms and actions required. Patients had a mean age of 67±11 years, and 68% were male. Over the 2 years of follow-up, 565 patients (16.0%) were admitted to an emergency department with ACS symptoms a total of 842 times. Neither median prehospital delay time (experimental, 2.20 versus control, 2.25 hours) nor emergency medical system use (experimental, 63.6% versus control, 66.9%) was different between groups, although experimental patients were more likely than control to call the emergency medical system if the symptoms occurred within the first 6 months following the intervention (P=0.036). Experimental patients were significantly more likely to take aspirin after symptom onset than control patients (experimental, 22.3% versus control, 10.1%, P=0.02). The intervention did not result in an increase in emergency department use (experimental, 14.6% versus control, 17.5%). Conclusions—The education and counseling intervention did not lead to reduced prehospital delay or increased ambulance use. Reducing the time from onset of ACS symptoms to arrival at the hospital continues to be a significant public health challenge. Clinical Trial Registration—clinicaltrials.gov. Identifier NCT00734760.

Accuracy of the EASI 12-lead electrocardiogram compared to the standard 12-lead electrocardiogram for diagnosing multiple cardiac abnormalities.

This study was performed to compare a derived 12-lead electrocardiogram (ECG) using a simple 5-electrode lead configuration (EASI 12-lead) with the standard ECG for multiple cardiac diagnoses. Accurate diagnosis of arrhythmias and ischemia often require analysis of multiple (ideally, 12) ECG leads; however, continuous 12-lead monitoring is impractical in hospital settings. EASI and standard ECGs were compared in 540 patients, 426 of whom also had continuous 12-lead ST segment monitoring with both lead methods. Independent standards relative to a correct diagnosis were used whenever possible, for example, echocardiographic data for chamber enlargement-hypertrophy, and troponin levels for acute infarction. Percent agreement between the 2 methods were: cardiac rhythm, 100%; chamber enlargement-hypertrophy, 84%-99%; right and left bundle branch block, 95% and 97%, respectively; left anterior and posterior fascicular block, 97% and 99%, respectively; prior anterior and inferior infarction, 95% and 92%, respectively. There was very little variation between the 2 lead methods in cardiac interval measurements; however, there was more variation in P, QRS, and T-wave axes. Of the 426 patients with ST monitoring, 138 patients had a total of 238 ST events (26, acute infarction; 62, angioplasty-induced ischemia; 150, spontaneous transient ischemia). There was 100% agreement between the 2 methods for acute infarction, 95% agreement for angioplasty-induced ischemia, and 89% agreement for transient ischemia. EASI and standard 12-lead ECGs are comparable for multiple cardiac diagnoses; however, serial ECG changes (eg, T-wave changes) should be assessed using one consistent 12-lead method.

The effect of a short one-on-one nursing intervention on knowledge, attitudes and beliefs related to response to acute coronary syndrome in people with coronary heart disease: A randomized controlled trial

BACKGROUND Coronary heart disease (CHD) and acute coronary syndrome (ACS) remain significant public health problems. The effect of ACS on mortality and morbidity is largely dependent on the time from symptom onset to the time of reperfusion, but patient delay in presenting for treatment is the main reason timely reperfusion is not received. OBJECTIVES We tested the effect of an education and counseling intervention on knowledge, attitudes and beliefs about ACS symptoms and the appropriate response to symptoms, and identified patient characteristics associated with changes in knowledge, attitudes and beliefs over time. METHODS We conducted a two-group randomized controlled trial in 3522 people with CHD. The intervention group received a 40 min, one-on-one education and counseling session. The control group received usual care. Knowledge, attitudes and beliefs were measured at baseline, 3 and 12 months using the ACS Response Index and analyzed with repeated measures analysis of variance. RESULTS Knowledge, attitudes and beliefs scores increased significantly from baseline in the intervention group compared to the control group at 3 months, and these differences were sustained at 12 months (p=.0005 for all). Higher perceived control over cardiac illness was associated with more positive attitudes (p<.0005) and higher state anxiety was associated with lower levels of knowledge (p<.05), attitudes (p<.05) and beliefs (p<.0005). CONCLUSION A relatively short education and counseling intervention increased knowledge, attitudes and beliefs about ACS and response to ACS symptoms in individuals with CHD. Higher perceived control over cardiac illness was associated with more positive attitudes and higher state anxiety was associated with lower levels of knowledge, attitudes and beliefs about responding to the health threat of possible ACS.

Bedside diagnosis of myocardial ischemia with ST-segment monitoring technology: Measurement issues for real-time clinical decision making and trial designs

Monitoring of the ST segment is a valuable tool for guiding clinical decision making and evaluating anti-ischemia interventions in clinical trials; however, measurement issues hamper its diagnostic accuracy. This study reports the frequency and type of false positives and other measurement issues we have encountered during 12-lead ST-segment monitoring of patients in a cardiac care unit. Of 292 patients, 117 (40%) had one or more false positive events during an average of 41 hours of ST-segment monitoring, for a total of 506 false positive events. The 506 false positive events included 167 (36%) due to body positional change; 132 (26%) due to sudden increase in QRS complex/ST-segment voltage; 96 (19%) due to transient arrhythmia or pacing; 80 (16%) due to heart rate change in steeply sloped ST-segment contours; 26 (5%) due to a noisy signal; and 5 (1%) due to lead misplacement. It is concluded that many conditions in addition to myocardial ischemia can cause transient ST-segment deviation in patients with unstable coronary syndromes. Accurate ST-segment monitoring requires expertise in electrocardiogram interpretation, an understanding of the patients clinical situation, and knowledge of the functions and limitations of the ST-segment monitoring system.

Randomized, Controlled Trial to Improve Self-Care in Patients With Heart Failure Living in Rural Areas

Background— Patients with heart failure (HF) who live in rural areas have less access to cardiac services than patients in urban areas. We conducted a randomized, clinical trial to determine the impact of an educational intervention on the composite end point of HF rehospitalization and cardiac death in this population. Methods and Results— Patients (n=602; age, 66±13 years; 41% female; 51% with systolic HF) were randomized to 1 of 3 groups: control (usual care), Fluid Watchers LITE, or Fluid Watchers PLUS. Both intervention groups included a face-to-face education session delivered by a nurse focusing on self-care. The LITE group received 2 follow-up phone calls, whereas the PLUS group received biweekly calls (mean, 5.3±3.6; range, 1–19) until the nurse judged the patient to be adequately trained. Over 2 years of follow-up, 35% of patients (n=211) experienced cardiac death or hospitalization for HF, with no difference among the 3 groups in the proportion who experienced the combined clinical outcome (P=0.06). Although patients in the LITE group had reduced cardiac mortality compared with patients in the control group over the 2 years of follow-up (7.5% and 17.7%, respectively; P=0.003), there was no significant difference in cardiac mortality between patients in the PLUS group and the control group. Conclusions— A face-to-face education intervention did not significantly decrease the combined end point of cardiac death or hospitalization for HF. Increasing the number of contacts between the patient and nurse did not significantly improve outcome. Clinical Trial Registration— http://www.clinicaltrials.gov. Unique identifier: NCT00415545.

Relationship of persistent symptoms of anxiety to morbidity and mortality outcomes in patients with coronary heart disease

Objective: To examine the association of symptoms of persistent anxiety with the development of acute cardiac events in patients with coronary heart disease (CHD) followed for 2 years. The prevalence of symptoms of anxiety is high in patients with CHD, but their effect on cardiac events and mortality has not been well characterized. Methods: Of 3522 patients with confirmed CHD enrolled, data on symptoms of anxiety were available at two time points in 3048 patients who were then followed up for detection of the composite end point of hospitalization for myocardial infarction, unstable or stable angina, other cardiac causes, or all-cause mortality. A composite anxiety symptoms score composed of baseline and 3-month anxiety data, in which the continuous-level scores were used, was tested using Cox proportional hazards regression model. Groups (persistent anxiety [anxiety at both time points] versus nonanxious [no anxiety at either time point] versus not persistently anxious [anxiety only at one time point]) were also compared. Results: Symptoms of persistent anxiety, whether considered as a continuous- or categorical-level variable, were associated with shorter time to event. Persistent anxiety remained as an independent predictor of the end point after controlling for multiple variables (persistent anxiety as a summary score [hazard ratio = 1.27, 95% confidence interval = 1.067-1.514] and persistent anxiety as a categorical variable [hazard ratio = 1.52, 95% confidence interval = 1.149-2.015]). Conclusions: By measuring anxiety symptoms at more than one time point and controlling for relevant sociodemographic, comorbidity, risk factor, and psychological covariates, we illustrate that symptoms of persistent anxiety are a strong, independent predictor of cardiac event-free survival.ACS = acute coronary syndrome; AMI = acute myocardial infarction; CHD = coronary heart disease; STAI = State-Trait Anxiety Inventory

How our ICU decreased the rate of hospital-acquired pressure ulcers.

We describe 7 strategies our intensive care unit implemented to decrease the rate of hospital-acquired pressure ulcers. These strategies include the following: (1) restructured risk assessment and documentation, (2) translated numeric data into graphs for ease of understanding by staff, (3) increased staff awareness, (4) implemented “turn rounds,” (5) increased prevalence assessments and redesigned structure of the skin team, (6) used evidence-based practice as a basis for care, and (7) created an Access database to track weekly prevalence.

Differences in mortality in acute coronary syndrome symptom clusters

BACKGROUND The timely and accurate identification of symptoms of acute coronary syndrome (ACS) is a challenge for patients and clinicians. It is unknown whether response times and clinical outcomes differ with specific symptoms. We sought to identify which ACS symptoms are related-symptom clusters-and to determine if sample characteristics, response times, and outcomes differ among symptom cluster groups. METHODS In a multisite randomized clinical trial, 3522 patients with known cardiovascular disease were followed up for 2 years. During follow-up, 331 (11%) had a confirmed ACS event. In this group, 8 presenting symptoms were analyzed using cluster analysis. Differences in symptom cluster group characteristics, delay times, and outcomes were examined. RESULTS The sample was predominantly male (67%), older (mean 67.8, S.D. 11.6 years), and white (90%). Four symptom clusters were identified: Classic ACS characterized by chest pain; Pain Symptoms (neck, throat, jaw, back, shoulder, arm pain); Stress Symptoms (shortness of breath, sweating, nausea, indigestion, dread, anxiety); and Diffuse Symptoms, with a low frequency of most symptoms. Those in the Diffuse Symptoms cluster tended to be older (P = .08) and the Pain Symptoms group was most likely to have a history of angina (P = .01). After adjusting for differences, the Diffuse Symptoms cluster demonstrated higher mortality at 2 years (17%) than the other 3 clusters (2%-5%, P < .001), although prehospital delay time did not differ significantly. CONCLUSION Most ACS symptoms occur in groups or clusters. Uncharacteristic symptom patterns may delay diagnosis and treatment by clinicians even when patients seek care rapidly. Knowledge of common symptom patterns may facilitate rapid identification of ACS.

Assessing Health Literacy in Heart Failure Patients

BACKGROUND Health literacy has important implications for health interventions and clinical outcomes. The Shortened Test of Functional Health Literacy in Adults (S-TOFHLA) is a timed test used to assess health literacy in many clinical populations. However, its usefulness in heart failure (HF) patients, many of whom are elderly with compromised cognitive function, is unknown. We investigated the relationship between the S-TOFHLA total score at the recommended 7-minute limit and with no time limit (NTL). METHODS AND RESULTS We enrolled 612 rural-dwelling adults with HF (mean age 66.0 ± 13.0 years, 58.8% male). Characteristics affecting health literacy were identified by multiple regression. Percentage of correct scores improved from 71% to 86% (mean percent change 15.1 ± 18.1%) between the 7-minute and NTL scores. Twenty-seven percent of patients improved ≥1 literacy level with NTL scores (P < .001). Demographic variables explained 24.2% and 11.1% of the variance in % correct scores in the 7-minute and the NTL scores, respectively. Female gender, younger age, higher education, and higher income were related to higher scores. CONCLUSION Patients with HF may be inaccurately categorized as having low or marginal health literacy when the S-TOFHLA time limits are enforced. New ways to assess health literacy in older adults are needed.

Effective Strategies for Implementing a Multicenter International Clinical Trial

PURPOSE International collaboration in research is essential in order to improve worldwide health. The purpose of this paper is to describe strategies used to administer an international multicenter trial to assess the effectiveness of a nursing educational intervention. DESIGN The study design was a two-group randomized multicenter international clinical trial conducted to determine whether a brief education and counselling intervention delivered by a nurse could reduce prehospital delay in the event of symptoms suggestive of acute coronary syndrome (ACS) in patients previously diagnosed with cardiovascular disease. METHOD A flexible but well-defined project structure showed intervention consistency in five sites among three countries and included experienced project coordinators, multidimensional communication methods, strategies to optimize intervention fidelity, site-specific recruitment and retention techniques, centralized data management, and consideration of ethical and budgetary requirements. FINDINGS Staff at five sites enrolled 3,522 participants from three countries and achieved 80% follow-up obtained at both 12 and 24 months. CONCLUSION Multidimensional approaches to maintain consistency across study sites, while allowing flexibility to meet local expectations and needs, contributed to the success of this trial. CLINICAL RELEVANCE In order to support appropriate development of an evidence base for practice, nursing interventions should be tested in multiple settings. A range of strategies is described in this paper that proved effective in conducting a multicenter international trial.