A simplified education program improves knowledge, self-care behavior, and disease severity in heart failure patients in rural settings

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1 A simplified education program improves knowledge, self-care behavior, and disease severity in heart failure patients in rural settings Mary A. Caldwell, RN, PhD, a Kathryn J. Peters, RN, MSN(c), b and Kathleen A. Dracup, RN, DNSc a San Francisco and San Rafael, Calif Background Self-monitoring by heart failure (HF) patients of worsening symptoms caused by fluid overload is a cornerstone of HF care. Disease management has improved outcomes in HF; however, these resource-intensive programs are limited to urban centers and are generally unavailable in rural or limited health care access areas. This pilot study sought to determine whether a simplified education program focused on a single component of disease management (symptom recognition and management of fluid weight) could improve knowledge, patient-reported self-care behavior, and HF severity in a rural setting. Methods This randomized clinical trial enrolled 36 rural HF patients into an intervention or control group. The intervention group received a simplified education program with a follow-up phone call focusing on symptom management delivered by a non cardiac-trained nurse. Patient knowledge, self-care behaviors, and HF severity (B-natriuretic peptide [BNP]) were measured at enrollment and at 3 months. Results The sample was primarily white men and married with a mean age of 71 years and ejection fraction of 47%. There were no differences between groups in knowledge, self-care behaviors and BNP at baseline; however, knowledge and self-care behavior related to daily weights improved significantly at 3 months in the intervention group ( P =.01 and.03, respectively). Although the changes in mean BNP at 3 months were in the hypothesized direction, the difference between the 2 groups was not significant. Conclusions A simplified education program designed for use in resource scarce settings improves knowledge and patient-reported self-care behaviors. These findings are important in providing care to patients with HF in limited access settings but should be studied for longer periods in more heterogeneous populations. (Am Heart J 2005;150:983.e7-983.e12.) Patients with heart failure (HF) present a multifaceted management challenge to health care providers. Self-monitoring and timely response by HF patients to worsening symptoms caused by fluid overload (the primary reason for hospital readmissions 1 ) are an important cornerstone of care in this population as prolonged periods of high cardiac filling pressure lead to increased damage to the myocardium and to further ventricular remodeling. 2,3 Multidisciplinary disease management (DM) models have successfully reduced morbidity and mortality in HF patients. 4 However, these resource-intensive programs are primarily limited to From the a University of California, San Francisco, San Francisco, Calif, and b Dominican University of California, San Rafael, Calif. This grant was funded by the Hellman Family Early Career Faculty Award. Submitted April 12, 2005; accepted August 8, Reprint requests: Mary A. Caldwell, RN, PhD, PO Box 1545, Healdsburg, CA mary.caldwell@nursing.ucsf.edu /$ - see front matter n 2005, Mosby, Inc. All rights reserved. doi: /j.ahj major urban medical centers and are generally unavailable to patients living in rural areas where resources and access to care are limited. 5 Individuals living in rural areas have an increased prevalence of cardiovascular disease when compared with urban areas, 6 and HF patients are more likely to be readmitted for their disease. 7 Unfortunately, they face major barriers to improving their health status and have limited access to care. They are more likely to be uninsured, 8 poor, and chronically ill. 5 Lack of health insurance limits access to preventative medicine, routine visits to health care providers, diagnostic tests, and prescriptions. 5 Rural settings are also characterized by shortages of physicians, particularly cardiac specialists and advanced practice nurses. 5 Access to DM programs is limited because of low-density populations and large geographic distances that make it difficult for patients to travel to a clinic. 5 To improve clinical outcomes in nonurban areas where patients have limited access to treatment, a logical next step in HF care would be the adaptation of DM programs for use in rural areas. Therefore, this

2 983.e8 Caldwell, Peters, and Dracup American Heart Journal November 2005 pilot study sought to determine whether a simplified education and counseling intervention for HF patients focused on a single component of DM (ie, symptom recognition and management of fluid weight) could improve knowledge, patient-reported self-care behavior, and HF severity in a nonspecialized rural setting. Methods This pilot study used a randomized experimental design with 2 groups. The control group received usual care and written material; the intervention group received usual care as well as a simple individualized education and counseling session focused on symptom recognition and fluid weight management, with a phone call at 1 month for reinforcement. Usual care was defined as routine counseling performed by the patient s physician about dietary modifications, physical activity, smoking and alcohol cessation, and compliance with medications. After randomization, the intervention was administered by a trained, non cardiac-trained registered nurse. Follow-up data were obtained at 3 months. Patients were recruited from a cardiology practice in a rural setting in Northern California with no formalized HF education program. Inclusion criteria were clinically stable New York Heart Association classes II to IV HF patients. Class I patients were also included if they had had an exacerbation of HF symptoms within the prior year necessitating an unplanned trip to the physician or an admission to the emergency department. Patients were required to read, write, and understand English and to be living independently. Patients were excluded if they had a neurological disorder that impaired cognition, had an untreated malignancy, or were part of a formalized HF education program. The study was approved by the institutional review board for human research at the University of California, San Francisco. Procedures Upon signing an informed consent, baseline information, including relevant demographics, medical history, and current medications, was collected, and questionnaires measuring knowledge and self-care behavior were administered. A blood sample for B-natriuretic peptide (BNP) was drawn to measure HF severity. Patients were then randomized to the control or intervention group. All patients continued to receive usual care. In addition, patients in the control group received a printed brochure on HF published by the American Heart Association that, among other things, promoted symptom recognition, daily weights, and calling a physician when symptoms worsen. Patients in the intervention group were given a one-on-one education and counseling session conducted by a non cardiac-trained registered nurse in the physician s office (n = 8) or patient s home (n = 12). The intervention group also received a phone call at 1 month for the purpose of reinforcing the content of the education program, as well as to determine if symptoms had worsened and whether they had sought medical attention. A follow-up questionnaire was administered at 3 months to both groups, and repeat BNP levels were drawn. Patients were also systematically questioned regarding symptoms and unplanned office visits or phone calls. Symptom-focused education and counseling program The education program was administered in a one-on-one session using a portable, standardized, high-impact, colored flip chart. The program included information about the causes and mechanisms of HF, signs and symptoms of HF, the importance of daily weights (emphasizing the differences in fluid vs fat weight), and the importance of seeking help promptly if symptoms worsened. Patients were advised to call their health care provider if a weight gain of 3 lb in 1 day or 5 lb in 1 week occurred. In addition, potential barriers to care were addressed and discussed with the patient. Patients in the intervention group were given written take-home information and a weight diary with a list of symptoms, potential barriers to seeking care, and actions to take if weight increased or symptoms worsened. Measurements Knowledge about HF and its symptoms, as well as barriers to seeking care, was assessed using a written questionnaire. In brief, the questionnaire contained 24 multiple choice and yes/no or true/false questions. The questions on HF disease knowledge were adapted for the HF population from the REACT study in the acute myocardial infarction population. 9 Content validity of the modified instrument was established by a review of 5 experts in cardiovascular care (a cardiologist, 2 doctorally prepared nurses, and 2 cardiovascular clinical nurse specialists). Predictive validity for the modified knowledge questionnaire was established in a previous study. 10 Internal consistency of 0.83 was established in the current study using Cronbach a. Self-care behaviors were measured using an abbreviated form of the European Heart Failure Self-Care Behavior Scale, 11 a self-administered yes/no questionnaire that covers items concerning self-care behavior of patients with HF. The 4 yes/no statements used from the scale and focusing on symptoms and fluid weight management in the questionnaire were (1) I weigh myself daily; (2) I contact my physician for shortness of breath; (3) I contact my physician for swollen feet/ankles; and (4) I contact my physician for weight gain. Total self-care behavior score was the total number of byesq answers. Face and content validity of the original instrument were tested using pooled data of 442 patients from 6 centers in Europe. Cronbach a was established at Heart failure severity was measured using BNP. BNP is a simple, easy-to-use test producing results in b15 minutes. A small sample of blood (5 ml) was collected into a tube containing potassium EDTA, and BNP levels were measured using the Triage test device (Biosite Diagnostics Inc, San Diego, Calif), a fluorescence immunoassay. The blood sample is added to a sample port, and the red blood cells are separated from the plasma via a filter. Plasma then moves by capillary action into a reaction chamber. The plasma and reagents mix, and the fluid flows through a device detection lane. The concentration of BNP is proportional to the fluorescence bound in the detection lane and is ultimately displayed by a portable Triage meter. Blood was processed within 1 hour of sampling. The Triage device has been shown to have high sensitivity and specificity in a number of studies. 12,13 The device is portable and the test can be performed in the patient s home.

3 American Heart Journal Volume 150, Number 5 Caldwell et al 983.e9 Table I. Sample characteristics at enrollment Table II. Differences between groups at 3 m Total (n = 36) Control (n = 16) Intervention (n = 20) P* Mean scores, range (poor to good) Control (n = 16) Intervention (n = 20) t P Age, mean F SD (y) 71 F F F Education, 14 F F F mean F SD (y) EF, mean F SD (%) 47 F F F Sex, men (%) Race, white (%) Married (%) Etiology ischemic/ coronary artery disease, (%) Mean scores/range (poor to good) Knowledge score 15.3 F F F at enrollment (range 0-24) Self-care behavior 1.5 F F F (range 1-4) HF severity (BNP) 253 F F F TP = difference between control and intervention. Data analysis Data were analyzed using SPSS for Windows (version 11.5, Chicago, Ill) statistical software. Descriptive statistics and measures of central tendency were used to characterize the sample. The comparability of the control and intervention groups at baseline was examined on key variables using v 2 or t tests, depending on the level of measurement; v 2 (or Fisher exact test where appropriate) and t tests were also used to assess the differences between groups at 3 months on knowledge, patient-reported self-care behavior, and BNP. A level of significance was established at P b.05. Results Thirty-six patients with documented HF were enrolled in the study. There were 16 patients in the control group and 20 in the intervention group. Of the 20 patients in the intervention group, 12 of the education sessions were performed in the patient s home at their request. The education sessions did not vary substantially between the 2 settings, and the BNP meter and all other measurements were easily transportable to the patient s home. Sample characteristics for the group as a whole and differences between the control and intervention groups are listed in Table I. Most of the sample was white men and married with a mean ejection fraction (EF) of 47%. Half of the patients had preserved systolic function (ie, EF N45%). The mean age was 71 years. There were no differences in key variables or measurement scores (knowledge, self-care behavior, and BNP) between the 2 groups at baseline. The differences between the control and intervention groups at 3 months are listed in Table II and described in the following section. Knowledge score at 14.9 F F m (range 0-24) Self-care behavior 1.9 F F (range 1-4)T HF Severity (BNP) 302 F F Values are presented as mean F SD. TSample size: control = 11, intervention = 14. Table III. Patient-reported self-care behaviors A. Patient-reported self-care behaviors at enrollment* % Yes Total Control Intervention (n = 25) (n = 11) (n = 14) P I weigh myself daily y I contact my physician y for shortness of breath I contact my physician y for swollen feet/ankles I contact my physician for weight gain y B. Patient-reported self-care behaviors at 3 m I weigh myself daily y I contact my physician y for shortness of breath I contact my physician for swollen feet/ankles I contact my physician for weight gain TThese questions were not asked of the first 11 patients. yfisher exact test. Knowledge The mean knowledge score of the entire sample at baseline was poor (mean 64%), but knowledge about HF was significantly improved by the intervention. The knowledge level of the control group was significantly lower than the intervention group (14.9 and 18.1, respectively; P =.01) 3 months after the intervention. Mean knowledge score for the control group remained unchanged from enrollment to 3 months (15.4 and 14.9, respectively). Patient-reported self-care behavior When the total score for self-care behaviors was examined (Table II), the intervention group s score was significantly higher than that of the control group ( P =.03). The intervention positively influenced patients monitoring of their weight each day but

4 983.e10 Caldwell, Peters, and Dracup American Heart Journal November 2005 that positive behavior change did not translate to improved self-reported behaviors related to seeking help from physicians as noted by responses to the self-care behavior questions (Table III). There were no differences in proportions between groups at baseline for any of the 4 individual questions comprising the Self-Care Behavior Score (Table III, A), but at 3 months, the proportion of those reporting that they weighed themselves daily was significantly higher in the intervention group compared with the control group ( P =.002); however, there were no differences between groups at 3 months when asked if they would actually call a physician for shortness of breath, swollen ankles, or weight gain (Table III, B). B-natriuretic peptide At 3 months, HF severity (as measured by BNP levels) was lower in the intervention group compared with the control group. However, the difference did not reach the level of significance ( P =.21). Discussion The primary finding of this pilot study is that a simplified education and counseling intervention and a brief follow-up phone call for reinforcement administered to HF patients which focused on symptom recognition and fluid weight management improved knowledge and patient-reported self-care behavior at 3 months when compared with a control group who did not receive the program. BNP levels (the measure of HF severity in this pilot) were not significantly different at 3 months, although the changes were in the hypothesized direction. Interestingly, the primary change in self-reported self-care was in daily weights where patients in the intervention group were significantly more likely to weigh themselves and maintain a weight diary when compared with the control group at 3 months. It is also important to note that these improvements were accomplished in a rural setting with minimal resources and delivered by a registered nurse with no prior specialized cardiovascular training. This finding is important for physicians and nurses practicing in settings where there is limited access to care. Previously, DM programs have been found to be very successful at improving clinical outcomes; however, these programs are not available to many patients outside major metropolitan or resource scarce areas. The development of an effective education program that uses existing resources could potentially impact HF management in rural and limited access settings. Because of the complexity of HF care and the chronic nature of the disease, knowledge about HF and self-care behaviors are vital to optimal clinical outcomes. Unfortunately, researchers have documented significant deficiencies in knowledge in the HF population. 14 Most HF patients do not know the signs and symptoms of an HF exacerbation. 15,16 In a study of hospitalized HF veterans, it was found that only those with an acute onset of dyspnea responded quickly (ie, b1 day) to changing symptoms. 17 The current study confirms these findings in that the total sample only scored 64% on the symptom knowledge questionnaire, but those in the intervention group were able to increase their scores significantly compared with the control group after intervention. Patients inability to identify symptoms as being related to HF leads to frequent admissions to the emergency department, resulting in the need for costly crisis management for what might otherwise be a long-standing stable condition. Therefore, increasing patient knowledge is a critical initial step in teaching patients to monitor their disease. Researchers have noted that the percentage of patients who weigh themselves daily and document their weight in a diary, as recommended in HF guidelines, 18 is very low. 1,15,19 The current study confirms past findings. At enrollment, only 28% of patients reported that they weighed themselves daily. However, self-reported self-care behavior in the intervention group was significantly improved at 3 months compared with the control group and significantly more patients in the intervention group reported weighing themselves daily at 3 months. It is interesting to note that the remaining self-care behavior questions relating to taking appropriate actions in response to increased weight or worsened symptoms did not improve, highlighting the need to identify and reduce barriers to calling a health care provider when symptoms worsen. Health care providers can explore individual patient s reluctance to seek help and target those issues for intervention. Other aids such as a toll-free number to a registered nurse might also promote prompt care-seeking behavior. Patients with HF apparently have difficulty identifying the importance of weight gain and are slow to seek medical care when their symptoms worsen. 14 In one study, the degree of uptake of various self-care behaviors, including daily weights, was compared between patients receiving an educational intervention and a group receiving usual care. 15 Patients in the intervention group in that study had greater use of weight diaries and demonstrated greater awareness regarding the significance of weight gain and actions to take. Patients in the intervention group who did not complete a diary were at higher risk for hospital readmission compared with those who did complete a diary. It is important to note that the study did not investigate whether patient adherence to completing a weight diary leads to actual changes in behavior regarding altering the diuretic dose or calling a health care provider in a timely manner if symptoms worsened. Therefore, it is important that, in the future, investigators monitor weight gains and

5 American Heart Journal Volume 150, Number 5 Caldwell et al 983.e11 document whether patients actually act appropriately such as increasing their diuretic dose or calling their health care provider in the face of increasing weight or worsening symptoms. Behavior change was noted in another randomized clinical trial of patients assigned to usual care or a nurse-led HF clinic with education and counseling by specially educated and experienced cardiac nurses. 20 The intervention group was significantly better at alerting their health care provider about weight gain at 12 months than the control group. However, this action of alerting the health care provider was self-reported, and there was no mention as to whether it was verified with the health care provider or medical records. Conversely, another randomized clinical trial 21 revealed that an educational intervention did not improve self-care agency (ability of patients to care for themselves) but did improve self-care behaviors. An important outcome of HF interventions is the reduction of cardiac decompensation and disease severity. In the past, surrogates such as New York Heart Association class have been used to measure decompensation and disease severity. However, pointof-care assays that measure BNP are now available. Increases in BNP levels indicate increased HF severity. 13 The current study is one of the first to use BNP levels to measure the physiological impact of an educational intervention. Although BNP was higher in the control group compared with the intervention group at 3 months follow-up (indicating a higher level of disease severity), it did not reach the level of significance. This lack of significance may have been a type II error because of the small sample size. There are a few limitations that should be noted in this study. Due to the fact that this was a pilot study, sample size was small and homogeneous. The small sample size could have had an impact on our ability to accurately identify a difference between groups on some of the variables measured. Moreover, the results may not be generalized to samples representing other rural populations. Most subjects were married, possibly affecting results because of the social support structure available to married individuals. However, there were no differences in marital status between the groups, making it unlikely that this factor impacted results. The study was short in duration, and it is not known whether improvements in knowledge and weighing behaviors can be maintained. The setting differed in that 12 of the 20 interventions were performed at home as opposed to the doctor s office. This could have impacted results; however, the intervention (flip chart and script), as well as all measurements, was easily transportable, and no substantial differences were noted by the research nurse in the implementation of the intervention between the 2 settings. Finally, patients reported on their behaviors related to seeking help with worsening symptoms, but these behaviors were not documented in physician or hospital medical records. Future studies should include medical chart review and review of physician phone logs as part of data collection. In summary, a simplified education and counseling program focused on symptom recognition and fluid weight management and intended for use in the nonspecialized rural setting improved knowledge and patient-reported self-care behavior, particularly weighing behaviors. Weighing behaviors are important as fluid weight gain is key to recognizing cardiac decompensation and to prompt care-seeking behaviors. BNP represents a simple method of monitoring the clinical effects of education programs. Although BNP decreased in the experimental group and increased in the control group, the difference was not significant, possibly because of the small sample size. Recommendations for future research include measurement of other clinical outcomes such as rehospitalizations and mortality, addressing whether improvements can be sustained over time, expansion of the education program to highlight overcoming barriers to seeking care (ie, calling the health care provider) when symptoms occur, and a larger, more heterogeneous sample collected in multiple settings. It will also be important to study differences between patients with preserved and low EF. References 1. Horowitz CR, Rein SB, Leventhal H. A story of maladies, misconceptions and mishaps: effective management of heart failure. Soc Sci Med 2004;58: Cohn JN. Structural basis for heart failure. 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