|Year : 2018 | Volume
| Issue : 2 | Page : 102-108
A randomized controlled trial to assess the effectiveness of structured discharge counseling on heart failure outcomes
Ankita Sharma1, L Gopichandran1, Sandeep Seth2
1 College of Nursing, All India Institute of Medical Sciences, New Delhi, India
2 Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India
|Date of Web Publication||10-Sep-2018|
College of Nursing, All India Institute of Medical Sciences, New Delhi - 110 029
Source of Support: None, Conflict of Interest: None
Introduction: A relatively common disease, heart failure (HF), has a significant impact on the quality of life (QOL). Many of the HF patients are unaware of the importance of self-care, such as weighing themselves regularly, fluid and sodium restriction, and HF symptom monitoring. Important patient-related factors that are known to be related to compliance are HF knowledge and its regimen. The Objectives of the Study: The objective of this study is to assess the effectiveness of structured discharge counseling on HF knowledge, QOL, frequency of repeated hospitalization, and improvement in the New York Heart Association (NYHA) functional class of acute decompensated HF (ADHF) patients. Materials and Methods: Sixty-eight ADHF patients (NYHA functional Class III) were selected and randomized into two groups. HF knowledge and QOL were measured for each patient. A 30-min discharge counseling was provided at hospital visit or at the time of discharge. Both the groups were followed for 1 month. Data on HF knowledge, QOL, NYHA functional class, and repeated hospitalization were collected at baseline and after 1 month. Results: The baseline HF knowledge and QOL were comparable in both the groups. The experimental group showed significant improvement in QOL scores (P = 0.001), HF knowledge score (P = 0.043), and NYHA functional class (P = 0.001) after 1 month of the discharge counseling. Conclusion: The present study showed that the discharge counseling could enhance HF knowledge, QOL, and NYHA functional class in those suffering from ADHF. It is, therefore, advisable that discharge counseling be incorporated in the HF management strategy.
Keywords: Acute decompensated heart failure, discharge counseling, New York Heart Association functional class, quality of life
|How to cite this article:|
Sharma A, Gopichandran L, Seth S. A randomized controlled trial to assess the effectiveness of structured discharge counseling on heart failure outcomes. J Pract Cardiovasc Sci 2018;4:102-8
|How to cite this URL:|
Sharma A, Gopichandran L, Seth S. A randomized controlled trial to assess the effectiveness of structured discharge counseling on heart failure outcomes. J Pract Cardiovasc Sci [serial online] 2018 [cited 2019 May 19];4:102-8. Available from: http://www.j-pcs.org/text.asp?2018/4/2/102/240961
| Introduction|| |
India is having an alarming burden of cardiovascular disorders. The estimated prevalence of heart failure (HF) in India is about 1% of the population or about 8–10 million individuals and the estimated mortality because of HF is about 0.1–0.16 million individuals per year. Acute decompensated heart failure (ADHF) is defined as sudden or gradual change in HF signs and symptoms resulting in need of emergency department visits, unplanned office visits, or hospitalization. Postdischarge major adverse events such as death and re-hospitalization are 27.3% at 1 month among ADHF patients.
HF can decompensate because of various reasons as underlying medical illness or failure of patients to adhere to fluid restriction, diet, and medicine. Risk factors predictive of hospitalization and readmission due to HF include poor knowledge, quality of life (QOL), New York Heart Association (NYHA) functional class, and adherence to the recommendations for self-care involving restriction of fluid intake, restriction of sodium intake in the diet, daily weight monitoring, physical activity, and the regular use of medications.
Health-care providers can reduce the hospital readmission rates and adverse events by focusing on high-quality discharge information and providing well-coordinated care. Assessment by health-care providers about accuracy of discharge information and whether the discharge information is understood by patients and their community counterparts are vital aspects of effective discharge.
Having knowledge about HF-specific self-care, medications, dietary, and fluid restrictions is found to be an important factor contributing toward compliance to the HF regimen. Compliant patients have better QOL which is a predictor of mortality and the need for hospitalization.
The patients with HF should be discharged with written instructions, or educational material should be given to the patients or their caregivers at discharge or during hospital stay which would include the following activities: diet, discharge drugs, follow-up appointment, activity level, weight monitoring, and what to do if symptoms worsen.
Inadequate planning of discharge from hospital and patients' nonadherence to instructions are indicated as factors that lead to the re-hospitalization of patients with HF. This emphasizes the importance of a discharge plan to improve QOL of patients. Nurses contribute to the quality of care and outcomes of patients with HF by comprehensive discharge planning in order to improve health outcomes and reduce readmission rates, which, in turn, can lead to cost savings.
Discharge teaching is found to be effective in various trials involving the outcomes such as HF knowledge, QOL, NYHA class, and reducing readmissions among the given population.,, In view of previous studies and gaps identified in the management of ADHF patients at discharge, the present study is undertaken to improve the teaching process in these patients by evaluating the effectiveness of structured discharge teaching.
| Materials and Methods|| |
The sample size was calculated considering a mean overall QOL summary score in HF patients in usual care as 60.0 (17.51). Anticipating ten-unit improvement in QOL score in the experimental group as compared to the usual care with a 5% level of significance and 80% power, the estimated sample size was calculated to be 29, and considering 15% dropout rate, 34 patients were estimated to be the sample size in each group. Sixty-eight patients (34 in each group) were enrolled who met the inclusion criteria and gave written consent to participate in the study from cardiology ward and HF clinic of a tertiary care hospital in New Delhi. They were randomly assigned to either the experimental or control group through a computer-generated list of random numbers. Both the groups received usual care (instructions given by cardiologist and cardiology nurses) while the experimental group, in addition, received the structured discharge counseling. Primary outcomes were QOL and HF knowledge, and secondary outcomes were re-hospitalization and NYHA functional class. The study was approved by the institutional ethics committee for postgraduate research. Patient information sheet was given, and informed consent was obtained before enrollment. CTRI registration was done (REF/2017/02/013473).
Adult patients with a diagnosis of ADHF (HF patients admitted within the past 6 months or has visited the emergency services for intravenous diuretics requiring frequent up-titration of his/her diuretic medications in the past 6 months), NYHA Class III and IV either being discharged from Cardiology ward or visiting the HF clinic and could understand Hindi or English were enrolled in the present study.
Patients having dyspnea other than cardiac cause (chronic obstructive pulmonary disease, asthma, chronic bronchitis, and anemia) and having illnesses that were likely to lead to hospitalization and death in near future were excluded from the study. The schematic presentation of the study design is developed in CONSORT diagram and presented in [Figure 1].
QOL refers to the patients' ability to enjoy normal life activities, measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item (15 questions) self-administered questionnaire designed to quantify various domains, i.e., physical limitations, symptoms (stability, frequency, and burden), social limitations, self-efficacy, and QOL among HF patients which ranges from 0 to 100 with higher scores indicating better health status.
HF knowledge refers to the information among patients about HF, symptom recognition, and its management, measured using the Dutch HF Knowledge Scale (DHFKS). The DHFKS consists of 15 multiple-choice questions, with higher scores correlating to higher levels of illness knowledge. The DHFKS includes question on general disease knowledge of HF, disease knowledge, treatment knowledge regarding diet, and fluid intake restriction, awareness of the symptoms of HF, exercise, and medication.
Re-hospitalization refers to the unplanned hospitalization of patients at any medical center for at least 24 h due to HF cause, as reported by medical documents after getting enrolled in study. Re-hospitalization was assessed using self-developed re-hospitalization assessment questionnaire.
The demographic and clinical profile of patients was collected using the structured self-developed questionnaire and HF discharge checklist.
Educational material in the form of pamphlet [Figure 2] for structured discharge counseling was developed and used to educate the patients. Structured discharge counseling was based upon the second and third component of HF discharge checklist [Figure 3]. The first part of checklist was medicines prescribed (medicines prescribed for the patients on discharge summary or OPD card were assessed, whether prescribed or not). The second component of checklist was intervention and counseling measures addressed. The structured discharge counseling included that the components listed in this part are general risk modification education, treatment and adherence education, HF monitoring, blood pressure control, smoking cessation counseling, dyslipidemia control, and dietary advice. The third component of this checklist was follow-up, whether fixed or not. Patients were explained about general risk modification (HF, its common causes, symptoms, and healthy lifestyle), treatment and adherence (medicines used for HF such as beta-blockers, diuretics, angiotensin-converting enzyme inhibitors, their action, common side effects, vaccination, and importance of adherence to medicines), HF monitoring (daily weight monitoring and warning sign monitoring in HF), blood pressure control (medication adherence, sodium restriction, and regular blood pressure monitoring), smoking cessation, and dietary advices (sodium and water restriction and foods containing cholesterol to be avoided).
|Figure 2: Educational material in form of pamphlet for heart failure patients.|
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Following the 30 min of discharge counseling, patients' doubts if any were clarified, and reinforcement was done regarding intervention. Educational material was given to the patients or their caregivers for future reference. Counseling was done on one-to-one basis.
Experimental and control groups were followed up until 1 month after giving discharge counseling.
The analysis was performed using STATA 14 version (STATA 14, StataCorp LLC, Texas, USA). Descriptive statistics (mean, standard deviation, median, interquartile range, percentage, and frequency) were used to describe demographic and clinical characteristics. Inferential statistics, including Student's t-test (two-sample independent t-test), paired t-test, Chi-square test, McNemar's test, Wilcoxon rank-sum test, and Wilcoxon signed-rank test. The level of significance was considered as P < 0.05.
| Results|| |
A total of 90 ADHF patients were screened, of whom 18 did not meet the inclusion criteria and 4 refused to participate. Seven participants were lost to follow-up, four participants in experimental group and three in control group died of cardiac arrest. The mean age was 45.6 ± 14.4 years in experimental and 46.2 ± 2.6 years in control group. Most of the patients were male in both the groups and were comparable in terms of demographic and clinical profile [Table 1] and also NYHA classification.
Quality of life
At pretest, all the KCCQ domains were similar among both the study groups. After intervention, the scores in the experimental group improved significantly in terms of QOL, overall summary score, and self-efficacy score [Table 2]. It was further seen that there was a significant improvement (P < 0.05) in posttest scores of the experimental group as compared to the control group.
|Table 2: Comparison of Kansas City Cardiomyopathy Questionnaire scores between study groups (n=61)|
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Heart failure knowledge
At baseline, both the groups were comparable in terms of HF knowledge as measured by DHFKS. After the intervention, there was a significant improvement in the HF knowledge within the experimental group immediately after intervention and 1 month after intervention and also as compared to the control group [Table 3].
|Table 3: Comparison of Dutch Heart Failure Knowledge scale scores among groups (n=61)|
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No re-hospitalization was noted in the experimental group while three readmissions were noted in the control group at follow-up (P = 0.238).
New York Heart Association functional class
At baseline, both the groups were comparable in terms of NYHA functional class. At follow-up, both the groups improved significantly to NYHA Class II. Among the groups, the experimental group was found to be improved significantly from control group (P = 0.001) [Table 4].
|Table 4: Comparison of New York Heart Association functional class among the groups (n=61)|
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| Discussion|| |
The structured discharge counseling was effective in improving QOL, HF knowledge, and NYHA class in ADHF patients [Figure 4].
Quality of life
In this study, QOL in the experimental group improved as compared to the control group after the intervention at 1 month.
Findings of some other studies,, were found to be comparable with the present study findings. These studies included the 1- and 2-month follow-up and telephonic follow-up weekly during the1st month and biweekly follow-up phone calls during the 2nd month, after the initiation of the intervention, and 3- and 6-month follow-up. Telephonic follow-up is done at 30, 90, and 180 days.
In contrast to the findings of this study, a systematic review on the effectiveness of nursing education on clinical outcomes with HF revealed no improvement in health-related QOL. However, this review included the studies in which computer-based education through an interactive multimedia program was provided to the patients.
Heart failure knowledge
In this study, HF knowledge improved significantly in experimental group at the first posttest as compared to control group. At 1 month (second follow-up, improvement was noted in both experimental and control group. However, at 1-month follow-up, the experimental group showed significant improvement as compared to the control group. This finding was supported by other studies, which reported improvement by the use of model-based education intervention, low literacy, language-free self-care education, and providing knowledge at each outpatient visit.
The improvement in control group at 1-month follow-up can be explained as possible contamination or getting information from personal or medical sources during hospital visit at follow-ups.
In this study, none of the participants from experimental group were readmitted, while three of the participants in the control group were readmitted, although the difference was not found to be statistically significant (P = 0.238). This finding was supported by other studies, which reported the use of counseling and evaluation of recall of information.
However, contrary to our findings, a retrospective study reported decreased readmissions in patients who received all discharge instructions than those who missed at least one type of instruction. Another study reported that the addition of 1-h counseling session lowers the risk of readmission or death at follow-up.
New York Heart Association functional class
In this study, the participants from experimental group showed more significant improvement to NYHA functional Class II as compared to control group (P = 0.001). This finding was supported by another study that reported that patient education and patients' adherence to medication regimen improved the NYHA functional class of patients at follow-up.
The HF discharge checklist used in the study revealed that only 37 (54%) participants were on beta-blockers [Table 5].
The strength of this study lies in the fact that it was the first randomized controlled trial assessing the effectiveness of structured discharge counseling in India for the management of the ADHF patients at discharge.
Some of the limitations of the study were small sample size, short follow-up time, and single-center study which limit the generalizability of the study and also there was no blinding that could lead to some bias.
The findings of the present study yield information regarding the importance of strengthening the discharge process of ADHF patients so that they will be able to manage their disease by themselves and seek needed care by monitoring their own symptoms. Furthermore, emphasis should be laid upon undergraduate and postgraduate nursing curriculum on the concept of incorporating discharge counseling in the HF management strategy.
Further, we recommend that a large-scale longitudinal study with a larger sample size in multicenter setting with weekly reinforcement can be conducted to further explore the effectiveness of structured discharge counseling in reducing the re-hospitalization rate.
| Conclusion|| |
It is concluded that the structured discharge counseling is an effective method to significantly improve the QOL, HF knowledge, and NYHA functional class in ADHF patients. Furthermore, this study projects the importance of strengthening the patient education system, in order to empower them to deal with HF to a greater extent.
The authors would like to thank KCCQ author Dr. John Spertus and DHFKS author Martze H. L. Vander Wal for permitting permission to use the tools in the study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]