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Solution to be formatted in APA and use appropriate references with in-text citations/nPatient Education and Counseling 86 (2012) 233-238
Contents lists available at ScienceDirect
Patient Education and Counseling
Patient Education and Counseling
journal homepage: www.elsevier.com/locate/pateducou
Intervention
Relationship between improvements in heart failure patient disease specific knowledge and clinical events as part of a randomized controlled trial
Naga V.A. Kommuria, Monica L. Johnson b, Todd M. Koelling b,*
ª Department of Internal Medicine, Wayne State University, Detroit, USA
b Department of Internal Medicine, University of Michigan, Ann Arbor, USA
ARTICLE INFO
Article history: Received 1 December 2010 Received in revised form 2 May 2011 Accepted 9 May 2011
Keywords: Heart failure Patient education Hospitalization Knowledge Outcomes
ABSTRACT
Objective: To examine the changes in performance on heart failure knowledge assessments administered before and after discharge education.
Methods: We conducted a randomized controlled trial comparing the effects of a 1-h, one-on-one teaching session with a nurse educator to the standard discharge process in patients with systolic heart failure. Patients completed a 30 point heart failure knowledge questionnaire (HFKQ) prior to and 3 months after the education intervention.
Results: Patients randomized to the nurse education intervention (n = 113) demonstrated significantly higher total HFKQ score increases compared to patients receiving the standard discharge process (n = 114) (median, IQR 1, 0 to 4 vs 0, -2 to 2, p = 0.007). Patients experiencing death or rehospitalization in the subsequent 6 months were found to have significantly lower HFKQ scores (10, 7 to 12 vs 11, 8 to 13, p = 0.002) compared to patients without a clinical event.
Conclusion: Heart failure nurse education at the time of hospital discharge results in improved patient knowledge and reduced risk of readmission.
Practice implications: Health care personnel should encourage education sessions for heart failure patients. Resources possibly need to be allocated for nurse led education sessions in heart failure patients as it improves outcomes and knowledge.
@ 2011 Elsevier Ireland Ltd. All rights reserved.
1. Introduction
Patient education has been recognized to play a critical role in the care of patients with heart failure [1,2]. Multiple studies have evaluated the effects of heart failure patient discharge education combined with various post-discharge support programs [3-16]. These studies have demonstrated improved clinical outcomes, reductions in hospitalizations, and reduced costs compared to control groups. Whether these benefits are due to the additional disease specific education, the post- discharge support programs, or a combination of the two is difficult to understand. Furthermore, because these prior studies have not assessed heart failure patient knowledge concurrently with the educational interventions, establishing a relationship
between improvements in knowledge and improvements in clinical outcomes has not been possible.
Recently, we demonstrated that heart failure patient educa- tion delivered face-to-face by a nurse educator at the time of hospital discharge leads to lower rates of hospital readmission compared to patients receiving written materials as part of the standard discharge process [7]. Additionally, patients random- ized to receive the nurse educator delivered intervention were more likely to be following appropriate self-care behaviors [7]. Whether heart failure patient education leads to measurable changes in disease specific knowledge is not known. Further- more, it is not known whether potential improvements in heart failure patient knowledge are associated with clinical outcomes and/or self-care behaviors. If a significant relationship exists between improvements in heart failure knowledge and clinical outcomes, then it may be possible to improve the efficiency of educational efforts by identifying patients most likely to benefit from the intervention. To improve this understanding, we have examined changes in performance on heart failure knowledge assessments administered before and after discharge education administered as part of a randomized controlled trial.
* Corresponding author at: Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan, 1500 E. Medical Center Drive, CVC Room 2167, SPC 5853, Ann Arbor, MI 48109, USA. Tel .: +1 734 764 7440; fax: +1 734 615 3326.
E-mail address: tkoellin@umich.edu (T.M. Koelling).
0738-3991/$ - see front matter @ 2011 Elsevier Ireland Ltd. All rights reserved. doi: 10.1016/j.pec.2011.05.019
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ELSEVIER
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2. Methods
2.1. Subjects
This study was performed at the University of Michigan Hospital and was approved by the Medical School Institutional Review Board. Study subjects were recruited from eligible candidates admitted to the hospital with a diagnosis of heart failure (International Classification of Diseases, 9th ed. [ICD9-CM] 402.1, 402.11, 402.91, 404.01, 404.91, or 428.x) and documented left ventricular systolic dysfunction (ejection fraction ≤ 0.40). For the current study, a total of 667 subjects were screened for enrollment into the study during the recruitment period. Of those screened 402 were excluded from enrollment and the remaining 265 patients were included in the study (Fig. 1). At the time of study enrollment, information regarding compliance with diet and medication was extracted from the medical records. The study coordinator reviewed the admission note, medical records and problem summary list for evidence of non compliance.
2.2. Study design
Details about the patient recruitment, randomization process, education intervention and patient follow up are described in our
previous papers [7,17]. Briefly, after obtaining informed consent, patients were randomized to receive usual care (standard discharge information) or usual care plus a 1-h long nurse educator delivered heart failure education program. The education session covered details about the basic principles of heart failure, role of dietary sodium, importance of limitation of fluid intake as well as the mechanisms of diuretics and the rationale for other pharmacotherapy. Specific instructions were given to limit the dietary sodium intake to 2000 mg or less and the daily fluid intake to 2000 ml or less. Furthermore, during the session patients were given information about the importance of daily weight monitor- ing, self care behaviors, compliance of medications, smoking cessation, avoiding non steroidal anti inflammatory drugs, limitation of alcohol intake and the measures to take when the symptoms are worse. The intervention group also received heart failure management guidelines written in layman's terms.
2.3. Heart failure knowledge questionnaire
The HFKQ was developed by the study team and has not been previously described. The HFKQ was administered to the study population at baseline and 3 months after hospital discharge by the study coordinator. The specific questions included in the HFKQ may be reviewed in the Appendix. The HFKQ contains 30 questions
No. Assessed for eligibility: 667
No. Excluded: 402
Refused to participate: 29
Other reasons: 373
Cardiac surgery workup: 80
Noncardiac life threatening illness: 62 Transplant evaluation: 48 Dementia/Psychiatric illness: 46 Unable to follow up by phone: 27
1
Creatinine > 3.5 mg/dl: 24 Long term care facility: 23 Aortic stenosis: 22
Discharged before enrollment: 18 Other research study: 8 Active infection: 8
Acute MI: 7
>
No. Consented for study: 265
>
No. Enrolled Control Group: 137
No. Enrolled Education Group: 128
No. Not tested in Control Group: 23
No. Not tested in Education Group: 15
Deceased prior to 3 mo FU: 11
Hospitalized at 3 mo FU: 7
Deceased prior to 3 mo FU: 6 Hospitalized at 3 mo FU: 5 Declined questionnaire: 4
<
Declined questionnaire: 5
>
No. Included at 3 month HFKQ
No. Included at 3 month HFKQ
testing in Control Group: 114
testing in Education Group: 113
Fig. 1. Patient screening and randomization assignment profile.
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N.V.A. Kommuri et al./ Patient Education and Counseling 86 (2012) 233-238
in total, and requires approximately 10 min to complete. The first 15 questions of the HFKQ assess general HF disease knowledge, self-care management behaviors, and medications used in the treatment of heart failure with left ventricular systolic dysfunction. For the purposes of this paper, these questions have been designated as the disease management knowledge (DMK) ques- tions. The remaining 15 questions of the HFKQ assess patient knowledge of dietary recommendations in heart failure and specific sodium content of common foods. These questions have been designated as the dietary and sodium knowledge (DSK) questions. Scoring of the questionnaire assigned a value of 1 point for each correct answer.
In addition to the HFKQ testing, enrolled patients completed a questionnaire regarding self-care practices at the time of enroll- ment, 30, 90 and 180 days after hospital discharge. These self-care practices entailed self reported adherence to daily weight monitoring, dietary sodium restriction, fluid restriction, avoidance of smoking tobacco products, having a plan for what to do for worsened symptoms and performance of exercise ≥3 times per week. In this study, we performed a comparison of the 3 month follow-up HFKQ scores with respect to compliance to each of the self-care measures.
2.4. Statistical analysis
The primary endpoint of the study was the change in HFKQ score from baseline to the 3 month time point after hospital discharge. Changes in HFKQ scores for the patients randomized to receive nurse education (NE) and controls were compared using the non-parametric Mann-Whitney U test. Changes in HFKQ scores were also compared for patients with or without a clinical event during the 180 day follow-up period. Clinical events were defined as death or hospitalization within the 180 day follow up period. We performed a stepwise multivariable logistic regression analysis to understand the contributors for improvement in heart
failure knowledge. Variables entered into the model included age greater than 70 years, gender, white race, duration of disease less than 3 months, no insurance, Medicaid insurance, Medicare insurance, adjusted gross income less than $45,000/year, educa- tion level achieved less than high school diploma and study group assignment. Forward stepwise regression was used to identify independent predictors of improved total HFKQ score. An additional multivariable regression was performed in the interest of understanding the mechanism of improved clinical outcomes in our study, using the technique of mediator analysis suggested by Mackinnon et al. [18] In this analysis, the clinical event, death or rehospitalization within 6 months was the dependent variable while the patient treatment assignment and total HFKQ score at 3 month follow up were entered as covariates. All analyses were performed with SPSS version 17.0 statistical software. A p value of <0.05 was considered statistically significant. Unless otherwise specified, data are expressed as median and interquartile range.
3. Results
The comparisons of baseline characteristics for the control and education groups are shown in Table 1 and demonstrate that the two groups were similar with respect to age, sex, socioeconomic status, left ventricular ejection fraction, NYHA classification, clinical comorbidities and laboratory values. Patients in the education group were found to have higher blood pressure than controls.
Table 2 shows that baseline knowledge was similar for the two groups. Patients in control group did not demonstrate any improvement in their knowledge (DSK, DMK, total score) at the 3 month follow-up. However, patients in the education group demonstrated a significant improvement in their DMK (<0.001) as well as in the total score (<0.001) during follow up. Neither the control group nor the education group demonstrated improve- ments in their DSK during the study (Table 2).
Table 1 Baseline characteristics of study population.
Control
Education n=128
p value
n=137
Age (years)
67 (57, 74)
67 (55, 76) 0.82
Female %
39
39
0.82
White % Education (% not finishing high school) Income ($ in thousands) Uninsured %
76
80
0.46
30
23
0.24
47.4 (37.9, 59.6)
44.8 (36.7, 59.1)
0.26
2
4
0.42
Medicare % Medicaid % Private insurance %
38
30
0.16 0.65 0.16
16
14
44
52
Lives alone % Daughters Left ventricular ejection fraction
24 1 (0, 2)
27 1 (1, 2)
0.64
0.31 0.45 0.93
26.5 (20, 35)
25 (20, 35)
NYHA (New York Heart Association)
3 (3, 4)
3 (3, 4)
Number of hospitalizations in prior 12 mo
2 (1, 4)
2 (1, 3)
Coronary artery disease %
Atrial fibrillation % Implantable cardiac defibrillator % Diabetes mellitus % Chronic obstructive pulmonary disease % Non compliance with diet % Current smoking % Heart rate supine (bpm) Mean arterial blood pressure (mm Hg)
66 32
65 43
0.22 0.88 0.13 0.56
20
23
43 26
34
0.11 0.49
23
18
12
15 81 (69, 96)
0.15 0.77 0.42
14
84 (71, 96)
90 (76, 100)
96 (83, 107)
0.02
Admission weight (pounds)
185 (155, 226)
194 (162, 220)
0.78
QRS interval (ms) Hemoglobin (g/dl) Serum sodium Blood urea nitrogen Serum creatinine
117 (92, 147) 12.3 (10.8, 13.7)
127 (98, 161)
0.16
12.4 (11.1, 13.7)
0.54
138 (135, 141)
140 (137, 141) 0.11
28 (19, 43)
25 (18, 37) 1.3 (1.0, 1.7)
0.14
1.4 (1.0, 1.9)
0.27
Data are expressed as median and interquartile range, or percentages, as appropriate.
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N.V.A. Kommuri et al./Patient Education and Counseling 86 (2012) 233-238
Table 2 Paired comparisons of knowledge in study population.
Knowledge Control
Education
p value
Baseline n=137
3 month follow up (p') n=114
Baseline
n=128
3 month follow up (p ) n=113
DSK score
5 (4, 6)
4 (2, 5)
5.5 (4, 6) (0.39)
4 (2, 5) (0.32)
9 (7, 12) (0.23)
6 (4, 7)
4 (3, 5)
6 (4, 7) (0.57)
0.32
5 (4,7) (<0.001)
0.55
DMK score
Total score
9 (7, 11)
9 (7, 11)
11 (8.5, 13) (<0.001)
0.33
Data are expressed as median and interquartile range.
Abbreviations: DSK - dietary sodium knowledge; DMK - disease management knowledge.
* Comparison between baseline and 3 month follow up period.
+ Comparison between baseline for Control and Education groups.
Table 3 Change in knowledge at 3 month follow-up in the study population.
Control n=114
Education n=113
p value
DSK score 0 (-1, 2)
0 (-1, 2)
0.87
DMK score
0(-1,1)
1 (0, 3)
<0.001
Total score 0 (-2, 2)
1 (0, 4)
0.007
Data are expressed as median and interquartile range.
Table 4 Association between Heart Failure Knowledge Questionnaire scores and clinical outcomes.
No event
Event p
Baseline HFKQ
n=119
n= 146
DSK score
6 (4, 7)
5 (4, 6)
0.352
DMK score
4 (2, 5)
3 (2, 5)
0.136
Total score
9 (7, 11)
9 (7, 11)
0.131
3 month follow up HFKQ
DSK score
n=110
n=117
6 (4, 7)
5 (4, 6)
0.068
DMK score
5 (3, 7) 11 (8, 13)
4 (3, 5.5) 10 (7, 12) n=117
0.001
Total score
0.002
Changes in HFKQ compared to baseline
DSK score
n=110
0 (-2, 2)
0(-1, 1)
0.416
DMK score
1 (0, 3)
1 (-1, 2)
0.045
Total score
1 (-2, 4)
1 (-1, 2)
0.072
Data are expressed as median and interquartile range.
Patients randomized to education had significantly higher total HFKQ score increases at 3 months compared to patients receiving standard discharge information (1, 0 to 4 vs 0, -2 to 2, p = 0.007) as shown in Table 3. Specific performance on the subset of questions regarding DMK also improved with nurse education (1, 0 to 3 vs 0, -1 to 1, p < 0.001). No significant changes in DSK were seen with nurse education (0, -1 to 2 vs 0, -1 to 2, p = 0.87). Multivariate linear regression showed that patient group assignment to nurse education (beta 0.871, OR 2.39, 95% CI 1.33-4.31, p = 0.004) and
duration of heart failure less than 3 months (beta 1.045, OR 2.84, 95% CI 1.41-5.73, p = 0.003) were found to be independent predictors of improved heart failure knowledge scores.
Mediator analysis to understand the relationship between the achieved disease specific knowledge and the clinical outcome while controlling for the patient treatment assignment showed that the total HFKQ score at the 3 month time period was strongly associated with the clinical outcome at 180 days. The total HFKQ score at 3 months was inversely associated with clinical events, where beta = - 0.110, OR 0.896 (95% CI 0.827-0.970), p = 0.007.
Of the 265 enrolled patients, 146 had clinical events during the 6 month follow-up. 136 patients were readmitted to the hospital, and 25 patients died during the 6 month follow up period. Twenty- three patients in the control group and 15 patients in the education group did not complete the 3 month follow-up HFKQ either due to death or refusal to complete the questionnaire. Patients experienc- ing clinical events were found to have similar baseline HFKQ scores when compared to patients without any clinical events (Table 4). Patients experiencing a clinical event were found to have a significantly lower total HFKQ scores (10, 7 to 12 vs 11, 8 to 13, p = 0.002) and DMK scores (4, 3 to 5.5 vs 5, 3 to 7, p = 0.001) at the 3 month follow-up examination. DSK scores at 3 months showed a nonsignificant trend to being higher for the event free patients (6, 4 to 7 vs 5, 4 to 6, p = 0.068). Furthermore, changes in the DMK score (from baseline to 3 month follow-up), but not the DSK score, were associated with clinical events (1, 0 to 3 vs 1, -1 to 2, p = 0.045). Changes in the total HFKQ score were higher in the patients without clinical events, but this difference did not reach statistical significance (p = 0.072).
The associations between total HFKQ scores and changes in HFKQ scores at 3 month follow-up and self reported compliance with heart failure self care measures are shown in Table 5. Patients reporting adherence to recommendations for daily weight monitoring, following a specific dietary sodium restriction and fluid restriction, and reporting a plan for what to do if their
Table 5 Association between Heart Failure Knowledge Questionnaire scores and self care measures.
Compliant
Not compliant
p
3 month follow up HFKQ
Daily weight monitoring Following sodium restriction Following fluid restriction
11 (8, 13), 133
9 (7, 11), 93
<0.001
13 (11, 14.5), 53
9 (7, 11), 173
<0.001
11 (8, 13.5), 97
9 (7, 12), 129
<0.001
Not smoking
10 (8, 12), 211
10 (7, 12), 15
0.394
Reports plan for worsened symptoms Performing exercise ≥3 times per week
10 (8, 13), 173
9 (7, 11), 53
0.009
10 (8, 13), 87
10 (7, 12), 139
0.082
Changes in HFKQ compared to baseline Daily weight monitoring
1 (-1, 4), 133
0 (-2, 2), 93
0.013
Following sodium restriction Following fluid restriction Not smoking
2 (1, 5), 53
0 (-2, 3), 173
0.015
2 (0, 4), 97
0 (-2, 2.5), 129
0.003
1 (-1, 3), 211
0 (-2, 2), 15
0.460
Reports plan for worsened symptoms
1 (-1, 3.5), 173
0 (-2, 2), 53
0.037
Performing exercise ≥3 times per week 1 (-1, 3), 87
1 (-2, 3), 139
0.34
Data are expressed as median (interquartile range), and n for group.
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N.V.A. Kommuri et al./ Patient Education and Counseling 86 (2012) 233-238
symptoms worsened demonstrated significantly higher scores on HFKQ testing. Similarly, patients following these measures were more likely to have increases in their HFKQ scores at 3 months compared to baseline. At 3 month follow-up, HFKQ scores and changes compared to baseline did not differ in patients based on their adherence to smoking and exercise self care measures.
4. Discussion and conclusion
4.1. Discussion
Findings from this study show that face to face nurse education significantly improves disease specific knowledge compared to the standard discharge process. Specifically, this patient targeted education program improved heart failure patient overall disease specific knowledge, and disease management knowledge, but did not significantly increase dietary sodium knowledge. This study also demonstrates that heart failure disease specific knowledge is associated with clinical outcomes in patients with heart failure, as patients without clinical events had higher increases in heart failure knowledge scores compared to patients experiencing clinical events in the 6 month follow up period. Patients randomized to receive the education intervention were found to be more than 2- fold more likely to have improved HFKQ scores at three months compared to controls receiving the standard discharge process.
Multiple previous studies demonstrated that multidisciplinary discharge education with post discharge follow up improves clinical outcomes [3-12]. Our previous publication first described the independent effects of nurse education on clinical outcomes in patients with systolic heart failure, demonstrating a 35% reduction in rehospitalization in patients randomized to the nurse education intervention [7]. Prior studies have also demonstrated that there is a wide gap between the perceived learning needs of the patients when compared to health care professionals [19-21]. While changes in heart failure knowledge have been reported with disease specific interventions by others [22-24], no studies have assessed the association between knowledge acquisition and subsequent self-care behavior [24]. Furthermore, none of these previous studies have shown that a measurable improvement in the knowledge is associated with clinical outcomes.
Findings from our study showed that heart failure knowledge is strongly associated with self reported adherence to heart failure self care measures. Patients reporting adherence with daily weight monitoring, dietary sodium and fluid restriction, and having a plan for what to do if their symptoms worsened had significantly higher HFKQ scores and higher improvement in HFKQ scores compared to patients reporting that they were not adherent to these recom- mendations. This observation supports the connections between the education intervention, the improvement in disease specific knowledge and the desired self care behaviors. It is plausible that these improved behaviors accounted for the better clinical outcomes demonstrated in the education group. Patients who retain educational principles conveyed by the nurse educator are more likely to practice appropriate self-care behaviors and alter their clinical course. Ni et al. previously demonstrated a trend toward an association between poor adherence to self care measures and lack of knowledge about self care. [25] This study did not assess the relationship between self care knowledge and clinical outcomes.
Although we were able to demonstrate improvements in overall heart failure knowledge using the education intervention, we were not able to show improvements in dietary knowledge. This possibly points out a significant weakness in our educational program. The HFKQ was written for the purpose of assessing patient disease specific and dietary specific knowledge before and after the education intervention. The questionnaire has not been previously studied and attributes such as reliability and validity cannot be
quoted. Previous studies demonstrated that specific education delivered by a registered dietician aimed at teaching skills for reading Nutritional Facts labels and sorting foods into high and low sodium groups led to clear improvements in patient's sodium knowledge [26]. Whether our education intervention would lead to improved ability to sort foods based on sodium content is unknown. Further refinements in our education program may need to include specific attention to Nutritional Facts label interpretation. Never- theless, while patients randomized to receive the education intervention did not improve their performance on the dietary sodium questions of the HFKQ, they reported clear improvement in adherence to dietary self care measures.
Previous investigators have described the potential challenges surrounding the education of patients with chronic illness, including heart failure [22]. Medications, blood flow and prior central nervous system insults may directly determine the cognitive abilities of patients presenting with heart failure. These issues, combined with the heterogeneity of educational level, vocabulary, prior knowledge, and reading/oral literacy, strongly influence the success of educational efforts in the heart failure population. Others have shown that despite concerted efforts to provide medication information, patients may not necessarily retain the information on the first try [27]. This had led many to suggest that education for chronic illnesses should be performed over multiple interactions [28], rather than just one, as was the case in this study.
4.2. Conclusion
This study demonstrates that a single face to face, 1 h long, educational session with a nurse educator leads to improved heart failure specific knowledge in patients hospitalized with heart failure and left ventricular systolic dysfunction. The knowledge that patients retained from the education session was apparent on testing at the 3 month follow up period, and this was strongly associated with appropriate self care behaviors. Furthermore, we have shown that patients with high heart failure knowledge scores are less likely to be readmitted to the hospital over a 6 month follow up period than patients with low scores.
4.3. Practice implications
Nurse led education sessions are effective in improving disease specific knowledge as well as clinical outcomes in heart failure patients with systolic dysfunction. Our study highlights the need for funding of educational sessions to reduce the cost burden of this common chronic illness.
Funding sources
Quality Care Research Fund from the Academic Medicine and Managed Care Forum.
Appendix A. Supplementary data
Supplementary data associated with this article can be found, in the online version, at doi: 10.1016/j.pec.2011.05.019.
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