A Supportive care program for patients with heart failure, a Pilot Study
Date Issued
2020
Author(s)
Advisor
Abstract
Introduction:
Long-term conditions, such as heart failure (HF), significantly impact patients and health care systems across Europe. HF has become a major and increasing public health problem worldwide. Despite advances in treatment, the prognosis of HF remains poor, accounting for 10% mortality rate after an acute event and 20-25% of patients will be readmitted within the first month after discharge. Disease management programs for HF are characterized by heterogeneity and different levels of complexity, thus the results regarding the effectiveness of those programs are controversial. There is a need for effective programs that promote the adherence of HF patients to treatment.
The chronic and life-limiting aspects of HF require supportive care: patient-centered care that integrates patient preferences and patient and family needs into the goals of care, manages symptoms to the level of comfort desired, and attempts to reduce the burden of illness for both the patient and his/her family. Based on this model, health care providers have to follow the illness trajectory of each patient and integrate supportive care based on the needs in each time point. Supportive HF care consists of the following four aspects: Communication, education, psychological and spiritual issues and symptom management.
Aim: The present study aspires to evaluate the effectiveness of an individualized supportive care management program in terms of the four different components that comprise supportive care in HF (communication, education, psychological and spiritual issues and self-management). The objectives of this study were to:
a) Determine supportive care needs of HF patients as reported in the literature.
b) Explore Cypriot patients’ identified supportive care needs.
c) Develop and pilot-test a self-management supportive care program for HF patients.
Study design
This was a multi-method study for developing and testing a supportive care management program for HF patients, following the Medical Research Council framework for complex interventions. A sequential exploratory approach was used in order to develop the content of the intervention. The study design consisted of two phases: Phase I: Development and Phase II: Pilot test of the management program. Phase I consisted by four different steps as follow:
1. Systematic review and meta-synthesis and systematic review and meta-analysis. Meta-synthesis conducted to identify what was reported as supportive needs of patients with HF and meta-analysis to identify which supportive care interventions were effective in order to be included in HF management programs. 2. Focus groups took place in order to explore Cypriot patients’ needs to determine if the literature reflects their needs or if specific areas are missing. 3. The care needs of patients with HF explored through the literature and focus groups and the research team develop the context of the management program. 4. The intervention was developed based on supportive needs as identified by Cypriot patients.
Phase II
Phase II consisted of a pilot and feasibility study to determine whether the intervention can be implemented in Cyprus, whether it is acceptable to patients, and potential effect on patient outcomes. This information will allow the intervention to be refined, and a randomized controlled trial to be planned and conducted.
Patients were randomly allocated to intervention or control group. Patients allocated in the intervention group received written material in the form of a booklet and the first brief educational session was conducted by the nurse in the bedside of the patient before their discharge.
The intervention consisted by educational sessions once a month including information about the syndrome of HF, pharmacological and non- pharmacological treatment/self-management actions as follow: low- sodium diet, monitor weight, daily fluid volume, breathing more effectively, coughing techniques, quitting smoking, managing fatigue, coping with stress, medication adherence, physical activity, socializing, relaxation, early detection of decompensation signs.
The evaluation of the intervention done using the following questionnaires: 1) The “Self-care of Heart Failure Index”, 2) The “Multidimensional scale of perceived social support”, 3) The “Minnesota Living with Heart Failure questionnaire”, 4) The “Dutch Heart Failure Knowledge Scale, hospital anxiety and depression scale. Furthermore, acute events and deterioration were measured. The influence of treatments and disease management strategies on outcomes measuring readmission rate and mortality. An open-ended question used to assess patient’s satisfaction regarding the perceived support of the supportive care program. Patient and family needs for information, communication, and assistance with care; the extent to which these needs are met assessed using an open-ended question. After the first month of hospital discharge, in three- and six-months period, patients were conducted by telephone call and evaluation was established using questionnaires.
Statistical comparisons were performed using the ""Kruskal Wallis Test"" for continuous variables, the Chi-Square test for categorical variables and the Fisher’s exact test for categorical variables. Missing values in the scales have been imputed using the multiple imputation algorithm as it was followed an intention to treat analysis. The scales reliability explored using Cronbach’s alpha internal consistency index. For the acute events, survival analysis was performed. Kaplan Meir curves and the log-rank test were utilised to explore the difference between Control and Intervention with regards to the time until the first acute event. Moreover, Cox regression was utilised to quantify the effect of the intervention on the hazard for an acute event while controlling for demographic and clinical characteristics. Statistical analysis was conducted in the statistical software R v.3.6.1
Results:
To develop the intervention of this research program, a sequential exploratory approach was followed. Firstly, a systematic review and meta-synthesis was performed to reveal the supportive care needs of HF patients and then a meta-analysis was undertaken to explore which supportive care interventions seem to be effective as part of HF management programs. To explore the needs of Cypriot patients with HF, focus groups were also conducted using a semi-structured guidance which was developed based on the results of the meta-synthesis and meta-analysis. Based on the process described, researchers developed and pilot-tested the interventional supportive management program.
The pilot study consisted from thirty-five patients with twenty- four patients participating in the intervention group and eleven patients in the control group. The implementation of the intervention lasted for a period of six months. One patient from the control group was lost to follow up and there were three fatal events, all from the control group. The mean age of the patients was 71 years old with no differences between the two groups. Most of the patients were married [30 (86%)] and had family history [17 (49%)].
As measured with MLWHFQ a better HR-QoL was found for both groups in the sixth time period [IG 6th month= 19.8 (21.2)/ CG 6th month= 19 (7.0)], but it was a difference in the social dimension of the HR-QoL favoring the intervention group [IG baseline= 4.8 (4.9) / 1st month=3.3 (3.5) / 6th month =2.8 (3.1)] [ CG baseline= 2.3 (1,1) / 1st month=3.4 (2,7) / 6th month =2.7 (2.8) ]. Importantly, a difference in the sub-scale of family/significant others indicated where patients in the intervention group followed an increased trend [IG baseline=50.9 (5.4) / 6th month= 52.7 (3.4)] [CG baseline =50.3 (8.9) / 6th month = 49.9 (4.2)]. In the overall scale of Gr9-EHFScB there was no difference between the two groups [IG baseline=37.8 (6.7)/ 1st month=39.9 (4.9) /6th month=40.7 (6.1)] [CG baseline=37.1 (4.5) / 1st month=37.2 (6.4) /6th month=39.0 (1.7)]. The same observed measuring self-care with the SCHFI [IG baseline=65.2(7.3)/6st month= IG= 69.8 (8,2)] [CG baseline= 51.9 (8.5)/6th month= CG =61.0 (7.3)]. Overall, scales demonstrated a satisfactory (>0.70) reliability index.
Survival analysis was performed for a 30, 90-day and 180-day period. The mean number of events per patient in the control group was 0.44 (SD=0.53) and 0.09(SD=0,29) events for the intervention group (p=0.026) in 30 days, 0.78 (SD=0.6) for control group and 0.09(SD=0,29) (p<0.001) events for the intervention group in 60 days and 0.78 (SD=0.6) for control group and 0.32(SD=057) events for the intervention group (p=0.048) in 180 days. The survival of the control group was lower than that of the Intervention’s in all three time points; 30 days: (log-rank test, X2(1) = 5.7, p=0.02), 90 days: (log-rank test, X2(1) = 12.3, p<0.001) and 180 days: (log-rank test, X2(1) = 6.8, p=0.009).
Discussion/Conclusion:
Supportive care seems to be a promising concept for HF management programs. There was a great effect in acute events (readmission rate and death), as it was found a reduced risk by 87% for a patient receiving supportive care. Apart from that the pilot study illustrated the effectiveness regarding multiple outcomes such as HR-QoL and perceived support. As shown from previous research, multi-component management programs are seemed to be effective. Patients’ satisfaction could be achieved when covering their needs. The mechanism by which this is feasible is supportive care; continuing assessment, support and early recognition of decompensation. It is also known that another component of sufficient and successful HF management programs is long term duration which could also be a marker for the value of continuity and long-term support. Thus, a structured program has to be offered to HF patients as part of the health care services.
Long-term conditions, such as heart failure (HF), significantly impact patients and health care systems across Europe. HF has become a major and increasing public health problem worldwide. Despite advances in treatment, the prognosis of HF remains poor, accounting for 10% mortality rate after an acute event and 20-25% of patients will be readmitted within the first month after discharge. Disease management programs for HF are characterized by heterogeneity and different levels of complexity, thus the results regarding the effectiveness of those programs are controversial. There is a need for effective programs that promote the adherence of HF patients to treatment.
The chronic and life-limiting aspects of HF require supportive care: patient-centered care that integrates patient preferences and patient and family needs into the goals of care, manages symptoms to the level of comfort desired, and attempts to reduce the burden of illness for both the patient and his/her family. Based on this model, health care providers have to follow the illness trajectory of each patient and integrate supportive care based on the needs in each time point. Supportive HF care consists of the following four aspects: Communication, education, psychological and spiritual issues and symptom management.
Aim: The present study aspires to evaluate the effectiveness of an individualized supportive care management program in terms of the four different components that comprise supportive care in HF (communication, education, psychological and spiritual issues and self-management). The objectives of this study were to:
a) Determine supportive care needs of HF patients as reported in the literature.
b) Explore Cypriot patients’ identified supportive care needs.
c) Develop and pilot-test a self-management supportive care program for HF patients.
Study design
This was a multi-method study for developing and testing a supportive care management program for HF patients, following the Medical Research Council framework for complex interventions. A sequential exploratory approach was used in order to develop the content of the intervention. The study design consisted of two phases: Phase I: Development and Phase II: Pilot test of the management program. Phase I consisted by four different steps as follow:
1. Systematic review and meta-synthesis and systematic review and meta-analysis. Meta-synthesis conducted to identify what was reported as supportive needs of patients with HF and meta-analysis to identify which supportive care interventions were effective in order to be included in HF management programs. 2. Focus groups took place in order to explore Cypriot patients’ needs to determine if the literature reflects their needs or if specific areas are missing. 3. The care needs of patients with HF explored through the literature and focus groups and the research team develop the context of the management program. 4. The intervention was developed based on supportive needs as identified by Cypriot patients.
Phase II
Phase II consisted of a pilot and feasibility study to determine whether the intervention can be implemented in Cyprus, whether it is acceptable to patients, and potential effect on patient outcomes. This information will allow the intervention to be refined, and a randomized controlled trial to be planned and conducted.
Patients were randomly allocated to intervention or control group. Patients allocated in the intervention group received written material in the form of a booklet and the first brief educational session was conducted by the nurse in the bedside of the patient before their discharge.
The intervention consisted by educational sessions once a month including information about the syndrome of HF, pharmacological and non- pharmacological treatment/self-management actions as follow: low- sodium diet, monitor weight, daily fluid volume, breathing more effectively, coughing techniques, quitting smoking, managing fatigue, coping with stress, medication adherence, physical activity, socializing, relaxation, early detection of decompensation signs.
The evaluation of the intervention done using the following questionnaires: 1) The “Self-care of Heart Failure Index”, 2) The “Multidimensional scale of perceived social support”, 3) The “Minnesota Living with Heart Failure questionnaire”, 4) The “Dutch Heart Failure Knowledge Scale, hospital anxiety and depression scale. Furthermore, acute events and deterioration were measured. The influence of treatments and disease management strategies on outcomes measuring readmission rate and mortality. An open-ended question used to assess patient’s satisfaction regarding the perceived support of the supportive care program. Patient and family needs for information, communication, and assistance with care; the extent to which these needs are met assessed using an open-ended question. After the first month of hospital discharge, in three- and six-months period, patients were conducted by telephone call and evaluation was established using questionnaires.
Statistical comparisons were performed using the ""Kruskal Wallis Test"" for continuous variables, the Chi-Square test for categorical variables and the Fisher’s exact test for categorical variables. Missing values in the scales have been imputed using the multiple imputation algorithm as it was followed an intention to treat analysis. The scales reliability explored using Cronbach’s alpha internal consistency index. For the acute events, survival analysis was performed. Kaplan Meir curves and the log-rank test were utilised to explore the difference between Control and Intervention with regards to the time until the first acute event. Moreover, Cox regression was utilised to quantify the effect of the intervention on the hazard for an acute event while controlling for demographic and clinical characteristics. Statistical analysis was conducted in the statistical software R v.3.6.1
Results:
To develop the intervention of this research program, a sequential exploratory approach was followed. Firstly, a systematic review and meta-synthesis was performed to reveal the supportive care needs of HF patients and then a meta-analysis was undertaken to explore which supportive care interventions seem to be effective as part of HF management programs. To explore the needs of Cypriot patients with HF, focus groups were also conducted using a semi-structured guidance which was developed based on the results of the meta-synthesis and meta-analysis. Based on the process described, researchers developed and pilot-tested the interventional supportive management program.
The pilot study consisted from thirty-five patients with twenty- four patients participating in the intervention group and eleven patients in the control group. The implementation of the intervention lasted for a period of six months. One patient from the control group was lost to follow up and there were three fatal events, all from the control group. The mean age of the patients was 71 years old with no differences between the two groups. Most of the patients were married [30 (86%)] and had family history [17 (49%)].
As measured with MLWHFQ a better HR-QoL was found for both groups in the sixth time period [IG 6th month= 19.8 (21.2)/ CG 6th month= 19 (7.0)], but it was a difference in the social dimension of the HR-QoL favoring the intervention group [IG baseline= 4.8 (4.9) / 1st month=3.3 (3.5) / 6th month =2.8 (3.1)] [ CG baseline= 2.3 (1,1) / 1st month=3.4 (2,7) / 6th month =2.7 (2.8) ]. Importantly, a difference in the sub-scale of family/significant others indicated where patients in the intervention group followed an increased trend [IG baseline=50.9 (5.4) / 6th month= 52.7 (3.4)] [CG baseline =50.3 (8.9) / 6th month = 49.9 (4.2)]. In the overall scale of Gr9-EHFScB there was no difference between the two groups [IG baseline=37.8 (6.7)/ 1st month=39.9 (4.9) /6th month=40.7 (6.1)] [CG baseline=37.1 (4.5) / 1st month=37.2 (6.4) /6th month=39.0 (1.7)]. The same observed measuring self-care with the SCHFI [IG baseline=65.2(7.3)/6st month= IG= 69.8 (8,2)] [CG baseline= 51.9 (8.5)/6th month= CG =61.0 (7.3)]. Overall, scales demonstrated a satisfactory (>0.70) reliability index.
Survival analysis was performed for a 30, 90-day and 180-day period. The mean number of events per patient in the control group was 0.44 (SD=0.53) and 0.09(SD=0,29) events for the intervention group (p=0.026) in 30 days, 0.78 (SD=0.6) for control group and 0.09(SD=0,29) (p<0.001) events for the intervention group in 60 days and 0.78 (SD=0.6) for control group and 0.32(SD=057) events for the intervention group (p=0.048) in 180 days. The survival of the control group was lower than that of the Intervention’s in all three time points; 30 days: (log-rank test, X2(1) = 5.7, p=0.02), 90 days: (log-rank test, X2(1) = 12.3, p<0.001) and 180 days: (log-rank test, X2(1) = 6.8, p=0.009).
Discussion/Conclusion:
Supportive care seems to be a promising concept for HF management programs. There was a great effect in acute events (readmission rate and death), as it was found a reduced risk by 87% for a patient receiving supportive care. Apart from that the pilot study illustrated the effectiveness regarding multiple outcomes such as HR-QoL and perceived support. As shown from previous research, multi-component management programs are seemed to be effective. Patients’ satisfaction could be achieved when covering their needs. The mechanism by which this is feasible is supportive care; continuing assessment, support and early recognition of decompensation. It is also known that another component of sufficient and successful HF management programs is long term duration which could also be a marker for the value of continuity and long-term support. Thus, a structured program has to be offered to HF patients as part of the health care services.
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