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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR013428 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The primary aim of the PAL-HF trial is to assess the impact of an interdisciplinary palliative care intervention combined with usual heart failure management on health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale.
Heart failure currently affects over 5 million Americans. Symptomatic patients have a median life expectancy of less than 5 years and those with late-stage disease have 1-year mortality rates approaching 90%. Despite recent therapeutic advances that reduce morbidity and mortality, heart failure continues to cause enormous suffering. Patients with advanced disease suffer not only from the physical effects of the illness, but also from psychosocial and spiritual distress. In addition, heart failure costs more than $34 billion annually to the healthcare system and a disproportionate amount is spent on patients in the last 6 months of life when some of the treatments may be either ineffective or undesired. Selected patients are candidates for aggressive treatments such as cardiac transplantation or mechanical circulatory support, but the application of these therapies to the broader heart failure population is limited by resource scarcity and their untested usefulness in older patients with significant co-morbidities.
The progressive nature of heart failure coupled with high mortality rates and poor quality of life mandates greater attention to palliative care as a routine component of heart failure management. Patients with advanced heart failure, particularly the elderly and those with significant co-morbidities, ought to be ideal candidates for palliative care that aims to relieve suffering and improve quality of life. Yet, several challenges have limited the use of palliative care approaches in heart failure:
Given these limitations, a properly designed and powered study is required to determine whether a multidimensional palliative care intervention in addition to usual care improves health-related outcomes relative to usual care alone in advanced heart failure patients with a highly probable short-term mortality.
PAL-HF is prospective, controlled, unblinded, 2-arm, single-center clinical trial of approximately 200 advanced heart failure patients with >50% predicted 6-month mortality randomized to usual, state of the art heart failure care or usual care combined with the PAL-HF intervention.
Patients will be randomized in a 1:1 ratio to either of 2 treatment regimens:
The primary endpoint will be health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale (FACIT-Pal) score at 6 months
The duration of the intervention in PAL-HF is 6 months, but patients in both groups will be followed until death, or the end of the study.
The study will be completed in both arms of the trial with a post-death interview with the caregiver.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual heart failure care | No Intervention | Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function. | |
| Usual care + palliative care | Active Comparator | Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual heart failure care | Behavioral | Usual heart failure care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) | The primary endpoint is health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item, disease-specific questionnaire scored from 0-100 with high scores representing better health status. | Baseline, 6 months |
| Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal) | The primary endpoint is health-related quality of life as measured by the FACIT-Pal. The FACIT-Pal is a 46-item measure of self-reported quality of life (27 general quality of life; 19 palliative care) that assesses quality of life in several domains. The range of FACIT-Pal total score is 0-184, a higher score is better. | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety | Depression and anxiety will be assessed in all patients using the self-administered Hospital Anxiety and Depression Scale (HADS) at 2 weeks, 3 months, and 6 months. Range of HADS total score is 0-42. It is divided into depression and anxiety. Each is 0-21. A score of 11 or higher indicates the possible presence of the mood disorder (clinical caseness) with a score of 8 to 10 being suggestive of the presence of the respective state. The two subscales, anxiety and depression, have been found to be independent measures. In its current form the HADS in this study is divided into 3 ranges: normal (0-7), borderline (8-10), abnormal (11-21). Movement between categories would constitute a clinically significant change in the health status. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph G. Rogers, MD | Duke University Medical Center - DCRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15737107 | Background | Hayden D, Pauler DK, Schoenfeld D. An estimator for treatment comparisons among survivors in randomized trials. Biometrics. 2005 Mar;61(1):305-10. doi: 10.1111/j.0006-341X.2005.030227.x. | |
| 34851740 | Derived | Tobin RS, Samsky MD, Kuchibhatla M, O'Connor CM, Fiuzat M, Warraich HJ, Anstrom KJ, Granger BB, Mark DB, Tulsky JA, Rogers JG, Mentz RJ, Johnson KS. Race Differences in Quality of Life following a Palliative Care Intervention in Patients with Advanced Heart Failure: Insights from the Palliative Care in Heart Failure Trial. J Palliat Med. 2022 Feb;25(2):296-300. doi: 10.1089/jpm.2021.0220. Epub 2021 Dec 1. |
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The duration of the intervention in PAL-HF is 6 months but patients in both groups were followed until death or until the end of the study (approximately 3.5 years). Please see the numbers "completed" in the "Overall Study" section.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care + Palliative Care | Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning. Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention. |
| FG001 | Usual Heart Failure Care | Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care + Palliative Care | Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning. Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) | The primary endpoint is health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item, disease-specific questionnaire scored from 0-100 with high scores representing better health status. | Participants that completed the baseline and 6 month KCCQ | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
|
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Per IRB approved protocol adverse events that required MedWatch reporting were the only adverse events collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care + Palliative Care | Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning. Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph G. Rogers, MD | Duke University Medical Center | 919-681-1370 | joseph.rogers@duke.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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|
|
| Interdisciplinary palliative care | Behavioral | Interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention. |
|
| Baseline (2 weeks post hospital discharge), 3 months, 6 months |
| After-Death Bereaved Family Member Interview - Hospice Version | A structured interview with the caregiver of those subjects that die during the study will be conducted 6 weeks following the study subject's death using the After-Death Bereaved Family Member Interview - Hospice Version. The interview provides an assessment of patient-focused, family-centered care and assesses overall quality of care received. An overall rating is derived from the ratings questions. The scoring is calculated using a pre-formatted Microsoft Excel spreadsheet for data entry and analysis. For scoring, the 5 rating questions were summed and the final scale varied between 0 (indicating worst possible care) to 50 (best possible care). | 6 weeks after patient's death |
| Change in FACIT-Sp | Spiritual well-being will be assessed using the Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale (FACIT-Sp) at 2 weeks, 3 months, and 6 months. The FACIT-Sp is a 12 item scale which assesses the role of faith in illness and meaning, peace, and purpose in life. The range of FACIT-Sp 12 score is 0-48, with higher values representing an increased spirituality across the range of religious traditions. | Baseline (2 weeks post hospital discharge), 3 months, 6 months |
| Utilization and Cost Measured by the Aggregate Cost of Care | The investigators will use administrative data from Duke Health System to estimate costs of care to determine the cost effectiveness of palliative care versus normal care. At all follow-up points in the study (2 weeks, 6 weeks, 3 months, 6 months, and every 6 months thereafter), patients will be asked if they received care outside of the Duke Health System and to estimate the number of physician visits and/or days in the hospital. The cost of such care will be estimated using the Medical Expenditure Panel Survey and included in the aggregate cost of care from randomization until completion of the study. Due to administrative delays, constraints and time to access the cost data, the study team is still working through the data aggregation for full utilization comparison as well as cost comparison. | time of randomization until end of follow-up, approximately 3.5 years |
| Utilization and Cost Measured by Hospital Readmissions | We evaluated the total burden of all-cause, cardiovascular and Heart Failure-specific readmissions with the palliative care intervention compared to usual care. | Baseline (2 weeks post hospital discharge), 6 months |
| 32268795 | Derived | Truby LK, O'Connor C, Fiuzat M, Stebbins A, Coles A, Patel CB, Granger B, Pagidipati N, Agarwal R, Rymer J, Lowenstern A, Douglas PS, Tulsky J, Rogers JG, Mentz RJ. Sex Differences in Quality of Life and Clinical Outcomes in Patients With Advanced Heart Failure: Insights From the PAL-HF Trial. Circ Heart Fail. 2020 Apr;13(4):e006134. doi: 10.1161/CIRCHEARTFAILURE.119.006134. Epub 2020 Apr 9. |
| 28705314 | Derived | Rogers JG, Patel CB, Mentz RJ, Granger BB, Steinhauser KE, Fiuzat M, Adams PA, Speck A, Johnson KS, Krishnamoorthy A, Yang H, Anstrom KJ, Dodson GC, Taylor DH Jr, Kirchner JL, Mark DB, O'Connor CM, Tulsky JA. Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial. J Am Coll Cardiol. 2017 Jul 18;70(3):331-341. doi: 10.1016/j.jacc.2017.05.030. |
| 25440791 | Derived | Mentz RJ, Tulsky JA, Granger BB, Anstrom KJ, Adams PA, Dodson GC, Fiuzat M, Johnson KS, Patel CB, Steinhauser KE, Taylor DH Jr, O'Connor CM, Rogers JG. The palliative care in heart failure trial: rationale and design. Am Heart J. 2014 Nov;168(5):645-651.e1. doi: 10.1016/j.ahj.2014.07.018. Epub 2014 Jul 30. |
| BG001 | Usual Heart Failure Care | Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Usual Heart Failure Care | Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function. |
|
|
|
| Primary | Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal) | The primary endpoint is health-related quality of life as measured by the FACIT-Pal. The FACIT-Pal is a 46-item measure of self-reported quality of life (27 general quality of life; 19 palliative care) that assesses quality of life in several domains. The range of FACIT-Pal total score is 0-184, a higher score is better. | Participants who completed the baseline and 6 month FACIT-Pal. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
|
|
|
|
| Secondary | Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety | Depression and anxiety will be assessed in all patients using the self-administered Hospital Anxiety and Depression Scale (HADS) at 2 weeks, 3 months, and 6 months. Range of HADS total score is 0-42. It is divided into depression and anxiety. Each is 0-21. A score of 11 or higher indicates the possible presence of the mood disorder (clinical caseness) with a score of 8 to 10 being suggestive of the presence of the respective state. The two subscales, anxiety and depression, have been found to be independent measures. In its current form the HADS in this study is divided into 3 ranges: normal (0-7), borderline (8-10), abnormal (11-21). Movement between categories would constitute a clinically significant change in the health status. | Participants that completed the baseline, 3 month, and 6 month HADS. | Posted | Mean | Standard Deviation | units on a scale | Baseline (2 weeks post hospital discharge), 3 months, 6 months |
|
|
|
|
| Secondary | After-Death Bereaved Family Member Interview - Hospice Version | A structured interview with the caregiver of those subjects that die during the study will be conducted 6 weeks following the study subject's death using the After-Death Bereaved Family Member Interview - Hospice Version. The interview provides an assessment of patient-focused, family-centered care and assesses overall quality of care received. An overall rating is derived from the ratings questions. The scoring is calculated using a pre-formatted Microsoft Excel spreadsheet for data entry and analysis. For scoring, the 5 rating questions were summed and the final scale varied between 0 (indicating worst possible care) to 50 (best possible care). | Overall rating scale 6 weeks after patient's death. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks after patient's death |
|
|
|
| Secondary | Change in FACIT-Sp | Spiritual well-being will be assessed using the Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale (FACIT-Sp) at 2 weeks, 3 months, and 6 months. The FACIT-Sp is a 12 item scale which assesses the role of faith in illness and meaning, peace, and purpose in life. The range of FACIT-Sp 12 score is 0-48, with higher values representing an increased spirituality across the range of religious traditions. | Participants that completed the baseline, 3 month, and 6 month FACIT-Sp. | Posted | Mean | Standard Deviation | units on a scale | Baseline (2 weeks post hospital discharge), 3 months, 6 months |
|
|
|
|
| Secondary | Utilization and Cost Measured by the Aggregate Cost of Care | The investigators will use administrative data from Duke Health System to estimate costs of care to determine the cost effectiveness of palliative care versus normal care. At all follow-up points in the study (2 weeks, 6 weeks, 3 months, 6 months, and every 6 months thereafter), patients will be asked if they received care outside of the Duke Health System and to estimate the number of physician visits and/or days in the hospital. The cost of such care will be estimated using the Medical Expenditure Panel Survey and included in the aggregate cost of care from randomization until completion of the study. Due to administrative delays, constraints and time to access the cost data, the study team is still working through the data aggregation for full utilization comparison as well as cost comparison. | Data not collected. | Posted | time of randomization until end of follow-up, approximately 3.5 years |
|
|
| Secondary | Utilization and Cost Measured by Hospital Readmissions | We evaluated the total burden of all-cause, cardiovascular and Heart Failure-specific readmissions with the palliative care intervention compared to usual care. | Posted | Number | Number of readmissions | Baseline (2 weeks post hospital discharge), 6 months |
|
|
|
|
| 40 |
| 75 |
| 0 |
| 75 |
| 0 |
| 75 |
| EG001 | Usual Heart Failure Care | Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function. | 38 | 75 | 0 | 75 | 0 | 75 |
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| FACIT-Pal at 6 months |
|
|
6 Months
| 0.0350 |
| Mean Difference (Net) |
| 11.7730 |
| 2-Sided |
| 95 |
| 0.8409 |
| 22.7052 |
| Superiority |
| HADS Anxiety at 3 months |
|
|
| HADS Anxiety at 6 months |
|
|
| HADS Depression at 2 weeks |
|
|
| HADS Depression at 3 months |
|
|
| HADS Depression at 6 months |
|
|
| 0.3657 |
| Mean Difference (Net) |
| -0.7946 |
| 2-Sided |
| 95 |
| -2.5285 |
| 0.9393 |
| Superiority |
HADS Anxiety 3 months |
| Mixed Models Analysis | 0.0480 | Mean Difference (Net) | -1.8269 | 2-Sided | 95 | -3.6375 | -0.0164 | Superiority | HADS Anxiety 6 months |
| Mixed Models Analysis | 0.2372 | Mean Difference (Net) | -0.9097 | 2-Sided | 95 | -2.4253 | 0.6058 | Superiority | HADS Depression at 2 weeks |
| Mixed Models Analysis | 0.4237 | Mean Difference (Net) | -0.6592 | 2-Sided | 95 | -2.2862 | 0.9678 | Superiority | HADS Depression 3 months |
| Mixed Models Analysis | 0.0202 | Mean Difference (Net) | -1.9379 | 2-Sided | 95 | -3.5672 | -0.3085 | Superiority | HADS Depression at 6 months |
| FACIT-Sp at 3 months |
|
|
| FACIT-Sp at 6 months |
|
|
| 0.5655 |
| Mean Difference (Net) |
| 1.1174 |
| 2-Sided |
| 95 |
| -2.7246 |
| 4.9594 |
| Superiority |
FACIT-Sp at 3 months |
| Mixed Models Analysis | 0.0271 | Mean Difference (Net) | 3.9809 | 2-Sided | 95 | 0.4581 | 7.5036 | Superiority | FACIT-Sp at 6 months |
| Heart failure readmissions |
|
| Non-Cardiovascular readmissions |
|
| 0.80 |
| Superiority |
Cardiovascular readmissions, Poisson regression with log link and Pearson scale |
| Poisson regression | 0.92 | Superiority | Heart failure readmissions, Poisson regression with log link and Pearson scale |
| Poisson regression | 0.12 | Superiority | Non-cardiovascular readmissions, Poisson regression with log link and Pearson scale |