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Heart failure (HF) greatly increases mortality and lowers quality of life (QOL). HF is the most common indication for readmission in older adults and the most frequent reason for 30-day readmission. Medications and restriction of dietary sodium constitute crucial therapy to lower HF recurrence. However, adherence to medications and dietary recommendations is low in HF patients. Nonadherence is often due to an interaction among the environment, the patient and providers. In the VALOR in Heart Failure Study, we will assess a novel quality improvement program (QIP) to improve HF care using a pretest-posttest design. This interdisciplinary theory-based prospective experimental study will target improving HF treatment using patient-based behavioral and checklist intervention, as well as provider and system-targeted checklists and treatment defaults (posttest or intervention phase); this will be compared to current best practice (CBP) evaluated in the pretest (pretest or pre-intervention) phase. It is hypothesized that the QIP, which intervenes on patient, provider and system levels, will improve QOL and lower HF recurrence compared to CBP.
Heart failure (HF) greatly increases mortality and lowers quality of life (QOL). HF is the most common indication for readmission in older adults and the most frequent reason for 30-day readmission. Medications and restriction of dietary sodium constitute crucial therapy to lower HF recurrence. However, adherence to medications and dietary recommendations is low in HF patients. Nonadherence is often due to an interaction among the environment, the patient and providers. In the VALOR in Heart Failure Study, we will assess a novel quality improvement program (QIP) to improve HF care using a pretest-posttest design. This interdisciplinary theory-based prospective experimental study will target improving HF treatment using patient-based behavioral and checklist intervention, as well as provider and system-targeted checklists and treatment defaults (posttest or intervention phase); this will be compared to current best practice (CBP) evaluated in the pretest (pretest or pre-intervention) phase. It is hypothesized that the QIP, which intervenes on patient, provider and system levels, will improve QOL and lower HF recurrence compared to CBP.
The primary specific aims are 1) To test the effect of QIP on HF-specific quality of life compared to the CBP group, and 2) To evaluate the impact of QIP group on general quality of life compared to the CBP group.
Secondary specific aims are to:
1) assess the effect of QIP on medication adherence at 3 months, 2) examine the effect of QIP on diet adherence at 3 months, and 3) evaluate the effect of QIP on satisfaction, and 4) assess the effect of QIP on intervention acceptability. We will also examine the impact of QIP at 3 months on keeping routine outpatient visits, health-care utilization, exercise capacity, weight, perceived stress, depression, cardiovascular events and deaths.
Exploratory aim is to examine the effect of the QIP on 30 day post-discharge HF readmission rates compared to CBP.
We have enrolled 136 veterans being discharged from the hospital with a diagnosis of HF. Patients enrolled in the pretest phase will receive the HF management based on current best practice (CBP). Patients enrolled in the posttest phase receive the comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients. Data, including quality of life (QOL), medication adherence, and dietary adherence, will be collected from patients at baseline (prior to hospital discharge) and 3 months. Hospital readmissions, emergency room visits, and healthcare utilization will be tracked for 6 months. If, as expected, there are no differences in demographic or other confounders (EF, comorbidities, etc), the pretest and posttest groups will be compared by the Fisher's Exact test for discrete outcomes (30-day readmissions or ER visits). We will use the Student's ttest (two-tailed) for normally distributed outcomes and the Wilcoxon rank-sum test for categorical variables and continuous variables not normally distributed.
This study will inform and enhance quality improvement efforts in heart failure care in VA New York Harbor and elsewhere. It will also provide data for a rigorous effectiveness trial to test this promising intervention that could reduce HF recurrence and improve QOL in HF. If this promising theory-driven approach can work in a clinical setting where improvements in HF care are so urgent, it will be an important scientific contribution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Current Best Practice (CBP) | No Intervention | CBP received no intervention and only current best practices for inpatient HF care. | |
| Quality improvement program (QIP) | Active Comparator | Comprehensive quality improvement program (QIP) intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive quality improvement program (QIP) | Behavioral | Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients. |
| Measure | Description | Time Frame |
|---|---|---|
| General Quality of Life From the Standardized Physical Component Score | Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 3 months after discharge |
| Heart Failure Specific Quality of Life | Measured by Minnesota Living with Heart Failure Questionnaire. Scores range from 0-105, with higher scores indicating poorer QOL. | 3 months after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Standardized Mental Component Score | Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 3 months after discharge |
| Physical Functioning |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sundar Natarajan, MD MSc | VA New York Harbor Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA New York Harbor Health Care System | New York | New York | 10010 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Current Best Practice (CBP) | CBP received no intervention and only current best practices for inpatient HF care. |
| FG001 | Comprehensive Quality Improvement Program (QIP) | Comprehensive quality improvement program (QIP) Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Current Best Practice (CBP) | Current best practice (CBP) receives the current treatment for patients discharged with heart failure |
| BG001 | Comprehensive Quality Improvement Program (QIP) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Standardized Mental Component Score | Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months after discharge |
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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 | Current Best Practice (CBP) | CBP received no intervention and only current best practices for inpatient HF care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery bypass graft | Surgical and medical procedures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sundar Natarajan, MD, M.Sc. | VA New York Harbor Healthcare System | 212-951-3395 | sundar.natarajan@va.gov |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
| 3 months after discharge |
| Role Physical | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 3 months after discharge |
| Pain Index | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 3 months after discharge |
| General Health | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 3 months after discharge |
| Vitality | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 3 months after discharge |
| Social Functioning | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 3 months after discharge |
| Role Emotional | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 3 months after discharge |
| Mental Health | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 3 months after discharge |
| Physical Subscale of Heart Failure Specific Quality of Life | Subscale of the Minnesota Living with Heart Failure Questionnaire (HF-specific quality of life measure). Scores range from 0-40, with higher scores indicating poorer QOL. | 3 months after discharge |
| Emotional Subscale of Heart Failure Specific Quality of Life | Subscale of the Minnesota Living with Heart Failure Questionnaire (HF-specific quality of life measure). Scores range from 0-25, with higher scores indicating poorer QOL. | 3 months after discharge |
| Lost to Follow-up |
|
Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Marital Status | Number | participants |
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| Education | Number | participants |
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| Employment status | Number | participants |
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| Campus | Number | participants |
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| BNP | B-type natriuretic peptide | Median | Inter-Quartile Range | pg/mL |
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| Number of heart failure medications | Median | Inter-Quartile Range | number of heart failure medications |
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| Length of hospital stay | Median | Inter-Quartile Range | days |
|
Comprehensive quality improvement program (QIP)
Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients.
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| Secondary | Physical Functioning | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months after discharge |
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| Secondary | Role Physical | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36. Additionally, a second participant in CBP did not complete the role physical subscale items, leaving a total of 49 in CBP and 46 in QIP for this outcome. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months after discharge |
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| Secondary | Pain Index | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months after discharge |
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| Secondary | General Health | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months after discharge |
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| Secondary | Vitality | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months after discharge |
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| Secondary | Social Functioning | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months after discharge |
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| Secondary | Role Emotional | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months after discharge |
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| Secondary | Mental Health | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months after discharge |
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| Primary | General Quality of Life From the Standardized Physical Component Score | Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life | 51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months after discharge |
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| Secondary | Physical Subscale of Heart Failure Specific Quality of Life | Subscale of the Minnesota Living with Heart Failure Questionnaire (HF-specific quality of life measure). Scores range from 0-40, with higher scores indicating poorer QOL. | 51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the Minnesota Living with Heart Failure Questionnaire, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months after discharge |
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| Primary | Heart Failure Specific Quality of Life | Measured by Minnesota Living with Heart Failure Questionnaire. Scores range from 0-105, with higher scores indicating poorer QOL. | 51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the MLHFQ, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months after discharge |
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| Secondary | Emotional Subscale of Heart Failure Specific Quality of Life | Subscale of the Minnesota Living with Heart Failure Questionnaire (HF-specific quality of life measure). Scores range from 0-25, with higher scores indicating poorer QOL. | 51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the Minnesota Living with Heart Failure Questionnaire, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months after discharge |
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| 7 |
| 68 |
| 6 |
| 68 |
| EG001 | Quality Improvement Program (QIP) | Quality improvement program (QIP) The comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients. | 8 | 68 | 5 | 68 |
| myocardial infarction | Cardiac disorders | Systematic Assessment |
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| angina | Cardiac disorders |
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| broken bone | Injury, poisoning and procedural complications |
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| hypertensive emergency | Cardiac disorders |
|
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