Heart Failure
Conditions
Keywords
heart failure, quality of life, readmissions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALComprehensive 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients admitted with either systolic or diastolic HF will be identified through ongoing daily prospective manual search of admission records in VA NYHHS * Men and women ( 21 years) being discharged after a HF admission will be eligible * They must have an available phone
Exclusion criteria
* Patients with poor short-term survival (\< 3 months) * recent major surgery (\< 1 month) * planned discharge to a long-term-care facility * severe dementia or other serious psychiatric illness * temporarily in the area * those unable to provide consent, refusal to participate * logistic or discretionary reasons (including participation in another study) will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General Quality of Life From the Standardized Physical Component Score | 3 months after discharge | Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life |
| Heart Failure Specific Quality of Life | 3 months after discharge | Measured by Minnesota Living with Heart Failure Questionnaire. Scores range from 0-105, with higher scores indicating poorer QOL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Role Physical | 3 months after discharge | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life |
| Pain Index | 3 months after discharge | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life |
| General Health | 3 months after discharge | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life |
| Vitality | 3 months after discharge | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life |
| Standardized Mental Component Score | 3 months after discharge | Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life |
| Role Emotional | 3 months after discharge | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life |
| Mental Health | 3 months after discharge | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life |
| Physical Subscale of Heart Failure Specific Quality of Life | 3 months after discharge | 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. |
| Emotional Subscale of Heart Failure Specific Quality of Life | 3 months after discharge | 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. |
| Social Functioning | 3 months after discharge | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life |
| Physical Functioning | 3 months after discharge | Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Current Best Practice (CBP) Current best practice (CBP) receives the current treatment for patients discharged with heart failure | 68 |
| 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. | 68 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 5 | 6 |
| Overall Study | Lost to Follow-up | 9 | 9 |
| Overall Study | Withdrawal by Subject | 3 | 6 |
Baseline characteristics
| Characteristic | Current Best Practice (CBP) | Comprehensive Quality Improvement Program (QIP) | Total |
|---|---|---|---|
| Age, Continuous | 75.3 years | 74.8 years | 74.8 years |
| BNP | 645.0 pg/mL | 739.0 pg/mL | 696.0 pg/mL |
| Campus Brooklyn | 18 participants | 23 participants | 41 participants |
| Campus Manhattan | 50 participants | 45 participants | 95 participants |
| Education High school graduate or below | 34 participants | 32 participants | 66 participants |
| Education Some college or higher | 34 participants | 36 participants | 70 participants |
| Employment status Employed | 6 participants | 4 participants | 10 participants |
| Employment status Not employed | 62 participants | 64 participants | 126 participants |
| Length of hospital stay | 6 days | 6 days | 6 days |
| Marital Status Married | 15 participants | 18 participants | 33 participants |
| Marital Status Not Married | 53 participants | 50 participants | 103 participants |
| Number of heart failure medications | 3 number of heart failure medications | 3 number of heart failure medications | 3 number of heart failure medications |
| Race/Ethnicity, Customized Black (non-Hispanic) | 14 participants | 16 participants | 30 participants |
| Race/Ethnicity, Customized Hispanic | 13 participants | 19 participants | 32 participants |
| Race/Ethnicity, Customized Other | 4 participants | 3 participants | 7 participants |
| Race/Ethnicity, Customized White (non-Hispanic) | 37 participants | 30 participants | 67 participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 66 Participants | 68 Participants | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 68 | 5 / 68 |
| serious Total, serious adverse events | 7 / 68 | 8 / 68 |
Outcome results
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
Time frame: 3 months after discharge
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Current Best Practice (CBP) | General Quality of Life From the Standardized Physical Component Score | 31.6 units on a scale |
| Comprehensive Quality Improvement Program (QIP) | General Quality of Life From the Standardized Physical Component Score | 35.5 units on a scale |
p-value: 0.05Wilcoxon (Mann-Whitney)
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.
Time frame: 3 months after discharge
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Current Best Practice (CBP) | Heart Failure Specific Quality of Life | 42.5 units on a scale |
| Comprehensive Quality Improvement Program (QIP) | Heart Failure Specific Quality of Life | 38.0 units on a scale |
p-value: 0.26Wilcoxon (Mann-Whitney)
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.
Time frame: 3 months after discharge
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Current Best Practice (CBP) | Emotional Subscale of Heart Failure Specific Quality of Life | 7.0 units on a scale |
| Comprehensive Quality Improvement Program (QIP) | Emotional Subscale of Heart Failure Specific Quality of Life | 6.0 units on a scale |
p-value: 0.36Wilcoxon (Mann-Whitney)
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
Time frame: 3 months after discharge
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Current Best Practice (CBP) | General Health | 41.0 units on a scale |
| Comprehensive Quality Improvement Program (QIP) | General Health | 57.0 units on a scale |
p-value: 0.008Wilcoxon (Mann-Whitney)
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
Time frame: 3 months after discharge
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Current Best Practice (CBP) | Mental Health | 74.0 units on a scale |
| Comprehensive Quality Improvement Program (QIP) | Mental Health | 80.0 units on a scale |
p-value: 0.56Wilcoxon (Mann-Whitney)
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
Time frame: 3 months after discharge
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Current Best Practice (CBP) | Pain Index | 51.0 units on a scale |
| Comprehensive Quality Improvement Program (QIP) | Pain Index | 61.5 units on a scale |
p-value: 0.34Wilcoxon (Mann-Whitney)
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
Time frame: 3 months after discharge
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Current Best Practice (CBP) | Physical Functioning | 37.5 units on a scale |
| Comprehensive Quality Improvement Program (QIP) | Physical Functioning | 41.4 units on a scale |
p-value: 0.22Wilcoxon (Mann-Whitney)
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.
Time frame: 3 months after discharge
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Current Best Practice (CBP) | Physical Subscale of Heart Failure Specific Quality of Life | 21.5 units on a scale |
| Comprehensive Quality Improvement Program (QIP) | Physical Subscale of Heart Failure Specific Quality of Life | 19.0 units on a scale |
p-value: 0.15Wilcoxon (Mann-Whitney)
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
Time frame: 3 months after discharge
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Current Best Practice (CBP) | Role Emotional | 66.7 units on a scale |
| Comprehensive Quality Improvement Program (QIP) | Role Emotional | 75.0 units on a scale |
p-value: 0.55Wilcoxon (Mann-Whitney)
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
Time frame: 3 months after discharge
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Current Best Practice (CBP) | Role Physical | 50.0 units on a scale |
| Comprehensive Quality Improvement Program (QIP) | Role Physical | 53.1 units on a scale |
p-value: 0.05Wilcoxon (Mann-Whitney)
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
Time frame: 3 months after discharge
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Current Best Practice (CBP) | Social Functioning | 62.0 units on a scale |
| Comprehensive Quality Improvement Program (QIP) | Social Functioning | 75.0 units on a scale |
p-value: 0.15Wilcoxon (Mann-Whitney)
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
Time frame: 3 months after discharge
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Current Best Practice (CBP) | Standardized Mental Component Score | 48.8 units on a scale |
| Comprehensive Quality Improvement Program (QIP) | Standardized Mental Component Score | 53.2 units on a scale |
p-value: 0.56Wilcoxon (Mann-Whitney)
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
Time frame: 3 months after discharge
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Current Best Practice (CBP) | Vitality | 45.0 units on a scale |
| Comprehensive Quality Improvement Program (QIP) | Vitality | 50.0 units on a scale |
p-value: 0.3Wilcoxon (Mann-Whitney)