Heart Failure
Conditions
Keywords
Heart Failure
Brief summary
The primary objective is to determine the efficacy of a strategy of biomarker-guided therapy compared with usual care in high risk patients with left ventricular systolic dysfunction.
Detailed description
Heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Common symptoms of heart failure include shortness of breath, swelling, and fatigue. Standard treatment for heart failure include diuretics to control fluid, as well as drugs called neurohormonal antagonists (such as beta-blockers and ACE-inhibitors) that help the heart work more efficiently and prevent worsening of heart function. Typically, doctors adjust these medicines based on their clinical judgment about what doses and combination will work best for you. We are testing whether the use of a blood test called NT-proBNP (which measures a hormone released by the heart) can help doctors do a better job of adjusting these heart failure medicines over time than clinical judgment alone.
Interventions
OTHERUsual Care
Usual Care
DEVICEBiomarker-guided care NT-proBNP
Device: NT-proBNP
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Most recent LVEF to be ≤ 40% by any method within 12 months of randomization. * High risk heart failure as defined by the following criteria: A Heart Failure Event in the prior 12 months, defined as any one of the following: * HF Hospitalization * Treatment in the Emergency Department (or equivalent) for Heart Failure * Outpatient treatment for heart failure with intravenous diuretics AND * NT-proBNP greater than 2000 pg/mL or BNP greater than 400 pg/mL at any time during the 30 days prior to randomization * Willing to provide informed consent
Exclusion criteria
* Acute coronary syndrome (clinical diagnosis) or cardiac revascularization procedure within 30 days * Cardiac resynchronization therapy (CRT) within prior 3 months or current plan to implant CRT device * Active myocarditis, Hypertrophic obstructive cardiomyopathy, pericarditis, or restrictive cardiomyopathy * Severe stenotic valvular disease * Anticipated heart transplantation or ventricular assist device within 12 months * Chronic inotropic therapy * Complex congenital heart disease * End stage renal disease with renal replacement therapy * Non cardiac terminal illness with expected survival less than 12 months * Women who are pregnant or planning to become pregnant * Inability to comply with planned study procedures * Enrollment or planned enrollment in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CV Death or Heart Failure Hospitalization | 24 Months | Composite of First Heart Failure Hospitalization or Cardiovascular Mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Morbidity | 24 months | Days alive and not hospitalized for CV reasons |
| CV Death | 24 months | CV death by treatment arm |
| Number of Hospitalizations for First Heart Failure | 24 months | First Heart Failure Hospitalization |
| Number of Hospitalizations for Recurrent Heart Failure | 24 months | Recurrent Heart Failure Hospitalization |
| Percentage of Patients With Moderate to Severe Depression | Baseline, 3,6, 12 and 24 months | Percentage of patients with moderate to severe depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D). CES-D is a 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression. Moderate to severe depression is indicated by a score of 11 or higher. |
| Duke Activity Status Index (DASI) | Baseline, 3, 6, 12 and 24 months | The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity). |
| EQ-5D Health Index | Baseline, 3, 6, 12 and 24 months | The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score, from -0.59 (worst) to 1 (best). |
| EQ-5D Visual Analog Scale | Baseline, 3, 6, 12 and 24 months | The EQ-5D VAS records participants self-rated health status on a vertical (0-100) scale with higher scores indicating higher Health-Related Quality of Life, where 0 = worst imaginable health state and 100 = best imaginable health state. |
| All-cause Mortality | 24 months | All-cause mortality by treatment arm |
| Short Form-36 (SF-36) General Health Subscale | Baseline, 3, 6, 12 and 24 months | SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life. |
| Short Form-36 (SF-36) Mental Health Subscale | Baseline, 3, 6, 12 and 24 months | SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life. |
| Short Form-36 (SF-36) Social Functioning Subscale | Baseline, 3, 6, 12 and 24 months | SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life. |
| Short Form-36 (SF-36) Physiological Functioning Subscale | Baseline, 3, 6, 12 and 24 months | SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life. |
| Short Form-36 (SF-36) Vitality Subscale | Baseline, 3, 6, 12 and 24 months | SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life. |
| Resource Utilization | 24 months | Observed Resource Use |
| Resource Utilization Cost | 24 months | Observed Hospital-Based Cost. |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score | Baseline, 3, 6,12 and 24 months | This KCCQ overall score represents the mean of the following 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. |
Countries
Canada, United States
Participant flow
Pre-assignment details
894 participants were randomized
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care | 448 |
| Biomarker-Guided Care Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP | 446 |
| Total | 894 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 77 | 66 |
| Overall Study | Futility | 197 | 200 |
| Overall Study | Had VAD, Dialysis or Transplant | 11 | 17 |
| Overall Study | Lost to Follow-up | 27 | 25 |
| Overall Study | Physician Decision | 3 | 7 |
| Overall Study | Withdrawal by Subject | 14 | 17 |
Baseline characteristics
| Characteristic | Biomarker-Guided Care | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 14.3 | 61.5 years STANDARD_DEVIATION 13.9 | 62.5 years STANDARD_DEVIATION 13.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants | 58 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 416 Participants | 836 Participants | 420 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 27 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 167 Participants | 322 Participants | 155 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 27 Participants | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants | 23 Participants | 7 Participants |
| Race (NIH/OMB) White | 228 Participants | 485 Participants | 257 Participants |
| Sex: Female, Male Female | 139 Participants | 286 Participants | 147 Participants |
| Sex: Female, Male Male | 307 Participants | 608 Participants | 301 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 77 / 448 | 66 / 446 |
| other Total, other adverse events | 157 / 448 | 178 / 446 |
| serious Total, serious adverse events | 36 / 448 | 51 / 446 |
Outcome results
Primary
CV Death or Heart Failure Hospitalization
Composite of First Heart Failure Hospitalization or Cardiovascular Mortality
Time frame: 24 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | CV Death or Heart Failure Hospitalization | 164 events |
| Biomarker-Guided Care | CV Death or Heart Failure Hospitalization | 164 events |
p-value: 0.8895% CI: [0.79, 1.22]Regression, Cox
Secondary
All-cause Mortality
All-cause mortality by treatment arm
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | All-cause Mortality | 77 deaths |
| Biomarker-Guided Care | All-cause Mortality | 66 deaths |
p-value: 0.3795% CI: [0.62, 1.2]Regression, Cox
Secondary
Cumulative Morbidity
Days alive and not hospitalized for CV reasons
Time frame: 24 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Cumulative Morbidity | 616 days |
| Biomarker-Guided Care | Cumulative Morbidity | 626 days |
p-value: 0.5395% CI: [-20, 39]Bang-Tsiatis Partitioned Estimator
Secondary
CV Death
CV death by treatment arm
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | CV Death | 57 deaths |
| Biomarker-Guided Care | CV Death | 53 deaths |
p-value: 0.7595% CI: [0.65, 1.37]Regression, Cox
Secondary
Duke Activity Status Index (DASI)
The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).
Time frame: Baseline, 3, 6, 12 and 24 months
Population: Number of participants analyzed is the number of participants who completed the questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Duke Activity Status Index (DASI) | 3 month | 16.9 units on a scale | Standard Deviation 14.2 |
| Usual Care | Duke Activity Status Index (DASI) | 12 month | 17.4 units on a scale | Standard Deviation 16.1 |
| Usual Care | Duke Activity Status Index (DASI) | 6 month | 17.9 units on a scale | Standard Deviation 15.8 |
| Usual Care | Duke Activity Status Index (DASI) | 24 month | 19.6 units on a scale | Standard Deviation 17.8 |
| Usual Care | Duke Activity Status Index (DASI) | Baseline | 11.1 units on a scale | Standard Deviation 12.6 |
| Biomarker-Guided Care | Duke Activity Status Index (DASI) | 24 month | 18.2 units on a scale | Standard Deviation 17.4 |
| Biomarker-Guided Care | Duke Activity Status Index (DASI) | Baseline | 12.6 units on a scale | Standard Deviation 13.5 |
| Biomarker-Guided Care | Duke Activity Status Index (DASI) | 3 month | 17.7 units on a scale | Standard Deviation 14.9 |
| Biomarker-Guided Care | Duke Activity Status Index (DASI) | 6 month | 19.7 units on a scale | Standard Deviation 16.6 |
| Biomarker-Guided Care | Duke Activity Status Index (DASI) | 12 month | 19.3 units on a scale | Standard Deviation 17 |
Comparison: 3 monthp-value: 0.40495% CI: [-1.188, 2.947]Mixed Models Analysis
Comparison: 6 monthp-value: 0.21995% CI: [-0.881, 3.836]Mixed Models Analysis
Comparison: 12 monthp-value: 0.10495% CI: [-0.433, 4.63]Mixed Models Analysis
Comparison: 24 monthp-value: 0.22895% CI: [-1.253, 5.25]Mixed Models Analysis
Secondary
EQ-5D Health Index
The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score, from -0.59 (worst) to 1 (best).
Time frame: Baseline, 3, 6, 12 and 24 months
Population: Number of participants analyzed is the number of participants who completed the questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | EQ-5D Health Index | 3 month | 0.7 units on a scale | Standard Deviation 0.3 |
| Usual Care | EQ-5D Health Index | 6 month | 0.7 units on a scale | Standard Deviation 0.3 |
| Usual Care | EQ-5D Health Index | 12 month | 0.7 units on a scale | Standard Deviation 0.3 |
| Usual Care | EQ-5D Health Index | 24 month | 0.7 units on a scale | Standard Deviation 0.3 |
| Usual Care | EQ-5D Health Index | Baseline | 0.7 units on a scale | Standard Deviation 0.3 |
| Biomarker-Guided Care | EQ-5D Health Index | Baseline | 0.7 units on a scale | Standard Deviation 0.3 |
| Biomarker-Guided Care | EQ-5D Health Index | 24 month | 0.7 units on a scale | Standard Deviation 0.3 |
| Biomarker-Guided Care | EQ-5D Health Index | 6 month | 0.7 units on a scale | Standard Deviation 0.3 |
| Biomarker-Guided Care | EQ-5D Health Index | 3 month | 0.7 units on a scale | Standard Deviation 0.3 |
| Biomarker-Guided Care | EQ-5D Health Index | 12 month | 0.7 units on a scale | Standard Deviation 0.3 |
Comparison: 3 monthp-value: 0.42195% CI: [-0.025, 0.06]Mixed Models Analysis
Comparison: 6 monthp-value: 0.23995% CI: [-0.018, 0.074]Mixed Models Analysis
Comparison: 12 monthp-value: 0.40295% CI: [-0.028, 0.07]Mixed Models Analysis
Comparison: 24 monthp-value: 0.7895% CI: [-0.057, 0.076]Mixed Models Analysis
Secondary
EQ-5D Visual Analog Scale
The EQ-5D VAS records participants self-rated health status on a vertical (0-100) scale with higher scores indicating higher Health-Related Quality of Life, where 0 = worst imaginable health state and 100 = best imaginable health state.
Time frame: Baseline, 3, 6, 12 and 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | EQ-5D Visual Analog Scale | 24 month | 65.9 units on a scale | Standard Deviation 24 |
| Usual Care | EQ-5D Visual Analog Scale | 3 month | 62.3 units on a scale | Standard Deviation 25.9 |
| Usual Care | EQ-5D Visual Analog Scale | Baseline | 60.2 units on a scale | Standard Deviation 37.6 |
| Usual Care | EQ-5D Visual Analog Scale | 6 month | 60.5 units on a scale | Standard Deviation 26.5 |
| Usual Care | EQ-5D Visual Analog Scale | 12 month | 63.7 units on a scale | Standard Deviation 25.8 |
| Biomarker-Guided Care | EQ-5D Visual Analog Scale | 6 month | 61.5 units on a scale | Standard Deviation 25.8 |
| Biomarker-Guided Care | EQ-5D Visual Analog Scale | 12 month | 62.1 units on a scale | Standard Deviation 24.9 |
| Biomarker-Guided Care | EQ-5D Visual Analog Scale | 24 month | 60.8 units on a scale | Standard Deviation 24.9 |
| Biomarker-Guided Care | EQ-5D Visual Analog Scale | Baseline | 59.2 units on a scale | Standard Deviation 22.6 |
| Biomarker-Guided Care | EQ-5D Visual Analog Scale | 3 month | 60.2 units on a scale | Standard Deviation 27.8 |
Comparison: 3 monthp-value: 0.26895% CI: [-5.902, 1.64]Mixed Models Analysis
Comparison: 6 monthp-value: 0.59995% CI: [-2.921, 5.058]Mixed Models Analysis
Comparison: 12 monthp-value: 0.85295% CI: [-4.486, 3.707]Mixed Models Analysis
Comparison: 24 monthp-value: 0.22195% CI: [-8.708, 2.022]Mixed Models Analysis
Secondary
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score
This KCCQ overall score represents the mean of the following 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time frame: Baseline, 3, 6,12 and 24 months
Population: Number of participants analyzed is the number of participants who completed the questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score | Baseline | 57.7 units on a scale | Standard Deviation 22.4 |
| Usual Care | Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score | 24 month | 71.6 units on a scale | Standard Deviation 24.4 |
| Usual Care | Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score | 6 month | 70.1 units on a scale | Standard Deviation 22.2 |
| Usual Care | Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score | 3 month | 69.2 units on a scale | Standard Deviation 22.8 |
| Usual Care | Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score | 12 month | 70.3 units on a scale | Standard Deviation 21.9 |
| Biomarker-Guided Care | Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score | 24 month | 70.2 units on a scale | Standard Deviation 22.6 |
| Biomarker-Guided Care | Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score | 12 month | 68.4 units on a scale | Standard Deviation 24.3 |
| Biomarker-Guided Care | Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score | 3 month | 68.8 units on a scale | Standard Deviation 22.6 |
| Biomarker-Guided Care | Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score | 6 month | 70.4 units on a scale | Standard Deviation 21.8 |
| Biomarker-Guided Care | Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score | Baseline | 57.5 units on a scale | Standard Deviation 21.6 |
Comparison: 3 monthp-value: 0.61595% CI: [-3.999, 2.367]Mixed Models Analysis
Comparison: 6 monthp-value: 0.87895% CI: [-2.977, 3.482]Mixed Models Analysis
Comparison: 12 monthp-value: 0.44195% CI: [-4.989, 2.178]Mixed Models Analysis
Comparison: 24 monthp-value: 0.65395% CI: [-3.673, 5.856]Mixed Models Analysis
Secondary
Number of Hospitalizations for First Heart Failure
First Heart Failure Hospitalization
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Number of Hospitalizations for First Heart Failure | 141 hospitalizations |
| Biomarker-Guided Care | Number of Hospitalizations for First Heart Failure | 147 hospitalizations |
p-value: 0.7695% CI: [0.82, 1.31]Regression, Cox
Secondary
Number of Hospitalizations for Recurrent Heart Failure
Recurrent Heart Failure Hospitalization
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Number of Hospitalizations for Recurrent Heart Failure | 277 hospitalizations |
| Biomarker-Guided Care | Number of Hospitalizations for Recurrent Heart Failure | 350 hospitalizations |
p-value: 0.0895% CI: [0.97, 1.72]Anderson-Gill Intensity Model
Secondary
Percentage of Patients With Moderate to Severe Depression
Percentage of patients with moderate to severe depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D). CES-D is a 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression. Moderate to severe depression is indicated by a score of 11 or higher.
Time frame: Baseline, 3,6, 12 and 24 months
Population: Number of participants analyzed is the number of participants who completed the questionnaire
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Percentage of Patients With Moderate to Severe Depression | 3 month | 26.2 percentage of participants |
| Usual Care | Percentage of Patients With Moderate to Severe Depression | 12 month | 25.9 percentage of participants |
| Usual Care | Percentage of Patients With Moderate to Severe Depression | 6 month | 25.6 percentage of participants |
| Usual Care | Percentage of Patients With Moderate to Severe Depression | 24 month | 25.4 percentage of participants |
| Usual Care | Percentage of Patients With Moderate to Severe Depression | Baseline | 34.6 percentage of participants |
| Biomarker-Guided Care | Percentage of Patients With Moderate to Severe Depression | 24 month | 25.8 percentage of participants |
| Biomarker-Guided Care | Percentage of Patients With Moderate to Severe Depression | Baseline | 36.2 percentage of participants |
| Biomarker-Guided Care | Percentage of Patients With Moderate to Severe Depression | 3 month | 27.8 percentage of participants |
| Biomarker-Guided Care | Percentage of Patients With Moderate to Severe Depression | 6 month | 27.6 percentage of participants |
| Biomarker-Guided Care | Percentage of Patients With Moderate to Severe Depression | 12 month | 27.6 percentage of participants |
Comparison: Baselinep-value: 0.636Mixed Models Analysis
Comparison: 3 monthp-value: 0.628Mixed Models Analysis
Comparison: 6 monthp-value: 0.586Mixed Models Analysis
Comparison: 12 monthp-value: 0.669Mixed Models Analysis
Comparison: 24 monthp-value: 0.949Mixed Models Analysis
Secondary
Resource Utilization
Observed Resource Use
Time frame: 24 months
Population: US Patients in Economics Substudy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Resource Utilization | Number of Hospitalizations | 1.93 events | Standard Deviation 2.8 |
| Usual Care | Resource Utilization | Number of ER only events | 0.57 events | Standard Deviation 1.28 |
| Usual Care | Resource Utilization | Number of Rehab facilities | 0.06 events | Standard Deviation 0.35 |
| Usual Care | Resource Utilization | Total admissions | 2.56 events | Standard Deviation 3.64 |
| Biomarker-Guided Care | Resource Utilization | Total admissions | 2.45 events | Standard Deviation 3.2 |
| Biomarker-Guided Care | Resource Utilization | Number of Hospitalizations | 1.83 events | Standard Deviation 2.36 |
| Biomarker-Guided Care | Resource Utilization | Number of Rehab facilities | 0.06 events | Standard Deviation 0.25 |
| Biomarker-Guided Care | Resource Utilization | Number of ER only events | 0.56 events | Standard Deviation 1.29 |
Comparison: Hospitalizationsp-value: 0.74Wilcoxon (Mann-Whitney)
Comparison: ER only eventsp-value: 0.45Wilcoxon (Mann-Whitney)
Comparison: Rehab facilitiesp-value: 0.67Wilcoxon (Mann-Whitney)
Comparison: Total admissionsp-value: 0.47Wilcoxon (Mann-Whitney)
Secondary
Resource Utilization Cost
Observed Hospital-Based Cost.
Time frame: 24 months
Population: US Patients with billing data
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care | Resource Utilization Cost | Hospital Costs | 47,055 2016 US dollars |
| Usual Care | Resource Utilization Cost | Physician Fees | 2,291 2016 US dollars |
| Usual Care | Resource Utilization Cost | Total Cost | 49,346 2016 US dollars |
| Biomarker-Guided Care | Resource Utilization Cost | Hospital Costs | 34,396 2016 US dollars |
| Biomarker-Guided Care | Resource Utilization Cost | Physician Fees | 1,761 2016 US dollars |
| Biomarker-Guided Care | Resource Utilization Cost | Total Cost | 36,157 2016 US dollars |
Comparison: Hospital Costsp-value: 0.88Wilcoxon (Mann-Whitney)
Comparison: Physician Feesp-value: 0.69Wilcoxon (Mann-Whitney)
Comparison: Total Costp-value: 0.88Wilcoxon (Mann-Whitney)
Secondary
Short Form-36 (SF-36) General Health Subscale
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Time frame: Baseline, 3, 6, 12 and 24 months
Population: Number of participants analyzed is the number of participants who completed the questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Short Form-36 (SF-36) General Health Subscale | 3 month | 51.1 units on a scale | Standard Deviation 12.6 |
| Usual Care | Short Form-36 (SF-36) General Health Subscale | Baseline | 48.4 units on a scale | Standard Deviation 11.1 |
| Usual Care | Short Form-36 (SF-36) General Health Subscale | 6 month | 50.5 units on a scale | Standard Deviation 12.7 |
| Usual Care | Short Form-36 (SF-36) General Health Subscale | 24 month | 48.8 units on a scale | Standard Deviation 12.8 |
| Usual Care | Short Form-36 (SF-36) General Health Subscale | 12 month | 51.0 units on a scale | Standard Deviation 12.2 |
| Biomarker-Guided Care | Short Form-36 (SF-36) General Health Subscale | 24 month | 50.4 units on a scale | Standard Deviation 11.9 |
| Biomarker-Guided Care | Short Form-36 (SF-36) General Health Subscale | 12 month | 50.8 units on a scale | Standard Deviation 12.6 |
| Biomarker-Guided Care | Short Form-36 (SF-36) General Health Subscale | Baseline | 48.6 units on a scale | Standard Deviation 10.7 |
| Biomarker-Guided Care | Short Form-36 (SF-36) General Health Subscale | 3 month | 50.0 units on a scale | Standard Deviation 12.9 |
| Biomarker-Guided Care | Short Form-36 (SF-36) General Health Subscale | 6 month | 49.9 units on a scale | Standard Deviation 12.9 |
Comparison: 3 monthp-value: 0.19995% CI: [-3.097, 0.645]Mixed Models Analysis
Comparison: 6 monthp-value: 0.46595% CI: [-2.735, 1.25]Mixed Models Analysis
Comparison: 12 monthp-value: 0.94395% CI: [-2.119, 1.97]Mixed Models Analysis
Comparison: 24 monthp-value: 0.29495% CI: [-1.286, 4.241]Mixed Models Analysis
Secondary
Short Form-36 (SF-36) Mental Health Subscale
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Time frame: Baseline, 3, 6, 12 and 24 months
Population: Number of participants analyzed is the number of participants who completed the questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Short Form-36 (SF-36) Mental Health Subscale | 3 month | 77.6 units on a scale | Standard Deviation 19.9 |
| Usual Care | Short Form-36 (SF-36) Mental Health Subscale | Baseline | 69.7 units on a scale | Standard Deviation 20.4 |
| Usual Care | Short Form-36 (SF-36) Mental Health Subscale | 6 month | 77.7 units on a scale | Standard Deviation 20.5 |
| Usual Care | Short Form-36 (SF-36) Mental Health Subscale | 24 month | 79.6 units on a scale | Standard Deviation 17.6 |
| Usual Care | Short Form-36 (SF-36) Mental Health Subscale | 12 month | 77.5 units on a scale | Standard Deviation 20.3 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Mental Health Subscale | 24 month | 76.6 units on a scale | Standard Deviation 22.1 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Mental Health Subscale | 3 month | 76.1 units on a scale | Standard Deviation 21.5 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Mental Health Subscale | 12 month | 76.2 units on a scale | Standard Deviation 22.2 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Mental Health Subscale | Baseline | 69.8 units on a scale | Standard Deviation 20.9 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Mental Health Subscale | 6 month | 77.1 units on a scale | Standard Deviation 21.3 |
Comparison: 3 monthp-value: 0.29495% CI: [-4.527, 1.369]Mixed Models Analysis
Comparison: 6 monthp-value: 0.55595% CI: [-4.096, 2.203]Mixed Models Analysis
Comparison: 12 monthp-value: 0.64395% CI: [-4.178, 2.583]Mixed Models Analysis
Comparison: 24 monthp-value: 0.75795% CI: [-4.767, 3.472]Mixed Models Analysis
Secondary
Short Form-36 (SF-36) Physiological Functioning Subscale
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Time frame: Baseline, 3, 6, 12 and 24 months
Population: Number of participants analyzed is the number of participants who completed the questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Short Form-36 (SF-36) Physiological Functioning Subscale | 6 month | 43.4 units on a scale | Standard Deviation 37.4 |
| Usual Care | Short Form-36 (SF-36) Physiological Functioning Subscale | 12 month | 41.9 units on a scale | Standard Deviation 38.2 |
| Usual Care | Short Form-36 (SF-36) Physiological Functioning Subscale | Baseline | 30.6 units on a scale | Standard Deviation 32.1 |
| Usual Care | Short Form-36 (SF-36) Physiological Functioning Subscale | 3 month | 43.5 units on a scale | Standard Deviation 35.9 |
| Usual Care | Short Form-36 (SF-36) Physiological Functioning Subscale | 24 month | 47.0 units on a scale | Standard Deviation 38.1 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Physiological Functioning Subscale | 24 month | 43.2 units on a scale | Standard Deviation 38.6 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Physiological Functioning Subscale | 6 month | 45.6 units on a scale | Standard Deviation 37.2 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Physiological Functioning Subscale | 3 month | 43.3 units on a scale | Standard Deviation 37.5 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Physiological Functioning Subscale | 12 month | 47.4 units on a scale | Standard Deviation 37.1 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Physiological Functioning Subscale | Baseline | 31.5 units on a scale | Standard Deviation 31.2 |
Comparison: 3 monthp-value: 0.69695% CI: [-4.25, 6.364]Mixed Models Analysis
Comparison: 6 monthsp-value: 0.49795% CI: [-3.715, 7.647]Mixed Models Analysis
Comparison: 12 monthp-value: 0.03595% CI: [0.456, 12.673]Mixed Models Analysis
Comparison: 24 monthp-value: 0.48895% CI: [-5.247, 10.961]Mixed Models Analysis
Secondary
Short Form-36 (SF-36) Social Functioning Subscale
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Time frame: Baseline, 3, 6, 12 and 24 months
Population: Number of participants analyzed is the number of participants who completed the questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Short Form-36 (SF-36) Social Functioning Subscale | 6 month | 77.0 units on a scale | Standard Deviation 32.3 |
| Usual Care | Short Form-36 (SF-36) Social Functioning Subscale | 12 month | 76.4 units on a scale | Standard Deviation 30.9 |
| Usual Care | Short Form-36 (SF-36) Social Functioning Subscale | 3 month | 75.4 units on a scale | Standard Deviation 30.8 |
| Usual Care | Short Form-36 (SF-36) Social Functioning Subscale | 24 month | 76.7 units on a scale | Standard Deviation 30.3 |
| Usual Care | Short Form-36 (SF-36) Social Functioning Subscale | Baseline | 60.2 units on a scale | Standard Deviation 32.7 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Social Functioning Subscale | 24 month | 77.2 units on a scale | Standard Deviation 31.7 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Social Functioning Subscale | 3 month | 74.9 units on a scale | Standard Deviation 31.8 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Social Functioning Subscale | 6 month | 75.0 units on a scale | Standard Deviation 32.1 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Social Functioning Subscale | 12 month | 74.5 units on a scale | Standard Deviation 31.5 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Social Functioning Subscale | Baseline | 64.8 units on a scale | Standard Deviation 30.1 |
Comparison: 3 monthp-value: 0.83795% CI: [-5.102, 4.133]Mixed Models Analysis
Comparison: 6 monthp-value: 0.28895% CI: [-7.662, 2.276]Mixed Models Analysis
Comparison: 12 monthp-value: 0.56795% CI: [-6.81, 3.732]Mixed Models Analysis
Comparison: 24 monthp-value: 0.47595% CI: [-4.394, 9.419]Mixed Models Analysis
Secondary
Short Form-36 (SF-36) Vitality Subscale
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Time frame: Baseline, 3, 6, 12 and 24 months
Population: Number of participants analyzed is the number of participants who completed the questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Short Form-36 (SF-36) Vitality Subscale | Baseline | 43.9 units on a scale | Standard Deviation 22.5 |
| Usual Care | Short Form-36 (SF-36) Vitality Subscale | 6 month | 55.1 units on a scale | Standard Deviation 24.6 |
| Usual Care | Short Form-36 (SF-36) Vitality Subscale | 3 month | 54.5 units on a scale | Standard Deviation 23.6 |
| Usual Care | Short Form-36 (SF-36) Vitality Subscale | 12 month | 54.4 units on a scale | Standard Deviation 23.6 |
| Usual Care | Short Form-36 (SF-36) Vitality Subscale | 24 month | 57.9 units on a scale | Standard Deviation 24.8 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Vitality Subscale | 12 month | 55.2 units on a scale | Standard Deviation 24.3 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Vitality Subscale | 24 month | 55.9 units on a scale | Standard Deviation 24.2 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Vitality Subscale | Baseline | 44.3 units on a scale | Standard Deviation 22.3 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Vitality Subscale | 3 month | 54.6 units on a scale | Standard Deviation 23.6 |
| Biomarker-Guided Care | Short Form-36 (SF-36) Vitality Subscale | 6 month | 55.8 units on a scale | Standard Deviation 23.9 |
Comparison: 3 monthp-value: 0.99295% CI: [-3.383, 3.417]Mixed Models Analysis
Comparison: 6 monthp-value: 0.88295% CI: [-3.409, 3.969]Mixed Models Analysis
Comparison: 12 monthp-value: 0.64795% CI: [-2.973, 4.782]Mixed Models Analysis
Comparison: 24 monthp-value: 0.90395% CI: [-4.894, 5.538]Mixed Models Analysis