Trial Outcomes & Findings for Veterans Affairs Lowering Readmission in Heart Failure (NCT NCT01144182)
NCT ID: NCT01144182
Last Updated: 2015-10-16
Results Overview
Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
COMPLETED
NA
136 participants
3 months after discharge
2015-10-16
Participant Flow
Participant milestones
| Measure |
Current Best Practice (CBP)
CBP received no intervention and only current best practices for inpatient HF care.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
68
|
|
Overall Study
COMPLETED
|
51
|
47
|
|
Overall Study
NOT COMPLETED
|
17
|
21
|
Reasons for withdrawal
| Measure |
Current Best Practice (CBP)
CBP received no intervention and only current best practices for inpatient HF care.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
5
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
|
Overall Study
Lost to Follow-up
|
9
|
9
|
Baseline Characteristics
Veterans Affairs Lowering Readmission in Heart Failure
Baseline characteristics by cohort
| Measure |
Current Best Practice (CBP)
n=68 Participants
Current best practice (CBP) receives the current treatment for patients discharged with heart failure
|
Comprehensive Quality Improvement Program (QIP)
n=68 Participants
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.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.3 years
n=5 Participants
|
74.8 years
n=7 Participants
|
74.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White (non-Hispanic)
|
37 participants
n=5 Participants
|
30 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black (non-Hispanic)
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13 participants
n=5 Participants
|
19 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Marital Status
Married
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Marital Status
Not Married
|
53 participants
n=5 Participants
|
50 participants
n=7 Participants
|
103 participants
n=5 Participants
|
|
Education
High school graduate or below
|
34 participants
n=5 Participants
|
32 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Education
Some college or higher
|
34 participants
n=5 Participants
|
36 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Employment status
Employed
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Employment status
Not employed
|
62 participants
n=5 Participants
|
64 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
Campus
Manhattan
|
50 participants
n=5 Participants
|
45 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Campus
Brooklyn
|
18 participants
n=5 Participants
|
23 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
BNP
|
645.0 pg/mL
n=5 Participants
|
739.0 pg/mL
n=7 Participants
|
696.0 pg/mL
n=5 Participants
|
|
Number of heart failure medications
|
3 number of heart failure medications
n=5 Participants
|
3 number of heart failure medications
n=7 Participants
|
3 number of heart failure medications
n=5 Participants
|
|
Length of hospital stay
|
6 days
n=5 Participants
|
6 days
n=7 Participants
|
6 days
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months after dischargePopulation: 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.
Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Outcome measures
| Measure |
Current Best Practice (CBP)
n=50 Participants
CBP received no intervention and only current best practices for inpatient HF care.
|
Comprehensive Quality Improvement Program (QIP)
n=46 Participants
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.
|
|---|---|---|
|
General Quality of Life From the Standardized Physical Component Score
|
31.6 units on a scale
Interval 25.4 to 38.5
|
35.5 units on a scale
Interval 28.0 to 44.3
|
PRIMARY outcome
Timeframe: 3 months after dischargePopulation: 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.
Measured by Minnesota Living with Heart Failure Questionnaire. Scores range from 0-105, with higher scores indicating poorer QOL.
Outcome measures
| Measure |
Current Best Practice (CBP)
n=50 Participants
CBP received no intervention and only current best practices for inpatient HF care.
|
Comprehensive Quality Improvement Program (QIP)
n=46 Participants
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.
|
|---|---|---|
|
Heart Failure Specific Quality of Life
|
42.5 units on a scale
Interval 20.0 to 67.0
|
38.0 units on a scale
Interval 21.0 to 55.0
|
SECONDARY outcome
Timeframe: 3 months after dischargePopulation: 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.
Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Outcome measures
| Measure |
Current Best Practice (CBP)
n=50 Participants
CBP received no intervention and only current best practices for inpatient HF care.
|
Comprehensive Quality Improvement Program (QIP)
n=46 Participants
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.
|
|---|---|---|
|
Standardized Mental Component Score
|
48.8 units on a scale
Interval 35.6 to 58.9
|
53.2 units on a scale
Interval 39.6 to 58.5
|
SECONDARY outcome
Timeframe: 3 months after dischargePopulation: 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.
Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Outcome measures
| Measure |
Current Best Practice (CBP)
n=50 Participants
CBP received no intervention and only current best practices for inpatient HF care.
|
Comprehensive Quality Improvement Program (QIP)
n=46 Participants
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.
|
|---|---|---|
|
Physical Functioning
|
37.5 units on a scale
Interval 15.0 to 60.0
|
41.4 units on a scale
Interval 25.0 to 65.0
|
SECONDARY outcome
Timeframe: 3 months after dischargePopulation: 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.
Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Outcome measures
| Measure |
Current Best Practice (CBP)
n=49 Participants
CBP received no intervention and only current best practices for inpatient HF care.
|
Comprehensive Quality Improvement Program (QIP)
n=46 Participants
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.
|
|---|---|---|
|
Role Physical
|
50.0 units on a scale
Interval 18.8 to 68.8
|
53.1 units on a scale
Interval 31.3 to 87.5
|
SECONDARY outcome
Timeframe: 3 months after dischargePopulation: 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.
Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Outcome measures
| Measure |
Current Best Practice (CBP)
n=50 Participants
CBP received no intervention and only current best practices for inpatient HF care.
|
Comprehensive Quality Improvement Program (QIP)
n=46 Participants
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.
|
|---|---|---|
|
Pain Index
|
51.0 units on a scale
Interval 31.0 to 84.0
|
61.5 units on a scale
Interval 41.0 to 100.0
|
SECONDARY outcome
Timeframe: 3 months after dischargePopulation: 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.
Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Outcome measures
| Measure |
Current Best Practice (CBP)
n=50 Participants
CBP received no intervention and only current best practices for inpatient HF care.
|
Comprehensive Quality Improvement Program (QIP)
n=46 Participants
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.
|
|---|---|---|
|
General Health
|
41.0 units on a scale
Interval 20.0 to 57.0
|
57.0 units on a scale
Interval 35.0 to 77.0
|
SECONDARY outcome
Timeframe: 3 months after dischargePopulation: 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.
Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Outcome measures
| Measure |
Current Best Practice (CBP)
n=50 Participants
CBP received no intervention and only current best practices for inpatient HF care.
|
Comprehensive Quality Improvement Program (QIP)
n=46 Participants
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.
|
|---|---|---|
|
Vitality
|
45.0 units on a scale
Interval 30.0 to 65.0
|
50.0 units on a scale
Interval 35.0 to 70.0
|
SECONDARY outcome
Timeframe: 3 months after dischargePopulation: 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.
Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Outcome measures
| Measure |
Current Best Practice (CBP)
n=50 Participants
CBP received no intervention and only current best practices for inpatient HF care.
|
Comprehensive Quality Improvement Program (QIP)
n=46 Participants
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.
|
|---|---|---|
|
Social Functioning
|
62.0 units on a scale
Interval 37.5 to 75.0
|
75.0 units on a scale
Interval 50.0 to 100.0
|
SECONDARY outcome
Timeframe: 3 months after dischargePopulation: 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.
Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Outcome measures
| Measure |
Current Best Practice (CBP)
n=50 Participants
CBP received no intervention and only current best practices for inpatient HF care.
|
Comprehensive Quality Improvement Program (QIP)
n=46 Participants
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.
|
|---|---|---|
|
Role Emotional
|
66.7 units on a scale
Interval 33.3 to 100.0
|
75.0 units on a scale
Interval 50.0 to 100.0
|
SECONDARY outcome
Timeframe: 3 months after dischargePopulation: 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.
Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Outcome measures
| Measure |
Current Best Practice (CBP)
n=50 Participants
CBP received no intervention and only current best practices for inpatient HF care.
|
Comprehensive Quality Improvement Program (QIP)
n=46 Participants
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.
|
|---|---|---|
|
Mental Health
|
74.0 units on a scale
Interval 56.0 to 88.0
|
80.0 units on a scale
Interval 48.0 to 88.0
|
SECONDARY outcome
Timeframe: 3 months after dischargePopulation: 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.
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.
Outcome measures
| Measure |
Current Best Practice (CBP)
n=50 Participants
CBP received no intervention and only current best practices for inpatient HF care.
|
Comprehensive Quality Improvement Program (QIP)
n=46 Participants
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.
|
|---|---|---|
|
Physical Subscale of Heart Failure Specific Quality of Life
|
21.5 units on a scale
Interval 8.0 to 32.0
|
19.0 units on a scale
Interval 9.0 to 24.0
|
SECONDARY outcome
Timeframe: 3 months after dischargePopulation: 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.
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.
Outcome measures
| Measure |
Current Best Practice (CBP)
n=50 Participants
CBP received no intervention and only current best practices for inpatient HF care.
|
Comprehensive Quality Improvement Program (QIP)
n=46 Participants
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.
|
|---|---|---|
|
Emotional Subscale of Heart Failure Specific Quality of Life
|
7.0 units on a scale
Interval 3.0 to 18.0
|
6.0 units on a scale
Interval 3.0 to 13.0
|
Adverse Events
Current Best Practice (CBP)
Quality Improvement Program (QIP)
Serious adverse events
| Measure |
Current Best Practice (CBP)
n=68 participants at risk
CBP received no intervention and only current best practices for inpatient HF care.
|
Quality Improvement Program (QIP)
n=68 participants at risk
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.
|
|---|---|---|
|
General disorders
Death
|
7.4%
5/68 • Number of events 5
|
8.8%
6/68 • Number of events 6
|
|
Cardiac disorders
myocardial infarction
|
2.9%
2/68 • Number of events 2
|
2.9%
2/68 • Number of events 2
|
Other adverse events
| Measure |
Current Best Practice (CBP)
n=68 participants at risk
CBP received no intervention and only current best practices for inpatient HF care.
|
Quality Improvement Program (QIP)
n=68 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Coronary artery bypass graft
|
1.5%
1/68 • Number of events 1
|
0.00%
0/68
|
|
Cardiac disorders
angina
|
2.9%
2/68 • Number of events 2
|
1.5%
1/68 • Number of events 1
|
|
Injury, poisoning and procedural complications
broken bone
|
0.00%
0/68
|
1.5%
1/68 • Number of events 1
|
|
Cardiac disorders
hypertensive emergency
|
4.4%
3/68 • Number of events 3
|
4.4%
3/68 • Number of events 3
|
Additional Information
Sundar Natarajan, MD, M.Sc.
VA New York Harbor Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place