Trial Outcomes & Findings for PCORI-1310-06998 Trial of a Decision Support Intervention for Patients and Caregivers Offered Destination Therapy Heart Assist Device (NCT NCT02344576)
NCT ID: NCT02344576
Last Updated: 2020-03-19
Results Overview
Reach: The proportion of the target population who participate in the intervention. We will assess the percentage of patients and caregivers that receive the pamphlet and video decision aids.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
445 participants
Primary outcome timeframe
Baseline 2 (post-education: average 3 days after enrollment)
Results posted on
2020-03-19
Participant Flow
Occurred from June 2015-Jan 2017 in both the inpatient and outpatient setting. Patients were identified by the study team when a destination therapy left ventricular assist device evaluation was initiated; caregivers were identified by the medical team or patient. Recruitment and data collection were identical across control and intervention arms.
This study had a stepped-wedge design. All 6 sites started in the control phase, and then were transitioned to the intervention phase over pre-determined and randomly assigned time points (all sites ended in intervention). Participant assignment to control or intervention was determined by phase the site was in at time of participant enrollment.
Participant milestones
| Measure |
Patient Control
Patients being considered for destination therapy (DT) LVAD therapy enrolled during the control phase. These patients receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Patient Intervention
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Enrollment
STARTED
|
142
|
121
|
111
|
71
|
|
Enrollment
Agreed to Survey Data Collection
|
135
|
113
|
111
|
71
|
|
Enrollment
COMPLETED
|
135
|
113
|
111
|
71
|
|
Enrollment
NOT COMPLETED
|
7
|
8
|
0
|
0
|
|
1-Month Follow-Up
STARTED
|
135
|
113
|
111
|
71
|
|
1-Month Follow-Up
Completed 1-Month Survey
|
104
|
79
|
89
|
53
|
|
1-Month Follow-Up
COMPLETED
|
117
|
86
|
92
|
58
|
|
1-Month Follow-Up
NOT COMPLETED
|
18
|
27
|
19
|
13
|
|
6-Month Follow-Up
STARTED
|
117
|
86
|
92
|
58
|
|
6-Month Follow-Up
Completed 6-Month Survey
|
98
|
67
|
78
|
50
|
|
6-Month Follow-Up
COMPLETED
|
98
|
67
|
78
|
50
|
|
6-Month Follow-Up
NOT COMPLETED
|
19
|
19
|
14
|
8
|
|
12-Month Medical Record Follow-Up
STARTED
|
98
|
67
|
78
|
50
|
|
12-Month Medical Record Follow-Up
COMPLETED
|
98
|
67
|
78
|
50
|
|
12-Month Medical Record Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Patient Control
Patients being considered for destination therapy (DT) LVAD therapy enrolled during the control phase. These patients receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Patient Intervention
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Enrollment
Agreed to Medical Record Review Only
|
7
|
8
|
0
|
0
|
|
1-Month Follow-Up
Death
|
13
|
8
|
0
|
0
|
|
1-Month Follow-Up
Withdrawal by Subject
|
3
|
14
|
8
|
10
|
|
1-Month Follow-Up
Lost to Follow-up
|
2
|
5
|
11
|
3
|
|
6-Month Follow-Up
Death
|
14
|
14
|
0
|
0
|
|
6-Month Follow-Up
Withdrawal by Subject
|
1
|
0
|
1
|
2
|
|
6-Month Follow-Up
Lost to Follow-up
|
4
|
5
|
13
|
6
|
Baseline Characteristics
PCORI-1310-06998 Trial of a Decision Support Intervention for Patients and Caregivers Offered Destination Therapy Heart Assist Device
Baseline characteristics by cohort
| Measure |
Patient Control
n=135 Participants
Patients being considered for destination therapy (DT) LVAD therapy enrolled during the control phase. These patients receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Patient Intervention
n=113 Participants
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
n=111 Participants
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
n=71 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Total
n=430 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
51 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 9.7 • n=93 Participants
|
63.2 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
60.2 years
STANDARD_DEVIATION 11.2 • n=27 Participants
|
62.2 years
STANDARD_DEVIATION 11.5 • n=483 Participants
|
62.2 years
STANDARD_DEVIATION 10.6 • n=36 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
62 Participants
n=483 Participants
|
193 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=93 Participants
|
98 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
237 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
124 Participants
n=93 Participants
|
100 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
396 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=93 Participants
|
88 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
59 Participants
n=483 Participants
|
342 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
19 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
135 participants
n=93 Participants
|
113 participants
n=4 Participants
|
111 participants
n=27 Participants
|
71 participants
n=483 Participants
|
430 participants
n=36 Participants
|
|
Mean Cognitive Function Score
|
0.7 scores on a scale
STANDARD_DEVIATION 1.55 • n=93 Participants
|
0.66 scores on a scale
STANDARD_DEVIATION 1.25 • n=4 Participants
|
0.60 scores on a scale
STANDARD_DEVIATION 1.69 • n=27 Participants
|
0.39 scores on a scale
STANDARD_DEVIATION 1.29 • n=483 Participants
|
0.61 scores on a scale
STANDARD_DEVIATION 1.49 • n=36 Participants
|
|
Mean Literacy Score, as measured by Revised (REALM-R) measure
|
6.93 scores on a scale
STANDARD_DEVIATION 1.9 • n=93 Participants
|
6.95 scores on a scale
STANDARD_DEVIATION 2.0 • n=4 Participants
|
7.46 scores on a scale
STANDARD_DEVIATION 1.50 • n=27 Participants
|
7.70 scores on a scale
STANDARD_DEVIATION 0.98 • n=483 Participants
|
7.24 scores on a scale
STANDARD_DEVIATION 1.61 • n=36 Participants
|
|
Numeracy Score
|
4.03 units on a scale
STANDARD_DEVIATION 1.10 • n=93 Participants
|
4.21 units on a scale
STANDARD_DEVIATION 1.13 • n=4 Participants
|
4.04 units on a scale
STANDARD_DEVIATION 1.28 • n=27 Participants
|
4.31 units on a scale
STANDARD_DEVIATION 1.19 • n=483 Participants
|
4.13 units on a scale
STANDARD_DEVIATION 1.18 • n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline 2 (post-education: average 3 days after enrollment)Population: Reach pertains to only those participants in the intervention phase, and therefore the control arms are not included here.
Reach: The proportion of the target population who participate in the intervention. We will assess the percentage of patients and caregivers that receive the pamphlet and video decision aids.
Outcome measures
| Measure |
Patient Intervention
n=113 Participants
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Intervention
n=71 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Reach of Intervention
|
107 Participants
|
64 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment)Population: Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Effectiveness analysis, as this data was collected in surveys.
Effectiveness: Assessed based on if the decision support intervention led to a quality decision. Decision quality is defined as "the extent to which the implemented decision reflects the considered preferences of a well-informed patient." By this definition, a decision is "a quality decision" if the treatment chosen is concordant with a knowledgeable patient's values. Decision quality measures consist of 2 domains: knowledge and values. This is part one of the decision quality measure: -Knowledge: DT LVAD knowledge score improvement from Baseline 1 (enrollment) to Baseline 2 (post-education), measured by percentage of score improvement (scale of 0-100%).
Outcome measures
| Measure |
Patient Intervention
n=135 Participants
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Intervention
n=113 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
n=111 Participants
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
n=71 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Effectiveness of Intervention: Knowledge
|
5.4 percentage of score improvement
Standard Error 1.6
|
10.9 percentage of score improvement
Standard Error 1.9
|
9.1 percentage of score improvement
Standard Error 1.7
|
13.9 percentage of score improvement
Standard Error 2.2
|
PRIMARY outcome
Timeframe: At time of intervention phase startPopulation: Adoption is measured by sites only; does not apply to the "Patient" and "Caregiver" arms. Adoption pertains to only the intervention phase; thus, for "overall number of participants analyzed", includes patients and caregivers in intervention phase only.
Adoption: The absolute number of settings who are willing to initiate a program. We will assess the number of sites who agreed to be part of the study and who initiate intervention at intervention period.
Outcome measures
| Measure |
Patient Intervention
n=6 Sites
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Intervention
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Adoption of Intervention
|
6 Sites
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline 2 (post-education: average 3 days after enrollment)Population: Implementation was collected for patient participants only; does not apply to the "Caregiver" arm. Implementation pertains to only patients in the intervention phase; control arms are not included here.Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included.
Implementation: The extent to which the intervention is implemented as intended. We will assess implementation by surveying the consistency of decision aid delivery by the sites to the enrolled patients.
Outcome measures
| Measure |
Patient Intervention
n=113 Participants
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Intervention
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Implementation of Intervention
Provided by Clinician (Non-Study Personnel)
|
98.3 percentage of eligible participants
|
—
|
—
|
—
|
|
Implementation of Intervention
Patient Kept Decision Aids
|
90.9 percentage of eligible participants
|
—
|
—
|
—
|
|
Implementation of Intervention
Clinician Went through Pamphlet with Patient
|
26.4 percentage of eligible participants
|
—
|
—
|
—
|
|
Implementation of Intervention
Patient Viewed Video in Clinical Setting
|
46.8 percentage of eligible participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 months after study enrollment end datePopulation: Maintenance is measured by sites only; does not apply to the "Patient" and "Caregiver" arms. Maintenance pertains to only the intervention phase; thus, for "overall number of participants analyzed", includes patients and caregivers in intervention phase only.
Maintenance: Assessing whether sites decide at the conclusion of the study to maintain, modify, or discontinue a program. We will assess maintenance by counting the number of sites who continue the intervention after the study enrollment period has ended.
Outcome measures
| Measure |
Patient Intervention
n=6 Sites
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Intervention
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Maintenance of Intervention
|
5 Sites
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline 1 (enrollment) and 1 Month Follow-UpPopulation: Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Effectiveness analysis, as this data was collected in surveys.
Effectiveness: Assessed based on if the decision support intervention led to a quality decision (see "Knowledge" outcome measure for full description). This is part two of the decision quality measure: -Values: Concordance between patients' and caregivers' stated values and their treatment choice at 1-Month. Values measured on a Likert scale of 1-10, with 1 being "Do everything I can to live longer, even if that means having major surgery and being dependent on a machine" and 10 being "Live with whatever time I have left, without going through major surgery or being dependent on a machine"; correlated with patient-reported treatment decision of accepted or declined DT LVAD. Measured by kendall's tau correlation coefficient, which ranges 1 to -1, score closer to 1 or -1 shows greater values-choice concordance (a correlation coefficient of 0 means no concordance). Confidence intervals obtained from the distribution after 500 bootstrap samples (2.5, 97.5 percentiles).
Outcome measures
| Measure |
Patient Intervention
n=135 Participants
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Intervention
n=113 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
n=111 Participants
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
n=71 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Effectiveness of Intervention: Values-Choice Concordance
|
0.17 kendall's tau correlation coefficient
Interval 0.15 to 0.29
|
0.48 kendall's tau correlation coefficient
Interval 0.28 to 0.63
|
0.12 kendall's tau correlation coefficient
Interval -0.17 to 0.34
|
0.49 kendall's tau correlation coefficient
Interval 0.26 to 0.67
|
SECONDARY outcome
Timeframe: Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment), 1 Month Follow-Up, and 6 Month Follow-UpPopulation: Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Decision Conflict analysis, as this data was collected in surveys.
Decision Conflict Scale: 16-items, scoring 0-100 with higher score indicating greater decisional conflict.
Outcome measures
| Measure |
Patient Intervention
n=135 Participants
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Intervention
n=113 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
n=111 Participants
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
n=71 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Changes in Decision Conflict (Decision Conflict Scale)
Baseline 1 Survey Score
|
20.2 units on a scale
Standard Error 1.99
|
23.4 units on a scale
Standard Error 2.24
|
19.0 units on a scale
Standard Error 2.06
|
21.4 units on a scale
Standard Error 2.59
|
|
Changes in Decision Conflict (Decision Conflict Scale)
Baseline 2 Survey Score
|
16.5 units on a scale
Standard Error 1.95
|
18.4 units on a scale
Standard Error 2.23
|
9.70 units on a scale
Standard Error 1.90
|
18.8 units on a scale
Standard Error 2.40
|
|
Changes in Decision Conflict (Decision Conflict Scale)
1-Month Follow-Up Survey Score
|
15.5 units on a scale
Standard Error 1.89
|
17.9 units on a scale
Standard Error 2.17
|
13.1 units on a scale
Standard Error 2.09
|
19.5 units on a scale
Standard Error 2.62
|
|
Changes in Decision Conflict (Decision Conflict Scale)
6-Month Follow-Up Survey Score
|
15.4 units on a scale
Standard Error 1.89
|
14.2 units on a scale
Standard Error 2.21
|
11.9 units on a scale
Standard Error 1.98
|
17.4 units on a scale
Standard Error 2.52
|
SECONDARY outcome
Timeframe: 1 Month Follow-Up, and 6 Month Follow-UpPopulation: Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Decision Regret analysis, as this data was collected in surveys.
Decision Regret Scale: 5-items, scoring 0-100 with higher score indicating greater decision regret.
Outcome measures
| Measure |
Patient Intervention
n=135 Participants
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Intervention
n=113 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
n=111 Participants
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
n=71 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Changes in Decision Regret (Decision Regret Scale)
6-Month Follow-Up Survey
|
12.1 units on a scale
Standard Error 2.28
|
19.1 units on a scale
Standard Error 2.96
|
10.4 units on a scale
Standard Error 2.46
|
17.1 units on a scale
Standard Error 3.38
|
|
Changes in Decision Regret (Decision Regret Scale)
1-Month Follow-Up Survey
|
14.3 units on a scale
Standard Error 2.15
|
17.9 units on a scale
Standard Error 2.84
|
11.2 units on a scale
Standard Error 2.37
|
17.5 units on a scale
Standard Error 3.32
|
SECONDARY outcome
Timeframe: Baseline 1 (enrollment), 1 month Follow-Up, and 6 Month Follow-UpPopulation: Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Stress and Depression analysis, as this data was collected in surveys.
Perceived Stress Scale (collected at Baseline 1 and 6-month follow-up only):10-items, scoring 0-40 with higher score indicating greater stress.; Patient Health Questionnaire-2: 2-items, score of 0-6 with higher score indicating greater depression.
Outcome measures
| Measure |
Patient Intervention
n=135 Participants
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Intervention
n=113 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
n=111 Participants
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
n=71 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2)
Stress: Baseline 1 Survey Score
|
16.1 units on a scale
Standard Error 0.68
|
14.1 units on a scale
Standard Error 0.81
|
14.3 units on a scale
Standard Error 0.86
|
16.4 units on a scale
Standard Error 1.06
|
|
Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2)
Stress: 6-Month Follow-Up Survey Score
|
12.6 units on a scale
Standard Error 0.82
|
11.9 units on a scale
Standard Error 1.03
|
12.1 units on a scale
Standard Error 1.00
|
12.7 units on a scale
Standard Error 1.24
|
|
Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2)
Depression: Baseline 1 Survey Score
|
1.80 units on a scale
Standard Error 0.21
|
1.56 units on a scale
Standard Error 0.24
|
0.79 units on a scale
Standard Error 0.22
|
1.04 units on a scale
Standard Error 0.26
|
|
Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2)
Depression: 1-Month Follow-Up Survey Score
|
1.64 units on a scale
Standard Error 0.23
|
1.39 units on a scale
Standard Error 0.26
|
0.80 units on a scale
Standard Error 0.24
|
1.35 units on a scale
Standard Error 0.29
|
|
Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2)
Depression: 6-Month Follow-Up Survey Score
|
1.06 units on a scale
Standard Error 0.21
|
0.97 units on a scale
Standard Error 0.25
|
0.54 units on a scale
Standard Error 0.21
|
0.69 units on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-UpPopulation: EuroQol Visual Analogue Scale was collected for patient participants only; does not apply to the "Caregiver" arm. Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in EuroQol Visual Analogue Scale analysis, as this data was collected in surveys.
EuroQol Visual Analogue Scale (patients only): 1-item scale, score of 0-100 with 0 being "worst imaginable health state" and 100 being "best imaginable health state".
Outcome measures
| Measure |
Patient Intervention
n=135 Participants
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Intervention
n=113 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only])
Baseline 1 Survey Score
|
44.6 units on a scale
Standard Error 2.69
|
48.6 units on a scale
Standard Error 3.07
|
—
|
—
|
|
Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only])
1-Month Follow-Up Survey Score
|
64.3 units on a scale
Standard Error 2.67
|
60.5 units on a scale
Standard Error 3.13
|
—
|
—
|
|
Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only])
6-Month Follow-Up Survey Score
|
69.6 units on a scale
Standard Error 2.57
|
68.8 units on a scale
Standard Error 3.07
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-UpPopulation: Preparedness for Caregiving Scale was collected for caregiver participants only; does not apply to the "Patient" arm.
Preparedness for Caregiving Scale (caregivers only): 8-items, scoring 0-4 with higher score indicating more preparedness.
Outcome measures
| Measure |
Patient Intervention
n=111 Participants
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Intervention
n=71 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only])
6-Month Follow-Up Survey Score
|
3.24 units on a scale
Standard Error 0.11
|
2.99 units on a scale
Standard Error 0.13
|
—
|
—
|
|
Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only])
Baseline 1 Survey Score
|
3.05 units on a scale
Standard Error 0.10
|
2.81 units on a scale
Standard Error 0.13
|
—
|
—
|
|
Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only])
1-Month Follow-Up Survey Score
|
3.17 units on a scale
Standard Error 0.10
|
3.02 units on a scale
Standard Error 0.13
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 Month Follow-UpPopulation: Bereaved Caregiver Satisfaction was collected for caregiver participants only; does not apply to the "Patient" arm. This measure was also collected among bereaved caregivers only; 11 bereaved caregivers responded.
Canadian Health Care Evaluation Project - Bereavement Questionnaire (bereaved caregivers only): Score of 0-100 with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Patient Intervention
n=6 Participants
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Intervention
n=5 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Changes in Bereaved Caregiver Satisfaction With End-of-Life Care (Canadian Health Care Evaluation Project - Bereavement Questionnaire [Bereaved Caregivers Only])
|
73.0 units on a scale
Standard Error 6.0
|
62.0 units on a scale
Standard Error 10.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-UpPopulation: Control Preferences Scale was collected for patient participants only; does not apply to the "Caregiver" arm. Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Control Preferences Scale analysis, as this data was collected in surveys.
Control Preferences Scale (patients only) includes 2 parts: "Preferred" and "Actual" ("Actual" at 1-Month and 6-Month only). Each is a 1-item question with 5-answer options, assessing preferred or actual control in decision making. "Active role" indicated if 1 of first 3 answer options were selected: for "Preferred", those 3 answer options were "I prefer to make the final selection about which treatment I will receive", "I prefer to make the final selection of my treatment after seriously considering my doctor's opinion", or "I prefer that my doctor and I share responsibility for deciding which treatment is best"; for "Actual", answer options were "I made the final selection about which treatment I would receive", "I made the final selection of my treatment after seriously considering my doctor's opinion", or "My doctor and I shared responsibility for deciding which was treatment best for me". The percentage of patients who selected an "active" response option was calculated.
Outcome measures
| Measure |
Patient Intervention
n=135 Participants
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Intervention
n=113 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only])
Actual: 6-Month Follow-Up Survey Score
|
85.8 percentage of patients in active role
|
89.4 percentage of patients in active role
|
—
|
—
|
|
Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only])
Preferred: Baseline 1 Survey Score
|
84.1 percentage of patients in active role
|
83.6 percentage of patients in active role
|
—
|
—
|
|
Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only])
Preferred: 1-Month Follow-Up Survey Score
|
86.6 percentage of patients in active role
|
89.8 percentage of patients in active role
|
—
|
—
|
|
Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only])
Preferred: 6-Month Follow-Up Survey Score
|
86.7 percentage of patients in active role
|
92.4 percentage of patients in active role
|
—
|
—
|
|
Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only])
Actual: 1-Month Follow-Up Survey Score
|
87.5 percentage of patients in active role
|
83.6 percentage of patients in active role
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-UpPopulation: PEACE Illness Acceptance Measure was collected for patient participants only; does not apply to the "Caregiver" arm. Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in PEACE Measure analysis, as this data was collected in surveys.
PEACE Illness Acceptance Measure (patients only): 2 part measure: part 1 measures illness acceptances (questions 1-5 of 12-items), scoring 5-20 with higher score indicating greater acceptance of illness; part 2 measures struggle with illness (questions 6-12 of 12-items), scoring 7-28 with higher score indicating greater struggle with illness.
Outcome measures
| Measure |
Patient Intervention
n=135 Participants
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Intervention
n=113 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only)
Acceptance of Illness: Baseline 1 Survey Score
|
17.5 units on a scale
Standard Error 0.26
|
17.1 units on a scale
Standard Error 0.31
|
—
|
—
|
|
Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only)
Acceptance of Illness: 1-Month Survey Score
|
17.4 units on a scale
Standard Error 0.27
|
17.4 units on a scale
Standard Error 0.32
|
—
|
—
|
|
Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only)
Acceptance of Illness: 6-Month Survey Score
|
17.5 units on a scale
Standard Error 0.28
|
18.2 units on a scale
Standard Error 0.34
|
—
|
—
|
|
Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only)
Struggle with Illness: Baseline 1 Survey Score
|
14.0 units on a scale
Standard Error 0.42
|
13.1 units on a scale
Standard Error 0.50
|
—
|
—
|
|
Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only)
Struggle with Illness: 1-Month Survey Score
|
13.6 units on a scale
Standard Error 0.47
|
12.9 units on a scale
Standard Error 0.57
|
—
|
—
|
|
Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only)
Struggle with Illness: 6-Month Survey Score
|
12.9 units on a scale
Standard Error 0.50
|
12.0 units on a scale
Standard Error 0.62
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 Month Follow-Up, and 6 Month Follow-UpPopulation: Family Satisfaction with Care was collected for caregiver participants only; does not apply to the "Patient" arm.
Family Satisfaction with Care (caregivers only): The 10-item "Family Satisfaction with Decision-Making around Care of Critically Ill Patients" subscale of the Family Satisfaction with Care in the Intensive Care Unit-24. Scoring for each question was on a scale of 0-100, with 0 indicating low satisfaction and 100 indicating high satisfaction; combined total of all 10 questions was taken for final mean score of 0-100 (higher score indicating higher satisfaction).
Outcome measures
| Measure |
Patient Intervention
n=111 Participants
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Intervention
n=71 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Changes in Family Satisfaction With Patient's Care (Family Satisfaction With Care [Caregivers Only])
1-Month Follow-Up Survey
|
76.2 units on a scale
Standard Error 1.93
|
74.8 units on a scale
Standard Error 2.63
|
—
|
—
|
|
Changes in Family Satisfaction With Patient's Care (Family Satisfaction With Care [Caregivers Only])
6-Month Follow-Up Survey
|
74.5 units on a scale
Standard Error 2.11
|
77.0 units on a scale
Standard Error 2.81
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 Month Follow-UpPopulation: Medical record data was collected for patient participants only; does not apply to the "Caregiver" arm. Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in medical record data analysis, as this data was collected in surveys.
Medical record review (patients only): Treatment received by 6 months, below numbers reported as number of participants who received an LVAD.
Outcome measures
| Measure |
Patient Intervention
n=135 Participants
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Intervention
n=113 Participants
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
Caregiver Control
Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Caregiver Intervention
Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|---|---|
|
Changes in Patient Treatment Status (Medical Record Review (Patients Only)
|
110 Participants
|
54 Participants
|
—
|
—
|
Adverse Events
Patient Control
Serious events: 87 serious events
Other events: 117 other events
Deaths: 31 deaths
Patient Intervention
Serious events: 57 serious events
Other events: 78 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Patient Control
n=135 participants at risk
Patients being considered for destination therapy (DT) LVAD therapy enrolled during the control phase. These patients receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Patient Intervention
n=113 participants at risk
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|
|
Cardiac disorders
Neurological Event
|
13.3%
18/135 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
15.0%
17/113 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
|
Blood and lymphatic system disorders
Major Bleeding Event
|
47.4%
64/135 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
33.6%
38/113 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
|
Cardiac disorders
Right Ventricular Assist Device Implant
|
3.0%
4/135 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
1.8%
2/113 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
|
Infections and infestations
Major Infection
|
41.5%
56/135 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
23.0%
26/113 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
|
Cardiac disorders
Endotrachael Mechanical Ventilation
|
26.7%
36/135 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
23.0%
26/113 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
Other adverse events
| Measure |
Patient Control
n=135 participants at risk
Patients being considered for destination therapy (DT) LVAD therapy enrolled during the control phase. These patients receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
|
Patient Intervention
n=113 participants at risk
Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education.
|
|---|---|---|
|
Cardiac disorders
Inotrope Support
|
79.3%
107/135 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
64.6%
73/113 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
|
Renal and urinary disorders
Renal Replacement Therapy/Dialysis
|
12.6%
17/135 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
7.1%
8/113 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
|
Cardiac disorders
Implantable Cardioverter Defibrillator Shocks
|
19.3%
26/135 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
10.6%
12/113 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
|
Psychiatric disorders
Psychiatric Episode
|
11.9%
16/135 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
9.7%
11/113 • Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
|
Additional Information
Dr. Larry Allen, Principal Investigator
University of Colorado School of Medicine
Phone: 303-724-4713
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place