Trial Outcomes & Findings for Development & Testing of a Decision Aid for LVAD Placement (NCT NCT02248974)
NCT ID: NCT02248974
Last Updated: 2019-05-31
Results Overview
Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At Baseline, this scale measures LVAD knowledge before patients receive any formal education (from their LVAD coordinators and/or physicians) about LVAD therapy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
98 participants
Primary outcome timeframe
Baseline
Results posted on
2019-05-31
Participant Flow
We enrolled a total of 98 participants. This number is consistent between the Protocol Section and the Participant Flow Module.
Participant milestones
| Measure |
LVAD Decision Aid
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
The standard education processis institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Baseline
STARTED
|
47
|
51
|
|
Baseline
COMPLETED
|
47
|
51
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
1-Day Follow-Up
STARTED
|
47
|
0
|
|
1-Day Follow-Up
COMPLETED
|
37
|
0
|
|
1-Day Follow-Up
NOT COMPLETED
|
10
|
0
|
|
1-Week Follow-Up
STARTED
|
37
|
51
|
|
1-Week Follow-Up
COMPLETED
|
29
|
34
|
|
1-Week Follow-Up
NOT COMPLETED
|
8
|
17
|
|
1-Month Follow-Up
STARTED
|
29
|
34
|
|
1-Month Follow-Up
COMPLETED
|
27
|
31
|
|
1-Month Follow-Up
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
LVAD Decision Aid
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
The standard education processis institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
1-Day Follow-Up
Lost to Follow-up
|
4
|
0
|
|
1-Day Follow-Up
Withdrawal by Subject
|
5
|
0
|
|
1-Day Follow-Up
Enrolled in another study
|
1
|
0
|
|
1-Week Follow-Up
Became ineligible for LVAD
|
4
|
1
|
|
1-Week Follow-Up
Enrolled in another study
|
1
|
1
|
|
1-Week Follow-Up
Transferred to another facility
|
1
|
0
|
|
1-Week Follow-Up
Cognitive Difficulty
|
1
|
0
|
|
1-Week Follow-Up
Death
|
1
|
1
|
|
1-Week Follow-Up
Excluded because of age
|
0
|
1
|
|
1-Week Follow-Up
Noncompliant with terms of participation
|
0
|
1
|
|
1-Week Follow-Up
Timing: implanted before survey
|
0
|
2
|
|
1-Week Follow-Up
Withdrawal by Subject
|
0
|
2
|
|
1-Week Follow-Up
Lost to Follow-up
|
0
|
8
|
|
1-Month Follow-Up
Lost to Follow-up
|
2
|
3
|
Baseline Characteristics
Development & Testing of a Decision Aid for LVAD Placement
Baseline characteristics by cohort
| Measure |
LVAD Decision Aid
n=47 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=51 Participants
The standard education processis institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Continuous
|
59.61 years
STANDARD_DEVIATION 14.03 • n=5 Participants
|
59.94 years
STANDARD_DEVIATION 9.67 • n=7 Participants
|
59.77 years
STANDARD_DEVIATION 12.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Caregiver
0 Caregivers
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Caregiver
1 Caregiver
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Caregiver
2 Caregivers
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Caregiver
>=3 Caregivers
|
23 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Caregiver
Prefer not to answer
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Income
<$15,000
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Income
$15,000-$30,000
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Income
$30,000-$60,000
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Income
$60,000-$100,00
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Income
>$100,000
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Income
Prefer not to answer
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Marital Status
Married
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Marital Status
Divorced
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Marital Status
Separated
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Marital Status
Single/never married
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Marital Status
Common law
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Marital Status
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
8th grade or less
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Education
Some high school
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Education
High school degree/GED
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Education
Some college
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Education
4-yr college graduate
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Education
Prefer not to answer
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Education
Missing data
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Insurance
Private
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Insurance
Public
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Insurance
Private and Public
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Insurance
Prefer not to answer
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineQuestionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At Baseline, this scale measures LVAD knowledge before patients receive any formal education (from their LVAD coordinators and/or physicians) about LVAD therapy.
Outcome measures
| Measure |
LVAD Decision Aid
n=47 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=51 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Left Ventricular Assist Device (LVAD) Knowledge Scale
|
45.6 units on a scale
Standard Deviation 22.2
|
43.8 units on a scale
Standard Deviation 18.3
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: Analysis only includes individuals who responded to the measure at 1-Week Follow-Up (DA=29, no-DA=34, Total=63).
Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At this time-point, the scale measures LVAD knowledge at 1 week following both formal education (from the clinic) as well as from our decision aid about LVAD therapy.
Outcome measures
| Measure |
LVAD Decision Aid
n=29 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=34 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Left Ventricular Assist Device (LVAD) Knowledge Scale
|
67.8 units on a scale
Standard Deviation 15.6
|
59.3 units on a scale
Standard Deviation 12.4
|
PRIMARY outcome
Timeframe: 1-Month Follow-upPopulation: Analysis only includes individuals who responded to the measure at 1-Week Follow-Up (DA=27, no-DA=31, Total=58).
Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At this time-point, the scale measures LVAD knowledge at 1 month following both formal education (from the clinic) as well as from our decision aid about LVAD therapy.
Outcome measures
| Measure |
LVAD Decision Aid
n=27 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=31 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Left Ventricular Assist Device (LVAD) Knowledge Scale
|
27.9 units on a scale
Standard Deviation 5.7
|
22.9 units on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis includes only those participants who completed the measure at Baseline (DA=44, no-DA=50, Total=94).
Measures the construct of decisional conflict, using a 5-point Likert scale with 12 question items. All question items have a positive valence, with higher scores indicating lower decision conflict. Scores range from 0-100.
Outcome measures
| Measure |
LVAD Decision Aid
n=44 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=50 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Decisional Conflict Scale
|
23.1 units on a scale
Standard Deviation 20.7
|
29.3 units on a scale
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: 1 Week Follow-upPopulation: Analysis includes only those participants who completed the measure at Baseline (DA=29, no-DA=33, Total=62).
Measures the construct of decisional conflict (at this timepoint, 1 week after baseline), using a 5-point Likert scale with 12 question items. All question items have a positive valence, with higher scores indicating lower decision conflict. Scores range from 0-100.
Outcome measures
| Measure |
LVAD Decision Aid
n=29 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=33 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Decisional Conflict Scale
|
15.7 units on a scale
Standard Deviation 11.8
|
17.4 units on a scale
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: 1 Week Follow-upPopulation: Analysis only includes participants who responded to the measure at 1-Week Follow-Up (DA=28, no-DA=34, Total=62).
Measures a participant's perceived degree of shared decision-making about treatment (at this time point: 1 week after baseline). All question items have a positive valence (higher scores indicating greater shared decision-making, a more positive outcome), with scores ranging from 0-100.
Outcome measures
| Measure |
LVAD Decision Aid
n=28 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=34 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
collaboRATE-Shared Decision Making
|
88.4 units on a scale
Standard Deviation 19.3
|
89.6 units on a scale
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: 1 Month Follow-upPopulation: Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=57).
Measures a participant's perceived degree of shared decision-making about treatment (at this time point: 1 month after baseline). All question items have a positive valence (higher scores indicating greater shared decision-making, a more positive outcome), with scores ranging from 0-100.
Outcome measures
| Measure |
LVAD Decision Aid
n=26 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=31 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
collaboRATE-Shared Decision Making
|
90.4 units on a scale
Standard Deviation 14.3
|
89.8 units on a scale
Standard Deviation 17.2
|
SECONDARY outcome
Timeframe: 1 Month Follow-upPopulation: Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=67).
Measures a participant's satisfaction with their decision of treatment (at this time point: 1 month after baseline). All question items have a positive valence (higher scores indicating greater satisfaction with the decision making process, a more positive outcome), with scores ranging from 0-100.
Outcome measures
| Measure |
LVAD Decision Aid
n=26 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=31 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Satisfaction With Decision Making Process
|
75.6 units on a scale
Standard Deviation 23.7
|
76.8 units on a scale
Standard Deviation 20.0
|
SECONDARY outcome
Timeframe: 1 Month Follow-upPopulation: Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=67).
The 'Decision Regret Scale' measures "distress or remorse after a (health care) decision." In a short introductory statement, respondents should be asked to reflect on a specific past decision, and then asked to indicate the extent to which they agree or disagree with the statements in the regret scale by indicating a number from 1 (Strongly Agree) to 5 (Strongly Disagree) that best indicates their level of agreement. Regret is measured at a point in time when the respondent can reflect on the effects of the decision. Items 2 and 4 should be reverse coded so that, for each item, a higher number will indicate more regret. To help others interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. A score of 0 means no regret; a score of 100 means high regret.
Outcome measures
| Measure |
LVAD Decision Aid
n=26 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=31 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Ottawa Decision Regret Scale
|
11.5 units on a scale
Standard Deviation 13.3
|
12.9 units on a scale
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: BaselineMeasures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.
Outcome measures
| Measure |
LVAD Decision Aid
n=47 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=51 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Satisfaction With Life Scale
|
22.8 units on a scale
Standard Deviation 6.6
|
20.4 units on a scale
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: 1 Month Follow-upPopulation: Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=67).
Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.
Outcome measures
| Measure |
LVAD Decision Aid
n=26 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=31 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Satisfaction With Life Scale
|
27.9 units on a scale
Standard Deviation 6.7
|
22.9 units on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: 1 Week Follow-upPopulation: Analysis only includes participants who responded to measure at 1-Week Follow-Up (DA=27, no-DA=33, Total=60).
The Preparedness for Decision-Making Scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation visit and making a health decision (treatment/diagnostic/screening, etc.). Items can be summed and scored (sum the 10 items and divide by 10). B) Scores are converted to a 0-100 scale by: subtracting 1 from the summed score in part a) and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision-making.
Outcome measures
| Measure |
LVAD Decision Aid
n=27 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=33 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Preparedness for Decision-Making Scale
|
86.9 units on a scale
Standard Deviation 15.1
|
81.8 units on a scale
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: 1 Day Follow-upPopulation: Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Outcome measures
| Measure |
LVAD Decision Aid
n=35 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment.
Strongly Agree
|
21 Participants
|
0 Participants
|
|
Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment.
Agree
|
12 Participants
|
0 Participants
|
|
Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment.
Neutral
|
2 Participants
|
0 Participants
|
|
Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment.
Disagree
|
0 Participants
|
0 Participants
|
|
Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment.
Strongly Disagree
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1-Week Follow-UpPopulation: Analysis only includes participants who responded to measure at 1-Week Follow-Up (DA=27, no-DA=34, Total=61).
A brief patient-report instrument for measuring Shared Decision Making (SDM) in clinical encounters. All question items have a positive valence. Summing up all items leads to a raw total score between 0 and 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. As it is more intuitively interpretable, the authors of the scale encourage the use of the transformed score, which we used.
Outcome measures
| Measure |
LVAD Decision Aid
n=27 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=34 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Shared Decision-Making (SDM-9)
|
84.8 units on a scale
Standard Deviation 16.8
|
84.3 units on a scale
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: 1-Month Follow-UpPopulation: Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=25, no-DA=31, Total=56).
A brief patient-report instrument for measuring Shared Decision Making (SDM) in clinical encounters. All question items have a positive valence. Summing up all items leads to a raw total score between 0 and 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. As it is more intuitively interpretable, the authors of the scale encourage the use of the transformed score, which we used.
Outcome measures
| Measure |
LVAD Decision Aid
n=25 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=31 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Shared Decision-Making (SDM-9)
|
87.5 units on a scale
Standard Deviation 12.8
|
85.2 units on a scale
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: 1-Month Follow-UpPopulation: Analysis only included participants who completed the measure at both Baseline and 1-Month followup, in order to calculate "match" in preferences.
Measure of the degree (percentage) of match in patient-reported preferences related to control over treatment decision at Baseline and 1-Month. This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points. The results are reported as the number of participants with a 1:1 "match" in preferences at both time points.
Outcome measures
| Measure |
LVAD Decision Aid
n=29 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=25 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Number and Percentage of Participants Whose Control Preferences for Treatment Decision-Making Match From Baseline to 1-month Follow-up
|
14 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 1-Week Follow-UpPopulation: Analysis only includes those who responded to this measure (DA=27, no-DA =33, Total=60).
Percentage of patients reporting that their ability to envision life with an LVAD was "Somewhat Easy" or "Easy."
Outcome measures
| Measure |
LVAD Decision Aid
n=27 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=33 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect
|
25 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 1-Month Follow-UpPopulation: Analysis only includes those who responded to this measure (DA=20, no-DA =21, Total=41).
Number and percentage of patients reporting that their ability to envision life with an LVAD was "Difficult" or that they had "No idea."
Outcome measures
| Measure |
LVAD Decision Aid
n=20 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=21 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Number and Percentage of Participants Reporting Ability to Envision Life With an LVAD: Difficult/no Idea What to Expect
|
15 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 1-Week Follow-UpPopulation: Analysis included only those participants who responded to the measure at 1-week (DA=26, no=DA=33, Total=59).
Measures the number and percentage of participants who perceived a strong likelihood of transplant.
Outcome measures
| Measure |
LVAD Decision Aid
n=26 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=33 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Number & Percentage of Participants Who Perceived a Strong Likelihood of Transplant
|
16 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 1-Month Follow-UpPopulation: Analysis included only those participants who responded to the measure at 1-month (DA=27, no-DA=31, Total=58).
Number and Percentage of participants who perceived and strong Likelihood of Transplant after 1-Month follow-up.
Outcome measures
| Measure |
LVAD Decision Aid
n=27 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=31 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Number and Percentage of Participants Who Perceived and Strong Likelihood of Transplant
|
17 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 1-Week Follow-UpPopulation: Analysis only includes those participants who responded to the measure at 1-Week Follow-Up (DA=27, no-DA=28, Total=55).
Patient-reported estimate of number of years the average patient is able to live after LVAD implant. Participants wrote in a number in a blank space, and numbers were recorded.
Outcome measures
| Measure |
LVAD Decision Aid
n=27 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=28 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Participants' Perceived Survival Estimate in Number of Years After LVAD Implant
|
10.17 years
Standard Deviation 7.14
|
9.7 years
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: 1-Month Follow-UpPopulation: Analysis only included those participants who completed the measure at 1-Month Follow-Up (DA=26, no=DA=30, Total=56).
Satisfaction with Life Scale, intended to measure respondents' perceived global life satisfaction. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.
Outcome measures
| Measure |
LVAD Decision Aid
n=26 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=30 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Satisfaction With Life
|
27.9 units on a scale
Standard Deviation 5.7
|
22.9 units on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis included only those participants who completed the measure at baseline (DA=46, no-DA=50, Total=96).
Responses to the question: "On a scale of 0 to 100 (0 is the worst health imaginable, 100 is the best health imaginable) what would you rate your health today?"
Outcome measures
| Measure |
LVAD Decision Aid
n=46 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=50 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Quality of Life -- Health Rating
|
55.8 units on a scale
Standard Deviation 24.0
|
43.1 units on a scale
Standard Deviation 24.5
|
SECONDARY outcome
Timeframe: 1-Month Follow-UpPopulation: Analysis included only those participants who completed measure at 1-Month (DA=26, no-DA=30, Total=56).
Responses to the question: "On a scale of 0 to 100 (0 is the worst health imaginable, 100 is the best health imaginable) what would you rate your health today?"
Outcome measures
| Measure |
LVAD Decision Aid
n=26 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=30 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Quality of Life -- Health Rating
|
81.0 units on a scale
Standard Deviation 3.7
|
69.1 units on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis only includes participants who responded to the question at baseline (DA=46, no-DA=50, Total=96).
Number of patients forecasting that they will choose LVAD treatment (before their actual decision), measured using a binary score representing yes (1) or no (0) indicating whether a patient predicted they would choose LVAD as a preferred treatment for their advanced heart failure.
Outcome measures
| Measure |
LVAD Decision Aid
n=46 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=50 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Preferred Treatment: Number of Patients Predicting They Will Choose LVAD
|
28 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 1-Week Follow-UpPopulation: Analysis only includes participants who responded to the question at 1-Week (DA=28, no-DA=33, Total=61).
Number of patients who definitively choose LVAD treatment, measured using a binary score representing yes (1) or no (0) indicating whether the patient chose LVAD as a preferred treatment for their advanced heart failure.
Outcome measures
| Measure |
LVAD Decision Aid
n=28 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=33 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Number of Patients Whose Preferred Treatment Was LVAD
|
21 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 1-Month Follow-UpPopulation: Analysis only includes participants who responded to the question at 1-Month (DA=26, no-DA=32, Total=58).
Number of patients who definitively choose LVAD treatment, measured using a binary score representing yes (1) or no (0) indicating whether the patient chose LVAD as a preferred treatment for their advanced heart failure.
Outcome measures
| Measure |
LVAD Decision Aid
n=26 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=32 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Number of Patients Whose Preferred Treatment Was LVAD
|
22 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 1-Month Follow-UpPopulation: Analysis only includes participants who responded to the question (DA=25, no-DA=27, Total=52).
Number and percentage of patients who filled out an Advanced Directive, using a binary measure indicating whether a respondent has filled out an advanced directive (1) or not (0).
Outcome measures
| Measure |
LVAD Decision Aid
n=25 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=27 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Number and Percentage of Patients Who Filled Out an Advanced Directive
|
17 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 1 Day Follow-upPopulation: Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Outcome measures
| Measure |
LVAD Decision Aid
n=35 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure.
Strongly Agree
|
19 Participants
|
0 Participants
|
|
Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure.
Agree
|
11 Participants
|
0 Participants
|
|
Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure.
Neutral
|
4 Participants
|
0 Participants
|
|
Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure.
Disagree
|
1 Participants
|
0 Participants
|
|
Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure.
Strongly Disagree
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 Day Follow-upPopulation: Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Outcome measures
| Measure |
LVAD Decision Aid
n=35 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Usability and Acceptability: Learned Something New That I Didn't Know Before.
Disagree
|
1 Participants
|
0 Participants
|
|
Usability and Acceptability: Learned Something New That I Didn't Know Before.
Strongly Disagree
|
0 Participants
|
0 Participants
|
|
Usability and Acceptability: Learned Something New That I Didn't Know Before.
Strongly Agree
|
20 Participants
|
0 Participants
|
|
Usability and Acceptability: Learned Something New That I Didn't Know Before.
Agree
|
9 Participants
|
0 Participants
|
|
Usability and Acceptability: Learned Something New That I Didn't Know Before.
Neutral
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 Day Follow-upPopulation: Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 37 patients in the DA group. The no-DA group did not receive the measure.
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Outcome measures
| Measure |
LVAD Decision Aid
n=37 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Usability and Acceptability: Would Recommend to Others.
Yes
|
34 Participants
|
0 Participants
|
|
Usability and Acceptability: Would Recommend to Others.
Unsure
|
3 Participants
|
0 Participants
|
|
Usability and Acceptability: Would Recommend to Others.
No
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 Day Follow-upPopulation: Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 37 patients in the DA group. The no-DA group did not receive the measure.
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Outcome measures
| Measure |
LVAD Decision Aid
n=37 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Usability and Acceptability: Held my Interest.
Yes
|
34 Participants
|
0 Participants
|
|
Usability and Acceptability: Held my Interest.
Unsure
|
2 Participants
|
0 Participants
|
|
Usability and Acceptability: Held my Interest.
No
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 Day Follow-upPopulation: Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Outcome measures
| Measure |
LVAD Decision Aid
n=35 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Usability and Acceptability: Helps Someone Make an Informed Decision.
Yes
|
33 Participants
|
0 Participants
|
|
Usability and Acceptability: Helps Someone Make an Informed Decision.
Unsure
|
2 Participants
|
0 Participants
|
|
Usability and Acceptability: Helps Someone Make an Informed Decision.
No
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 Day Follow-upPopulation: Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Outcome measures
| Measure |
LVAD Decision Aid
n=35 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me.
Yes
|
30 Participants
|
0 Participants
|
|
Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me.
Unsure
|
4 Participants
|
0 Participants
|
|
Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me.
No
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis only included participants who completed the measure at baseline.
This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points.
Outcome measures
| Measure |
LVAD Decision Aid
n=46 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=49 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Participants' Control Preferences Over Treatment Decision-Making
Patient made final decision
|
5 Participants
|
5 Participants
|
|
Participants' Control Preferences Over Treatment Decision-Making
Patient, after seriously considering doctor opinio
|
15 Participants
|
17 Participants
|
|
Participants' Control Preferences Over Treatment Decision-Making
Doctor and patient shared responsibility
|
18 Participants
|
21 Participants
|
|
Participants' Control Preferences Over Treatment Decision-Making
Doctor made decision after considering patient opi
|
5 Participants
|
4 Participants
|
|
Participants' Control Preferences Over Treatment Decision-Making
All decisions left to doctor
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1-MonthPopulation: Analysis only included participants who completed the measure at baseline, minus participants lost to attrition between baseline and 1-month follow-up.
This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points (baseline and 1-month follow-up).
Outcome measures
| Measure |
LVAD Decision Aid
n=26 Participants
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
|
No LVAD Decision Aid
n=30 Participants
The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
|
|---|---|---|
|
Participants' Control Preferences Over Treatment Decision-Making
Patient made final decision
|
3 Participants
|
1 Participants
|
|
Participants' Control Preferences Over Treatment Decision-Making
Patient, after seriously considering doctor opinio
|
10 Participants
|
18 Participants
|
|
Participants' Control Preferences Over Treatment Decision-Making
Doctor and patient shared responsibility
|
10 Participants
|
8 Participants
|
|
Participants' Control Preferences Over Treatment Decision-Making
Doctor made decision after considering patient opi
|
1 Participants
|
3 Participants
|
|
Participants' Control Preferences Over Treatment Decision-Making
All decisions left to doctor
|
2 Participants
|
0 Participants
|
Adverse Events
LVAD Decision Aid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No LVAD Decision Aid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jennifer Blumenthal-Barby
Baylor College of Medicine
Phone: (713) 798-3785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place