Bridge-to-Transplant LVAD Placement (BTT), Destination Therapy LVAD Placement (DT), End-Stage Heart Failure, LVAD Caregivers, Refusal of LVAD Placement (Decliners)
Conditions
Keywords
End-Stage Heart Failure, Left Ventricular Assist Device, Decision Aid, Medical Decision-Making
Brief summary
The goal of this project is to develop a patient-centered decision aid for decision-making about end-stage heart failure treatment. This study seeks to create a decision aid that presents outcomes, risks, projected experiences, and uncertainties about Left Ventricular Assist Device (LVAD) placement to help patients make values-based decisions about placement. The investigators propose a mixed methods design involving a literature search of clinical evidence, semi-structured patient interviews, and quantitative data from a multi-site trial of patients receiving the decision aid compared to patients not receiving the aid.
Interventions
OTHERLVAD 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).
Sponsors
The Methodist Hospital Research Institute
The University of Texas Health Science Center, Houston
M.D. Anderson Cancer Center
INTEGRIS Baptist Medical Center
Texas Heart Institute
Wake Forest University Health Sciences
The Cleveland Clinic
Patient-Centered Outcomes Research Institute
Ochsner Health System
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* LVAD Candidates (NYHA Class III and IV patients with an acceptable surgical risk/benefit ratio for LVAD implantation and with good psychosocial support, coping mechanisms, and financial resources, as determined by clearance from the transplant social worker) * LVAD Patients * LVAD Decliners * LVAD Caregivers
Exclusion criteria
* subjects who lack the capacity to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Assist Device (LVAD) Knowledge Scale | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| collaboRATE-Shared Decision Making | 1 Week Follow-up | 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. |
| Satisfaction With Decision Making Process | 1 Month Follow-up | 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. |
| Ottawa Decision Regret Scale | 1 Month Follow-up | 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. |
| Satisfaction With Life Scale | Baseline | Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life. |
| Preparedness for Decision-Making Scale | 1 Week Follow-up | 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. |
| Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment. | 1 Day Follow-up | Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool |
| Shared Decision-Making (SDM-9) | 1-Week Follow-Up | 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. |
| Number and Percentage of Participants Whose Control Preferences for Treatment Decision-Making Match From Baseline to 1-month Follow-up | 1-Month Follow-Up | 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. |
| Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect | 1-Week Follow-Up | Percentage of patients reporting that their ability to envision life with an LVAD was Somewhat Easy or Easy. |
| Number and Percentage of Participants Reporting Ability to Envision Life With an LVAD: Difficult/no Idea What to Expect | 1-Month Follow-Up | Number and percentage of patients reporting that their ability to envision life with an LVAD was Difficult or that they had No idea. |
| Number & Percentage of Participants Who Perceived a Strong Likelihood of Transplant | 1-Week Follow-Up | Measures the number and percentage of participants who perceived a strong likelihood of transplant. |
| Number and Percentage of Participants Who Perceived and Strong Likelihood of Transplant | 1-Month Follow-Up | Number and Percentage of participants who perceived and strong Likelihood of Transplant after 1-Month follow-up. |
| Decisional Conflict Scale | Baseline | 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. |
| Satisfaction With Life | 1-Month Follow-Up | Satisfaction with Life Scale, intended to measure respondents' perceived global life satisfaction. Out of 0-30 scale. Higher scores indicate higher satisfaction with life. |
| Quality of Life -- Health Rating | Baseline | 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? |
| Preferred Treatment: Number of Patients Predicting They Will Choose LVAD | Baseline | 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. |
| Number of Patients Whose Preferred Treatment Was LVAD | 1-Week Follow-Up | 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. |
| Number and Percentage of Patients Who Filled Out an Advanced Directive | 1-Month Follow-Up | 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). |
| Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure. | 1 Day Follow-up | Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool |
| Usability and Acceptability: Learned Something New That I Didn't Know Before. | 1 Day Follow-up | Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool |
| Usability and Acceptability: Would Recommend to Others. | 1 Day Follow-up | Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool |
| Usability and Acceptability: Held my Interest. | 1 Day Follow-up | Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool |
| Usability and Acceptability: Helps Someone Make an Informed Decision. | 1 Day Follow-up | Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool |
| Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me. | 1 Day Follow-up | Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool |
| Participants' Control Preferences Over Treatment Decision-Making | 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. |
| Participants' Perceived Survival Estimate in Number of Years After LVAD Implant | 1-Week Follow-Up | 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. |
Countries
United States
Participant flow
Pre-assignment details
We enrolled a total of 98 participants. This number is consistent between the Protocol Section and the Participant Flow Module.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 47 |
| 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. | 51 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 1-Day Follow-Up | Enrolled in another study | 1 | 0 |
| 1-Day Follow-Up | Lost to Follow-up | 4 | 0 |
| 1-Day Follow-Up | Withdrawal by Subject | 5 | 0 |
| 1-Month Follow-Up | Lost to Follow-up | 2 | 3 |
| 1-Week Follow-Up | Became ineligible for LVAD | 4 | 1 |
| 1-Week Follow-Up | Cognitive Difficulty | 1 | 0 |
| 1-Week Follow-Up | Death | 1 | 1 |
| 1-Week Follow-Up | Enrolled in another study | 1 | 1 |
| 1-Week Follow-Up | Excluded because of age | 0 | 1 |
| 1-Week Follow-Up | Lost to Follow-up | 0 | 8 |
| 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 | Transferred to another facility | 1 | 0 |
| 1-Week Follow-Up | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | No LVAD Decision Aid | Total | LVAD Decision Aid |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 32 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 66 Participants | 33 Participants |
| Age, Continuous | 59.94 years STANDARD_DEVIATION 9.67 | 59.77 years STANDARD_DEVIATION 12.08 | 59.61 years STANDARD_DEVIATION 14.03 |
| Caregiver 0 Caregivers | 1 Participants | 1 Participants | 0 Participants |
| Caregiver 1 Caregiver | 16 Participants | 24 Participants | 8 Participants |
| Caregiver 2 Caregivers | 16 Participants | 32 Participants | 16 Participants |
| Caregiver >=3 Caregivers | 16 Participants | 39 Participants | 23 Participants |
| Caregiver Prefer not to answer | 2 Participants | 2 Participants | 0 Participants |
| Education 4-yr college graduate | 7 Participants | 11 Participants | 4 Participants |
| Education 8th grade or less | 2 Participants | 7 Participants | 5 Participants |
| Education High school degree/GED | 18 Participants | 34 Participants | 16 Participants |
| Education Missing data | 1 Participants | 1 Participants | 0 Participants |
| Education Prefer not to answer | 3 Participants | 9 Participants | 6 Participants |
| Education Some college | 16 Participants | 24 Participants | 8 Participants |
| Education Some high school | 4 Participants | 12 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 16 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 81 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Income >$100,000 | 2 Participants | 7 Participants | 5 Participants |
| Income <$15,000 | 13 Participants | 27 Participants | 14 Participants |
| Income $15,000-$30,000 | 10 Participants | 18 Participants | 8 Participants |
| Income $30,000-$60,000 | 6 Participants | 11 Participants | 5 Participants |
| Income $60,000-$100,00 | 6 Participants | 11 Participants | 5 Participants |
| Income Prefer not to answer | 14 Participants | 24 Participants | 10 Participants |
| Insurance Prefer not to answer | 5 Participants | 7 Participants | 2 Participants |
| Insurance Private | 22 Participants | 38 Participants | 16 Participants |
| Insurance Private and Public | 10 Participants | 24 Participants | 14 Participants |
| Insurance Public | 14 Participants | 29 Participants | 15 Participants |
| Marital Status Common law | 2 Participants | 2 Participants | 0 Participants |
| Marital Status Divorced | 4 Participants | 9 Participants | 5 Participants |
| Marital Status Married | 30 Participants | 61 Participants | 31 Participants |
| Marital Status Other | 1 Participants | 1 Participants | 0 Participants |
| Marital Status Separated | 2 Participants | 2 Participants | 0 Participants |
| Marital Status Single/never married | 9 Participants | 16 Participants | 7 Participants |
| Marital Status Widowed | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 27 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 37 Participants | 66 Participants | 29 Participants |
| Sex: Female, Male Female | 41 Participants | 54 Participants | 13 Participants |
| Sex: Female, Male Male | 10 Participants | 44 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 47 | 0 / 51 |
| serious Total, serious adverse events | 0 / 47 | 0 / 51 |
Outcome results
Primary
Left Ventricular Assist Device (LVAD) Knowledge Scale
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | Left Ventricular Assist Device (LVAD) Knowledge Scale | 45.6 units on a scale | Standard Deviation 22.2 |
| No LVAD Decision Aid | Left Ventricular Assist Device (LVAD) Knowledge Scale | 43.8 units on a scale | Standard Deviation 18.3 |
Primary
Left Ventricular Assist Device (LVAD) Knowledge Scale
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.
Time frame: 1-Week Follow-up
Population: Analysis only includes individuals who responded to the measure at 1-Week Follow-Up (DA=29, no-DA=34, Total=63).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | Left Ventricular Assist Device (LVAD) Knowledge Scale | 67.8 units on a scale | Standard Deviation 15.6 |
| No LVAD Decision Aid | Left Ventricular Assist Device (LVAD) Knowledge Scale | 59.3 units on a scale | Standard Deviation 12.4 |
Comparison: The model uses a general linear mixed model with fixed effects for baseline Knowledge Scale score, time (discrete), arm, and a time-arm interaction term. The matrix of correlated residual terms assumes an unstructured format.p-value: 0.01Mixed Models Analysis
Primary
Left Ventricular Assist Device (LVAD) Knowledge Scale
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.
Time frame: 1-Month Follow-up
Population: Analysis only includes individuals who responded to the measure at 1-Week Follow-Up (DA=27, no-DA=31, Total=58).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | Left Ventricular Assist Device (LVAD) Knowledge Scale | 27.9 units on a scale | Standard Deviation 5.7 |
| No LVAD Decision Aid | Left Ventricular Assist Device (LVAD) Knowledge Scale | 22.9 units on a scale | Standard Deviation 6.6 |
Comparison: The model uses a general linear mixed model with fixed effects for baseline KS score, time (discrete), arm, and a time-arm interaction term. The matrix of correlated residual terms assumes an unstructured format.p-value: 0.47Mixed Models Analysis
Secondary
Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect
Percentage of patients reporting that their ability to envision life with an LVAD was Somewhat Easy or Easy.
Time frame: 1-Week Follow-Up
Population: Analysis only includes those who responded to this measure (DA=27, no-DA =33, Total=60).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LVAD Decision Aid | Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect | 25 Participants |
| No LVAD Decision Aid | Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect | 25 Participants |
Secondary
collaboRATE-Shared Decision Making
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.
Time frame: 1 Week Follow-up
Population: Analysis only includes participants who responded to the measure at 1-Week Follow-Up (DA=28, no-DA=34, Total=62).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | collaboRATE-Shared Decision Making | 88.4 units on a scale | Standard Deviation 19.3 |
| No LVAD Decision Aid | collaboRATE-Shared Decision Making | 89.6 units on a scale | Standard Deviation 15.6 |
p-value: 0.99Wilcoxon (Mann-Whitney)
Secondary
collaboRATE-Shared Decision Making
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.
Time frame: 1 Month Follow-up
Population: Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=57).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | collaboRATE-Shared Decision Making | 90.4 units on a scale | Standard Deviation 14.3 |
| No LVAD Decision Aid | collaboRATE-Shared Decision Making | 89.8 units on a scale | Standard Deviation 17.2 |
p-value: 0.94Wilcoxon (Mann-Whitney)
Secondary
Decisional Conflict Scale
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.
Time frame: Baseline
Population: Analysis includes only those participants who completed the measure at Baseline (DA=44, no-DA=50, Total=94).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | Decisional Conflict Scale | 23.1 units on a scale | Standard Deviation 20.7 |
| No LVAD Decision Aid | Decisional Conflict Scale | 29.3 units on a scale | Standard Deviation 19.3 |
Comparison: Used Wilcoxon 2-sample test to see if DA group had significantly better (i.e. lower) Decisional Conflict Scores than no-DA (Control) group.p-value: 0.12Wilcoxon (Mann-Whitney)
Secondary
Decisional Conflict Scale
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.
Time frame: 1 Week Follow-up
Population: Analysis includes only those participants who completed the measure at Baseline (DA=29, no-DA=33, Total=62).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | Decisional Conflict Scale | 15.7 units on a scale | Standard Deviation 11.8 |
| No LVAD Decision Aid | Decisional Conflict Scale | 17.4 units on a scale | Standard Deviation 14.7 |
Comparison: Used Wilcoxon 2-sample test to see if DA group had significantly better (i.e. lower) Decisional Conflict Scores than no-DA (Control) group.p-value: 0.79Wilcoxon (Mann-Whitney)
Secondary
Number and Percentage of Participants Reporting Ability to Envision Life With an LVAD: Difficult/no Idea What to Expect
Number and percentage of patients reporting that their ability to envision life with an LVAD was Difficult or that they had No idea.
Time frame: 1-Month Follow-Up
Population: Analysis only includes those who responded to this measure (DA=20, no-DA =21, Total=41).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LVAD Decision Aid | Number and Percentage of Participants Reporting Ability to Envision Life With an LVAD: Difficult/no Idea What to Expect | 15 Participants |
| No LVAD Decision Aid | Number and Percentage of Participants Reporting Ability to Envision Life With an LVAD: Difficult/no Idea What to Expect | 9 Participants |
Secondary
Number and Percentage of Participants Who Perceived and Strong Likelihood of Transplant
Number and Percentage of participants who perceived and strong Likelihood of Transplant after 1-Month follow-up.
Time frame: 1-Month Follow-Up
Population: Analysis included only those participants who responded to the measure at 1-month (DA=27, no-DA=31, Total=58).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LVAD Decision Aid | Number and Percentage of Participants Who Perceived and Strong Likelihood of Transplant | 17 Participants |
| No LVAD Decision Aid | Number and Percentage of Participants Who Perceived and Strong Likelihood of Transplant | 15 Participants |
p-value: 0.27Wilcoxon (Mann-Whitney)
Secondary
Number and Percentage of Participants Whose Control Preferences for Treatment Decision-Making Match From Baseline to 1-month Follow-up
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.
Time frame: 1-Month Follow-Up
Population: Analysis only included participants who completed the measure at both Baseline and 1-Month followup, in order to calculate match in preferences.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LVAD Decision Aid | Number and Percentage of Participants Whose Control Preferences for Treatment Decision-Making Match From Baseline to 1-month Follow-up | 14 Participants |
| No LVAD Decision Aid | Number and Percentage of Participants Whose Control Preferences for Treatment Decision-Making Match From Baseline to 1-month Follow-up | 13 Participants |
Secondary
Number and Percentage of Patients Who Filled Out an Advanced Directive
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).
Time frame: 1-Month Follow-Up
Population: Analysis only includes participants who responded to the question (DA=25, no-DA=27, Total=52).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LVAD Decision Aid | Number and Percentage of Patients Who Filled Out an Advanced Directive | 17 Participants |
| No LVAD Decision Aid | Number and Percentage of Patients Who Filled Out an Advanced Directive | 12 Participants |
p-value: 0.12Fisher Exact
Secondary
Number of Patients Whose Preferred Treatment Was LVAD
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.
Time frame: 1-Week Follow-Up
Population: Analysis only includes participants who responded to the question at 1-Week (DA=28, no-DA=33, Total=61).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LVAD Decision Aid | Number of Patients Whose Preferred Treatment Was LVAD | 21 Participants |
| No LVAD Decision Aid | Number of Patients Whose Preferred Treatment Was LVAD | 26 Participants |
p-value: 0.77Wilcoxon (Mann-Whitney)
Secondary
Number of Patients Whose Preferred Treatment Was LVAD
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.
Time frame: 1-Month Follow-Up
Population: Analysis only includes participants who responded to the question at 1-Month (DA=26, no-DA=32, Total=58).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LVAD Decision Aid | Number of Patients Whose Preferred Treatment Was LVAD | 22 Participants |
| No LVAD Decision Aid | Number of Patients Whose Preferred Treatment Was LVAD | 25 Participants |
p-value: 0.74Wilcoxon (Mann-Whitney)
Secondary
Number & Percentage of Participants Who Perceived a Strong Likelihood of Transplant
Measures the number and percentage of participants who perceived a strong likelihood of transplant.
Time frame: 1-Week Follow-Up
Population: Analysis included only those participants who responded to the measure at 1-week (DA=26, no=DA=33, Total=59).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LVAD Decision Aid | Number & Percentage of Participants Who Perceived a Strong Likelihood of Transplant | 16 Participants |
| No LVAD Decision Aid | Number & Percentage of Participants Who Perceived a Strong Likelihood of Transplant | 22 Participants |
p-value: 0.6Wilcoxon (Mann-Whitney)
Secondary
Ottawa Decision Regret Scale
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.
Time frame: 1 Month Follow-up
Population: Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=67).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | Ottawa Decision Regret Scale | 11.5 units on a scale | Standard Deviation 13.3 |
| No LVAD Decision Aid | Ottawa Decision Regret Scale | 12.9 units on a scale | Standard Deviation 16.6 |
p-value: 0.95Wilcoxon (Mann-Whitney)
Secondary
Participants' Control Preferences Over Treatment Decision-Making
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).
Time frame: 1-Month
Population: Analysis only included participants who completed the measure at baseline, minus participants lost to attrition between baseline and 1-month follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | Patient, after seriously considering doctor opinio | 10 Participants |
| LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | Doctor and patient shared responsibility | 10 Participants |
| LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | Doctor made decision after considering patient opi | 1 Participants |
| LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | All decisions left to doctor | 2 Participants |
| LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | Patient made final decision | 3 Participants |
| No LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | All decisions left to doctor | 0 Participants |
| No LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | Patient made final decision | 1 Participants |
| No LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | Patient, after seriously considering doctor opinio | 18 Participants |
| No LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | Doctor made decision after considering patient opi | 3 Participants |
| No LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | Doctor and patient shared responsibility | 8 Participants |
p-value: 0.2Fisher Exact
Secondary
Participants' Control Preferences Over Treatment Decision-Making
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.
Time frame: Baseline
Population: Analysis only included participants who completed the measure at baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | Patient, after seriously considering doctor opinio | 15 Participants |
| LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | Doctor made decision after considering patient opi | 5 Participants |
| LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | Doctor and patient shared responsibility | 18 Participants |
| LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | All decisions left to doctor | 3 Participants |
| LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | Patient made final decision | 5 Participants |
| No LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | All decisions left to doctor | 2 Participants |
| No LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | Patient made final decision | 5 Participants |
| No LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | Patient, after seriously considering doctor opinio | 17 Participants |
| No LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | Doctor and patient shared responsibility | 21 Participants |
| No LVAD Decision Aid | Participants' Control Preferences Over Treatment Decision-Making | Doctor made decision after considering patient opi | 4 Participants |
p-value: 0.98Fisher Exact
Secondary
Participants' Perceived Survival Estimate in Number of Years After LVAD Implant
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.
Time frame: 1-Week Follow-Up
Population: Analysis only includes those participants who responded to the measure at 1-Week Follow-Up (DA=27, no-DA=28, Total=55).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | Participants' Perceived Survival Estimate in Number of Years After LVAD Implant | 10.17 years | Standard Deviation 7.14 |
| No LVAD Decision Aid | Participants' Perceived Survival Estimate in Number of Years After LVAD Implant | 9.7 years | Standard Deviation 9.8 |
p-value: 0.45Wilcoxon (Mann-Whitney)
Secondary
Preferred Treatment: Number of Patients Predicting They Will Choose LVAD
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.
Time frame: Baseline
Population: Analysis only includes participants who responded to the question at baseline (DA=46, no-DA=50, Total=96).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LVAD Decision Aid | Preferred Treatment: Number of Patients Predicting They Will Choose LVAD | 28 Participants |
| No LVAD Decision Aid | Preferred Treatment: Number of Patients Predicting They Will Choose LVAD | 31 Participants |
Secondary
Preparedness for Decision-Making Scale
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.
Time frame: 1 Week Follow-up
Population: Analysis only includes participants who responded to measure at 1-Week Follow-Up (DA=27, no-DA=33, Total=60).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | Preparedness for Decision-Making Scale | 86.9 units on a scale | Standard Deviation 15.1 |
| No LVAD Decision Aid | Preparedness for Decision-Making Scale | 81.8 units on a scale | Standard Deviation 17.4 |
p-value: 0.27Wilcoxon (Mann-Whitney)
Secondary
Quality of Life -- Health Rating
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?
Time frame: 1-Month Follow-Up
Population: Analysis included only those participants who completed measure at 1-Month (DA=26, no-DA=30, Total=56).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | Quality of Life -- Health Rating | 81.0 units on a scale | Standard Deviation 3.7 |
| No LVAD Decision Aid | Quality of Life -- Health Rating | 69.1 units on a scale | Standard Deviation 3.5 |
p-value: 0.03Wilcoxon (Mann-Whitney)
Secondary
Quality of Life -- Health Rating
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?
Time frame: Baseline
Population: Analysis included only those participants who completed the measure at baseline (DA=46, no-DA=50, Total=96).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | Quality of Life -- Health Rating | 55.8 units on a scale | Standard Deviation 24 |
| No LVAD Decision Aid | Quality of Life -- Health Rating | 43.1 units on a scale | Standard Deviation 24.5 |
p-value: 0.01Wilcoxon (Mann-Whitney)
Secondary
Satisfaction With Decision Making Process
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.
Time frame: 1 Month Follow-up
Population: Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=67).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | Satisfaction With Decision Making Process | 75.6 units on a scale | Standard Deviation 23.7 |
| No LVAD Decision Aid | Satisfaction With Decision Making Process | 76.8 units on a scale | Standard Deviation 20 |
p-value: 1Wilcoxon (Mann-Whitney)
Secondary
Satisfaction With Life
Satisfaction with Life Scale, intended to measure respondents' perceived global life satisfaction. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.
Time frame: 1-Month Follow-Up
Population: Analysis only included those participants who completed the measure at 1-Month Follow-Up (DA=26, no=DA=30, Total=56).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | Satisfaction With Life | 27.9 units on a scale | Standard Deviation 5.7 |
| No LVAD Decision Aid | Satisfaction With Life | 22.9 units on a scale | Standard Deviation 6.9 |
p-value: 0.006Wilcoxon (Mann-Whitney)
Secondary
Satisfaction With Life Scale
Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.
Time frame: 1 Month Follow-up
Population: Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=67).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | Satisfaction With Life Scale | 27.9 units on a scale | Standard Deviation 6.7 |
| No LVAD Decision Aid | Satisfaction With Life Scale | 22.9 units on a scale | Standard Deviation 6.6 |
p-value: 0.006Wilcoxon (Mann-Whitney)
Secondary
Satisfaction With Life Scale
Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | Satisfaction With Life Scale | 22.8 units on a scale | Standard Deviation 6.6 |
| No LVAD Decision Aid | Satisfaction With Life Scale | 20.4 units on a scale | Standard Deviation 7.2 |
p-value: 0.13Wilcoxon (Mann-Whitney)
Secondary
Shared Decision-Making (SDM-9)
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.
Time frame: 1-Month Follow-Up
Population: Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=25, no-DA=31, Total=56).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | Shared Decision-Making (SDM-9) | 87.5 units on a scale | Standard Deviation 12.8 |
| No LVAD Decision Aid | Shared Decision-Making (SDM-9) | 85.2 units on a scale | Standard Deviation 15 |
p-value: 0.74Wilcoxon (Mann-Whitney)
Secondary
Shared Decision-Making (SDM-9)
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.
Time frame: 1-Week Follow-Up
Population: Analysis only includes participants who responded to measure at 1-Week Follow-Up (DA=27, no-DA=34, Total=61).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVAD Decision Aid | Shared Decision-Making (SDM-9) | 84.8 units on a scale | Standard Deviation 16.8 |
| No LVAD Decision Aid | Shared Decision-Making (SDM-9) | 84.3 units on a scale | Standard Deviation 13.6 |
p-value: 0.65Wilcoxon (Mann-Whitney)
Secondary
Usability and Acceptability: Held my Interest.
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Time frame: 1 Day Follow-up
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LVAD Decision Aid | Usability and Acceptability: Held my Interest. | Yes | 34 Participants |
| LVAD Decision Aid | Usability and Acceptability: Held my Interest. | Unsure | 2 Participants |
| LVAD Decision Aid | Usability and Acceptability: Held my Interest. | No | 1 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Held my Interest. | Yes | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Held my Interest. | Unsure | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Held my Interest. | No | 0 Participants |
Secondary
Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me.
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Time frame: 1 Day Follow-up
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LVAD Decision Aid | Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me. | Yes | 30 Participants |
| LVAD Decision Aid | Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me. | Unsure | 4 Participants |
| LVAD Decision Aid | Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me. | No | 1 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me. | Yes | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me. | Unsure | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me. | No | 0 Participants |
Secondary
Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment.
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Time frame: 1 Day Follow-up
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LVAD Decision Aid | Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment. | Agree | 12 Participants |
| LVAD Decision Aid | Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment. | Disagree | 0 Participants |
| LVAD Decision Aid | Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment. | Neutral | 2 Participants |
| LVAD Decision Aid | Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment. | Strongly Disagree | 0 Participants |
| LVAD Decision Aid | Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment. | Strongly Agree | 21 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment. | Strongly Disagree | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment. | Strongly Agree | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment. | Agree | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment. | Neutral | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment. | Disagree | 0 Participants |
Secondary
Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure.
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Time frame: 1 Day Follow-up
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LVAD Decision Aid | Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure. | Agree | 11 Participants |
| LVAD Decision Aid | Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure. | Disagree | 1 Participants |
| LVAD Decision Aid | Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure. | Neutral | 4 Participants |
| LVAD Decision Aid | Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure. | Strongly Disagree | 0 Participants |
| LVAD Decision Aid | Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure. | Strongly Agree | 19 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure. | Strongly Disagree | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure. | Strongly Agree | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure. | Agree | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure. | Neutral | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure. | Disagree | 0 Participants |
Secondary
Usability and Acceptability: Helps Someone Make an Informed Decision.
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Time frame: 1 Day Follow-up
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LVAD Decision Aid | Usability and Acceptability: Helps Someone Make an Informed Decision. | Yes | 33 Participants |
| LVAD Decision Aid | Usability and Acceptability: Helps Someone Make an Informed Decision. | Unsure | 2 Participants |
| LVAD Decision Aid | Usability and Acceptability: Helps Someone Make an Informed Decision. | No | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Helps Someone Make an Informed Decision. | Yes | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Helps Someone Make an Informed Decision. | No | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Helps Someone Make an Informed Decision. | Unsure | 0 Participants |
Secondary
Usability and Acceptability: Learned Something New That I Didn't Know Before.
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Time frame: 1 Day Follow-up
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LVAD Decision Aid | Usability and Acceptability: Learned Something New That I Didn't Know Before. | Agree | 9 Participants |
| LVAD Decision Aid | Usability and Acceptability: Learned Something New That I Didn't Know Before. | Disagree | 1 Participants |
| LVAD Decision Aid | Usability and Acceptability: Learned Something New That I Didn't Know Before. | Neutral | 5 Participants |
| LVAD Decision Aid | Usability and Acceptability: Learned Something New That I Didn't Know Before. | Strongly Disagree | 0 Participants |
| LVAD Decision Aid | Usability and Acceptability: Learned Something New That I Didn't Know Before. | Strongly Agree | 20 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Learned Something New That I Didn't Know Before. | Strongly Disagree | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Learned Something New That I Didn't Know Before. | Strongly Agree | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Learned Something New That I Didn't Know Before. | Agree | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Learned Something New That I Didn't Know Before. | Neutral | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Learned Something New That I Didn't Know Before. | Disagree | 0 Participants |
Secondary
Usability and Acceptability: Would Recommend to Others.
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Time frame: 1 Day Follow-up
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LVAD Decision Aid | Usability and Acceptability: Would Recommend to Others. | Yes | 34 Participants |
| LVAD Decision Aid | Usability and Acceptability: Would Recommend to Others. | Unsure | 3 Participants |
| LVAD Decision Aid | Usability and Acceptability: Would Recommend to Others. | No | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Would Recommend to Others. | Yes | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Would Recommend to Others. | Unsure | 0 Participants |
| No LVAD Decision Aid | Usability and Acceptability: Would Recommend to Others. | No | 0 Participants |