Development & Testing of a Decision Aid for LVAD Placement

Study Overview
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Brief Summary
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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.

Official Title
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Development and User Testing of a Decision Aid for Left Ventricular Assist Device (LVAD) Placement

Conditions
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End-Stage Heart Failure, Bridge-to-Transplant LVAD Placement (BTT), Destination Therapy LVAD Placement (DT), Refusal of LVAD Placement (Decliners), LVAD Caregivers

Intervention / Treatment
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* Other: LVAD Decision Aid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LVAD Decision Aid<br>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. | Other: LVAD Decision Aid<br>* 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).<br>|
| No Intervention: No LVAD Decision Aid<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| 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. | 1-Week Follow-up | 
| 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. | 1-Month Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| 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. | 1 Week Follow-up | 
| 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. | 1 Week Follow-up | 
| 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. | 1 Month Follow-up | 
| 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. | 1 Month Follow-up | 
| 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. | 1 Month Follow-up | 
| Satisfaction With Life Scale | Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life. | Baseline | 
| Satisfaction With Life Scale | Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life. | 1 Month Follow-up | 
| 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. | 1 Week Follow-up | 
| 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 | 1 Day Follow-up | 
| 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. | 1-Week Follow-Up | 
| 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. | 1-Month Follow-Up | 
| 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. | 1-Month Follow-Up | 
| 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. | 1-Week Follow-Up | 
| 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. | 1-Month Follow-Up | 
| 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. | 1-Week Follow-Up | 
| 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. | 1-Month Follow-Up | 
| 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. | 1-Week Follow-Up | 
| 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. | 1-Month Follow-Up | 
| 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? | Baseline | 
| 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? | 1-Month Follow-Up | 
| 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. | Baseline | 
| 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. | 1-Week Follow-Up | 
| 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. | 1-Month Follow-Up | 
| 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). | 1-Month Follow-Up | 
| 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 | 1 Day Follow-up | 
| 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 | 1 Day Follow-up | 
| Usability and Acceptability: Would Recommend to Others. | Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool | 1 Day Follow-up | 
| Usability and Acceptability: Held my Interest. | Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool | 1 Day Follow-up | 
| 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 | 1 Day Follow-up | 
| 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 | 1 Day Follow-up | 
| 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 | 
| 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). | 1-Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End-Stage Heart Failure, Left Ventricular Assist Device, Decision Aid, Medical Decision-Making