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Development & Testing of a Decision Aid for LVAD Placement (VADDA)

Primary Purpose

End-Stage Heart Failure, Bridge-to-Transplant LVAD Placement (BTT), Destination Therapy LVAD Placement (DT)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LVAD Decision Aid
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End-Stage Heart Failure focused on measuring End-Stage Heart Failure, Left Ventricular Assist Device, Decision Aid, Medical Decision-Making

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ochsner Health System
  • Cleveland Clinic
  • INTEGRIS Baptist Medical Center
  • CHI ST. Luke's - Baylor St. Lukes Medical Center / Texas Heart Institute
  • Houston Methodist Hospital
  • Baylor College of Medicine
  • Aurora Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

LVAD Decision Aid

No LVAD Decision Aid

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Satisfaction With Life Scale
Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.
Satisfaction With Life Scale
Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.
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.
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
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.
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.
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.
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."
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."
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.
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.
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.
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.
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?"
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?"
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.
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.
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.
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).
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
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
Usability and Acceptability: Would Recommend to Others.
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Usability and Acceptability: Held my Interest.
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.
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.
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
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.
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).

Full Information

First Posted
September 17, 2014
Last Updated
February 14, 2019
Sponsor
Baylor College of Medicine
Collaborators
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, Aurora Health Care, The Cleveland Clinic, Patient-Centered Outcomes Research Institute, Ochsner Health System
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1. Study Identification

Unique Protocol Identification Number
NCT02248974
Brief Title
Development & Testing of a Decision Aid for LVAD Placement
Acronym
VADDA
Official Title
Development and User Testing of a Decision Aid for Left Ventricular Assist Device (LVAD) Placement
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
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, Aurora Health Care, The Cleveland Clinic, Patient-Centered Outcomes Research Institute, Ochsner Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Heart Failure, Bridge-to-Transplant LVAD Placement (BTT), Destination Therapy LVAD Placement (DT), Refusal of LVAD Placement (Decliners), LVAD Caregivers
Keywords
End-Stage Heart Failure, Left Ventricular Assist Device, Decision Aid, Medical Decision-Making

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LVAD Decision Aid
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No LVAD Decision Aid
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
LVAD Decision Aid
Intervention Description
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).
Primary Outcome Measure Information:
Title
Left Ventricular Assist Device (LVAD) Knowledge Scale
Description
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
Title
Left Ventricular Assist Device (LVAD) Knowledge Scale
Description
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
Title
Left Ventricular Assist Device (LVAD) Knowledge Scale
Description
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
Secondary Outcome Measure Information:
Title
Decisional Conflict Scale
Description
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
Title
Decisional Conflict Scale
Description
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
Title
collaboRATE-Shared Decision Making
Description
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
Title
collaboRATE-Shared Decision Making
Description
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
Title
Satisfaction With Decision Making Process
Description
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
Title
Ottawa Decision Regret Scale
Description
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
Title
Satisfaction With Life Scale
Description
Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.
Time Frame
Baseline
Title
Satisfaction With Life Scale
Description
Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.
Time Frame
1 Month Follow-up
Title
Preparedness for Decision-Making Scale
Description
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
Title
Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment.
Description
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Time Frame
1 Day Follow-up
Title
Shared Decision-Making (SDM-9)
Description
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
Title
Shared Decision-Making (SDM-9)
Description
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
Title
Number and Percentage of Participants Whose Control Preferences for Treatment Decision-Making Match From Baseline to 1-month Follow-up
Description
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
Title
Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect
Description
Percentage of patients reporting that their ability to envision life with an LVAD was "Somewhat Easy" or "Easy."
Time Frame
1-Week Follow-Up
Title
Number and Percentage of Participants Reporting Ability to Envision Life With an LVAD: Difficult/no Idea What to Expect
Description
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
Title
Number & Percentage of Participants Who Perceived a Strong Likelihood of Transplant
Description
Measures the number and percentage of participants who perceived a strong likelihood of transplant.
Time Frame
1-Week Follow-Up
Title
Number and Percentage of Participants Who Perceived and Strong Likelihood of Transplant
Description
Number and Percentage of participants who perceived and strong Likelihood of Transplant after 1-Month follow-up.
Time Frame
1-Month Follow-Up
Title
Participants' Perceived Survival Estimate in Number of Years After LVAD Implant
Description
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
Title
Satisfaction With Life
Description
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
Title
Quality of Life -- Health Rating
Description
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
Title
Quality of Life -- Health Rating
Description
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
Title
Preferred Treatment: Number of Patients Predicting They Will Choose LVAD
Description
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
Title
Number of Patients Whose Preferred Treatment Was LVAD
Description
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
Title
Number of Patients Whose Preferred Treatment Was LVAD
Description
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
Title
Number and Percentage of Patients Who Filled Out an Advanced Directive
Description
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
Title
Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure.
Description
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Time Frame
1 Day Follow-up
Title
Usability and Acceptability: Learned Something New That I Didn't Know Before.
Description
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Time Frame
1 Day Follow-up
Title
Usability and Acceptability: Would Recommend to Others.
Description
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Time Frame
1 Day Follow-up
Title
Usability and Acceptability: Held my Interest.
Description
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Time Frame
1 Day Follow-up
Title
Usability and Acceptability: Helps Someone Make an Informed Decision.
Description
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Time Frame
1 Day Follow-up
Title
Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me.
Description
Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
Time Frame
1 Day Follow-up
Title
Participants' Control Preferences Over Treatment Decision-Making
Description
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
Title
Participants' Control Preferences Over Treatment Decision-Making
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Blumenthal-Barby, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristin M Kostick, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ochsner Health System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
INTEGRIS Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
CHI ST. Luke's - Baylor St. Lukes Medical Center / Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Aurora Health Care
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25239054
Citation
Bruce CR, Delgado E, Kostick K, Grogan S, Ashrith G, Trachtenberg B, Estep JD, Bhimaraj A, Pham L, Blumenthal-Barby JS. Ventricular assist devices: a review of psychosocial risk factors and their impact on outcomes. J Card Fail. 2014 Dec;20(12):996-1003. doi: 10.1016/j.cardfail.2014.09.006. Epub 2014 Sep 17.
Results Reference
background
Citation
Blumenthal-Barby, J. S., Kristin M. Kostick, Estevan D. Delgado, Robert J. Volk, Holland M. Kaplan, L. A. Wilhelms, Sheryl A. McCurdy, Jerry D. Estep, Matthias Loebe, and Courtenay R. Bruce.
Results Reference
background
PubMed Identifier
30195826
Citation
Kostick KM, Bruce CR, Minard CG, Volk RJ, Civitello A, Krim SR, Horstmanshof D, Thohan V, Loebe M, Hanna M, Bruckner BA, Blumenthal Barby JS, Estep JD. A Multisite Randomized Controlled Trial of a Patient-Centered Ventricular Assist Device Decision Aid (VADDA Trial). J Card Fail. 2018 Oct;24(10):661-671. doi: 10.1016/j.cardfail.2018.08.008. Epub 2018 Sep 7.
Results Reference
derived
PubMed Identifier
28073849
Citation
Bruce CR, Minard CG, Wilhelms LA, Abraham M, Amione-Guerra J, Pham L, Grogan SD, Trachtenberg B, Smith ML, Bruckner BA, Estep JD, Kostick KM. Caregivers of Patients With Left Ventricular Assist Devices: Possible Impacts on Patients' Mortality and Interagency Registry for Mechanically Assisted Circulatory Support-Defined Morbidity Events. Circ Cardiovasc Qual Outcomes. 2017 Jan;10(1):e002879. doi: 10.1161/CIRCOUTCOMES.116.002879.
Results Reference
derived
PubMed Identifier
26922278
Citation
Kostick KM, Minard CG, Wilhelms LA, Delgado E, Abraham M, Bruce CR, Estep JD, Loebe M, Volk RJ, Blumenthal-Barby JS. Development and validation of a patient-centered knowledge scale for left ventricular assist device placement. J Heart Lung Transplant. 2016 Jun;35(6):768-76. doi: 10.1016/j.healun.2016.01.015. Epub 2016 Jan 21.
Results Reference
derived
PubMed Identifier
26483098
Citation
Bruce CR, Blumenthal-Barby JS, Meyers D. Benefits and Challenges of Early Introduction of Left Ventricular Assist Device Placement: A Patient-Centered Perspective. J Am Coll Cardiol. 2015 Oct 20;66(16):1762-1765. doi: 10.1016/j.jacc.2015.08.852. No abstract available.
Results Reference
derived
PubMed Identifier
26087668
Citation
Blumenthal-Barby JS, Kostick KM, Delgado ED, Volk RJ, Kaplan HM, Wilhelms LA, McCurdy SA, Estep JD, Loebe M, Bruce CR. Assessment of patients' and caregivers' informational and decisional needs for left ventricular assist device placement: Implications for informed consent and shared decision-making. J Heart Lung Transplant. 2015 Sep;34(9):1182-9. doi: 10.1016/j.healun.2015.03.026. Epub 2015 Mar 31.
Results Reference
derived
Links:
URL
http://www.lvaddecisionaid.com
Description
Project Website

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Development & Testing of a Decision Aid for LVAD Placement

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