End-Stage Heart FailureVADDANCT02248974
Development & Testing of a Decision Aid for LVAD Placement
A study testing LVAD Decision Aid in people with End-Stage Heart Failure and Bridge-to-Transplant LVAD Placement (BTT), run by Baylor College of Medicine at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- End-Stage Heart Failure, Bridge-to-Transplant LVAD Placement (BTT), Destination Therapy LVAD Placement (DT)
- What is being tested?
- LVAD Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- subjects who lack the capacity to give informed consent
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cleveland Clinic
Cleveland, Ohio, 44195
CHI ST. Luke's - Baylor St. Lukes Medical Center / Texas Heart Institute
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
Baylor College of Medicine
Houston, Texas, 77054
Aurora Health Care
Milwaukee, Wisconsin, 53204
Ochsner Health System
New Orleans, Louisiana, 70115
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
About this study
Official title: Development and User Testing of a Decision Aid for Left Ventricular Assist Device (LVAD) Placement
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.
- Conditions
- End-Stage Heart Failure, Bridge-to-Transplant LVAD Placement (BTT), Destination Therapy LVAD Placement (DT), Refusal of LVAD Placement (Decliners), LVAD Caregivers
- Being tested
- LVAD Decision Aid
- Keywords
- End-Stage Heart Failure, Left Ventricular Assist Device, Decision Aid, Medical Decision-Making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVAD Decision AidOther
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).
| Study group | Role | What they receive |
|---|---|---|
| LVAD Decision Aid | Active comparator | 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. Receives: Other: LVAD Decision Aid |
| No LVAD Decision Aid | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1-Month Follow-up
Secondary outcomes (33)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Satisfaction With Life Scale
Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?"
Measured: 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?"
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 1-Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for End-Stage Heart FailureStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- 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, Wake Forest University Health Sciences, The Cleveland Clinic, Patient-Centered Outcomes Research Institute, Ochsner Health System
- Responsible party
- Principal investigator, Jennifer Blumenthal-Barby, Baylor College of Medicine
- Investigators
- Jennifer Blumenthal-Barby, PhD, Principal investigator, Baylor College of MedicineKristin M Kostick, PhD, Study director, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248974
- Sponsor's protocol ID
- H-34286
- Other IDs
- CDR-1306-01769
- Acronym
- VADDA
- Status last verified
- Feb 2019
- First submitted
- 17 Sep 2014
- Last updated
- 31 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25239054Blumenthal-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.
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.
PubMed 30195826Bruce 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.
PubMed 28073849Kostick 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.
PubMed 26922278Bruce 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.
PubMed 26483098Blumenthal-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.
PubMed 26087668
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and User Testing of a Decision Aid for Left Ventricular Assist Device (LVAD) Placement
- ClinicalTrials.gov ID
- NCT02248974
- Acronym / sponsor ID
- VADDA / H-34286
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- 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, Wake Forest University Health Sciences, The Cleveland Clinic, Patient-Centered Outcomes Research Institute, Ochsner Health System
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Posted 31 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LVAD Decision Aid | Active comparator | Other: LVAD Decision AidDecision 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. |
| No LVAD Decision Aid | No intervention | –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. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- subjects who lack the capacity to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LVAD Decision AidDecision 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). | Other | LVAD Decision Aid |
Primary outcome
Left Ventricular Assist Device (LVAD) Knowledge Scale
Time frame: 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.
Left Ventricular Assist Device (LVAD) Knowledge Scale
Time frame: 1-Week Follow-up
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
Time frame: 1-Month Follow-up
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.
33 secondary outcomes
Decisional Conflict Scale
Time frame: Baseline
Decisional Conflict Scale
Time frame: 1 Week Follow-up
collaboRATE-Shared Decision Making
Time frame: 1 Week Follow-up
collaboRATE-Shared Decision Making
Time frame: 1 Month Follow-up
Satisfaction With Decision Making Process
Time frame: 1 Month Follow-up
Ottawa Decision Regret Scale
Time frame: 1 Month Follow-up
Satisfaction With Life Scale
Time frame: Baseline
Satisfaction With Life Scale
Time frame: 1 Month Follow-up
Preparedness for Decision-Making Scale
Time frame: 1 Week Follow-up
Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment.
Time frame: 1 Day Follow-up
Shared Decision-Making (SDM-9)
Time frame: 1-Week Follow-Up
Shared Decision-Making (SDM-9)
Time frame: 1-Month Follow-Up
Number and Percentage of Participants Whose Control Preferences for Treatment Decision-Making Match From Baseline to 1-month Follow-up
Time frame: 1-Month Follow-Up
Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect
Time frame: 1-Week Follow-Up
Number and Percentage of Participants Reporting Ability to Envision Life With an LVAD: Difficult/no Idea What to Expect
Time frame: 1-Month Follow-Up
Number & Percentage of Participants Who Perceived a Strong Likelihood of Transplant
Time frame: 1-Week Follow-Up
Number and Percentage of Participants Who Perceived and Strong Likelihood of Transplant
Time frame: 1-Month Follow-Up
Participants' Perceived Survival Estimate in Number of Years After LVAD Implant
Time frame: 1-Week Follow-Up
Satisfaction With Life
Time frame: 1-Month Follow-Up
Quality of Life -- Health Rating
Time frame: Baseline
Quality of Life -- Health Rating
Time frame: 1-Month Follow-Up
Preferred Treatment: Number of Patients Predicting They Will Choose LVAD
Time frame: Baseline
Number of Patients Whose Preferred Treatment Was LVAD
Time frame: 1-Week Follow-Up
Number of Patients Whose Preferred Treatment Was LVAD
Time frame: 1-Month Follow-Up
Number and Percentage of Patients Who Filled Out an Advanced Directive
Time frame: 1-Month Follow-Up
Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure.
Time frame: 1 Day Follow-up
Usability and Acceptability: Learned Something New That I Didn't Know Before.
Time frame: 1 Day Follow-up
Usability and Acceptability: Would Recommend to Others.
Time frame: 1 Day Follow-up
Usability and Acceptability: Held my Interest.
Time frame: 1 Day Follow-up
Usability and Acceptability: Helps Someone Make an Informed Decision.
Time frame: 1 Day Follow-up
Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me.
Time frame: 1 Day Follow-up
Participants' Control Preferences Over Treatment Decision-Making
Time frame: Baseline
Participants' Control Preferences Over Treatment Decision-Making
Time frame: 1-Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25239054Bruce 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.
- BackgroundBlumenthal-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.
- Derived from this study: PubMed 30195826Kostick 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.
- Derived from this study: PubMed 28073849Bruce 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.
- Derived from this study: PubMed 26922278Kostick 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.
- Derived from this study: PubMed 26483098Bruce 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.
- Derived from this study: PubMed 26087668Blumenthal-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.
- Project WebsiteLink provided by the sponsor.
Related trials for End-Stage Heart Failure
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Active, not recruitingPhase 3
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD)
RecruitingPhase 2/3
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
End Stage Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Blumenthal-Barby, PhD principal investigator
Baylor College of Medicine
Kristin M Kostick, PhD study director
Baylor College of Medicine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LVAD Decision Aid in people with End-Stage Heart Failure and Bridge-to-Transplant LVAD Placement (BTT), run by Baylor College of Medicine at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Assist Device (LVAD) Knowledge Scale (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02248974, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.