N/A
N=98
Development & Testing of a Decision Aid for LVAD Placement
End-Stage Heart Failure · Bridge-to-Transplant LVAD Placement (BTT) · Destination Therapy LVAD Placement (DT) · Refusal of LVAD Placement (Decliners) · LVAD Caregivers
Bottom Line
View on ClinicalTrials.gov: NCT02248974 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Left Ventricular Assist Device (LVAD) Knowledge Scale — 45.6; 43.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LVAD Decision Aid (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Left Ventricular Assist Device (LVAD) Knowledge Scale |
27.9; 22.9 | 0.47 |
| PRIMARY Left Ventricular Assist Device (LVAD) Knowledge Scale |
27.9; 22.9 | 0.47 |
| PRIMARY Left Ventricular Assist Device (LVAD) Knowledge Scale |
27.9; 22.9 | 0.47 |
| SECONDARY Decisional Conflict Scale |
15.7; 17.4 | 0.79 |
| SECONDARY Decisional Conflict Scale |
15.7; 17.4 | 0.79 |
| SECONDARY collaboRATE-Shared Decision Making |
90.4; 89.8 | 0.94 |
| SECONDARY collaboRATE-Shared Decision Making |
90.4; 89.8 | 0.94 |
| SECONDARY Satisfaction With Decision Making Process |
75.6; 76.8 | 1.00 |
| SECONDARY Ottawa Decision Regret Scale |
11.5; 12.9 | 0.95 |
| SECONDARY Satisfaction With Life Scale |
27.9; 22.9 | 0.006 sig |
| SECONDARY Satisfaction With Life Scale |
27.9; 22.9 | 0.006 sig |
| SECONDARY Preparedness for Decision-Making Scale |
86.9; 81.8 | 0.27 |
| SECONDARY Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment. |
21; 0; 12; 0; 2; 0 | — |
| SECONDARY Shared Decision-Making (SDM-9) |
87.5; 85.2 | 0.74 |
| SECONDARY Shared Decision-Making (SDM-9) |
87.5; 85.2 | 0.74 |
| SECONDARY Number and Percentage of Participants Whose Control Preferences for Treatment Decision-Making Match From Baseline to 1-month Follow-up |
14; 13 | — |
| SECONDARY Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect |
25; 25 | — |
| SECONDARY Number and Percentage of Participants Reporting Ability to Envision Life With an LVAD: Difficult/no Idea What to Expect |
15; 9 | — |
| SECONDARY Number & Percentage of Participants Who Perceived a Strong Likelihood of Transplant |
16; 22 | 0.60 |
| SECONDARY Number and Percentage of Participants Who Perceived and Strong Likelihood of Transplant |
17; 15 | 0.27 |
| SECONDARY Participants' Perceived Survival Estimate in Number of Years After LVAD Implant |
10.17; 9.7 | 0.45 |
| SECONDARY Satisfaction With Life |
27.9; 22.9 | 0.006 sig |
| SECONDARY Quality of Life -- Health Rating |
81.0; 69.1 | 0.03 sig |
| SECONDARY Quality of Life -- Health Rating |
81.0; 69.1 | 0.03 sig |
| SECONDARY Preferred Treatment: Number of Patients Predicting They Will Choose LVAD |
28; 31 | — |
| SECONDARY Number of Patients Whose Preferred Treatment Was LVAD |
22; 25 | 0.74 |
| SECONDARY Number of Patients Whose Preferred Treatment Was LVAD |
22; 25 | 0.74 |
| SECONDARY Number and Percentage of Patients Who Filled Out an Advanced Directive |
17; 12 | 0.12 |
| SECONDARY Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure. |
19; 0; 11; 0; 4; 0 | — |
| SECONDARY Usability and Acceptability: Learned Something New That I Didn't Know Before. |
20; 0; 9; 0; 5; 0 | — |
| SECONDARY Usability and Acceptability: Would Recommend to Others. |
34; 0; 3; 0; 0; 0 | — |
| SECONDARY Usability and Acceptability: Held my Interest. |
34; 0; 2; 0; 1; 0 | — |
| SECONDARY Usability and Acceptability: Helps Someone Make an Informed Decision. |
33; 0; 2; 0; 0; 0 | — |
| SECONDARY Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me. |
30; 0; 4; 0; 1; 0 | — |
| SECONDARY Participants' Control Preferences Over Treatment Decision-Making |
3; 1; 10; 18; 10; 8 | 0.20 |
| SECONDARY Participants' Control Preferences Over Treatment Decision-Making |
3; 1; 10; 18; 10; 8 | 0.20 |
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.
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
Data sourced from ClinicalTrials.gov (NCT02248974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.