Clinical trial NCT02248974: Development & Testing of a Decision Aid for LVAD Placement
Official title: Development and User Testing of a Decision Aid for Left Ventricular Assist Device (LVAD) Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: The Methodist Hospital Research Institute
name: The University of Texas Health Science Center, Houston
name: M.D. Anderson Cancer Center
name: INTEGRIS Baptist Medical Center
name: Texas Heart Institute
name: Wake Forest University Health Sciences
name: The Cleveland Clinic
name: Patient-Centered Outcomes Research Institute
name: Ochsner Health System
First posted: 2014-09-25
Enrollment: 98
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Left Ventricular Assist Device (LVAD) Knowledge Scale
timeFrame: Baseline
measure: Left Ventricular Assist Device (LVAD) Knowledge Scale
timeFrame: 1-Week Follow-up
measure: Left Ventricular Assist Device (LVAD) Knowledge Scale
timeFrame: 1-Month Follow-up
Secondary outcomes:
measure: Decisional Conflict Scale
timeFrame: Baseline
measure: Decisional Conflict Scale
timeFrame: 1 Week Follow-up
measure: collaboRATE-Shared Decision Making
timeFrame: 1 Week Follow-up
measure: collaboRATE-Shared Decision Making
timeFrame: 1 Month Follow-up
measure: Satisfaction With Decision Making Process
timeFrame: 1 Month Follow-up
measure: Ottawa Decision Regret Scale
timeFrame: 1 Month Follow-up
measure: Satisfaction With Life Scale
timeFrame: Baseline
measure: Satisfaction With Life Scale
timeFrame: 1 Month Follow-up
measure: Preparedness for Decision-Making Scale
timeFrame: 1 Week Follow-up
measure: Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment.
timeFrame: 1 Day Follow-up
measure: Shared Decision-Making (SDM-9)
timeFrame: 1-Week Follow-Up
measure: Shared Decision-Making (SDM-9)
timeFrame: 1-Month Follow-Up
measure: Number and Percentage of Participants Whose Control Preferences for Treatment Decision-Making Match From Baseline to 1-month Follow-up
timeFrame: 1-Month Follow-Up
measure: Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect
timeFrame: 1-Week Follow-Up
measure: Number and Percentage of Participants Reporting Ability to Envision Life With an LVAD: Difficult/no Idea What to Expect
timeFrame: 1-Month Follow-Up
measure: Number & Percentage of Participants Who Perceived a Strong Likelihood of Transplant
timeFrame: 1-Week Follow-Up
measure: Number and Percentage of Participants Who Perceived and Strong Likelihood of Transplant
timeFrame: 1-Month Follow-Up
measure: Participants' Perceived Survival Estimate in Number of Years After LVAD Implant
timeFrame: 1-Week Follow-Up
measure: Satisfaction With Life
timeFrame: 1-Month Follow-Up
measure: Quality of Life -- Health Rating
timeFrame: Baseline
measure: Quality of Life -- Health Rating
timeFrame: 1-Month Follow-Up
measure: Preferred Treatment: Number of Patients Predicting They Will Choose LVAD
timeFrame: Baseline
measure: Number of Patients Whose Preferred Treatment Was LVAD
timeFrame: 1-Week Follow-Up
measure: Number of Patients Whose Preferred Treatment Was LVAD
timeFrame: 1-Month Follow-Up
measure: Number and Percentage of Patients Who Filled Out an Advanced Directive
timeFrame: 1-Month Follow-Up
measure: Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure.
timeFrame: 1 Day Follow-up
measure: Usability and Acceptability: Learned Something New That I Didn't Know Before.
timeFrame: 1 Day Follow-up
measure: Usability and Acceptability: Would Recommend to Others.
timeFrame: 1 Day Follow-up
measure: Usability and Acceptability: Held my Interest.
timeFrame: 1 Day Follow-up
measure: Usability and Acceptability: Helps Someone Make an Informed Decision.
timeFrame: 1 Day Follow-up
measure: Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me.
timeFrame: 1 Day Follow-up
measure: Participants' Control Preferences Over Treatment Decision-Making
timeFrame: Baseline
measure: Participants' Control Preferences Over Treatment Decision-Making
timeFrame: 1-Month
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: INTEGRIS Baptist Medical Center
state: Oklahoma
city: Houston
country: United States
facility: CHI ST. Luke's - Baylor St. Lukes Medical Center / Texas Heart Institute
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Milwaukee
country: United States
facility: Aurora Health Care
state: Wisconsin
Study officials:
affiliation: Baylor College of Medicine
name: Jennifer Blumenthal-Barby, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Kristin M Kostick, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.