NCT02248974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

May 31, 2019

Completed
Last Updated

May 31, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

September 17, 2014

Results QC Date

April 3, 2017

Last Update Submit

February 14, 2019

Conditions

End-Stage Heart FailureBridge-to-Transplant LVAD Placement (BTT)Destination Therapy LVAD Placement (DT)Refusal of LVAD Placement (Decliners)LVAD Caregivers

Keywords

End-Stage Heart FailureLeft Ventricular Assist DeviceDecision AidMedical Decision-Making

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (33)

  • Decisional Conflict Scale

    Baseline

  • Decisional Conflict Scale

    1 Week Follow-up

  • collaboRATE-Shared Decision Making

    1 Week Follow-up

  • collaboRATE-Shared Decision Making

    1 Month Follow-up

  • Satisfaction With Decision Making Process

    1 Month Follow-up

  • +28 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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).

LVAD Decision Aid

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • subjects who lack the capacity to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Ochsner Health System

New Orleans, Louisiana, 70115, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

CHI ST. Luke's - Baylor St. Lukes Medical Center / Texas Heart Institute

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Baylor College of Medicine

Houston, Texas, 77054, United States

Location

Aurora Health Care

Milwaukee, Wisconsin, 53204, United States

Location

Related Publications (7)

  • 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.

    PMID: 25239054BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 30195826DERIVED

  • 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.

    PMID: 28073849DERIVED

  • 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.

    PMID: 26922278DERIVED

  • 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.

    PMID: 26483098DERIVED

  • 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.

    PMID: 26087668DERIVED

Related Links

Limitations and Caveats

No significant limitations to report. One consideration is that because we tested for efficacy at sites with established LVAD programs, results may not be generalizable to other less well-run programs, where effect sizes may be even greater.

Results Point of Contact

Title
Dr. Jennifer Blumenthal-Barby
Organization
Baylor College of Medicine
jennifer.blumenthal-barby@bcm.edu
(713) 798-3785

Study Officials

  • Jennifer Blumenthal-Barby, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

  • Kristin M Kostick, PhD

    Baylor College of Medicine

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Philosophy/Bioethics

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 25, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

May 31, 2019

Results First Posted

May 31, 2019

Record last verified: 2019-02

Locations

US(7)