CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 98 enrolled
Drug / intervention
LVAD Decision Aidother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02248974
NCT02248974N/ACompleted
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Development and User Testing of a Decision Aid for Left Ventricular Assist Device (LVAD) Placement

Baylor College of Medicine·interventional·Posted Sep 25, 2014·Updated May 31, 2019

In Brief

A clinical study evaluating LVAD Decision Aid for End-Stage Heart Failure and 4 related conditions. Completed, enrolled 98 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd-Stage Heart Failure, Bridge-to-Transplant LVAD Placement (BTT), Destination Therapy LVAD Placement (DT), Refusal of LVAD Placement (Decliners), LVAD Caregivers
CountriesUnited States
CollaboratorsThe 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

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 25, 2014
Enrollment StartFeb 1, 2014
Primary CompletionDec 1, 2016
Study CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 11.8 years ago

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).