Development & Testing of a Decision Aid for LVAD Placement (VADDA)

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.

Study Overview

• Status: Completed
• Conditions: End-Stage Heart Failure; Bridge-to-Transplant LVAD Placement (BTT); Destination Therapy LVAD Placement (DT); Refusal of LVAD Placement (Decliners); LVAD Caregivers
• Intervention / Treatment: Other: LVAD Decision Aid

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Ochsner Health System
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Baptist Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77054
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • CHI ST. Luke's - Baylor St. Lukes Medical Center / Texas Heart Institute
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53204
      • Aurora Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LVAD Decision Aid; 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; 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).
No Intervention: No LVAD Decision Aid; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	Baseline
Satisfaction With Life Scale	Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.	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.	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	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.	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.	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.	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."	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."	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.	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.	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.	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.	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?"	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?"	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.	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.	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.	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).	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	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	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	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	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	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	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.	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).	1-Month

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Patient-Centered Outcomes Research Institute; M.D. Anderson Cancer Center; The University of Texas Health Science Center, Houston; The Cleveland Clinic; Aurora Health Care; The Methodist Hospital Research Institute; Texas Heart Institute; Ochsner Health System; INTEGRIS Baptist Medical Center
• Investigators: Principal Investigator: Jennifer Blumenthal-Barby, PhD, Baylor College of Medicine; Study Director: Kristin M Kostick, PhD, Baylor College of Medicine

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Project Website

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: September 17, 2014
• First Submitted That Met QC Criteria: September 23, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): May 31, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Decision Aid; Left Ventricular Assist Device; End-Stage Heart Failure; Medical Decision-Making
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: H-34286; CDR-1306-01769 (Other Grant/Funding Number: PCORI)