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Completed

NCT Number: NCT02248974

Development & Testing of a Decision Aid for 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.

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Key information

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ochsner Health System, New Orleans, Louisiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LVAD Decision Aid

Other

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).

Primary outcomes

  1. Left Ventricular Assist Device (LVAD) Knowledge Scale

    Time frame: Baseline

    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.

  2. Left Ventricular Assist Device (LVAD) Knowledge Scale

    Time frame: 1-Week Follow-up

    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.

  3. Left Ventricular Assist Device (LVAD) Knowledge Scale

    Time frame: 1-Month Follow-up

    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.

Secondary outcomes

  1. Decisional Conflict Scale

    Time frame: Baseline

    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.

  2. Decisional Conflict Scale

    Time frame: 1 Week Follow-up

    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.

  3. collaboRATE-Shared Decision Making

    Time frame: 1 Week Follow-up

    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.

  4. collaboRATE-Shared Decision Making

    Time frame: 1 Month Follow-up

    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.

  5. Satisfaction With Decision Making Process

    Time frame: 1 Month Follow-up

    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.

  6. Ottawa Decision Regret Scale

    Time frame: 1 Month Follow-up

    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.

  7. Satisfaction With Life Scale

    Time frame: Baseline

    Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.

  8. Satisfaction With Life Scale

    Time frame: 1 Month Follow-up

    Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.

  9. Preparedness for Decision-Making Scale

    Time frame: 1 Week Follow-up

    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.

  10. Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment.

    Time frame: 1 Day Follow-up

    Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool

  11. Shared Decision-Making (SDM-9)

    Time frame: 1-Week Follow-Up

    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.

  12. Shared Decision-Making (SDM-9)

    Time frame: 1-Month Follow-Up

    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.

  13. Number and Percentage of Participants Whose Control Preferences for Treatment Decision-Making Match From Baseline to 1-month Follow-up

    Time frame: 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.

  14. Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect

    Time frame: 1-Week Follow-Up

    Percentage of patients reporting that their ability to envision life with an LVAD was "Somewhat Easy" or "Easy."

  15. Number and Percentage of Participants Reporting Ability to Envision Life With an LVAD: Difficult/no Idea What to Expect

    Time frame: 1-Month Follow-Up

    Number and percentage of patients reporting that their ability to envision life with an LVAD was "Difficult" or that they had "No idea."

  16. Number & Percentage of Participants Who Perceived a Strong Likelihood of Transplant

    Time frame: 1-Week Follow-Up

    Measures the number and percentage of participants who perceived a strong likelihood of transplant.

  17. Number and Percentage of Participants Who Perceived and Strong Likelihood of Transplant

    Time frame: 1-Month Follow-Up

    Number and Percentage of participants who perceived and strong Likelihood of Transplant after 1-Month follow-up.

  18. Participants' Perceived Survival Estimate in Number of Years After LVAD Implant

    Time frame: 1-Week Follow-Up

    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.

  19. Satisfaction With Life

    Time frame: 1-Month Follow-Up

    Satisfaction with Life Scale, intended to measure respondents' perceived global life satisfaction. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.

  20. Quality of Life -- Health Rating

    Time frame: Baseline

    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?"

  21. Quality of Life -- Health Rating

    Time frame: 1-Month Follow-Up

    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?"

  22. Preferred Treatment: Number of Patients Predicting They Will Choose LVAD

    Time frame: Baseline

    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.

  23. Number of Patients Whose Preferred Treatment Was LVAD

    Time frame: 1-Week Follow-Up

    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.

  24. Number of Patients Whose Preferred Treatment Was LVAD

    Time frame: 1-Month Follow-Up

    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.

  25. Number and Percentage of Patients Who Filled Out an Advanced Directive

    Time frame: 1-Month Follow-Up

    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).

  26. Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure.

    Time frame: 1 Day Follow-up

    Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool

  27. Usability and Acceptability: Learned Something New That I Didn't Know Before.

    Time frame: 1 Day Follow-up

    Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool

  28. Usability and Acceptability: Would Recommend to Others.

    Time frame: 1 Day Follow-up

    Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool

  29. Usability and Acceptability: Held my Interest.

    Time frame: 1 Day Follow-up

    Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool

  30. Usability and Acceptability: Helps Someone Make an Informed Decision.

    Time frame: 1 Day Follow-up

    Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool

  31. Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me.

    Time frame: 1 Day Follow-up

    Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool

  32. Participants' Control Preferences Over Treatment Decision-Making

    Time frame: Baseline

    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.

  33. Participants' Control Preferences Over Treatment Decision-Making

    Time frame: 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 (baseline and 1-month follow-up).

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • INTEGRIS Baptist Medical Center
  • M.D. Anderson Cancer Center
  • Ochsner Health System
  • Patient-Centered Outcomes Research Institute
  • Texas Heart Institute
  • The Cleveland Clinic
  • The Methodist Hospital Research Institute
  • The University of Texas Health Science Center, Houston
  • Wake Forest University Health Sciences

Registry information

Official study title

Development and User Testing of a Decision Aid for Left Ventricular Assist Device (LVAD) Placement

Acronym: VADDA

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Sep 25, 2014
Registry last updated
May 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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