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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
98
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).
Ochsner Health System
New Orleans, Louisiana, United States
Cleveland Clinic
Cleveland, Ohio, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States
CHI ST. Luke's - Baylor St. Lukes Medical Center / Texas Heart Institute
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Aurora Health Care
Milwaukee, Wisconsin, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 1-Month Follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Satisfaction With Life Scale
Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: 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."
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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?"
Time frame: 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?"
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 1-Month
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