Development & Testing of a Decision Aid for LVAD Placement

End-Stage Heart Failure Clinical Trial

— VADDA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248974
• Other study ID #: H-34286
• Secondary ID: CDR-1306-01769
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: January 2017

Study information

• Verified date: February 2019
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	Baylor College of Medicine	Houston	Texas
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	Aurora Health Care	Milwaukee	Wisconsin
United States	Ochsner Health System	New Orleans	Louisiana
United States	INTEGRIS Baptist Medical Center	Oklahoma City	Oklahoma

Sponsors (10)

Lead Sponsor	Collaborator
Baylor College of Medicine	Aurora Health Care, 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 System, The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Satisfaction With Life Scale	Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Project Website