Development and User Testing of a Decision Aid for Left Ventricular Assist Device (LVAD) Placement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 14
- 主要终点
- Left Ventricular Assist Device (LVAD) Knowledge Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •subjects who lack the capacity to give informed consent
研究组 & 干预措施
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.
干预措施: LVAD Decision Aid (Other)
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.
结局指标
主要结局
Left Ventricular Assist Device (LVAD) Knowledge Scale
时间窗: 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.
次要结局
- Decisional Conflict Scale(1 Week Follow-up)
- collaboRATE-Shared Decision Making(1 Month Follow-up)
- Satisfaction With Decision Making Process(1 Month Follow-up)
- Ottawa Decision Regret Scale(1 Month Follow-up)
- Satisfaction With Life Scale(1 Month Follow-up)
- Preparedness for Decision-Making Scale(1 Week Follow-up)
- Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment.(1 Day Follow-up)
- Shared Decision-Making (SDM-9)(1-Month Follow-Up)
- Number and Percentage of Participants Whose Control Preferences for Treatment Decision-Making Match From Baseline to 1-month Follow-up(1-Month Follow-Up)
- Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect(1-Week Follow-Up)
- Number and Percentage of Participants Reporting Ability to Envision Life With an LVAD: Difficult/no Idea What to Expect(1-Month Follow-Up)
- Number & 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(1-Month Follow-Up)
- Participants' Perceived Survival Estimate in Number of Years After LVAD Implant(1-Week Follow-Up)
- Satisfaction With Life(1-Month Follow-Up)
- Quality of Life -- Health Rating(1-Month Follow-Up)
- Preferred Treatment: Number of Patients Predicting They Will Choose LVAD(Baseline)
- Number of Patients Whose Preferred Treatment Was LVAD(1-Month Follow-Up)
- Number and Percentage of Patients Who Filled Out an Advanced Directive(1-Month Follow-Up)
- Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure.(1 Day Follow-up)
- Usability and Acceptability: Learned Something New That I Didn't Know Before.(1 Day Follow-up)
- Usability and Acceptability: Would Recommend to Others.(1 Day Follow-up)
- Usability and Acceptability: Held my Interest.(1 Day Follow-up)
- Usability and Acceptability: Helps Someone Make an Informed Decision.(1 Day Follow-up)
- Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me.(1 Day Follow-up)
- Participants' Control Preferences Over Treatment Decision-Making(1-Month)
研究者
Jennifer Blumenthal-Barby
Assistant Professor of Philosophy/Bioethics
Baylor College of Medicine