Decision-Aid for Renal Therapy Pilot Trial (DART Pilot Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Completion of advance directives at 3 months.
研究概览
简要总结
Successful communication between patients, caregivers, and physicians can improve how patients feel about their treatment. Our recent studies of older dialysis patients find, however, that many patients do not engage in this type of communication about treatment options. This study aims to determine whether the Decision-Aid for Renal Therapy (DART), a web-based program, can improve shared decision-making (decisions where patients are actively engaged) among patients, caregivers, and physicians, and improve certainty and satisfaction in treatment decisions.
详细描述
Successful end-of-life communication between patients, caregivers, and physicians is associated with superior psychosocial outcomes, less intensive treatment, greater satisfaction, and higher likelihood of death at home. The Decision-Aid for Renal Therapy (DART) is an interactive web-based decision-aid that can empower patients and caregivers to select the treatment choice for chronic kidney disease that best suits them. DART was developed using a rigorous, validated, patient-engaged process and helps clarify decision-points and tradeoffs by providing individualized information about outcomes that matter most to patients. DART is designed to promote shared decision-making between patients, caregivers, and physicians and align preferences with treatment received.
Although proven effective and in current use in the general population, DART's effectiveness in an older population is unclear. The purpose of this project is to conduct a pilot study of DART's feasibility and effectiveness to improve end-of-life planning and shared decision-making among older end-stage renal disease patients.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic kidney disease stages 4 or 5, not currently on dialysis
- •Age >=70
- •English-speaking
- •Willingness to be randomized to DART
- •Able to sign informed consent
- •5-year kidney failure risk probability > 15% using [www.kidneyfailurerisk.com]
- •Glomerular filtration rate (GFR) < 30
排除标准
- •Non-English speaking
研究组 & 干预措施
Usual care
Participants receive an educational pamphlet from the National Kidney Foundation, "Choosing a Treatment for Kidney Failure."
干预措施: Choosing a Treatment for Kidney Failure (Behavioral)
DART
Participants receive an educational pamphlet from the National Kidney Foundation, "Choosing a Treatment for Kidney Failure." They also receive a link to access the web-based decision-aid program, Decision-Aid for Renal Therapy (DART). Participants may access this program using a computer at home throughout the duration of the trial. Those who do not have a computer with web access at home are assisted in watching the program in the clinic.
干预措施: DART (Behavioral)
DART
Participants receive an educational pamphlet from the National Kidney Foundation, "Choosing a Treatment for Kidney Failure." They also receive a link to access the web-based decision-aid program, Decision-Aid for Renal Therapy (DART). Participants may access this program using a computer at home throughout the duration of the trial. Those who do not have a computer with web access at home are assisted in watching the program in the clinic.
干预措施: Choosing a Treatment for Kidney Failure (Behavioral)
结局指标
主要结局
Completion of advance directives at 3 months.
时间窗: Assessed at 3 months
Participants will be asked if they have completed an advance directive.
Change in baseline Decisional Conflict Scale score at 3 months.
时间窗: Assessed in patients at 3 months.
Measures personal perceptions of: a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
次要结局
- Congruence in patient-caregiver goals of care(Assessed in patients and caregivers at 6 months.)
- Change in baseline overall patient satisfaction score from the Canadian Health Care Evaluation Project (CANHELP) questionnaire at 3 months.(Assessed in patients at 3 months.)
- Change in baseline overall caregiver satisfaction score from the Canadian Health Care Evaluation Project (CANHELP) questionnaire at 3 months.(Assessed in caregivers at 3 months.)
研究者
Keren Ladin
Assistant Professor
Tufts University