The Integrated Shared Decision-making Program of Critical Hemodialysis Initiation - the Effects on Decision Conflict, Decision Regret, Anxiety and Depression Among Family Members
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- decision conflict
研究概览
简要总结
Background:Acute kidney injury (AKI) is a frequent and serious complication in critically ill patients, often necessitating difficult decisions about starting hemodialysis. While shared decision-making (SDM) is known to improve communication, the effectiveness of structured SDM programs specifically designed for family members in this critical context is not well-established.
Aims: The primary purpose of this study is to evaluate the effectiveness of a structured shared decision-making (SDM) program for family members of patients requiring critical hemodialysis initiation. We will assess the program's impact on the quality of the decision-making process (e.g., decision conflict, regret) and the psychological well-being (e.g., anxiety, depression) of the family members.
Methods: This study is a parallel-group, randomized controlled trial. Eligible participants (family members of patients with AKI initiating hemodialysis) will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured SDM support program, while the control group will receive standard care. Primary outcomes, including decision conflict, decision regret, anxiety, and depression, will be measured at baseline and follow-up. Data will be analyzed using the generalized estimating equation (GEE) model to compare the effectiveness between the two groups.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(A)Patients: (1)Age ≥ 20 years. (2)Admitted to the ICU. (3)Diagnosed with acute kidney injury (AKI) requiring urgent hemodialysis. (4)No medical disputes occurred during the current hospitalization. (B) Family members:
- •Age ≥ 20 years.
- •Mentally alert and able to communicate in Mandarin or Taiwanese.
- •Key person for the patient's admission (primary contact between patient, family, and medical team).
- •Willing to participate in the clinical trial.
排除标准
- •(A) Patients:
- •Age < 20 years.
- •End-stage kidney disease already receiving renal replacement therapy (including hemodialysis, peritoneal dialysis, or kidney transplantation). (B) Family members:
- •(1)Unable to comply with study procedures. (2)Rarely visiting the patient (less than once every three days). (3)History of alcohol or substance abuse, mental disorders, or cognitive impairment affecting participation.
结局指标
主要结局
decision conflict
时间窗: Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.
This scale is used to assess family members' decisional conflict and satisfaction when facing high-risk choices. The scale consists of 16 items, with higher scores indicating greater regret regarding the decision outcome.
decision conflict
时间窗: Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.
This scale is used to assess family members' decisional conflict and satisfaction when facing high-risk choices. The scale consists of 16 items, with higher scores indicating greater regret regarding the decision outcome.
次要结局
- decision regret(Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.)
- the quality of doctor-patient communication(Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.)
- anxiety- depression status(Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.)
- decision regret(Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.)
- the quality of doctor-patient communication(Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.)
- anxiety- depression status(Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.)