Shared Decision-Making for Families in Critical Dialysis Initiation

Not Applicable

Not yet recruiting

• Conditions: Acute Kidney Injury; Decision Making ,Shared; Emotional Dysfunction

• Registration Number: NCT07150182
• Lead Sponsor: Taipei Medical University WanFang Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-24
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study First Posted: 2025-09-02
• Last Update Posted: 2025-09-02
• Study Start: 2025-10-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

(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:

1. Age ≥ 20 years.
2. Mentally alert and able to communicate in Mandarin or Taiwanese.
3. Key person for the patient's admission (primary contact between patient, family, and medical team).
4. Willing to participate in the clinical trial.

Exclusion Criteria

(A) Patients:

1. Age < 20 years.
2. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
decision conflict	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.

Secondary Outcome Measures

Name	Time	Method
decision regret	Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.	This scale consists of 5 items, with higher scores indicating greater regret regarding the decision outcome. this Cronbach's α was 0.84-0.86.
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.	This scale is used to assess the quality of communication between family members (the patient's designated healthcare proxy for the current hospitalization) and medical staff regarding the patient's condition. The scale consists of 9 items, with higher scores indicating better communication between the family and healthcare providers.
anxiety- depression status	Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.	This scale consists of 14 items, including 7 items measuring anxiety and 7 items measuring depression. Higher scores indicate greater levels of anxiety or depression