Shared Decision-Making for Families in Critical Dialysis Initiation

Taipei Medical University

Status

Not yet enrolling

Conditions

Emotional Dysfunction

Acute Kidney Injury

Decision Making ,Shared

Treatments

Other: The Integrated Shared Decision-making Program

Study type

Interventional

Funder types

Other

Identifiers

NCT07150182

TMU-JIRB:N202303124

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

20 to 99 years old

Volunteers

No Healthy Volunteers

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:

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.

Exclusion criteria

(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.