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NCT Number: NCT07150182

Shared Decision-Making for Families in Critical Dialysis Initiation

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.

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Key information

Conditions

Acute Kidney Injury Decision Making ,Shared Emotional Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Integrated Shared Decision-making Program

Other

The Integrated Shared Decision-making Program

Primary outcomes

  1. decision conflict

    Time frame: 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 outcomes

  1. decision regret

    Time frame: 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.

  2. the quality of doctor-patient communication

    Time frame: 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.

  3. anxiety- depression status

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chung-te Liu

CONTACT

[email protected]

+886970746583

Hui-Ling Hsieh

CONTACT

[email protected]

+886988585142

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Official study title

The Integrated Shared Decision-making Program of Critical Hemodialysis Initiation - the Effects on Decision Conflict, Decision Regret, Anxiety and Depression Among Family Members

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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