Shared Decision-Making for Families in Critical Dialysis Initiation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-99
SponsorTaipei Medical University WanFang Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age < 20 years.
Trial design
Design model
Parallel
Treatments tested in this trial
The Integrated Shared Decision-making Program
Other interventionThe Integrated Shared Decision-making Program
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
decision conflict
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.
Time frame
Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.Secondary outcomes
1
decision regret
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.
Time frame
Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.2
the quality of doctor-patient communication
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.
Time frame
Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.3
anxiety- depression status
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
Time frame
Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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