Shared Decision-Making for Families in Critical Dialysis Initiation

Official title

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

Overview

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.

Interventions

• Other The Integrated Shared Decision-making Program
  The Integrated Shared Decision-making Program

Primary outcome measures

• decision conflict [Time frame: Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.]

Secondary outcome measures (3)

• decision regret [Time frame: 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 [Time frame: Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.]
• 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Wong SPY, McFarland LV, Liu CF, Laundry RJ, Hebert PL, O'Hare AM. Care Practices for Patients With Advanced Kidney Disease Who Forgo Maintenance Dialysis. JAMA Intern Med. 2019 Mar 1;179(3):305-313. doi: 10.1001/jamainternmed.2018.6197. PMID 30667475
• Palevsky PM, Liu KD, Brophy PD, Chawla LS, Parikh CR, Thakar CV, Tolwani AJ, Waikar SS, Weisbord SD. KDOQI US commentary on the 2012 KDIGO clinical practice guideline for acute kidney injury. Am J Kidney Dis. 2013 May;61(5):649-72. doi: 10.1053/j.ajkd.2013.02.349. Epub 2013 Mar 15. PMID 23499048
• Oprea AD, Del Rio JM, Cooter M, Green CL, Karhausen JA, Nailer P, Guinn NR, Podgoreanu MV, Stafford-Smith M, Schroder JN, Fontes ML, Kertai MD. Pre- and postoperative anemia, acute kidney injury, and mortality after coronary artery bypass grafting surgery: a retrospective observational study. Can J Anaesth. 2018 Jan;65(1):46-59. doi: 10.1007/s12630-017-0991-0. Epub 2017 Nov 2. PMID 29098634
• Kerr M, Bedford M, Matthews B, O'Donoghue D. The economic impact of acute kidney injury in England. Nephrol Dial Transplant. 2014 Jul;29(7):1362-8. doi: 10.1093/ndt/gfu016. Epub 2014 Apr 21. PMID 24753459
• Hsieh YC, Lee KC, Chen PH, Su CW, Hou MC, Lin HC. Acute kidney injury predicts mortality in cirrhotic patients with gastric variceal bleeding. J Gastroenterol Hepatol. 2017 Nov;32(11):1859-1866. doi: 10.1111/jgh.13777. PMID 28271564
• Hemmat V, Corbett C. Palliative Care for Nephrology Patients in the Intensive Care Unit. Crit Care Nurs Clin North Am. 2022 Dec;34(4):467-479. doi: 10.1016/j.cnc.2022.07.003. Epub 2022 Oct 12. PMID 36336436
• Groenwold RH. Falsification end points for observational studies. JAMA. 2013 May 1;309(17):1769-70. doi: 10.1001/jama.2013.3089. No abstract available. PMID 23632712
• Fang T, Du P, Wang Y, Chen D, Lu H, Cheng H, Hu W, Jiang D. Role Mismatch in Medical Decision-Making Participation Is Associated with Anxiety and Depression in Family Members of Patients in the Intensive Care Unit. J Trop Med. 2022 Apr 16;2022:8027422. doi: 10.1155/2022/8027422. eCollection 2022. PMID 35469334

Identifiers

NCT: NCT07150182 · TMU-JIRB:N202303124

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗