Shared Decision-Making for Families in Critical Dialysis Initiation

NCT07150182 | Not Yet Recruiting

• 1 other identifier: TMU-JIRB:N202303124
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Kidney Injury; Decision Making ,Shared; Emotional Dysfunction

Outcome Measures

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.

  Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.

Secondary Outcomes (3)

• decision regret

  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

  Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.

• anxiety- depression status

  Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.

Study Arms (2)

Intervention group

EXPERIMENTAL

received integrated shared decision-making program

Other: The Integrated Shared Decision-making Program

Control group

NO INTERVENTION

Interventions

The Integrated Shared Decision-making Program OTHER

The Integrated Shared Decision-making Program

Intervention group

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Related Publications (15)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Chang PY, Wang HP, Chang TH, Yu JM, Lee SY. Stress, stress-related symptoms and social support among Taiwanese primary family caregivers in intensive care units. Intensive Crit Care Nurs. 2018 Dec;49:37-43. doi: 10.1016/j.iccn.2018.05.002. Epub 2018 Jun 22.

  PMID: 29937076 RESULT

• Collister D, Pannu N, Ye F, James M, Hemmelgarn B, Chui B, Manns B, Klarenbach S; Alberta Kidney Disease Network. Health Care Costs Associated with AKI. Clin J Am Soc Nephrol. 2017 Nov 7;12(11):1733-1743. doi: 10.2215/CJN.00950117. Epub 2017 Oct 19.

  PMID: 29051143 RESULT

• Becerra Perez MM, Menear M, Brehaut JC, Legare F. Extent and Predictors of Decision Regret about Health Care Decisions: A Systematic Review. Med Decis Making. 2016 Aug;36(6):777-90. doi: 10.1177/0272989X16636113. Epub 2016 Mar 14.

  PMID: 26975351 RESULT

• Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.

  PMID: 11832252 RESULT

• Bagshaw SM, Adhikari NKJ, Burns KEA, Friedrich JO, Bouchard J, Lamontagne F, McIntrye LA, Cailhier JF, Dodek P, Stelfox HT, Herridge M, Lapinsky S, Muscedere J, Barton J, Griesdale D, Soth M, Ambosta A, Lebovic G, Wald R; Canadian Critical Care Trials Group. Selection and Receipt of Kidney Replacement in Critically Ill Older Patients with AKI. Clin J Am Soc Nephrol. 2019 Apr 5;14(4):496-505. doi: 10.2215/CJN.05530518. Epub 2019 Mar 21.

  PMID: 30898872 RESULT

• Athavale AM, Fu CY, Bokhari F, Bajani F, Hart P. Incidence of, Risk Factors for, and Mortality Associated With Severe Acute Kidney Injury After Gunshot Wound. JAMA Netw Open. 2019 Dec 2;2(12):e1917254. doi: 10.1001/jamanetworkopen.2019.17254.

  PMID: 31825505 RESULT

• Abebe A, Kumela K, Belay M, Kebede B, Wobie Y. Mortality and predictors of acute kidney injury in adults: a hospital-based prospective observational study. Sci Rep. 2021 Aug 2;11(1):15672. doi: 10.1038/s41598-021-94946-3.

  PMID: 34341369 RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Chung-te Liu

CONTACT

+886970746583; 96320@w.tmu.edu.tw

Hui-Ling Hsieh

CONTACT

+886988585142; huilinghsieh@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 2, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share