Shared Decision-Making for Families in Critical Dialysis Initiation
NCT ID: NCT07150182
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-10-01
2026-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Intervention group
received integrated shared decision-making program
The Integrated Shared Decision-making Program
The Integrated Shared Decision-making Program
Control group
No interventions assigned to this group
Interventions
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The Integrated Shared Decision-making Program
The Integrated Shared Decision-making Program
Eligibility Criteria
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Inclusion Criteria
1. Age ≥ 20 years.
2. Mentally alert and able to communicate in Mandarin or Taiwanese.
3. Key person for the patient's admission (primary contact between patient, family, and medical team).
4. Willing to participate in the clinical trial.
Exclusion Criteria
1. Age \< 20 years.
2. 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.
20 Years
99 Years
ALL
No
Sponsors
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Taipei Medical University WanFang Hospital
OTHER
Responsible Party
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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TMU-JIRB:N202303124
Identifier Type: -
Identifier Source: org_study_id
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