Acute Kidney InjuryNCT07150182
Shared Decision-Making for Families in Critical Dialysis Initiation
A study testing The Integrated Shared Decision-making Program in people with Acute Kidney Injury and Decision Making ,Shared, run by Taipei Medical University WanFang Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Acute Kidney Injury, Decision Making ,Shared, Emotional Dysfunction
- What is being tested?
- The Integrated Shared Decision-making Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- The Integrated Shared Decision-making Program
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Integrated Shared Decision-making ProgramOther
The Integrated Shared Decision-making Program
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | received integrated shared decision-making program Receives: Other: The Integrated Shared Decision-making Program |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.
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
Measured: Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150182
- Sponsor's protocol ID
- TMU-JIRB:N202303124
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study has not been completed.
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.
PubMed 30667475Palevsky 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.
PubMed 23499048Oprea 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.
PubMed 29098634Kerr 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.
PubMed 24753459Hsieh 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.
PubMed 28271564Hemmat 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.
PubMed 36336436Groenwold RH. Falsification end points for observational studies. JAMA. 2013 May 1;309(17):1769-70. doi: 10.1001/jama.2013.3089. No abstract available.
PubMed 23632712Fang 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.
PubMed 35469334Chang 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.
PubMed 29937076Collister 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.
PubMed 29051143Becerra 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.
PubMed 26975351Bjelland 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.
PubMed 11832252Bagshaw 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.
PubMed 30898872Athavale 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.
PubMed 31825505Abebe 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.
PubMed 34341369
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07150182
- Acronym / sponsor ID
- TMU-JIRB:N202303124
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: The Integrated Shared Decision-making Programreceived integrated shared decision-making program |
| Control group | No intervention | – |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Integrated Shared Decision-making ProgramThe Integrated Shared Decision-making Program | Other | Intervention group |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Results publication: PubMed 30667475Wong 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.
- Results publication: PubMed 23499048Palevsky 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.
- Results publication: PubMed 29098634Oprea 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.
- Results publication: PubMed 24753459Kerr 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.
- Results publication: PubMed 28271564Hsieh 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.
- Results publication: PubMed 36336436Hemmat 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.
- Results publication: PubMed 23632712Groenwold RH. Falsification end points for observational studies. JAMA. 2013 May 1;309(17):1769-70. doi: 10.1001/jama.2013.3089. No abstract available.
- Results publication: PubMed 35469334Fang 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.
- Results publication: PubMed 29937076Chang 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.
- Results publication: PubMed 29051143Collister 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.
- Results publication: PubMed 26975351Becerra 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.
- Results publication: PubMed 11832252Bjelland 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.
- Individual participant dataSharing planned: No. This study has not been completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing The Integrated Shared Decision-making Program in people with Acute Kidney Injury and Decision Making ,Shared, run by Taipei Medical University WanFang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chung-te Liu (+886970746583, 96320@w.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decision conflict (time frame: Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07150182, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.