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Chronic Kidney Disease Stage 4NCT06799936

A Communication-Priming Intervention to Improve Shared Decision-Making Between Older Adults With Advanced CKD and Clinicians

A study testing "CKD Jumpstart- Tips" priming intervention in people with Chronic Kidney Disease Stage 4 and Chronic Kidney Disease Stage 5, run by The University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To achieve the goal of reaching consensus about the preferred treatment option that best aligns with the goals and values of patients, the investigators developed a 'CKD Jumpstart- Tips" priming tool tailored for older adults with advanced CKD that is based on communication principles from VitalTalk and Elwyn's… Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
"CKD Jumpstart- Tips" priming intervention
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteHong Kong
Study dates
4 Feb 2025to 30 Sep 2027
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

None listed.

Who cannot join

  • Patients will be excluded if they
  • have a confirmed advanced CKD treatment decision for dialysis, palliative care, or renal transplant documented in clinical notes
  • have initiated any of these treatments
  • lack decision-making capacity

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jacqueline KY Yuen, Dr contact

(852) 2255-4608

jkyuen@hku.hk

Hong Kong1 site, 1 recruiting

  • Queen Mary Hospital

    Hong Kong

    Jacqueline KY Yuen, (852) 2255 4608, jkyuen@hku.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: A Communication-Priming Intervention to Improve Shared Decision-Making Between Older Adults With Advanced Chronic Kidney Disease and Clinicians: A Cluster-Randomized Controlled Trial

To achieve the goal of reaching consensus about the preferred treatment option that best aligns with the goals and values of patients, the investigators developed a 'CKD Jumpstart- Tips" priming tool tailored for older adults with advanced CKD that is based on communication principles from VitalTalk and Elwyn's goal-based SDM model.

The investigators hypothesize that compared with patients in the usual care group, patients in the 'CKD Jumpstart- Tips' intervention group will have:

  1. increased level of shared decision-making (observer-based and patient-reported),
  2. improved quality of communication,
  3. increased patient involvement in decision-making,
  4. lower decisional conflict,
  5. lower decision regret,
  6. decreased time to decision,
  7. improved adherence to treatment choice, and
  8. improved health-related quality-of-life.
Read the detailed description

To enhance the communication on shared decision-making between older adults with advanced kidney disease and clinicians, the investigator's research team developed the "CKD Jumpstart- Tips" communication-priming intervention.

This study aims to conduct a cluster-randomized controlled trial to assess the effects of the 'CKD Jumpstart- Tips' communication-priming intervention on shared decision-making between older adults with advanced kidney disease and their clinicians.

The primary objective of the study is to evaluate the effects of the intervention on observer-based shared decision-making in the target consultation.

The secondary objective is to evaluate the effects of intervention on patient-reported shared decision-making, quality of communication, patient involvement in decision-making, decisional conflict, decision regret, timing of and adherence to treatment choice, and health-related quality of life. Consultation length will also be captured as a process measure.

Being tested
"CKD Jumpstart- Tips" priming intervention
Keywords
Communication, Priming, Decision-making, Older adults, Chronic kidney disease, CKD-Priming Jumpstart
Medical subject headings
Renal Insufficiency, Chronic, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "CKD Jumpstart- Tips" priming interventionOther

    The intervention includes 2 components:

    1. Patient Priming: Patients will receive the "Jumpstart CKD- Tips" communication priming tool within 1 week before and on the day of a target clinic visit, which includes surveys on (i) Understanding of illness and possible treatment options, (ii) Readiness for treatment discussion and information preferences, (iii) Health priorities, goals, and preferences (iv) Preferred roles in decision-making. The "Jumpstart CKD- Tips" patient priming sheet includes (a) A summary of their survey responses that can be shared with their healthcare team, and (b) Tips on communication with clinician during upcoming visit.
    2. Clinician Priming: Within 1 week before and on the day of the target clinic visit, clinicians will receive a "Jumpstart CKD- Tips" clinician priming sheet which contains (a) An abstracted version of the patients' survey responses and (b) Communication tips tailored to the patient's responses based on Vitaltalk curricula materials.
Study groups in NCT06799936
Study groupRoleWhat they receive
Priming Intervention armExperimentalPatients in the priming intervention arm will be provided and are expected to complete the "CKD Jumpstart- Tips" communication priming tool prior to a target clinic visit. Within one week prior to and on the day of the target clinic visit, patients will receive a "CKD Jumpstart- Tips" patient summary sheet which includes a summary of survey responses that can be shared with their healthcare team and tips on communication with clinician during upcoming visit. Clinicians in the priming intervention arm will receive a "CKD Jumpstart- Tips" clinician priming sheet in the patient's medical chart within one week prior to and on the day of the target clinic visit. The priming sheet includes an abstracted version of the patients' survey responses and communication tips tailored to the patient's responses based on Vitaltalk curricular materials.
Receives: Other: "CKD Jumpstart- Tips" priming intervention
Usual care armNo interventionAdditional education classes and information in written or multimedia formats reviewing kidney failure treatment options will be made available per routine care and will not be dictated by the study. Patients will be asked whether they have attended an education session or provided informational materials at baseline.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Observer-rated shared decision making

    Observer-rated shared decision making will be measured using the validated 5-item OPTION5 instrument based on Collaborative Deliberation. Each item is scored on a 0 (no effort) to 4 (exemplary effort) scale. Two raters will complete an online training module from the OPTION5 developers and then undergo calibration training through assessing five audio-recordings of consultations with other trained study team members. The two raters will independently rate audio-recordings of the target visit, and then compare ratings and resolve discrepancies by consensus. The final item scores will be added for a summary score ranging from 0 to 20 and a scale score ranging from 0 to 100. Higher total scores imply higher degrees of SDM.

    Measured: T1 (Immediately after target visit)

Secondary outcomes (8)

  1. Patient-reported shared decision-making

    Patient-reported shared decision-making will be measured using the Chinese-validated 9-item SDM-Q-9 after the target visit. Patients will rate the items on a scale from 0 (Completely disagree) to 5 (Completely Agree). Total scores range from 0 to 100. The higher the score, the higher the perception of SDM. The SDM-Q-9 showed a high reliability with a high internal consistency (Cronbach's α > 0.9) and item discrimination.

    Measured: T1 (Immediately after target visit)

  2. Quality of Communication

    Quality of Communication will be assessed using the Chinese version of the patient-reported Quality of Communication questionnaire (QOC-C). The QOC-C was previously validated by the investigator's team in advanced CKD patients to assess patients' perception of the quality of clinician communication on end-of-life care issues and has a 3-factor structure. The investigators will administer the illness trajectory (4 items) and end-of-life care planning subscales (6 items) and the two summary items. Each item rates the clinician's skill on a scale from 0 ("very worst I can imagine") to 10 ("very best I can imagine").

    Measured: T1 (Immediately after target visit)

  3. Consultation time

    Consultation time will be assessed from audio-recordings of the target clinic visit consultations.

    Measured: T1 (Immediately after target visit)

  4. Patient involvement in decision-making

    Patient involvement in decision-making will be measured using the 1-item validated modified Control Preferences Scale (CPS). The CPS consists of 1 item with five response options, each corresponding to a description of the patient's role in decision-making. The score representing these role descriptions ranges from 1 to 5, from 1 indicating the patient making the treatment decisions, 3 indicating the patient making the decisions jointly with the physician, to 5 indicating the physician making the decisions. The CPS has shown good reliability and validity.

    Measured: T1 (Immediately after target visit)

  5. Decisional conflict

    Decisional conflict will be measured using the Chinese validated 16-item Decisional Conflict scale (DCS). The DCS covers five subscales measuring how well informed patients feel about their choices and associated benefits and risks, clarity of values, support received in decision making, level of uncertainty about the best choice, and perceived effectiveness of decision making. Each item is rated on a five-point Likert scale. The total score is calculated by averaging the sum of the items and then multiplying by 25. The total score ranges from 0 to 100, with a higher score indicating more decisional conflict. The Chinese version has good internal consistency, with Cronbach's α of 0.81.

    Measured: T1 (Immediately after target visit), T2 (3 Months), T3 (6 Months)

  6. Decisional regret

    Decisional regret will be measured using the Chinese validated five-item Decision Regret scale (DRS). The DRS measures distress or remorse after a health care decision. Each item is rated on a five-point Likert scale. The total score is calculated by averaging the sum of the five items and then multiplying by 25. The total score ranges from 0 to 100, with a higher score indicating greater decision regret. The Chinese version has good internal consistency with Cronbach's α of 0.83.

    Measured: T2 (3 Months), T3 (6 Months)

  7. Timing of and adherence to treatment choice

    Timing of and adherence to treatment choice will be assessed by patient report and by chart review. Patients will be asked whether and when they have indicated their treatment choice and any changes in their treatment choice. Chart abstraction from the medical record will occur at the end of data collection period to assess for clinician documentation of the initial treatment choice and any subsequent change in treatment choice. The timing and setting of the documentation will also be recorded.

    Measured: T1 (Immediately after target visit), T2 (3 Months), T3 (6 Months)

  8. Health-related quality of life

    Health-related quality of life will be assessed using the validated Chinese version of the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal). The FACIT Pal is a patient-reported measure of health-related quality of life (QOL) for patients with advanced illness. It contains four domains: physical (7 items), social/family (7 items), emotional (6 items) and functional (7) wellbeing and a Palliative care subscale (PalS, 19 items). Each item is rated from 0 (not at all) to 4 (very much). Higher scores reflect higher QOL.

    Measured: T2 (3 Months), T3 (6 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2025
  2. Study start4 Feb 2025
  3. Primary completionApr 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
The Study Model includes two components for priming intervention, for patients and clinicians respectively: Patients: Patients will complete a "CKD Jumpstart- Tips" communication priming tool before a target clinic visit. Within one week prior to and on the day of the visit, patients will receive a "CKD Jumpstart- Tips" patient summary sheet. Clinicians: Within one week prior to and on the day of the target clinic visit, clinicians will receive a "CKD Jumpstart- Tips" clinician priming sheet which contains an abstracted version of the patients' survey responses and communication tips tailored to the patient's responses. Patients in the control group will receive usual care (e.g. education classes and information on kidney failure treatment options). Clinicians in the control group will provide consultations to patients under usual practices. Clinicians will be randomized at a 1:1 ratio to the intervention or control group with stratification by study site.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06799936
Sponsor's protocol ID
17609724
Status last verified
Aug 2026
First submitted
27 Jan 2025
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared in order to protect patient privacy. However, summary data of patients will be shared upon reasonable request to the study's Principal Investigator"

Publications

  • Zhou X, Tian X, Fan Y, Sun M, Wang Z, Huang Y, Xiao W. Psychometric Properties of the Chinese Version of the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal) in Patients With Advanced Cancer. J Pain Symptom Manage. 2024 Jan;67(1):e8-e15. doi: 10.1016/j.jpainsymman.2023.09.020. Epub 2023 Sep 26.

    PubMed 37769823

  • Xu RH, Zhou LM, Wong EL, Wang D, Chang JH. Psychometric Evaluation of the Chinese Version of the Decision Regret Scale. Front Psychol. 2020 Dec 3;11:583574. doi: 10.3389/fpsyg.2020.583574. eCollection 2020.

    PubMed 33424697

  • Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.

    PubMed 12926578

  • Lam WW, Kwok M, Liao Q, Chan M, Or A, Kwong A, Suen D, Fielding R. Psychometric assessment of the Chinese version of the decisional conflict scale in Chinese women making decision for breast cancer surgery. Health Expect. 2015 Apr;18(2):210-20. doi: 10.1111/hex.12021. Epub 2012 Nov 21.

    PubMed 23167846

  • O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.

    PubMed 7898294

  • Elwyn G, Vermunt NPCA. Goal-Based Shared Decision-Making: Developing an Integrated Model. J Patient Exp. 2020 Oct;7(5):688-696. doi: 10.1177/2374373519878604. Epub 2019 Oct 17.

    PubMed 33294602

  • McCaffery KJ, Holmes-Rovner M, Smith SK, Rovner D, Nutbeam D, Clayman ML, Kelly-Blake K, Wolf MS, Sheridan SL. Addressing health literacy in patient decision aids. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S10. doi: 10.1186/1472-6947-13-S2-S10. Epub 2013 Nov 29.

    PubMed 24624970

  • Sepucha KR, Borkhoff CM, Lally J, Levin CA, Matlock DD, Ng CJ, Ropka ME, Stacey D, Joseph-Williams N, Wills CE, Thomson R. Establishing the effectiveness of patient decision aids: key constructs and measurement instruments. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S12. doi: 10.1186/1472-6947-13-S2-S12. Epub 2013 Nov 29.

    PubMed 24625035

  • Davis JL, Davison SN. Hard choices, better outcomes: a review of shared decision-making and patient decision aids around dialysis initiation and conservative kidney management. Curr Opin Nephrol Hypertens. 2017 May;26(3):205-213. doi: 10.1097/MNH.0000000000000321.

    PubMed 28212179

  • Morton R. Do Dialysis Decision Aids Improve Treatment Decision-Making? Perit Dial Int. 2016 Jul-Aug;36(4):359-61. doi: 10.3747/pdi.2016.00017. No abstract available.

    PubMed 27385805

  • Jungers P, Zingraff J, Albouze G, Chauveau P, Page B, Hannedouche T, Man NK. Late referral to maintenance dialysis: detrimental consequences. Nephrol Dial Transplant. 1993;8(10):1089-93.

    PubMed 8272221

  • Hughes SA, Mendelssohn JG, Tobe SW, McFarlane PA, Mendelssohn DC. Factors associated with suboptimal initiation of dialysis despite early nephrologist referral. Nephrol Dial Transplant. 2013 Feb;28(2):392-7. doi: 10.1093/ndt/gfs431. Epub 2012 Dec 4.

    PubMed 23222418

  • Davison SN. End-of-life care preferences and needs: perceptions of patients with chronic kidney disease. Clin J Am Soc Nephrol. 2010 Feb;5(2):195-204. doi: 10.2215/CJN.05960809. Epub 2010 Jan 14.

    PubMed 20089488

  • Berkhout-Byrne N, Gaasbeek A, Mallat MJK, Rabelink TJ, Mooijaart SP, Dekker FW, van Buren M. Regret about the decision to start dialysis: a cross-sectional Dutch national survey. Neth J Med. 2017 Jul;75(6):225-234.

    PubMed 28741581

  • Ladin K, Lin N, Hahn E, Zhang G, Koch-Weser S, Weiner DE. Engagement in decision-making and patient satisfaction: a qualitative study of older patients' perceptions of dialysis initiation and modality decisions. Nephrol Dial Transplant. 2017 Aug 1;32(8):1394-1401. doi: 10.1093/ndt/gfw307.

    PubMed 27576590

Questions about this trial

What is this clinical trial studying?

A study testing "CKD Jumpstart- Tips" priming intervention in people with Chronic Kidney Disease Stage 4 and Chronic Kidney Disease Stage 5, run by The University of Hong Kong at 1 site in Hong Kong.

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 0 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Jacqueline KY Yuen, Dr ((852) 2255-4608, jkyuen@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Observer-rated shared decision making (time frame: T1 (Immediately after target visit)). 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 NCT06799936, which also lists 27 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 8 Sep 2026.

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