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

March 31, 2025 updated by: YUEN Jacqueline Kwan Yuk, The University of Hong Kong

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jacqueline KY Yuen, Dr
  • Phone Number: (852) 2255-4608
  • Email: jkyuen@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
          • Jacqueline KY Yuen
          • Phone Number: (852) 2255 4608
          • Email: jkyuen@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria for the two groups of participants (i.e. Clinicians and Patients):

  1. Clinicians

    - Nephrology specialists or higher physician trainees who provide specialty care to older adults with advanced chronic kidney disease

  2. Patients

    • Diagnosis of advanced CKD Stage 4 or 5 (eGRF <30 ml/min)
    • Chinese- or English-speaking
    • Identified as patient with whom their clinician plans to discuss advanced kidney disease treatment options in the upcoming clinic visit
    • Able to provide written informed consent and complete questionnaires
    • Can be contacted by phone

Exclusion criteria for patients:

  • Patients will be excluded if they are eligible for kidney transplant, currently on dialysis, or lack decision-making capacity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Priming Intervention arm

Patients 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.
Other: "CKD Jumpstart- Tips" priming intervention

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.
No Intervention: Usual care arm
Additional 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observer-rated shared decision making
Time Frame: T1 (Immediately after target visit)
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.
T1 (Immediately after target visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported shared decision-making
Time Frame: T1 (Immediately after target visit)
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.
T1 (Immediately after target visit)
Consultation time
Time Frame: T1 (Immediately after target visit)
Consultation time will be assessed from audio-recordings of the target clinic visit consultations.
T1 (Immediately after target visit)
Quality of Communication
Time Frame: T1 (Immediately after target visit)
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").
T1 (Immediately after target visit)
Patient involvement in decision-making
Time Frame: T1 (Immediately after target visit)
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.
T1 (Immediately after target visit)
Decisional conflict
Time Frame: T1 (Immediately after target visit), T2 (3 Months), T3 (6 Months)
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.
T1 (Immediately after target visit), T2 (3 Months), T3 (6 Months)
Decisional regret
Time Frame: T2 (3 Months), T3 (6 Months)
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.
T2 (3 Months), T3 (6 Months)
Timing of and adherence to treatment choice
Time Frame: T1 (Immediately after target visit), T2 (3 Months), T3 (6 Months)
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.
T1 (Immediately after target visit), T2 (3 Months), T3 (6 Months)
Health-related quality of life
Time Frame: T2 (3 Months), T3 (6 Months)
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.
T2 (3 Months), T3 (6 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Jacqueline KY Yuen, Dr, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17609724

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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"

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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