Clinical trial NCT06799936: A Communication-Priming Intervention to Improve Shared Decision-Making Between Older Adults With Advanced CKD and Clinicians
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease Stage 4
Chronic Kidney Disease Stage 5
Keywords: Communication
Priming
Decision-making
Older adults
Chronic kidney disease
CKD-Priming Jumpstart
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 280
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Observer-rated shared decision making
timeFrame: T1 (Immediately after target visit)
Secondary outcomes:
measure: Patient-reported shared decision-making
timeFrame: T1 (Immediately after target visit)
measure: Quality of Communication
timeFrame: T1 (Immediately after target visit)
measure: Consultation time
timeFrame: T1 (Immediately after target visit)
measure: Patient involvement in decision-making
timeFrame: T1 (Immediately after target visit)
measure: Decisional conflict
timeFrame: T1 (Immediately after target visit), T2 (3 Months), T3 (6 Months)
measure: Decisional regret
timeFrame: T2 (3 Months), T3 (6 Months)
measure: Timing of and adherence to treatment choice
timeFrame: T1 (Immediately after target visit), T2 (3 Months), T3 (6 Months)
measure: Health-related quality of life
timeFrame: T2 (3 Months), T3 (6 Months)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Jacqueline KY Yuen, Dr
role: PRINCIPAL_INVESTIGATOR
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