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

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Chronic Kidney Disease Stage 4; Chronic Kidney Disease Stage 5

Treatments: Other: "CKD Jumpstart- Tips" priming intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06799936

17609724

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

Priming Intervention arm

Experimental group

Description:

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.

Treatment:

Other: "CKD Jumpstart- Tips" priming intervention

Usual care arm

No Intervention group

Description:

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.