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

NCT06799936 | Recruiting

• 1 other identifier: 17609724
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Kidney Disease Stage 4; Chronic Kidney Disease Stage 5

Keywords

Communication; Priming; Decision-making; Older adults; Chronic kidney disease; CKD-Priming Jumpstart

Outcome Measures

Primary Outcomes (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.

  T1 (Immediately after target visit)

Secondary Outcomes (8)

• Patient-reported shared decision-making

  T1 (Immediately after target visit)

• Quality of Communication

  T1 (Immediately after target visit)

• Consultation time

  T1 (Immediately after target visit)

• Patient involvement in decision-making

  T1 (Immediately after target visit)

• Decisional conflict

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

Study Arms (2)

Priming Intervention arm

EXPERIMENTAL

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

Usual care arm

NO INTERVENTION

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.

Interventions

"CKD Jumpstart- Tips" priming intervention OTHER

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.

Priming Intervention arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

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Related Links

• The communication tips used in the "CKD Jumpstart- Tips" intervention were based on VitalTalk curricular materials.

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Communication

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Jacqueline KY Yuen, Dr

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline KY Yuen, Dr

CONTACT

(852) 2255-4608; jkyuen@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistical analyst will be blinded to site and arm assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 29, 2025
• Study Start: February 4, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)