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NCT Number: NCT06799936

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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

Exclusion criteria

for patients:

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

Treatment and study plan

"CKD Jumpstart- Tips" priming intervention

Other

The intervention includes 2 components:

  • 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.
  • 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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").

  3. Consultation time

    Time frame: T1 (Immediately after target visit)

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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacqueline KY Yuen, Dr

CONTACT

[email protected]

(852) 2255-4608

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 29, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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