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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorThe University of Hong Kong

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinicians

Patients

Diagnosis of advanced CKD Stage 4 or 5 defined by estimated Glomerular Filtration Rate (eGFR) of ≤ 20 and a creatinine level ≥350 (umol/L) on two measurements at least 90 days apart in the prior year.

Chinese- or English-speaking

Disqualifiers

have a confirmed advanced CKD treatment decision for dialysis, palliative care, or renal transplant documented in clinical notes

have initiated any of these treatments

lack decision-making capacity

Trial design

Design model

Parallel

Treatments tested in this trial

  • "CKD Jumpstart- Tips" priming intervention

    Other 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.

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Priming Intervention armExperimental treatment 1 intervention
Group B: Usual care armNo intervention 0 interventions

Trial outcomes

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.

Time frame
T1 (Immediately after target visit)

Secondary outcomes

1

Patient-reported shared decision-making

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.

Time frame
T1 (Immediately after target visit)
2

Quality of Communication

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").

Time frame
T1 (Immediately after target visit)
3

Consultation time

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

Time frame
T1 (Immediately after target visit)
4

Patient involvement in decision-making

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.

Time frame
T1 (Immediately after target visit)

Other outcomes

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