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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "CKD Jumpstart- Tips" priming intervention | Other | The intervention includes 2 components:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
Exclusion criteria for patients:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline KY Yuen, Dr | Contact | (852) 2255-4608 | jkyuen@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Jacqueline KY Yuen, Dr | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37769823 | Background | Zhou X, Tian X, Fan Y, Sun M, Wang Z, Huang Y, Xiao W. Psychometric Properties of the Chinese Version of the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal) in Patients With Advanced Cancer. J Pain Symptom Manage. 2024 Jan;67(1):e8-e15. doi: 10.1016/j.jpainsymman.2023.09.020. Epub 2023 Sep 26. | |
| 33424697 |
| Label | URL |
|---|---|
| The communication tips used in the "CKD Jumpstart- Tips" intervention were based on VitalTalk curricular materials. | View source |
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IPD will not be shared in order to protect patient privacy. However, summary data of patients will be shared upon reasonable request to the study's Principal Investigator"
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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.
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The statistical analyst will be blinded to site and arm assignment.
|
| T1 (Immediately after target visit) |
| 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"). | T1 (Immediately after target visit) |
| Consultation time | Consultation time will be assessed from audio-recordings of the target clinic visit consultations. | T1 (Immediately after target visit) |
| 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. | T1 (Immediately after target visit) |
| Decisional conflict | 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. | T1 (Immediately after target visit), T2 (3 Months), T3 (6 Months) |
| Decisional regret | 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. | T2 (3 Months), T3 (6 Months) |
| Timing of and adherence to treatment choice | 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. | T1 (Immediately after target visit), T2 (3 Months), T3 (6 Months) |
| Health-related quality of life | 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. | T2 (3 Months), T3 (6 Months) |
| Xu RH, Zhou LM, Wong EL, Wang D, Chang JH. Psychometric Evaluation of the Chinese Version of the Decision Regret Scale. Front Psychol. 2020 Dec 3;11:583574. doi: 10.3389/fpsyg.2020.583574. eCollection 2020. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003142 | Communication |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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