A Communication-Priming Intervention to Improve Shared Decision-Making Between Older Adults With Advanced CKD and Clinicians
NCT ID: NCT06799936
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
280 participants
INTERVENTIONAL
2025-02-04
2027-06-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Priming Intervention arm
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.
"CKD Jumpstart- Tips" priming 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.
Usual care arm
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.
No interventions assigned to this group
Interventions
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"CKD Jumpstart- Tips" priming 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.
Eligibility Criteria
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Inclusion Criteria
\- 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
65 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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YUEN Jacqueline Kwan Yuk
Clinical Assistant Professor
Principal Investigators
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Jacqueline KY Yuen, Dr
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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Queen Mary Hospital
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.
Lam WW, Kwok M, Liao Q, Chan M, Or A, Kwong A, Suen D, Fielding R. Psychometric assessment of the Chinese version of the decisional conflict scale in Chinese women making decision for breast cancer surgery. Health Expect. 2015 Apr;18(2):210-20. doi: 10.1111/hex.12021. Epub 2012 Nov 21.
O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
Elwyn G, Vermunt NPCA. Goal-Based Shared Decision-Making: Developing an Integrated Model. J Patient Exp. 2020 Oct;7(5):688-696. doi: 10.1177/2374373519878604. Epub 2019 Oct 17.
McCaffery KJ, Holmes-Rovner M, Smith SK, Rovner D, Nutbeam D, Clayman ML, Kelly-Blake K, Wolf MS, Sheridan SL. Addressing health literacy in patient decision aids. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S10. doi: 10.1186/1472-6947-13-S2-S10. Epub 2013 Nov 29.
Sepucha KR, Borkhoff CM, Lally J, Levin CA, Matlock DD, Ng CJ, Ropka ME, Stacey D, Joseph-Williams N, Wills CE, Thomson R. Establishing the effectiveness of patient decision aids: key constructs and measurement instruments. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S12. doi: 10.1186/1472-6947-13-S2-S12. Epub 2013 Nov 29.
Davis JL, Davison SN. Hard choices, better outcomes: a review of shared decision-making and patient decision aids around dialysis initiation and conservative kidney management. Curr Opin Nephrol Hypertens. 2017 May;26(3):205-213. doi: 10.1097/MNH.0000000000000321.
Morton R. Do Dialysis Decision Aids Improve Treatment Decision-Making? Perit Dial Int. 2016 Jul-Aug;36(4):359-61. doi: 10.3747/pdi.2016.00017. No abstract available.
Jungers P, Zingraff J, Albouze G, Chauveau P, Page B, Hannedouche T, Man NK. Late referral to maintenance dialysis: detrimental consequences. Nephrol Dial Transplant. 1993;8(10):1089-93.
Hughes SA, Mendelssohn JG, Tobe SW, McFarlane PA, Mendelssohn DC. Factors associated with suboptimal initiation of dialysis despite early nephrologist referral. Nephrol Dial Transplant. 2013 Feb;28(2):392-7. doi: 10.1093/ndt/gfs431. Epub 2012 Dec 4.
Davison SN. End-of-life care preferences and needs: perceptions of patients with chronic kidney disease. Clin J Am Soc Nephrol. 2010 Feb;5(2):195-204. doi: 10.2215/CJN.05960809. Epub 2010 Jan 14.
Berkhout-Byrne N, Gaasbeek A, Mallat MJK, Rabelink TJ, Mooijaart SP, Dekker FW, van Buren M. Regret about the decision to start dialysis: a cross-sectional Dutch national survey. Neth J Med. 2017 Jul;75(6):225-234.
Ladin K, Lin N, Hahn E, Zhang G, Koch-Weser S, Weiner DE. Engagement in decision-making and patient satisfaction: a qualitative study of older patients' perceptions of dialysis initiation and modality decisions. Nephrol Dial Transplant. 2017 Aug 1;32(8):1394-1401. doi: 10.1093/ndt/gfw307.
Song MK, Lin FC, Gilet CA, Arnold RM, Bridgman JC, Ward SE. Patient perspectives on informed decision-making surrounding dialysis initiation. Nephrol Dial Transplant. 2013 Nov;28(11):2815-23. doi: 10.1093/ndt/gft238. Epub 2013 Jul 30.
Hussain JA, Flemming K, Murtagh FE, Johnson MJ. Patient and health care professional decision-making to commence and withdraw from renal dialysis: a systematic review of qualitative research. Clin J Am Soc Nephrol. 2015 Jul 7;10(7):1201-15. doi: 10.2215/CJN.11091114. Epub 2015 May 5.
Morton RL, Tong A, Howard K, Snelling P, Webster AC. The views of patients and carers in treatment decision making for chronic kidney disease: systematic review and thematic synthesis of qualitative studies. BMJ. 2010 Jan 19;340:c112. doi: 10.1136/bmj.c112.
Verberne WR, Konijn WS, Prantl K, Dijkers J, Roskam MT, van Delden JJM, Bos WJW. Older patients' experiences with a shared decision-making process on choosing dialysis or conservative care for advanced chronic kidney disease: a survey study. BMC Nephrol. 2019 Jul 16;20(1):264. doi: 10.1186/s12882-019-1423-x.
Frazier R, Levine S, Porteny T, Tighiouart H, Wong JB, Isakova T, Koch-Weser S, Gordon EJ, Weiner DE, Ladin K. Shared Decision Making Among Older Adults With Advanced CKD. Am J Kidney Dis. 2022 Nov;80(5):599-609. doi: 10.1053/j.ajkd.2022.02.017. Epub 2022 Mar 26.
Waldron T, Carr T, McMullen L, Westhorp G, Duncan V, Neufeld SM, Bandura LA, Groot G. Development of a program theory for shared decision-making: a realist synthesis. BMC Health Serv Res. 2020 Jan 23;20(1):59. doi: 10.1186/s12913-019-4649-1.
Stiggelbout AM, Pieterse AH, De Haes JC. Shared decision making: Concepts, evidence, and practice. Patient Educ Couns. 2015 Oct;98(10):1172-9. doi: 10.1016/j.pec.2015.06.022. Epub 2015 Jul 15.
Galla JH. Clinical practice guideline on shared decision-making in the appropriate initiation of and withdrawal from dialysis. The Renal Physicians Association and the American Society of Nephrology. J Am Soc Nephrol. 2000 Jul;11(7):1340-1342. doi: 10.1681/ASN.V1171340. No abstract available.
Cheung AK, Chang TI, Cushman WC, Furth SL, Hou FF, Ix JH, Knoll GA, Muntner P, Pecoits-Filho R, Sarnak MJ, Tobe SW, Tomson CRV, Lytvyn L, Craig JC, Tunnicliffe DJ, Howell M, Tonelli M, Cheung M, Earley A, Mann JFE. Executive summary of the KDIGO 2021 Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease. Kidney Int. 2021 Mar;99(3):559-569. doi: 10.1016/j.kint.2020.10.026.
Jassal SV, Watson D. Dialysis in late life: benefit or burden. Clin J Am Soc Nephrol. 2009 Dec;4(12):2008-12. doi: 10.2215/CJN.04610709. Epub 2009 Nov 5.
Tang SC. CKD prevention: Perspectives in Hong Kong. Nephrology (Carlton). 2018 Oct;23 Suppl 4:72-75. doi: 10.1111/nep.13468.
Xie Y, Bowe B, Mokdad AH, Xian H, Yan Y, Li T, Maddukuri G, Tsai CY, Floyd T, Al-Aly Z. Analysis of the Global Burden of Disease study highlights the global, regional, and national trends of chronic kidney disease epidemiology from 1990 to 2016. Kidney Int. 2018 Sep;94(3):567-581. doi: 10.1016/j.kint.2018.04.011. Epub 2018 Aug 3.
Related Links
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The communication tips used in the "CKD Jumpstart- Tips" intervention were based on VitalTalk curricular materials.
Other Identifiers
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17609724
Identifier Type: -
Identifier Source: org_study_id
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