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Идёт набор NCT06799936

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

Без фазы С лечением Chronic Kidney Disease Stage 4 Chronic Kidney Disease Stage 5

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: "CKD Jumpstart- Tips" priming intervention.
Кому может быть актуально
Состояния в реестре: Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 5. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Communication-Priming Intervention to Improve Shared Decision-Making Between Older Adults With Advanced Chronic Kidney Disease and Clinicians: A Cluster-Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое "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

Первичные конечные точки

  • Observer-rated shared decision making [Срок оценки: T1 (Immediately after target visit)]
Вторичные конечные точки (8)
  • Patient-reported shared decision-making [Срок оценки: T1 (Immediately after target visit)]
  • Quality of Communication [Срок оценки: T1 (Immediately after target visit)]
  • Consultation time [Срок оценки: T1 (Immediately after target visit)]
  • Patient involvement in decision-making [Срок оценки: T1 (Immediately after target visit)]
  • Decisional conflict [Срок оценки: T1 (Immediately after target visit), T2 (3 Months), T3 (6 Months)]
  • Decisional regret [Срок оценки: T2 (3 Months), T3 (6 Months)]
  • Timing of and adherence to treatment choice [Срок оценки: T1 (Immediately after target visit), T2 (3 Months), T3 (6 Months)]
  • Health-related quality of life [Срок оценки: T2 (3 Months), T3 (6 Months)]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

Гонконг · 1 центр
  • Queen Mary Hospital — Гонконг

Публикации

  • 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. PMID 37769823
  • 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. PMID 33424697
  • 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. PMID 12926578
  • 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. PMID 23167846
  • O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105. PMID 7898294
  • 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. PMID 33294602
  • 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. PMID 24624970
  • 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. PMID 24625035

Идентификаторы

NCT: NCT06799936 · 17609724

Первоисточники (государственные реестры)

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