A Pilot Study of The CKM JumpStart Tool

Обзор

This is a randomized pilot study to test the feasibility and acceptability of a tool to promote discussion about conservative kidney management (CKM) among older patients with advanced CKD and their providers.

Подробное описание

This study is a randomized pilot study to test the acceptability and feasibility of a novel communication tool, called the CKM Jumpstart Tool, to promote discussion of CKM between patients with advanced CKM and their healthcare providers, the investigators hypothesize that the Guide will be feasible and acceptable to patients and their healthcare providers as reflected in greater discussion of CKM between them following use of the Tool as compared with usual care. The investigators will enroll 76 patients aged 75 years and older with advanced CKD and their healthcare providers from University of Washington Medicine and Veterans Affairs Puget Sound Health Care System. Patients will be randomized together in a 1:1 fashion to receive the intervention or usual care. Data from participants will be collected at the time of enrollment (T1), within 2-weeks of their following clinic visit with their healthcare provider (T2), and approximately 3-month after this clinic visit (T3). The primary outcome measure and measure of feasibility is difference in patient-reported rates of discussion of CKM with a healthcare provider at T2 and T3. The investigators will also evaluate whether provider document in the medical chart of patients whether they had a discussion about CKM with the patient at T2 and T3. The investigators will also collect attrition rates at T2 and T3 as a measure of acceptability. The investigators will further assess user experience of the CKM JumpStart by performing a qualitative analysis of post-intervention interviews with patients and nephrologists, coding for themes elucidating pros, cons and other considerations with using the CKM JumpStart Tool and discussion about CKM.

Вмешательства

• Поведенческое CKM Jumpstart Tool
  The CKM JumpStart Tool is a 1-page handout that describes the values of a patient and words that a providers can try with the patient to explore the patient' values more and to provide a values-based introduction to CKM. The values described in the CKM JumpStart Tool is based on a patient's response to a single validated question that we will ask the patient at T1, if they had to choose, do they value care directed at longevity or comfort. Using the patient's answer to the values question, study

Первичные конечные точки

• Patient-provider discussion of CKM [Срок оценки: 3 months]
• Attrition [Срок оценки: 3 months]

Вторичные конечные точки (5)

• Treatment preference [Срок оценки: 3 months]
• Quality of Communication [Срок оценки: 3 months]
• Documentation of CKM Discussion [Срок оценки: 3 months]
• Patient Post-Intervention Interview [Срок оценки: 2 weeks]
• Provider Use of CKM Jumpstart Tool [Срок оценки: 2 weeks]

Критерии участия

Patients

Inclusion:

• Adults aged ≥75 years
• Advanced CKD as defined as having at least 2 outpatient measures of eGFR <25 ml/min/1.73m2 separated by >90 days in the prior year and with at least 1 eGFR measure <20.
• English-speaking
• Receive care from a provider at UW Medicine or VA Puget Sound
• Open to discussing their values and treatment options for kidney disease with their provider.

Exclusion:

• Unable to complete the informed consent process
• Currently receiving maintenance dialysis

Providers Inclusion

• Their patient is a participant in the study.
• Are a UW Medicine or VA Puget Sound provider or trainee.

Exclusion

• None

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

США · 2 центра

• VA Puget Sound Health Care System — Seattle
• University of Washington — Seattle

Публикации

• Wong SPY, Gaughran O, Lee D, Schell J, Lam DY, Paden G, Kross EK. Conservative Kidney Management Jumpstart: Designing a Behavioral Nudge to Jumpstart Conversations about Conservative Kidney Management between Patients and Nephrologists. Kidney360. 2026 May 1;7(5):1076-1085. doi: 10.34067/KID.0000001079. Epub 2025 Dec 24. PMID 41442200

Идентификаторы

NCT: NCT05753020 · STUDY00017195

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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