NCT05753020 · University of Washington
A Pilot Study of The CKM JumpStart Tool
What this study is about
This is a randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 staff will generate a CKM JumpStart Tool prior to their upcoming clinic visit with their nephrologist. Study staff will inform the patient that their response to the values question will be shared with their provider prior to their next clinic visit and that their providers might bring up their values and treatment options for kidney disease, if the situation permits. We will share the CKM Jumpstart Tool with their provider and provide instruction on how to use the Tool.
Primary outcome measures
Patient-provider discussion of CKM
Time frame: 3 months
We will ask patients whether they had discussed CKM with their healthcare provider at T2 and T3.
Attrition
Time frame: 3 months
We will record the proportion of participants in each study arm who withdraw from the study and the reasons why at T2 and T3. Study withdrawal would indicate that the Tool and/or study is unacceptable or burdensome to the participant.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 9, 2024 · Source of record for eligibility and locations