HIPAA Compliant
ISO 27001 CertifiedActively Recruiting
Led by University of Washington · Updated on 2024-08-09
76
Participants Needed
2
Research Sites
52 weeks
Total Duration
Researchers are evaluating the use of a new communication tool called the CKM JumpStart Tool to encourage discussions about conservative kidney management CKM between older patients with advanced chronic kidney disease CKD and their healthcare providers. This randomized pilot study involves patients aged 75 years and older, aiming to test if the tool is feasible and acceptable compared to usual care. The study is sponsored by the University of Washington and includes patients from two healthcare systems. The CKM JumpStart Tool is a one-page handout tailored to each patient based on their values related to longevity or comfort. Study staff generate this tool before the patients clinic visit and share it with both patient and provider to facilitate values-based conversations about CKM. Participants are randomly assigned either to receive this intervention or to continue with usual care without the tool. The study collects data at enrollment, within two weeks after the clinic visit, and about three months later. Participants will provide information through surveys and interviews at three time points at enrollment, shortly after their next clinic visit, and three months later. Researchers will assess how often CKM discussions occur between patients and providers, whether providers document these discussions, and how acceptable and feasible the tool is based on participant retention and feedback. The study also includes qualitative interviews with patients and nephrologists to understand their experiences using the tool.
CONDITIONS
A Pilot Study of The CKM JumpStart Tool
O
Olivia Gaughran, MA
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University of Washington
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | CKM JumpStart Tool | Control (No Intervention) | Standard Conservative Kidney Management |
|---|---|---|---|
| What it is | A one‑page values‑based communication handout delivered before a nephrologist visit to prompt discussion of patient goals (longevity vs comfort) | Usual care without any added communication tool | Shared decision‑making and values‑based conservative management of advanced CKD as recommended in current guidance |
| Role in trial | Assigned investigational communication intervention | Assigned control group receiving no intervention | Reflects routine conservative CKM decision process outside trial |
| Primary use | To prompt nephrologist discussion of patient values and CKM options | Serves as baseline usual care comparison | Guidance‑based shared decision‑making for advanced CKD management aligned with patient values |
| How it is given or performed | Study staff generate and share a personalized one‑page handout with provider before patient’s visit based on values response | Nothing additional is provided beyond usual nephrology care | Structured shared decision‑making using clinician discussion often supported by values tools |
| Evidence status | Pilot trial underway to test feasibility and impact on provider‑patient discussion initiation | Represents current usual care with no added structured communication intervention | Guideline‑endorsed practice reflecting shared decision‑making in conservative CKM |
| Important risks | None specifically identified for this behavioral intervention | Not applicable | Not applicable |
| Important limitations | Pilot nature with small sample; outcomes limited to discussion initiation not downstream outcomes | Usual care arm may vary widely in how shared decision‑making is conducted | Guideline recommendations may not consistently reflect real‑world practice implementation |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 visit
Participants provide informed consent and complete baseline assessments including a values question to guide the CKM JumpStart Tool.
1 enrollment visit (in-person)
Duration - Within 2 weeks after enrollment
Participants randomized to receive the CKM JumpStart Tool will have the tool shared with their provider prior to their next clinic visit to promote discussion about conservative kidney management (CKM). Participants in the control group receive usual care.
1 clinic visit with healthcare provider
Duration - Approximately 3 months
Participants complete follow-up assessments approximately 3 months after the clinic visit to evaluate discussions about CKM, treatment preferences, and quality of communication.
1 follow-up visit or assessment
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Susan P Y Wong, Olivia Gaughran, Deborah Lee...
https://pubmed.ncbi.nlm.nih.gov/41442200/University of Washington
Lead Sponsor
