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Chronic Kidney DiseasesNCT05753020

A Pilot Study of The CKM JumpStart Tool

A study testing CKM Jumpstart Tool in people with Chronic Kidney Diseases, run by University of Washington at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 75 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
CKM Jumpstart Tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
2 sitesUnited States
Study dates
10 Apr 2023to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • None

Trial locations and contacts

2 sites in 1 country.

Olivia Gaughran, MA contact

206-277-4376

ollyg@uw.edu

United States2 sites, 2 recruiting

  • VA Puget Sound Health Care System

    Seattle, Washington, 98108

    Olivia Gaughran

    Recruiting

  • University of Washington

    Seattle, Washington, 98195

    Olivia Gaughran

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
CKM Jumpstart Tool
Keywords
Kidney supportive care, Communication, Shared decision-making, Conservative kidney management, Palliative care, End-of-life care
Medical subject headings
Renal Insufficiency, Chronic, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CKM Jumpstart ToolBehavioural

    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.

Study groups in NCT05753020
Study groupRoleWhat they receive
CKM Jumpstart ToolExperimentalReceives intervention
Receives: Behavioral: CKM Jumpstart Tool
ControlNo interventionDoes not receive intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-provider discussion of CKM

    We will ask patients whether they had discussed CKM with their healthcare provider at T2 and T3.

    Measured: 3 months

  2. Attrition

    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.

    Measured: 3 months

Secondary outcomes (5)

  1. Treatment preference

    At each study visit, we will record each patient's preference for dialysis or CKM using the Decision Conflict Scale at each study visit.

    Measured: 3 months

  2. Quality of Communication

    At each study visit, patients will be asked to rate the quality of serious illness communication with their nephrologists using the Quality of Communication Questionnaire.

    Measured: 3 months

  3. Documentation of CKM Discussion

    At T2 and T3, we will review each patient's recent nephrology clinic notes to determine whether their providers documented a discussion with patients about CKM.

    Measured: 3 months

  4. Patient Post-Intervention Interview

    For patients randomized to receive the intervention, at T2, patients will be invited to answer 4 open-ended questions about their clinical encounter with their provider. Questions will pertain to topics discussed during the encounter with their provider, whether their provider asked them about their values, whether CKM was discussed, and their perception of CKM based on the conversation.

    Measured: 2 weeks

  5. Provider Use of CKM Jumpstart Tool

    For patients randomized to receive the intervention, at T2, their providers will be asked whether they had used the CKM Jumpstart Tool during their visit, and if not their reasons for not using the Tool.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2023
  2. Study start10 Apr 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05753020
Sponsor's protocol ID
STUDY00017195
Status last verified
Aug 2024
First submitted
21 Feb 2023
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wong SPY, Gaughran O, Prince DK, Schell J, Lam DY, Bates D, Paden G, Kross EK. A Randomized Pilot Trial of a Nephrologist Communication Tool for Discussing Conservative Management. Clin J Am Soc Nephrol. 2026 Sep 3. doi: 10.2215/CJN.0000001213. Online ahead of print.

    PubMed 42690921

  • 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.

    PubMed 41442200

Questions about this trial

What is this clinical trial studying?

A study testing CKM Jumpstart Tool in people with Chronic Kidney Diseases, run by University of Washington at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Olivia Gaughran, MA (206-277-4376, ollyg@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-provider discussion of CKM (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05753020, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024; AzTrials last refreshed its copy on 26 Oct 2026.

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