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A Pilot Study of The CKM JumpStart Tool

Primary Purpose

Chronic Kidney Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CKM Jumpstart Tool
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Kidney Diseases focused on measuring communication, shared-decision making, conservative kidney management, medical management, supportive care, dialysis palliative care, end-of-life care

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    CKM Jumpstart Tool

    Control

    Arm Description

    Receives intervention

    Does not receive intervention

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    February 21, 2023
    Last Updated
    February 21, 2023
    Sponsor
    University of Washington
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05753020
    Brief Title
    A Pilot Study of The CKM JumpStart Tool
    Official Title
    A Pilot Study of The CKM JumpStart Tool
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 15, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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, We 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. We 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). Our 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. We 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. We will also collect attrition rates at T2 and T3 as a measure of acceptability. We 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Diseases
    Keywords
    communication, shared-decision making, conservative kidney management, medical management, supportive care, dialysis palliative care, end-of-life care

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    76 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CKM Jumpstart Tool
    Arm Type
    Experimental
    Arm Description
    Receives intervention
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Does not receive intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    CKM Jumpstart Tool
    Intervention Description
    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 Measure Information:
    Title
    Patient-provider discussion of CKM
    Description
    We will ask patients whether they had discussed CKM with their healthcare provider at T2 and T3.
    Time Frame
    3 months
    Title
    Attrition
    Description
    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.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Treatment preference
    Description
    At each study visit, we will record each patient's preference for dialysis or CKM using the Decision Conflict Scale at each study visit.
    Time Frame
    3 months
    Title
    Quality of Communication
    Description
    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.
    Time Frame
    3 months
    Title
    Documentation of CKM Discussion
    Description
    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.
    Time Frame
    3 months
    Title
    Patient Post-Intervention Interview
    Description
    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.
    Time Frame
    2 weeks
    Title
    Provider Use of CKM Jumpstart Tool
    Description
    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.
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    self-representation
    Minimum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Olivia Gaughran, MA
    Phone
    206-277-4376
    Email
    ollyg@uw.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Susan P Wong, MD, MS
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Pilot Study of The CKM JumpStart Tool

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