NCT05753020

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 10, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1.7 years

First QC Date

February 21, 2023

Last Update Submit

August 6, 2024

Conditions

Chronic Kidney Diseases

Keywords

Kidney supportive careCommunicationShared decision-makingConservative kidney managementPalliative careEnd-of-life care

Outcome Measures

Primary Outcomes (2)

  • Patient-provider discussion of CKM

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

    3 months

  • 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.

    3 months

Secondary Outcomes (5)

  • Treatment preference

    3 months

  • Quality of Communication

    3 months

  • Documentation of CKM Discussion

    3 months

  • Patient Post-Intervention Interview

    2 weeks

  • Provider Use of CKM Jumpstart Tool

    2 weeks

Study Arms (2)

CKM Jumpstart Tool

EXPERIMENTAL

Receives intervention

Behavioral: CKM Jumpstart Tool

Control

NO INTERVENTION

Does not receive intervention

Interventions

CKM Jumpstart ToolBEHAVIORAL

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.

CKM Jumpstart Tool

Eligibility Criteria

Age75 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-representation
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to complete the informed consent process
  • Currently receiving maintenance dialysis
  • Their patient is a participant in the study.
  • Are a UW Medicine or VA Puget Sound provider or trainee.
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, ChronicCommunication

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Susan P Wong, MD, MS

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia Gaughran, MA

CONTACT

206-277-4376ollyg@uw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor: School of Medicine

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 3, 2023

Study Start

April 10, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations

US(2)