A Guide to Conservative Care
A Pilot Study of A Guide to Conservative Care
2 other identifiers
interventional
92
1 country
2
Brief Summary
This is a randomized pilot study to test the feasibility and acceptability of a patient decision aid on conservative care among older patients with advanced CKD and their close persons.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2020
CompletedFirst Submitted
Initial submission to the registry
May 28, 2021
CompletedFirst Posted
Study publicly available on registry
June 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedJune 24, 2022
June 1, 2021
1.4 years
May 28, 2021
June 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Questionnaire on patient-provider discussions of conservative care .
Using a questionnaire, patients will be asked whether they had discussed conservative care with any of their healthcare providers prior to T1 and by T3. Possible responses are "yes", "no" or "unsure." Greater motivation to discuss conservative care with their care providers at T3 after would indicate that the Guide is acceptable to patients and can be feasibly incorporated by them into their care planning.
3 months
Attrition
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 Guide and/or study is unacceptable or burdensome to the participant.
3 months
Secondary Outcomes (4)
Treatment Preference
3 months
Treatment Goals
3 months
Guide Questionnaire
2 weeks
Guide Interview
3 months
Study Arms (2)
Decision aid
EXPERIMENTALThe intervention is receipt of a patient decision aid on conservative care, entitled A Guide to Conservative Care. This is 12-page printed handout that provides an overview of conservative care. Participants assigned to the intervention group are mailed a copy of the Guide after their initial baseline visit (T1). Participants keep the Guide throughout the duration of the study.
Control
NO INTERVENTIONDid not receive the decision aid.
Interventions
The intervention is receipt of a patient decision aid on conservative care, entitled A Guide to Conservative Care. This is 12-page printed handout that provides an overview of conservative care. Participants assigned to the intervention group are mailed a copy of the Guide after their initial baseline visit (T1). Participants keep the Guide throughout the duration of the study.
Eligibility Criteria
You may qualify if:
- Patients
- Adults aged ≥75 years
- Diagnosis of 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 of these measures of eGFR \<20 ml/min/1.73m2
- Must be english-speaking
- Close persons
- Adults aged ≥18 years
- Must assist patient with their kidney disease care
- Must be English-speaking
You may not qualify if:
- Patients and Close Person
- Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
VA Puget Sound Health Care System
Seattle, Washington, 98108, United States
University of Washington Medicine
Seattle, Washington, 98198, United States
Related Publications (1)
Wong SPY, Oestreich T, Prince DK, Curtis JR. A Patient Decision Aid About Conservative Kidney Management in Advanced Kidney Disease: A Randomized Pilot Trial. Am J Kidney Dis. 2023 Aug;82(2):179-188. doi: 10.1053/j.ajkd.2022.12.007. Epub 2023 Feb 4.
PMID: 36740038DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan P Wong, MD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, School of Medicine: Nephrology
Study Record Dates
First Submitted
May 28, 2021
First Posted
June 9, 2021
Study Start
August 31, 2020
Primary Completion
January 31, 2022
Study Completion
April 30, 2022
Last Updated
June 24, 2022
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Immediately following publication and through 5 years after article publication
- Access Criteria
- Written request and sound research plan.
All de-identified individual participant data collected and study protocols will be shared immediately following publication and ending 5 years following article publication with researchers who provide a written request and sound research proposal. Interested researchers can contact the principal investigator directly.