Back to resultsIntegrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program
Primary Purpose
Advance Care Planning, Chronic Kidney Diseases, Conservative Kidney Management
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ESRD education + conservative kidney management and ACP education
Sponsored by
About this trial
This is an interventional health services research trial for Advance Care Planning
Eligibility Criteria
Inclusion Criteria:
- Stage 4 or 5 CKD (defined by the CKD-EPI estimation of GFR < 30 ml/min/1.73m2)
- Age 65 years or greater or frail
- self-reported Black or White race
Exclusion Criteria:
- History of dementia
- History of legal blindness
- Listed for kidney transplantation
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard pre-dialysis education
ESRD education + ACP
Arm Description
Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation
Standard ESRD education + conservative kidney management and advance care planning education
Outcomes
Primary Outcome Measures
Knowledge of conservative kidney management and advance care planning
Change in knowledge of conservative kidney management and advance care planning (mean score)
Secondary Outcome Measures
Communication of EOL preferences with healthcare providers and family members
Binary outcome (yes/no)
Full Information
NCT ID
NCT03229811
First Posted
July 21, 2017
Last Updated
October 6, 2022
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT03229811
Brief Title
Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program
Official Title
Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
The PI left academic practice
Study Start Date
October 24, 2021 (Actual)
Primary Completion Date
December 14, 2021 (Actual)
Study Completion Date
December 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goals of this work will be to evaluate the preliminary efficacy of a comprehensive pre-dialysis education program on increased knowledge of conservative kidney management and advance care planning among patients with advanced CKD.
Detailed Description
This intervention will be randomized among patients with advanced chronic kidney disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advance Care Planning, Chronic Kidney Diseases, Conservative Kidney Management
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comprehensive pre-dialysis program incorporating conservative and advance care planning education
Masking
Investigator
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard pre-dialysis education
Arm Type
No Intervention
Arm Description
Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation
Arm Title
ESRD education + ACP
Arm Type
Active Comparator
Arm Description
Standard ESRD education + conservative kidney management and advance care planning education
Intervention Type
Other
Intervention Name(s)
ESRD education + conservative kidney management and ACP education
Intervention Description
Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers
Primary Outcome Measure Information:
Title
Knowledge of conservative kidney management and advance care planning
Description
Change in knowledge of conservative kidney management and advance care planning (mean score)
Time Frame
Baseline and Day 1 post-intervention
Secondary Outcome Measure Information:
Title
Communication of EOL preferences with healthcare providers and family members
Description
Binary outcome (yes/no)
Time Frame
12 weeks post-intervention
Other Pre-specified Outcome Measures:
Title
Completion of healthcare proxy forms, living wills, and POLST forms
Description
Binary outcome (yes/no)
Time Frame
Day 1 post intervention and 12 weeks post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage 4 or 5 CKD (defined by the CKD-EPI estimation of GFR < 30 ml/min/1.73m2)
Age 65 years or greater or frail
self-reported Black or White race
Exclusion Criteria:
History of dementia
History of legal blindness
Listed for kidney transplantation
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33619188
Citation
Stallings TL, Temel JS, Klaiman TA, Paasche-Orlow MK, Alegria M, O'Hare A, O'Connor N, Dember LM, Halpern SD, Eneanya ND. Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial. BMJ Open. 2021 Feb 22;11(2):e042620. doi: 10.1136/bmjopen-2020-042620.
Results Reference
derived
Learn more about this trial
Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program
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