Advance Care Planning, Chronic Kidney Diseases, Conservative Kidney Management
Conditions
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.
Interventions
OTHERESRD education + conservative kidney management and ACP education
Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Intervention model description
Comprehensive pre-dialysis program incorporating conservative and advance care planning education
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of Conservative Kidney Management and Advance Care Planning (Pre-intervention) | Pre-intervention and Day 1 post-intervention | Knowledge of conservative kidney management and advance care planning pre-intervention (mean score) Total score ranges from 0 to 9, where 9 represents having the most knowledge about conservative kidney management and advance care planning |
| Knowledge of Conservative Kidney Management and Advance Care Planning (Post-intervention) | Immediate post-intervention | Knowledge of conservative kidney management and advance care planning post-intervention (mean score) Total score ranges from 0 to 9, where 9 represents having the most knowledge about conservative kidney management and advance care planning |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Pre-dialysis Education Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation | 0 |
| ESRD Education + ACP Standard ESRD education + conservative kidney management and advance care planning education
ESRD education + conservative kidney management and ACP education: Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | ESRD Education + ACP | Total | Standard Pre-dialysis Education |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 76 years STANDARD_DEVIATION 6.06 | 76 years STANDARD_DEVIATION 6.06 | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | — |
| Region of Enrollment United States | 4 participants | 4 participants | — |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 4 |
| serious Total, serious adverse events | 0 / 0 | 0 / 4 |
Outcome results
Primary
Knowledge of Conservative Kidney Management and Advance Care Planning (Post-intervention)
Knowledge of conservative kidney management and advance care planning post-intervention (mean score) Total score ranges from 0 to 9, where 9 represents having the most knowledge about conservative kidney management and advance care planning
Time frame: Immediate post-intervention
Population: No participants were randomized to standard education. One enrolled participant did not complete the post-knowledge questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESRD Education + ACP | Knowledge of Conservative Kidney Management and Advance Care Planning (Post-intervention) | 8.67 score on a scale | Standard Deviation 0.58 |
Primary
Knowledge of Conservative Kidney Management and Advance Care Planning (Pre-intervention)
Knowledge of conservative kidney management and advance care planning pre-intervention (mean score) Total score ranges from 0 to 9, where 9 represents having the most knowledge about conservative kidney management and advance care planning
Time frame: Pre-intervention and Day 1 post-intervention
Population: No participants were randomized to standard education
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESRD Education + ACP | Knowledge of Conservative Kidney Management and Advance Care Planning (Pre-intervention) | 5.75 score on a scale | Standard Deviation 3.6 |