Acute Kidney Injury Standardized Clinical Assessment and Management Plan for Renal Replacement Initiation
Primary Purpose
Acute Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care delivery algorithim
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury
Eligibility Criteria
Inclusion Criteria:
- Acute kidney injury, followed by nephrology consult service
- Intensive care unit
Exclusion Criteria:
- End stage renal disease
- Renal replacement therapy for advanced chronic kidney disease rather than acute kidney injury.
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SCAMP arm
Control arm "SHAM SCAMP
Arm Description
The SCAMP is a clinical decision support tool. See Mendu et al. CJASN 2017.
The control arm will be a form that asks questions about indications for renal replacement therapy but does not provide suggestions about when to initiate renal replacement therapy, as is being done in the active SCAMP arm. The goal of the control group is to test whether the SCAMP clinical decision support influences provider practice patterns and improves care.
Outcomes
Primary Outcome Measures
Mortality
Mortality
Secondary Outcome Measures
Full Information
NCT ID
NCT03368183
First Posted
November 14, 2017
Last Updated
August 8, 2022
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03368183
Brief Title
Acute Kidney Injury Standardized Clinical Assessment and Management Plan for Renal Replacement Initiation
Official Title
Acute Kidney Injury Standardized Clinical Assessment and Management Plan for Renal Replacement Initiation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
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 study is of a clinical decision support tool for clinicians taking care of patients with severe acute kidney injury in the intensive care unit. Nephrologists will be given a standardized clinical assessment and management plan (SCAMP), which is a tool to assist clinicians in decision making on the need for renal replacement therapy (Mendu et al., CJASN 2017). In alternating months, nephrologists will be given the SCAMP vs. another simplified form. The goal is to test whether patients whose clinicians are asked to fill out the SCAMP have improved outcomes compared to the control group. The investigators are also collecting information about provider adherence to the SCAMP and deviations from the SCAMP recommendations to understand clinical decision making related to renal replacement.
Detailed Description
Background: Acute Kidney Injury (AKI) is common among critically ill patients and is associated with substantial morbidity and mortality. Severe AKI requiring renal replacement therapy (RRT) is associated with in-hospital mortality rates exceeding 40%. The investigators designed and implemented an AKI Standardized Clinical Assessment and Management Plan (SCAMP), a decision-making algorithm to assist front-line nephrologists caring for patients with AKI. The investigators piloted the implementation of the AKI SCAMP in the medical intensive care unit at Brigham and Women's Hospital prospectively over the course of 1-year, and illustrated that patients whose nephrologists adhered to the SCAMP recommendations had lower in-hospital mortality. The investigators have a publication in press in the Clinical Journal of the American Society of Nephrology detailing our findings (Mendu et al. CJASN January 2017).
Aims: The primary aim of this study is to expand the prospective implementation of the AKI SCAMP to multiple intensive care units (ICUs) at Brigham and Women's Hospital in an interrupted time series study (nephrologists will be asked to complete the AKI SCAMP alternate months). The investigators aim to test the hypothesis generated by our pilot study, that the utilization of an AKI SCAMP by providers in a critical care setting can reduce in-hospital mortality. Expanding to multiple ICUs and introducing a time series design will mitigate the limitations of our pilot data, such as a small sample size and confounding by disease severity.
Design: The investigators seek to conduct a prospective interrupted time series study of the implementation of an AKI SCAMP utilized by nephrologists in intensive care units during the time period of 1 year to determine if utilization of the AKI SCAMP reduces in-hospital mortality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
In alternating months providers will be given the SCAMP vs. a shorter forms that does not include clinical decision support
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SCAMP arm
Arm Type
Experimental
Arm Description
The SCAMP is a clinical decision support tool. See Mendu et al. CJASN 2017.
Arm Title
Control arm "SHAM SCAMP
Arm Type
Active Comparator
Arm Description
The control arm will be a form that asks questions about indications for renal replacement therapy but does not provide suggestions about when to initiate renal replacement therapy, as is being done in the active SCAMP arm. The goal of the control group is to test whether the SCAMP clinical decision support influences provider practice patterns and improves care.
Intervention Type
Other
Intervention Name(s)
Care delivery algorithim
Intervention Description
SCAMP
Primary Outcome Measure Information:
Title
Mortality
Description
Mortality
Time Frame
60 day (or in hospital mortality)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute kidney injury, followed by nephrology consult service
Intensive care unit
Exclusion Criteria:
End stage renal disease
Renal replacement therapy for advanced chronic kidney disease rather than acute kidney injury.
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34911731
Citation
Kelly YP, Mistry K, Ahmed S, Shaykevich S, Desai S, Lipsitz SR, Leaf DE, Mandel EI, Robinson E, McMahon G, Czarnecki PG, Charytan DM, Waikar SS, Mendu ML. Controlled Study of Decision-Making Algorithms for Kidney Replacement Therapy Initiation in Acute Kidney Injury. Clin J Am Soc Nephrol. 2022 Feb;17(2):194-204. doi: 10.2215/CJN.02060221. Epub 2021 Dec 15.
Results Reference
derived
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Acute Kidney Injury Standardized Clinical Assessment and Management Plan for Renal Replacement Initiation
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