Acute Kidney Injury Standardized Clinical Assessment and Management Plan for Renal Replacement Initiation

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03368183
• Collaborator: (none)
• Enrollment: 224
• Location: 1
• Arms: 2
• Actual Duration (Months): 56
• Patients Per Site Per Month: 4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Other: Care delivery algorithim	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 224 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: In alternating months providers will be given the SCAMP vs. a shorter forms that does not include clinical decision supportIn alternating months providers will be given the SCAMP vs. a shorter forms that does not include clinical decision support
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Acute Kidney Injury Standardized Clinical Assessment and Management Plan for Renal Replacement Initiation
• Actual Study Start Date: Jul 1, 2017
• Actual Primary Completion Date: Feb 28, 2022
• Actual Study Completion Date: Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SCAMP arm The SCAMP is a clinical decision support tool. See Mendu et al. CJASN 2017.	Other: Care delivery algorithim; SCAMP
Active Comparator: Control arm "SHAM SCAMP 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.	Other: Care delivery algorithim; SCAMP

Outcome Measures

Primary Outcome Measures

1. Mortality [60 day (or in hospital mortality)]

   Mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sushrut S Waikar, Associate Professor of Medicine, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT03368183
• Other Study ID Numbers: 99904021983
• First Posted: Dec 11, 2017
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Kidney Injury; Wounds and Injuries

Study Results

No Results Posted as of Aug 10, 2022