Critical Care OptimizatIon of Albumin Ordering

NCT04187534 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50000

Last updated 2022-11-02

No results posted yet for this study

Summary

Strong evidence suggests that human albumin solutions should not be used for fluid resuscitation except among patients undergoing therapeutic plasmapheresis and select patients with complications of liver cirrhosis (i.e. spontaneous bacterial peritonitis, or large volume ascitic fluid removal). Previous work by the investigators reported albumin use outside these circumstances as a quality improvement opportunity in Alberta ICUs. In 2017, the investigators began a pilot initiative to reduce albumin overuse in 6 ICUs in Alberta. The intervention was developed according to the Theoretical Domains Framework, and consisted of establishing a clinical champion, educating clinicians, changing the process for albumin ordering (albumin-specific order sheet), and providing quarterly audit/feedback data to clinicians on albumin utilization. During the intervention, there was a 41% relative reduction in albumin utilization. However, follow-up data identified problems with sustainability. These sustainability challenges combined with data suggesting high albumin use in other ICUs throughout Alberta have led the current project to build on the pilot initiative to reduce albumin overuse within all adult ICUs in Alberta.

The proposed quality improvement intervention will be implemented in 16 adult ICUs using a registry-based, stepped-wedge implementation design that will lean heavily on existing Provincial healthcare infrastructure. The intervention was developed using the Theoretical Domains Framework, and tailored to the unique features of each participating ICU. It will be implemented at the level of ICU. Clusters of 2 ICUs will be assigned to receive the intervention every month such that all ICUs in Alberta will receive the intervention by the end of the implementation period. To evaluate the quality improvement initiative, eCritical will serve as a 'registry' and will be used to capture all clinical and outcome data. The primary outcome will be the proportion of ICU admissions without an evidence-based indication for albumin, prescribed at least 1 unit of albumin (any concentration) during admission to ICU. 'Evidence-based indication' will be operationally defined as receipt of therapeutic plasmapheresis OR having a diagnosis of liver cirrhosis and being in receipt of a paracentesis. This latter criterion enables identification of patients with spontaneous bacterial peritonitis or large volume ascitic fluid removal.

Conditions

  • Critical Illness

Interventions

OTHER

Albumin Fluid Resuscitation Optimization Intervention

Multi-faceted quality improvement intervention to optimize appropriateness of albumin use for fluid resuscitation

OTHER

Usual Practice

Albumin fluid resuscitation according to usual practice

Sponsors & Collaborators

  • Alberta Health services

    collaborator OTHER
  • University of Calgary

    lead OTHER

Principal Investigators

  • Daniel J Niven, MD, PhD · University of Calgary

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2022-01-21
Completion
2022-11-01

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04187534 on ClinicalTrials.gov