Critical Care OptimizatIon of Albumin Ordering

NCT04187534 | Completed

• 1 other identifier: 19-1143
• Study Type: interventional
• Target: 50,000
• Locations: 1 country
• Sites: 15

Brief 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

Keywords

Albumin; fluid resuscitation; de-adoption; de-implementation; low-value care

Outcome Measures

Primary Outcomes (1)

• Proportion of ICU admissions receiving albumin

  Proportion of ICU admissions without an evidence-based indication for albumin prescribed at least 1 unit of albumin (any concentration) during admission to ICU

  During ICU admission

Secondary Outcomes (9)

• Mean number of albumin units among those receiving albumin

  During ICU admission

• Total fluid administration

  ICU day 7

• Total crystalloid fluid

  ICU Day 7

• Duration of vasopressor administration

  From date of ICU admission to date of discharge, on average 1-6 days

• Length of mechanical ventilation

  From date mechanical ventilation commended to date discontinued, on average 0-3 days

Study Arms (2)

Albumin Fluid Resuscitation Optimization Intervention

EXPERIMENTAL

Our quality improvement intervention seeking to improve appropriate use and reduce inappropriate use of albumin for fluid resuscitation will consist of establishing a clinical champion, educating clinicians, changing the process for albumin ordering through development of an albumin order sheet, and providing quarterly unit-level audit/feedback data to clinicians on albumin utilization.

Other: Albumin Fluid Resuscitation Optimization Intervention

Usual Practice

ACTIVE COMPARATOR

Stepped-wedge roll out of 'Albumin Fluid Resuscitation Optimization Intervention' will permit those ICUs wherein intervention has not yet been implemented to serve as controls. These ICUs will prescribe albumin according to usual practice and not be exposed to any components of the intervention.

Other: Usual Practice

Interventions

Albumin Fluid Resuscitation Optimization Intervention OTHER

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

Albumin Fluid Resuscitation Optimization Intervention

Usual Practice OTHER

Albumin fluid resuscitation according to usual practice

Usual Practice

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients admitted to the study ICUs

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator

Study Sites (15)

Peter Lougheed Centre

Calgary, Alberta, T1Y 6J4, Canada

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Rockyview General Hospital

Calgary, Alberta, T2V 1P9, Canada

Location

South Health Campus

Calgary, Alberta, T3M 1M4, Canada

Location

Mazankowski Heart Institute

Edmonton, Alberta, T4N 4E7, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Misericordia Community Hospital

Edmonton, Alberta, T5R 4H5, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Grey Nun's Hospital

Edmonton, Alberta, T6L 5X8, Canada

Location

Northern Lights Regional Health Centre

Fort McMurray, Alberta, T9H 1P2, Canada

Location

Queen Elizabeth II Hospital

Grande Prairie, Alberta, T8V 2E8, Canada

Location

Chinook Regional Hospital

Lethbridge, Alberta, T1J 1W5, Canada

Location

Medicine Hat Regional Hospital

Medicine Hat, Alberta, T1A 4H6, Canada

Location

Red Deer Regional Hospital Centre

Red Deer, Alberta, T4N 4E7, Canada

Location

Sturgeon Community Hospital

St. Albert, Alberta, T8N 6C4, Canada

Location

Related Publications (1)

• Sauro K, Bagshaw SM, Niven D, Soo A, Brundin-Mather R, Parsons Leigh J, Cook DJ, Stelfox HT. Barriers and facilitators to adopting high value practices and de-adopting low value practices in Canadian intensive care units: a multimethod study. BMJ Open. 2019 Mar 15;9(3):e024159. doi: 10.1136/bmjopen-2018-024159.

  PMID: 30878979 RESULT

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel J Niven, MD, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Registry-based, stepped-wedge, implementation trial

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 5, 2019
• Study Start: November 25, 2019
• Primary Completion: January 21, 2022
• Study Completion: November 1, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (15)