Critical Care OptimizatIon of Albumin Ordering (RATIONALE)

Critical Care Optimization of Albumin Ordering

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: Albumin Fluid Resuscitation Optimization Intervention; Other: Usual Practice

Detailed Description

BACKGROUND: 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 overuse of albumin fluid resuscitation as a stakeholder-identified quality improvement opportunity in Alberta ICUs. Audit data from the provincial electronic medical record (EMR) for critical care, eCritical, reinforced stakeholder opinion and demonstrated that within Alberta ICUs in 2016 a considerable amount of albumin use deviated from evidence-based indications. On average, 14% of admissions to adult ICUs received at least one albumin unit during their ICU admission, with several high-use units providing albumin to between 20% and 35% of admissions. In 2017 the investigators began a pilot quality improvement initiative to reduce albumin overuse in six ICUs in Alberta. The intervention was developed according to the Theoretical Domains Framework. Questionnaires completed by clinicians working in the target ICU identified local culture and opinion of clinical leaders as barriers, and education, order sets, and clinical champions as facilitators to reducing albumin use. The intervention thus consisted of establishing a clinical champion, educating clinicians, changing the process for albumin through development of an albumin order sheet, and providing quarterly unit-level audit/feedback data to clinicians on albumin utilization. There was a 41% reduction in albumin utilization, however follow-up data identified problems with sustainability. The current project will build on the pilot initiative to implement a quality improvement intervention to reduce albumin overuse within all adult ICUs in Alberta.

OBJECTIVE: Evaluate albumin reduction within all adult ICUs in Alberta.

METHODS: This will be a registry-based, stepped-wedge quality improvement initiative.

Quality Improvement Initiative: Spread to 16 adult ICUs in Alberta will require understanding and adapting the investigators pilot intervention to local barriers and facilitators. The intervention for this quality improvement initiative will be developed using the Theoretical Domains Framework. The research team will develop working groups responsible for tailoring the intervention and implementation strategy to each participating ICU. This will be conducted as part of the Province-wide quality improvement initiative. The investigators will conduct the quality improvement initiative using a registry-based, stepped-wedge, implementation trial. Owing to the nature of this design, the interventions 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.

Registry-based data analysis: To evaluate this quality improvement initiative, the Provincial EMR for critical care, eCritical, will serve as a 'registry' and will be used to capture all clinical and outcome data. Data will be collected until patient death or hospital discharge and censored at 60 days. To optimize efficiency and power, data will be collected 3-months before and after implementation of the interventions.

SETTING: 16 adult ICUs in Alberta's critical care strategic clinical network reflecting teaching/non-teaching and urban/rural hospitals will participate.

STUDY POPULATION: All adult patients (>18 years) admitted to the study ICUs during the study period (November 2019 to January 2021). Study ICUs will include 14 general medical-surgical ICUs, and 2 cardiovascular surgery ICUs.

OUTCOMES: The primary outcome of this study will be the proportion of ICU patients 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 either spontaneous bacterial peritonitis or large volume ascitic fluid removal. This outcome was selected because: 1) there is precedent within current literature; 2) previous experience auditing albumin utilization in Alberta ICUs demonstrate it is available through eCritical; 3) it provides a relevant, broadly understandable estimate of the effect of the implementation science intervention to change albumin overuse; and 4) it permits assessment of the feasibility of implementing the platform to develop and carry out multi-stakeholder implementation science interventions to promote evidence-informed clinical practices and evaluate the intervention.

• Study Type: Interventional
• Enrollment (Actual): 50000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre
    • Calgary, Alberta, Canada, T1Y 6J4
      • Peter Lougheed Centre
    • Calgary, Alberta, Canada, T2V 1P9
      • Rockyview General Hospital
    • Calgary, Alberta, Canada, T3M 1M4
      • South Health Campus
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital
    • Edmonton, Alberta, Canada, T5R 4H5
      • Misericordia Community Hospital
    • Edmonton, Alberta, Canada, T4N 4E7
      • Mazankowski Heart Institute
    • Edmonton, Alberta, Canada, T6L 5X8
      • Grey Nun's Hospital
    • Fort McMurray, Alberta, Canada, T9H 1P2
      • Northern Lights Regional Health Centre
    • Grande Prairie, Alberta, Canada, T8V 2E8
      • Queen Elizabeth II Hospital
    • Lethbridge, Alberta, Canada, T1J 1W5
      • Chinook Regional Hospital
    • Medicine Hat, Alberta, Canada, T1A 4H6
      • Medicine Hat Regional Hospital
    • Red Deer, Alberta, Canada, T4N 4E7
      • Red Deer Regional Hospital Centre
    • St. Albert, Alberta, Canada, T8N 6C4
      • Sturgeon Community Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All adult patients admitted to the study ICUs

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Albumin Fluid Resuscitation Optimization Intervention; 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; Multi-faceted quality improvement intervention to optimize appropriateness of albumin use for fluid resuscitation
ACTIVE_COMPARATOR: Usual Practice; 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; Albumin fluid resuscitation according to usual practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean number of albumin units among those receiving albumin	Mean number of albumin units prescribed to patients without an evidence-based indication for albumin that received at least 1 unit of albumin	During ICU admission
Total fluid administration	Total volume of fluid administered during days 1-7 in ICU	ICU day 7
Total crystalloid fluid	Total volume of crystalloid fluid administered during days 1-7 in ICU	ICU Day 7
Duration of vasopressor administration	Number of days vasopressors administered during ICU length of stay	From date of ICU admission to date of discharge, on average 1-6 days
Length of mechanical ventilation	Number of days on mechanical ventilation from time of starting mechanical ventilation during ICU length of stay	From date mechanical ventilation commended to date discontinued, on average 0-3 days
ICU length of stay	Number of days admitted to ICU (unique number per admission)	From date of ICU admission to date of discharge, on average 1-6 days
Hospital length of stay	Number of days admitted to hospital (unique number per admission)	From date of hospital admission to date of discharge, on average 5-20 days
ICU mortality	Survival to discharge from ICU	From date of ICU admission to date of discharge, on average 1-6 days
Hospital mortality	Survival to discharge from hospital	From date of hospital admission to date of discharge, on average 5-20 days

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Alberta Health services
• Investigators: Principal Investigator: Daniel J Niven, MD, PhD, University of Calgary

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 25, 2019
• Primary Completion (ACTUAL): January 21, 2022
• Study Completion (ACTUAL): November 1, 2022

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (ACTUAL): December 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: fluid resuscitation; Albumin; de-adoption; de-implementation; low-value care
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 19-1143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No