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Critical IllnessRATIONALENCT04187534

Critical Care OptimizatIon of Albumin Ordering

A study testing Albumin Fluid Resuscitation Optimization Intervention and Usual Practice in people with Critical Illness, run by University of Calgary at 15 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Critical Illness
What is being tested?
Albumin Fluid Resuscitation Optimization Intervention and Usual Practice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50,000 participants
Where
15 sitesCanada
Study dates
25 Nov 2019to 1 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All adult patients admitted to the study ICUs

Who cannot join

  • -

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Canada15 sites
  • Peter Lougheed Centre

    Calgary, Alberta, T1Y 6J4

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • Rockyview General Hospital

    Calgary, Alberta, T2V 1P9

  • South Health Campus

    Calgary, Alberta, T3M 1M4

  • Mazankowski Heart Institute

    Edmonton, Alberta, T4N 4E7

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • Misericordia Community Hospital

    Edmonton, Alberta, T5R 4H5

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Grey Nun's Hospital

    Edmonton, Alberta, T6L 5X8

  • Northern Lights Regional Health Centre

    Fort McMurray, Alberta, T9H 1P2

  • Queen Elizabeth II Hospital

    Grande Prairie, Alberta, T8V 2E8

  • Chinook Regional Hospital

    Lethbridge, Alberta, T1J 1W5

  • Medicine Hat Regional Hospital

    Medicine Hat, Alberta, T1A 4H6

  • Red Deer Regional Hospital Centre

    Red Deer, Alberta, T4N 4E7

  • Sturgeon Community Hospital

    St. Albert, Alberta, T8N 6C4

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Albumin Fluid Resuscitation Optimization Intervention, Usual Practice
Keywords
Albumin, fluid resuscitation, de-adoption, de-implementation, low-value care
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Albumin Fluid Resuscitation Optimization InterventionOther

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

  • Usual PracticeOther

    Albumin fluid resuscitation according to usual practice

Study groups in NCT04187534
Study groupRoleWhat they receive
Albumin Fluid Resuscitation Optimization InterventionExperimentalOur 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.
Receives: Other: Albumin Fluid Resuscitation Optimization Intervention
Usual PracticeActive comparatorStepped-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.
Receives: Other: Usual Practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: During ICU admission

Secondary outcomes (9)
  1. 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

    Measured: During ICU admission

  2. Total fluid administration

    Total volume of fluid administered during days 1-7 in ICU

    Measured: ICU day 7

  3. Total crystalloid fluid

    Total volume of crystalloid fluid administered during days 1-7 in ICU

    Measured: ICU Day 7

  4. Duration of vasopressor administration

    Number of days vasopressors administered during ICU length of stay

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

  5. Length of mechanical ventilation

    Number of days on mechanical ventilation from time of starting mechanical ventilation during ICU length of stay

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

  6. ICU length of stay

    Number of days admitted to ICU (unique number per admission)

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

  7. Hospital length of stay

    Number of days admitted to hospital (unique number per admission)

    Measured: From date of hospital admission to date of discharge, on average 5-20 days

  8. ICU mortality

    Survival to discharge from ICU

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

  9. Hospital mortality

    Survival to discharge from hospital

    Measured: From date of hospital admission to date of discharge, on average 5-20 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2019
  2. Study start25 Nov 2019
  3. Primary completion21 Jan 2022
  4. Study completion1 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Sequential
Model description
Registry-based, stepped-wedge, implementation trial
Masking
None (open label)
Enrolment
50,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04187534
Sponsor's protocol ID
19-1143
Acronym
RATIONALE
Status last verified
Oct 2022
First submitted
26 Nov 2019
Last updated
2 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 30878979

Questions about this trial

What is this clinical trial studying?

A study testing Albumin Fluid Resuscitation Optimization Intervention and Usual Practice in people with Critical Illness, run by University of Calgary at 15 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of ICU admissions receiving albumin (time frame: During ICU admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04187534, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.

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