NCT07013175

Brief Summary

Aim: to evaluate if the Choosing Wisely campaign can be introduced without harming critically ill patients. Background: Each year, around 45,000 patients are admitted to Sweden's 81 ICUs (intensive care units), costing 6-7 billion SEK (6% of total healthcare expenditure). The high costs of health care are partly attributable to overuse of diagnostic tests. Up to 30% of these tests lead to treatments that provide no benefit for patients, some of them may even be harmful(1-3). To improve quality of care while combating this problem of cost, the American Board of Internal Medicine Foundation developed the Choosing Wisely Campaign, tasking professional societies to develop lists of top five medical services patients and physicians should question. Patients in the ICU, can especially benefit from this paradigm shift. They are subjected to multiple testing on a daily - sometimes hourly - basis, therefore this field of medicine responded to the campaign quickly. Two sets of top-five-lists of tests and interventions that can be questioned have been published(4 5). In multiple countries, including Sweden, the Choosing Wisely campaign is gathering traction among critical care physicians and is on the verge of being introduced. It is both common-sensical and will save money, so health care leaders are positive. However, the investigators have an opportunity, and a duty, to assess the evidence; can the Choosing Wisely campaign be introduced without harming ICU patients? The present study thus aims to evaluate the introduction of the Choosing Wisely campaign in the context of the ICU. Is this change of care strategy associated with changes in 30-day-mortality? Secondary outcomes include ICU length of stay, use of non-invasive- or invasive mechanical ventilation and continuous renal replacement therapy. This is a registry-based cluster randomized controlled study (R-RCT), targeting Swedish ICU's across multiple regions. Primary and secondary outcomes will be retrieved from the Swedish Intensive care Register (SIR), making ICU participation easier and less costly.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Nov 2025Dec 2027

First Submitted

Initial submission to the registry

June 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

November 3, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

June 2, 2025

Last Update Submit

November 24, 2025

Conditions

Keywords

critical illnesschoosing wisely

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    Death within 30 days of ICU admission

    30 days after index ICU admission

Secondary Outcomes (4)

  • ICU length of stay

    Up to one year after index ICU admission

  • Time in invasive/ non-invasive mechanical ventilation

    Up to one year after index ICU admission

  • Time on continuous renal replacement therapy

    Up to one year after index ICU admission

  • ICU readmission

    72 hours post ICU discharge

Other Outcomes (1)

  • ICU readmission

    Within 72 hours of ICU discharge

Study Arms (2)

Choosing wisely intervention

ACTIVE COMPARATOR

The Choosing Wisely (CW) protocol in the critical care setting; specifically minimizing the number of arterial blood gases, number of venous tests and number of chest x-rays

Procedure: Choosing wisely protocol

Choosing wisely control

NO INTERVENTION

Regular critical care

Interventions

Se arm description

Choosing wisely intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years or older, treated in Swedish ICU's

You may not qualify if:

  • Patients under the age of 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karolinska University Hospital

Stockholm, 171 76, Sweden

RECRUITING

Karolinska Institutet

Stockholm, Sweden

RECRUITING

Related Publications (7)

  • Costante A, Chen XK, Dudevich A, Dennis Christy A, Francis L, Chui C. Overuse of Tests and Treatments: Has Canada Made Progress? Healthc Q. 2023 Jan;25(4):10-12. doi: 10.12927/hcq.2023.27024.

    PMID: 36826234BACKGROUND
  • Mafi JN, Reid RO, Baseman LH, Hickey S, Totten M, Agniel D, Fendrick AM, Sarkisian C, Damberg CL. Trends in Low-Value Health Service Use and Spending in the US Medicare Fee-for-Service Program, 2014-2018. JAMA Netw Open. 2021 Feb 1;4(2):e2037328. doi: 10.1001/jamanetworkopen.2020.37328.

    PMID: 33591365BACKGROUND
  • Shrank WH, Rogstad TL, Parekh N. Waste in the US Health Care System: Estimated Costs and Potential for Savings. JAMA. 2019 Oct 15;322(15):1501-1509. doi: 10.1001/jama.2019.13978.

    PMID: 31589283BACKGROUND
  • Halpern SD, Becker D, Curtis JR, Fowler R, Hyzy R, Kaplan LJ, Rawat N, Sessler CN, Wunsch H, Kahn JM; Choosing Wisely Taskforce; American Thoracic Society; American Association of Critical-Care Nurses; Society of Critical Care Medicine. An official American Thoracic Society/American Association of Critical-Care Nurses/American College of Chest Physicians/Society of Critical Care Medicine policy statement: the Choosing Wisely(R) Top 5 list in Critical Care Medicine. Am J Respir Crit Care Med. 2014 Oct 1;190(7):818-26. doi: 10.1164/rccm.201407-1317ST.

    PMID: 25271745BACKGROUND
  • Zimmerman JJ, Harmon LA, Smithburger PL, Chaykosky D, Heffner AC, Hravnak M, Kane JM, Kayser JB, Lane-Fall MB, Matos RI, Mauricio RV, Murphy DJ, Nurok M, Reddy AJ, Ringle E, Seferian EG, Smalls-Mantey NM, To KB, Kaplan LJ. Choosing Wisely For Critical Care: The Next Five. Crit Care Med. 2021 Mar 1;49(3):472-481. doi: 10.1097/CCM.0000000000004876.

    PMID: 33555779BACKGROUND
  • Salisbury AC, Reid KJ, Alexander KP, Masoudi FA, Lai SM, Chan PS, Bach RG, Wang TY, Spertus JA, Kosiborod M. Diagnostic blood loss from phlebotomy and hospital-acquired anemia during acute myocardial infarction. Arch Intern Med. 2011 Oct 10;171(18):1646-53. doi: 10.1001/archinternmed.2011.361. Epub 2011 Aug 8.

    PMID: 21824940BACKGROUND
  • Bodley T, Levi O, Chan M, Friedrich JO, Hicks LK. Reducing unnecessary diagnostic phlebotomy in intensive care: a prospective quality improvement intervention. BMJ Qual Saf. 2023 Aug;32(8):485-494. doi: 10.1136/bmjqs-2022-015358. Epub 2023 Jan 19.

    PMID: 36657786BACKGROUND

MeSH Terms

Conditions

Critical IllnessRespiratory AspirationAcute Kidney Injury

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Max B Bell, MD, PhD

    N32276 PMI/Karolinska

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: There are two phases in this block randomized stepped-wedge ICU study, the control phase and the intervention phase. All participating ICU's start with a control period. During this phase, clinical monitors assess the number of arterial blood gases, -venous tests and number of chest x-rays performed at the ICU. This monitoring will assess all patients treated during a week and report tests per patient per day. As ICU's are randomized to the intervention phase the same clinical monitoring will be performed. Importantly, after six- and 12 months (irrespective of randomization allocation, if the ICU is still in the control- or intervention phase), the clinical monitor will re-assess the testing/diagnostic metrics.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 2, 2025

First Posted

June 10, 2025

Study Start

November 3, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

This study uses data on a block level from participating ICUs; therefore it is not feasible to share IPD, but we may opt to share other information

Locations