Clinical trial NCT07013175: WICH-ICU, a Cluster Randomized Registry Based Clinical Trial
Official title: WIse CHoices in the ICU, a Cluster Randomized Registry Based Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Critical Illness
Ventilation Therapy; Complications
Outcome, Fatal
Dialysis; Complications
Keywords: critical illness
choosing wisely
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Uppsala-Örebro Regional Research Council
name: Vastra Gotaland Region
name: Region Jönköping County
name: Region Skane
name: Region Stockholm
name: Sormland County Council, Sweden
First posted: 2025-06-10
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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, we 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.

Detailed description: Purpose and aims 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, we 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.

Survey of the field Investigations on mortality, ICU length of stay (LOS) or effect on organ support among critically ill patients after the introduction of the Choosing Wisely protocol are lacking. Evidence suggests that routine laboratory testing is associated with preventable harms, such as hospital-acquired anemia and further unnecessary testing(6).

Can we reduce unnecessary diagnostics? A Canadian single center before- and after study aimed at reducing (unnecessary diagnostic) phlebotomy in the ICU(7). They showed a decrease of 6.6mL/patient-day, blood tube consumption decreased, amounting to 13276 tubes saved over 11 months. Red blood cell transfusions decreased significantly.

Study design Research questions Can the Choosing Wisely protocol, specifically minimizing the number of arterial blood gases, -venous tests and -chest x-rays, be introduced safely in Swedish ICU's?

P: Adult patients treated in Swedish intensive care units.

I: The Choosing Wisely (CW) protocol, specifically minimizing the number of arterial blood gases, number of venous tests and number of chest x-rays

C: ICU care as of today, without the introduction of the CW protocol. Each ICU is its own and others' control.

O: Primary outcome: 30-day-mortality. Secondary outcomes: ICU length of stay, time in invasive/ non-invasive mechanical ventilation, time on continuous renal replacement therapy.

Variables and measures 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.

Outcomes from this R-RCT will be extracted using the Swedish Intensive care Register (SIR). These include the primary outcome, 30-day-mortality and secondary outcomes: ICU length of stay, time in invasive/non-invasive mechanical ventilation, time on continuous renal replacement therapy.

References

1. Costante A, Chen XK, Dudevich A, et al. Overuse of Tests and Treatments: Has Canada Made Progress? Healthc Q 2023;25(4):10-12. doi: 10.12927/hcq.2023.27024
2. Mafi JN, Reid RO, Baseman LH, et al. Trends in Low-Value Health Service Use and Spending in the US Medicare Fee-for-Service Program, 2014-2018. JAMA Netw Open 2021;4(2):e2037328. doi: 10.1001/jamanetworkopen.2020.37328 \[published Online First: 20210201\]
3. Shrank WH, Rogstad TL, Parekh N. Waste in the US Health Care System: Estimated Costs and Potential for Savings. JAMA 2019;322(15):1501-09. doi: 10.1001/jama.2019.13978
4. Halpern SD, Becker D, Curtis JR, et al. 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;190(7):818-26. doi: 10.1164/rccm.201407-1317ST
5. Zimmerman JJ, Harmon LA, Smithburger PL, et al. Choosing Wisely For Critical Care: The Next Five. Crit Care Med 2021;49(3):472-81. doi: 10.1097/CCM.0000000000004876
6. Salisbury AC, Reid KJ, Alexander KP, et al. Diagnostic blood loss from phlebotomy and hospital-acquired anemia during acute myocardial infarction. Arch Intern Med 2011;171(18):1646-53. doi: 10.1001/archinternmed.2011.361 \[published Online First: 20110808\]
7. Bodley T, Levi O, Chan M, et al. Reducing unnecessary diagnostic phlebotomy in intensive care: a prospective quality improvement intervention. BMJ Qual Saf 2023;32(8):485-94. doi: 10.1136/bmjqs-2022-015358 \[published Online First: 20230119\]

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients under the age of 18 years

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days after index ICU admission
Secondary outcomes:
measure: ICU length of stay
timeFrame: Up to one year after index ICU admission
measure: Time in invasive/ non-invasive mechanical ventilation
timeFrame: Up to one year after index ICU admission
measure: Time on continuous renal replacement therapy
timeFrame: Up to one year after index ICU admission
Other outcomes:
measure: ICU readmission
timeFrame: Within 72 hours of ICU discharge
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: N32276 PMI/Karolinska
name: Max B Bell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.