Reducing Low-value Care for Trauma Admissions

Trauma Injury Clinical Trial

Official title:

A Multifaceted Intervention to Reduce Low-value Care for Trauma Admissions: Evaluation of Effectiveness in a Pragmatic Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05744154
• Other study ID #: 113664
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: December 2026

Study information

• Verified date: February 2023
• Source: Laval University
• Contact: Lynne Moore, PhD
• Phone: 4186490252
• Email: lynne.moore[@]fmed.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In Canada, injury leads to more potential years of life lost and to greater costs than heart and stroke diseases combined. Furthermore, more than 50% of patients hospitalised following injury do not receive optimal care, 20% of injury deaths are estimated to be preventable, and significant variations in injury mortality and morbidity have been observed across trauma centers in Canada, the United Kingdom, Australia and the United States. Over the past decades, emphasis on adherence to evidence-based processes of care (rewards for doing more) and rapid innovation in imaging and therapeutic techniques has led to an exponential rise in unnecessary tests and procedures. Whole body computed tomography scan for single-system trauma is just one example. Low-value clinical practices, defined as "the common use of a particular intervention when the benefits don't justify the potential harm or cost" consume up to 30% of healthcare budgets. They expose patients to physical and psychological adverse events and put enormous pressure on healthcare budgets, thereby threatening accessible, universal health care. The objective of this research project is to evaluate the effectiveness of an intervention targeting reductions in low-value clinical practices for injury admissions. The results of this study should directly lead to improvements in the health systems across Canada and elsewhere. Medium and long-term advantages include an increase in healthcare efficiency and effectiveness, a reduction in costs, an increase in the availability of resources for patients who need them and a reduction in adverse events for patients hospitalized following injury.

Description:

RATIONALE: While simple Audit & Feedback (A&F) has shown modest effectiveness for reducing low-value care, there is a knowledge gap on the effectiveness of multifaceted interventions to support de-implementation efforts. Given the need to make rapid decisions in a context of multiple diagnostic and therapeutic options, trauma is a high-risk setting for low-value care. Furthermore, trauma systems are a favorable setting for de-implementation interventions as they have quality improvement teams with medical leadership, routinely collected clinical data, and performance linked to accreditation.

OBJECTIVES: We aim to evaluate the effectiveness of a multifaceted intervention for reducing low-value clinical practices in acute adult trauma care.

METHODS: We will conduct a pragmatic cluster randomized controlled trial. Level I-III trauma centers in an inclusive Canadian trauma system (n=29) will be randomized (1:1) to receive simple A&F (control) or a multifaceted intervention (intervention). The multifaceted intervention, developed using extensive background work and United Kingdom Medical Research Council guidelines for the Development of Complex Interventions, includes an A&F report, educational materials, virtual educational meetings, and virtual facilitation visits. The primary outcome will be patient-level use of low-value initial diagnostic imaging, assessed using routinely collected trauma registry data. Secondary outcomes will be low-value specialist consultation, low-value repeat imaging for transfers, unintended consequences, and Incremental Cost-Effectiveness Ratios.

IMPACT: This innovative, timely research project will advance knowledge on the incremental effectiveness of a multifaceted intervention over simple A&F to de-implement low-value care. The intervention has a high probability of success because it targets a problem identified by stakeholders, is based on extensive background work, is low-cost, and is linked to accreditation. This intervention has the potential to reduce the adverse effects and indirect expenses of low-value trauma care for patients and families. It could also free up resources, reduce delays to care, and decrease healthcare professionals' workload, at a time of unprecedented strain on healthcare resources.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 29
• Est. completion date: December 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria: All adult level I-III trauma centers in the Trauma Care Continuum of the province of Québec -

Exclusion Criteria: Level IV centers (patient volume too low)

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Related Conditions & MeSH terms

• Trauma Injury
• Wounds and Injuries

Intervention

Behavioral:
• Audit & feedback with educational outreach and facilitation
As in arm descriptions
• Simple audit & feedback (usual practice)
As in arm descriptions

Locations

Country	Name	City	State
Canada	Université Laval	Québec	Quebec

Sponsors (7)

Lead Sponsor	Collaborator
Laval University	Audit & Feedback Metalab, Choosing Wisely Canada, Health Standards Organisation, Institut national de la pertinence des actes médicaux, Institut national en santé et services sociaux, Trauma Association of Canada

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Abiala G, Berube M, Mercier E, Yanchar N, Stelfox HT, Archambault P, Bourgeois G, Belcaid A, Neveu X, Isaac CJ, Clement J, Lamontagne F, Moore L. Pre- and posttransfer computed tomography imaging in Canadian trauma centers: A multicenter retrospective cohort study. Acad Emerg Med. 2022 Sep;29(9):1084-1095. doi: 10.1111/acem.14536. Epub 2022 Jun 8. — View Citation

Berube M, Moore L, Tardif PA, Berry G, Belzile E, Lesieur M, Paquet J. Low-value injury care in the adult orthopaedic trauma population: A systematic review. Int J Clin Pract. 2021 Dec;75(12):e15009. doi: 10.1111/ijcp.15009. Epub 2021 Nov 30. — View Citation

Moore L, Berube M, Tardif PA, Lauzier F, Turgeon A, Cameron P, Champion H, Yanchar N, Lecky F, Kortbeek J, Evans D, Mercier E, Archambault P, Lamontagne F, Gabbe B, Paquet J, Razek T, Belcaid A, Berthelot S, Malo C, Lang E, Stelfox HT. Validation of Quality Indicators Targeting Low-Value Trauma Care. JAMA Surg. 2022 Sep 14;157(11):1008-16. doi: 10.1001/jamasurg.2022.3912. Online ahead of print. — View Citation

Moore L, Berube M, Tardif PA, Lauzier F, Turgeon A, Cameron P, Champion H, Yanchar N, Lecky F, Kortbeek J, Evans D, Mercier E, Archambault P, Lamontagne F, Gabbe B, Paquet J, Razek T, Stelfox HT; Low-Value Practices in Trauma Care Expert Consensus Group. Quality Indicators Targeting Low-Value Clinical Practices in Trauma Care. JAMA Surg. 2022 Jun 1;157(6):507-514. doi: 10.1001/jamasurg.2022.0812. — View Citation

Moore L, Lauzier F, Tardif PA, Boukar KM, Farhat I, Archambault P, Mercier E, Lamontagne F, Chasse M, Stelfox HT, Berthelot S, Gabbe B, Lecky F, Yanchar N, Champion H, Kortbeek J, Cameron P, Bonaventure PL, Paquet J, Truchon C, Turgeon AF; Canadian Traumatic brain injury Research Consortium. Low-value clinical practices in injury care: A scoping review and expert consultation survey. J Trauma Acute Care Surg. 2019 Jun;86(6):983-993. doi: 10.1097/TA.0000000000002246. — View Citation

Moore L, Tardif PA, Lauzier F, Berube M, Archambault P, Lamontagne F, Chasse M, Stelfox HT, Gabbe B, Lecky F, Kortbeek J, Lessard Bonaventure P, Truchon C, Turgeon AF. Low-Value Clinical Practices in Adult Traumatic Brain Injury: An Umbrella Review. J Neurotrauma. 2020 Dec 15;37(24):2605-2615. doi: 10.1089/neu.2020.7044. Epub 2020 Sep 30. — View Citation

Soltana K, Moore L, Bouderba S, Lauzier F, Clement J, Mercier E, Krouchev R, Tardif PA, Belcaid A, Stelfox T, Lamontagne F, Archambault P, Turgeon A; Canadian Traumatic Brain Injury Research Consortium. Adherence to Clinical Practice Guideline Recommendations on Low-Value Injury Care: A Multicenter Retrospective Cohort Study. Value Health. 2021 Dec;24(12):1728-1736. doi: 10.1016/j.jval.2021.06.008. Epub 2021 Aug 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	Proportion of patients admitted who die in hospital	18-month interval (6 to 24 months) after implementation
Other	Unplanned readmission	Proportion of patients discharged alive with an unplanned readmission within 30 days of discharge	18-month interval (6 to 24 months) after implementation
Other	Missed injuries	Proportion of patients admitted for whom an injury was missed in the emergency department and later detected as an inpatient	18-month interval (6 to 24 months) after implementation
Other	Hospital stay	Mean hospital length of stay in days for all hospital admissions	18-month interval (6 to 24 months) after implementation
Other	Intensive care unit stay	Mean intensive care unit stay in days for all patients admitted to the intensive care unit	18-month interval (6 to 24 months) after implementation
Other	Complications	Proportion of patients admitted with an event of deep vein thrombosis/pulmonary embolism, decubitus ulcers, delirium, pneumonia, or urinary tract infection during their in-patient stay	18-month interval (6 to 24 months) after implementation
Other	Incremental Cost-Effectiveness Ratios	Economic evaluation	0 to 24 months after implementation
Primary	Low-value initial diagnostic imaging	Proportion of low-risk patients who receive head, cervical spine or whole-body computed tomography in the emergency department	18-month interval (6 to 24 months) after implementation
Secondary	Low-value specialist consultation	Proportion of low-risk patients who receive neurosurgical or spine surgery consultation	18-month interval (6 to 24 months) after implementation
Secondary	Pre-transfer imaging	Proportion of patients with a clear indication to transfer who receive imaging in referral center	18-month interval (6 to 24 months) after implementation
Secondary	Repeat post-transfer imaging	Proportion of patients with imaging in referral center with no disease progression who are re-imaged in receiving center following transfer	18-month interval (6 to 24 months) after implementation