Clinical trial NCT05744154: Reducing Low-value Care for Trauma Admissions
Official title: A Multifaceted Intervention to Reduce Low-value Care for Trauma Admissions: Evaluation of Effectiveness in a Pragmatic Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma Injury
Keywords: Low-value care
Multifaceted intervention
De-implementation
Trauma system
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Institut national en santé et services sociaux
name: Trauma Association of Canada
name: Health Standards Organisation
name: Choosing Wisely Canada
name: Audit & Feedback Metalab
name: Institut national de la pertinence des actes médicaux
First posted: 2023-02-24
Enrollment: 29
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will conduct a parallel arm, pragmatic cluster randomized trial (CRT) embedded in the provincial trauma quality assurance program. As the trial will be based on routinely collected data that are available at no extra cost, we will use a baseline observation period pre-randomization to increase study power. We will randomize at the hospital level because quality programs operate at the local trauma committee level in each hospital. A stepped wedge design will not be used as the minimum one-year roll-out period is unacceptably long for stakeholders and parallel arm CRTs have fewer risks of bias than stepped wedge CRTs. The trial is pragmatic as the intervention will be embedded in the 2023 evaluation cycle of the provincial quality assurance program.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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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Primary outcomes:
measure: Low-value initial diagnostic imaging
timeFrame: 18-month interval (6 to 24 months) after implementation
Secondary outcomes:
measure: Low-value specialist consultation
timeFrame: 18-month interval (6 to 24 months) after implementation
measure: Pre-transfer imaging
timeFrame: 18-month interval (6 to 24 months) after implementation
measure: Repeat post-transfer imaging
timeFrame: 18-month interval (6 to 24 months) after implementation
Other outcomes:
measure: Mortality
timeFrame: 18-month interval (6 to 24 months) after implementation
measure: Unplanned readmission
timeFrame: 18-month interval (6 to 24 months) after implementation
measure: Missed injuries
timeFrame: 18-month interval (6 to 24 months) after implementation
measure: Hospital stay
timeFrame: 18-month interval (6 to 24 months) after implementation
measure: Intensive care unit stay
timeFrame: 18-month interval (6 to 24 months) after implementation
measure: Complications
timeFrame: 18-month interval (6 to 24 months) after implementation
measure: Incremental Cost-Effectiveness Ratios
timeFrame: 0 to 24 months after implementation
Locations:
city: Québec
country: Canada
facility: Université Laval
state: Quebec
Study officials:
References:
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.
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.
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.
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.
citation: 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.
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.
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.