- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05744154
Reducing Low-value Care for Trauma Admissions
A Multifaceted Intervention to Reduce Low-value Care for Trauma Admissions: Evaluation of Effectiveness in a Pragmatic Cluster Randomized Controlled Trial
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lynne Moore, PhD
- Phone Number: 63366 4186490252
- Email: lynne.moore@fmed.ulaval.ca
Study Contact Backup
- Name: Mélanie Bérubé, PhD
- Phone Number: 66600 4186490252
- Email: melanie.berube@fsi.ulaval.ca
Study Locations
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Quebec
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Québec, Quebec, Canada
- Universite Laval
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Audit & feedback with educational outreach and facilitation
The intervention includes: 1) refinement with end users, 2) an A&F report sent to local governing authorities presenting for each practice: performance compared to peers (simple A&F), a summary message indicating if action is required and a list of potential actions, 3) educational materials (a clinical vignette; consequences of the practice; links to practice guidelines, clinical decision rules and shared decision-making tools; a case review tool), 4) virtual educational meetings with the local trauma Medical Director, trauma program manager and data analyst, and 5) two virtual facilitation visits 2 and 4 months after the transmission of the report to support committees in preparing their action plan.
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As in arm descriptions
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Other: Simple audit & feedback
The control arm will receive the quality improvement intervention currently in place in the Québec Trauma Care Continuum (i.e.
simple A&F report presenting their performance compared to peers on quality indicators measuring adherence to high-value care and risk-adjusted outcomes) with the addition of quality indicators on low-value care (already planned by provincial authorities for the 2023 evaluation cycle).
Simple A&F was chosen for the control because it is standard practice in Québec and in most integrated trauma systems and the effectiveness of A&F for de-implementation has been documented.
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As in arm descriptions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low-value initial diagnostic imaging
Time Frame: 18-month interval (6 to 24 months) after implementation
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Proportion of low-risk patients who receive head, cervical spine or whole-body computed tomography in the emergency department
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18-month interval (6 to 24 months) after implementation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low-value specialist consultation
Time Frame: 18-month interval (6 to 24 months) after implementation
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Proportion of low-risk patients who receive neurosurgical or spine surgery consultation
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18-month interval (6 to 24 months) after implementation
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Pre-transfer imaging
Time Frame: 18-month interval (6 to 24 months) after implementation
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Proportion of patients with a clear indication to transfer who receive imaging in referral center
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18-month interval (6 to 24 months) after implementation
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Repeat post-transfer imaging
Time Frame: 18-month interval (6 to 24 months) after implementation
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Proportion of patients with imaging in referral center with no disease progression who are re-imaged in receiving center following transfer
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18-month interval (6 to 24 months) after implementation
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 18-month interval (6 to 24 months) after implementation
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Proportion of patients admitted who die in hospital
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18-month interval (6 to 24 months) after implementation
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Unplanned readmission
Time Frame: 18-month interval (6 to 24 months) after implementation
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Proportion of patients discharged alive with an unplanned readmission within 30 days of discharge
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18-month interval (6 to 24 months) after implementation
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Missed injuries
Time Frame: 18-month interval (6 to 24 months) after implementation
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Proportion of patients admitted for whom an injury was missed in the emergency department and later detected as an inpatient
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18-month interval (6 to 24 months) after implementation
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Hospital stay
Time Frame: 18-month interval (6 to 24 months) after implementation
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Mean hospital length of stay in days for all hospital admissions
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18-month interval (6 to 24 months) after implementation
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Intensive care unit stay
Time Frame: 18-month interval (6 to 24 months) after implementation
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Mean intensive care unit stay in days for all patients admitted to the intensive care unit
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18-month interval (6 to 24 months) after implementation
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Complications
Time Frame: 18-month interval (6 to 24 months) after implementation
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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
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18-month interval (6 to 24 months) after implementation
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Incremental Cost-Effectiveness Ratios
Time Frame: 0 to 24 months after implementation
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Economic evaluation
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0 to 24 months after implementation
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 113664
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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