Reducing Low-value Care for Trauma Admissions

NCT05744154 | Not Yet Recruiting

• 1 other identifier: 113664
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma Injury

Keywords

Low-value care; Multifaceted intervention; De-implementation; Trauma system

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Low-value specialist consultation

  18-month interval (6 to 24 months) after implementation

• Pre-transfer imaging

  18-month interval (6 to 24 months) after implementation

• Repeat post-transfer imaging

  18-month interval (6 to 24 months) after implementation

Other Outcomes (7)

• Mortality

  18-month interval (6 to 24 months) after implementation

• Unplanned readmission

  18-month interval (6 to 24 months) after implementation

• Missed injuries

  18-month interval (6 to 24 months) after implementation

Study Arms (2)

Audit & feedback with educational outreach and facilitation

EXPERIMENTAL

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.

Behavioral: Audit & feedback with educational outreach and facilitation

Simple audit & feedback

OTHER

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.

Behavioral: Simple audit & feedback (usual practice)

Interventions

Audit & feedback with educational outreach and facilitation BEHAVIORAL

As in arm descriptions

Audit & feedback with educational outreach and facilitation

Simple audit & feedback (usual practice) BEHAVIORAL

As in arm descriptions

Simple audit & feedback

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Laval University: lead
• Institut national en santé et services sociaux: collaborator
• Trauma Association of Canada: collaborator
• Health Standards Organisation: collaborator
• Choosing Wisely Canada: collaborator
• Audit & Feedback Metalab: collaborator
• Institut national de la pertinence des actes médicaux: collaborator

Study Sites (1)

Université Laval

Québec, Quebec, Canada

Location

Related Publications (9)

• 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.

  PMID: 35476055 BACKGROUND

• 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.

  PMID: 36103195 BACKGROUND

• 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.

  PMID: 31124896 BACKGROUND

• 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.

  PMID: 34838270 BACKGROUND

• 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.

  PMID: 35612384 BACKGROUND

• 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.

  PMID: 32791886 BACKGROUND

• 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.

  PMID: 34816530 BACKGROUND

• Berube M, Lapierre A, Sykes M, Grimshaw J, Turgeon AF, Lauzier F, Taljaard M, Stelfox HT, Witteman H, Berthelot S, Mercier E, Gonthier C, Paquet J, Fowler R, Yanchar N, Haas B, Lessard-Bonaventure P, Archambault P, Gabbe B, Guertin JR, Ouyang Y, Moore L; Canadian Traumatic Brain Injury Research Consortium. Development and usability testing of a multifaceted intervention to reduce low-value injury care. BMC Health Serv Res. 2025 Jan 7;25(1):37. doi: 10.1186/s12913-024-12153-y.

  PMID: 39773251 DERIVED

• Moore L, Berube M, Belcaid A, Turgeon AF, Taljaard M, Fowler R, Yanchar N, Mercier E, Paquet J, Stelfox HT, Archambault P, Berthelot S, Guertin JR, Haas B, Ivers N, Grimshaw J, Lapierre A, Ouyang Y, Sykes M, Witteman H, Lessard-Bonaventure P, Gabbe B, Lauzier F; Canadian Traumatic Brain Injury Research Consortium (CTRC). Evaluating the effectiveness of a multifaceted intervention to reduce low-value care in adults hospitalized following trauma: a protocol for a pragmatic cluster randomized controlled trial. Implement Sci. 2023 Jul 7;18(1):27. doi: 10.1186/s13012-023-01279-y.

  PMID: 37420284 DERIVED

MeSH Terms

Conditions

Accidental Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Lynne Moore, PhD

CONTACT

4186490252; lynne.moore@fmed.ulaval.ca

Mélanie Bérubé, PhD

CONTACT

4186490252; melanie.berube@fsi.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Local trauma committees will not be told explicitly what aspect of the intervention is randomised; they will only be aware that there are two variations of the intervention. Data extractors and analysts will be blinded to group allocation. Due to the nature of the intervention, it will not be possible to blind the investigators to allocation groups.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 24, 2023
• Study Start: June 1, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Six months after publication of all study results up to 10 years after study initiation
• Access Criteria: Supporting data will be made available on request. Patient-level data from the provincial trauma registry can be accessed on request through provincial authorities.

Locations

CA (1)