- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07580976
Tru-Vu Wrist Positioning Aid Multi-Center Implementation Within NLHS
This study has two primary aims: 1) to determine whether a novel wrist x-ray positioning aid can be implemented within 3 different healthcare centers in Newfoundland and Labrador, and 2) to determine the ability of the tool to improve patient positioning in wrist x-rays. It will also learn about the number of repeat x-rays required with or without the use of the tool and radiographer confidence. The main questions it aims to answer are:
- Will the implementation of the Tru-Vu differ between an urban health center, rural clinic, and remote regional hospital?
- Can the Tru-Vu improve the positioning procedure for radiographers performing wrist x-rays, resulting with more useful x-rays.
Researchers will compare x-rays before and after the implementation of the tool as well as between centers.
Technologist participants will:
- Use the tool during the positioning procedure for wrist x-rays.
- Provide feedback regarding tool use and perceived implementation barriers and facilitators.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Emily Lalone, PhD
- Phone Number: 88243 519-661-2111
- Email: emily.lalone@uwo.ca
Study Locations
-
-
Labrador
-
Happy Valley-Goose Bay, Labrador, Canada, A0P1C0
- Labrador Health Centre
-
Contact:
- Emily Lalone, PhD
- Phone Number: 88243 519-661-2111
- Email: emily.lalone@uwo.ca
-
-
Newfoundland and Labrador
-
Norris Point, Newfoundland and Labrador, Canada, A8A3L1
- Bonne Bay Health Centre
-
Contact:
- Emily Lalone, PhD
- Phone Number: 88243 519-661-2111
- Email: emily.lalone@uwo.ca
-
St. John's, Newfoundland and Labrador, Canada, A1B3V6
- Health Sciences Centre
-
Contact:
- Emily Lalone, PhD
- Phone Number: 88243 519-661-2111
- Email: emily.lalone@uwo.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must be 18 years of age or older
- Must be proficient in English (reading/writing)
- Must have been referred for wrist imaging at one of the following healthcare centers: Health Sciences Center (St. John's, NL), Bonne Bay Health Center (Norris Point, NL), or Labrador Health Center (Happy Valley-Goose Bay, NL).
Exclusion Criteria:
- Incapable of providing informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Urban hospital
Radiographs will be retrospectively collected and compared to radiographs captured after the implementation of the tool.
Additional radiographs will be collected over a 6-month follow-up period.
|
A positioning aid and training videos for wrist x-rays
|
|
Experimental: Rural health center
Radiographs will be retrospectively collected and compared to radiographs captured after the implementation of the tool.
Additional radiographs will be collected over a 6-month follow-up period.
|
A positioning aid and training videos for wrist x-rays
|
|
Experimental: Regional remote hospital
Radiographs will be retrospectively collected and compared to radiographs captured after the implementation of the tool.
Additional radiographs will be collected over a 6-month follow-up period.
|
A positioning aid and training videos for wrist x-rays
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiograph grading score
Time Frame: Radiographs will be collected retrospectively 4 months prior to implementation and 6 months prospectively after the implementation of the tool.
|
Radiographs collected retrospectively and prospectively will be graded by a radiologist and radiographer
|
Radiographs will be collected retrospectively 4 months prior to implementation and 6 months prospectively after the implementation of the tool.
|
|
Tool adoption (and associated implementation outcomes)
Time Frame: The survey will be administered 6 months after the implementation of the tool and training.
|
A survey will collect perceived tool use and other perceived implementation outcomes (including fidelity, appropriateness, acceptability, and adoption).
|
The survey will be administered 6 months after the implementation of the tool and training.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sustainability
Time Frame: 6 months after the conclusion of the implementation period
|
Post-follow up survey will be conducted 6 months after the end of the implementation period and will collect perceived tool use.
|
6 months after the conclusion of the implementation period
|
|
Repeated radiographs
Time Frame: Repeat radiographs will be collected and compared 4 months retrospectively prior to implementation and 6 months after the start of implementation.
|
Document the number of repeat radiographs captured.
|
Repeat radiographs will be collected and compared 4 months retrospectively prior to implementation and 6 months after the start of implementation.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- 129141
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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