- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05540444
RadConnect Communication Application (RadConnect)
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Leiden, Netherlands, 2333 ZA
- Leiden University Medical Center (LUMC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals that are employed by LUMC
- Individuals that are radiologists, radiology fellows, radiology residents, radiology technologists, doctor assistants, physician assistants or other support personnel in the Department of Radiology that raise managing image acquisition related questions.
- Individuals that consent to participating in the study.
- Individuals scheduled to work at locations at Sending Extensions, Receiving Extensions and Control Extensions.
Exclusion Criteria:
- Individuals not able to understand or not willing to sign the informed consent form.
- Individuals that indicate that they do no comprehend RadConnect and/or its intended use after two educational sessions.
- Individuals not able to not willing to comply with the intended use of RadConnect.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Test the hypothesis that adoption of RadConnect leads to reduction of phone calls to radiologists.
Time Frame: Numbers are continously measured during each shift of the subjects over a period of 40 consecutive working days during the before (phase 1) and 40 consecutive working days during the after phase (phase 2) of this study.
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The primary endpoint will be obtained by testing the hypothesis that P1 > P2 using Wilcoxon's one-tailed test with significance level P < 0.05. |
Numbers are continously measured during each shift of the subjects over a period of 40 consecutive working days during the before (phase 1) and 40 consecutive working days during the after phase (phase 2) of this study.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Compare experiences and attitudes of technicians and radiologists towards RadConnect versus phone calls.
Time Frame: Continously measured during each shift of the subjects over a period of 40 consecutive working days during the before (phase 1) and 40 consecutive working days during the after phase(phase 2) of this study.
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The first secondary endpoint will be obtained by testing the hypothesis that C1 ≠ C2 using Wilcoxon's two-tailed test with significance level P < 0.05. |
Continously measured during each shift of the subjects over a period of 40 consecutive working days during the before (phase 1) and 40 consecutive working days during the after phase(phase 2) of this study.
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Measure the characteristics of technician questions raised over phone and through RadConnect.
Time Frame: Continously measured during each shift of the subjects over a period of 40 consecutive working days during the before phase (phase 1) and 40 consecutive working days during the after phase (phase 2) of this study.
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• R2 = Mean number of completed RadConnect consultations per working day during regular working hours between Sending Extensions and Receiving Extensions in After Phase The second secondary endpoint will be obtained by testing the hypothesis that P1 ≠ P2 + R2 using Wilcoxon's two-tailed test with significance level P < 0.05. |
Continously measured during each shift of the subjects over a period of 40 consecutive working days during the before phase (phase 1) and 40 consecutive working days during the after phase (phase 2) of this study.
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Consolidated opinion usability and experience of RadConnect in itself and in comparison to alternative communication methods.
Time Frame: 1 hour, after completion of the after phase (phase 2 of this study)
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The third secondary endpoint will be obtained by aggregating survey responses.
In the structured online survey, if more than half of the respondents indicate that they prefer communication over RadConnect to calling, it will be concluded that RadConnect is a viable alternative to calling.
If more than half of radiologist respondents indicate that they believe RadConnect helps them avoid interruptions, it will be concluded that RadConnect is a viable alternative to calling that may help reduce radiologist interruptions.
The opinions of study participants are captured as Likert scale response and averaged to obtain a consolidated opinion.
The consolidated responses are visualized as histograms.
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1 hour, after completion of the after phase (phase 2 of this study)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hildo Lamb, Prof. Dr., Leiden University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Other Study ID Numbers
- ICBE-S-000556
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
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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