- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05798065
Inpatient Endoscopy Procedure Planning Delays and Impact on Length of Stay and 30-day Readmission (Impatience)
Study Overview
Status
Intervention / Treatment
Detailed Description
Background: Delays in inpatient endoscopy planning negatively influence the quality and accessibility of care. This may result in higher healthcare costs, negative health outcomes, and unnecessary readmissions and use of hospital beds. Additionally, prolonged hospital stay is associated with poorer health outcomes and risk of nosocomial infections, amongst others.
Objective: To asses factors associated with inpatient endoscopy delays and impact on length of stay and 30-day readmission
Study design: Single center retrospective cohort study of all inpatient endoscopy procedures (gastroscopy, colonoscopy, ERCP, sigmoidoscopy) during 2016-2022. Data will be identified and extracted using CTCue. Only pseudonymized data will be used. Inpatient endoscopy delay will be defined as the number of days between the planned date versus the actual date. Multivariable logistic regression models will be performed to assess factors associated with inpatient endoscopy delay.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Milou van Riswijk, MD, Msc
- Phone Number: +31615280185
- Email: milou.vanriswijk@radboudumc.nl
Study Locations
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6525GA
- Radboud University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (>18 years)
- Clinical admission in any hospital department of at least two days during 1 January 2016 and 1 December 2022
- Endoscopic procedure during clinical admission, including gastroscopy, endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound (EUS), flexible sigmoidoscopy, colonoscopy
Exclusion Criteria:
- Elective admission
- Procedure only for insertion of nasogastric or nasojejunal (feeding) tube without any other diagnostic or therapeutic aims
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of inpatient endoscopy delays (IED)
Time Frame: at endoscopic procedure
|
IED will be defined as the number of days between the planned date versus the actual date.
|
at endoscopic procedure
|
Difference in type of endoscopic procedure between patients with and without IED
Time Frame: at endoscopic procedure
|
Type of endoscopic procedure: gastroscopy/colonoscopy/endoscopic retrograde cholangio-pancreaticography (ERCP)
|
at endoscopic procedure
|
Difference in type of sedation between patients with and without IED
Time Frame: at endoscopic procedure
|
Type of sedation during endoscopic procedure: No sedation/conscious sedation/general anesthesia
|
at endoscopic procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median length of hospital stay
Time Frame: through study cohort period from 1 january 2016 until 31 december 2022
|
length of hospital admission in days
|
through study cohort period from 1 january 2016 until 31 december 2022
|
rate of 30-day readmissions
Time Frame: up to 30 days
|
percentage of readmissions within 30 days after initial discharge
|
up to 30 days
|
Odds ratio of presence of inpatient endoscopy delays for risk of prolonged length of hospital stay and 30-day readmissions
Time Frame: from admission till 30 days after discharge
|
multivariable logistic regression modelling to assess factors associated with both outcomes and the impact of inpatient endoscopy delay
|
from admission till 30 days after discharge
|
Odds ratio of presence of inpatient endoscopy delays for risk of 30-day readmissions
Time Frame: from admission till 30 days after discharge
|
multivariable logistic regression modelling to assess factors associated with both outcomes and the impact of inpatient endoscopy delay
|
from admission till 30 days after discharge
|
Collaborators and Investigators
Investigators
- Principal Investigator: Peter Siersema, MD, PhD, Radboud University Medical Center
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
Other Study ID Numbers
- 2023-16151
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
- 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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