Health Care Associated InfectionNCT06454500
Clinical Decision Support to Reduce Catheter Associated Urinary Tract Infections
A study testing Clinical decision support in people with Health Care Associated Infection and Catheter-associated Urinary Tract Infection, run by Columbia University at 8 sites in United States.
Trial summary
The goal of this randomized controlled trial is to compare the effects of a clinical decision support tool consisting of a 48-hour stop order for indwelling urinary catheters versus no clinical decision support in hospitalized patients with indwelling urinary catheters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Care Associated Infection, Catheter-associated Urinary Tract Infection
- What is being tested?
- Clinical decision support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79,369 participants
- Where
- 8 sitesUnited States
- Study dates
- 17 Aug 2021to 4 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Admitted to hospital
- At least 18 years old
- Has order placed for indwelling urinary catheter
Who cannot join
- Indication for urinary catheter labeled as either "Chronic" or "Placed by urology"
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
NewYork-Presbyterian Westchester
Bronxville, New York, 10708
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
NewYork-Presbyterian Hudson Valley Hospital
Cortlandt Manor, New York, 10567
NewYork-Presbyterian Queens
Flushing, New York, 11355
NewYork-Presbyterian Columbia University Irving Medical Center
New York, New York, 10032
NewYork-Presbyterian Allen Hospital
New York, New York, 10034
NewYork-Presbyterian Lower Manhattan Hospital
New York, New York, 10038
NewYork-Presbyterian Weill Cornell Medical Center
New York, New York, 10065
About this study
Official title: Randomized, Controlled Evaluations of the Effectiveness of Clinical Decision Support Systems (REEDS)
The goal of this randomized controlled trial is to compare the effects of a clinical decision support tool consisting of a 48-hour stop order for indwelling urinary catheters versus no clinical decision support in hospitalized patients with indwelling urinary catheters. The main questions it aims to answer are:
- Does the presence of an automated stop order integrated as part of a clinical decision support tool reduce dwell time of urinary catheters and the rate of catheter associated urinary tract infections?
Participants who have indwelling urinary catheters ordered will be randomized to either have these orders automatically expire after 48 hours unless an action is taken or have orders without expiration. Researchers will compare the urinary catheter dwell time and the rate of catheter associated urinary tract infections between the two groups.
- Being tested
- Clinical decision support
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision supportOther
A 48 hour expiration on orders placed for indwelling urinary catheters.
| Study group | Role | What they receive |
|---|---|---|
| Stop Orders | Experimental | For participants in this arm, a clinical decision support tool consisting of stop orders and an expiring alert that was displayed to care team clinicians. Receives: Other: Clinical decision support |
| Continuous Orders | No intervention | For participants in this arm, no clinical decision support or alerts were displayed to care team clinicians and the urinary catheter order was continuous. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary catheter dwell time
The time between urinary catheter insertion and removal
Measured: Measured from time of catheter insertion until catheter removal or hospital discharge if the catheter was not removed, up to 250 days.
Secondary outcomes (3)
Catheter Associate Urinary Tract Infection (CAUTI) rate
The number of CAUTI's per 1000 catheter days. CAUTIs were defined according to NHSN (National Healthcare Safety Network) criteria as a urinary tract infection where an indwelling urinary catheter (IUC) was in place for more than two consecutive days in an inpatient location on the date of event or the day before, with day of device placement being Day 1. All positive urine cultures are reviewed by members of Infection Prevention and Control to determine if they meet the defined criteria for CAUTI. Events verified as CAUTIs are then recorded in the hospital data registry. The hospital data registry was used to determine CAUTI events in this study.
Measured: The development of a CAUTI was assessed from time of catheter insertion until either catheter removal or hospital discharge if the catheter was not removed, up to 250 days.
CAUTI population rate
The number of CAUTI's per 10000 hospital days CAUTIs were defined according to NHSN (National Healthcare Safety Network) criteria as a urinary tract infection where an indwelling urinary catheter (IUC) was in place for more than two consecutive days in an inpatient location on the date of event or the day before, with day of device placement being Day 1. All positive urine cultures are reviewed by members of Infection Prevention and Control to determine if they meet the defined criteria for CAUTI. Events verified as CAUTIs are then recorded in the hospital data registry. The hospital data registry was used to determine CAUTI events in this study.
Measured: The development of a CAUTI was assessed from time of catheter insertion until either catheter removal or hospital discharge if the catheter was not removed, up to 250 days.
CAUTI Free survival
The time a catheter "survived" before developing a CAUTI CAUTIs were defined according to NHSN (National Healthcare Safety Network) criteria as a urinary tract infection where an indwelling urinary catheter (IUC) was in place for more than two consecutive days in an inpatient location on the date of event or the day before, with day of device placement being Day 1. All positive urine cultures are reviewed by members of Infection Prevention and Control to determine if they meet the defined criteria for CAUTI. Events verified as CAUTIs are then recorded in the hospital data registry. The hospital data registry was used to determine CAUTI events in this study.
Measured: The development of a CAUTI was assessed from time of catheter insertion until either catheter removal or hospital discharge if the catheter was not removed, up to 250 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start17 Aug 2021
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care Associated InfectionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79,369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Adelman, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454500
- Sponsor's protocol ID
- AAAU3416
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Evaluations of the Effectiveness of Clinical Decision Support Systems (REEDS)
- ClinicalTrials.gov ID
- NCT06454500
- Acronym / sponsor ID
- AAAU3416
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79,369 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled trial is to compare the effects of a clinical decision support tool consisting of a 48-hour stop order for indwelling urinary catheters versus no clinical decision support in hospitalized patients with indwelling urinary catheters. The main questions it aims to answer are:
- Does the presence of an automated stop order integrated as part of a clinical decision support tool reduce dwell time of urinary catheters and the rate of catheter associated urinary tract infections?
Participants who have indwelling urinary catheters ordered will be randomized to either have these orders automatically expire after 48 hours unless an action is taken or have orders without expiration. Researchers will compare the urinary catheter dwell time and the rate of catheter associated urinary tract infections between the two groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stop Orders | Experimental | Other: Clinical decision supportFor participants in this arm, a clinical decision support tool consisting of stop orders and an expiring alert that was displayed to care team clinicians. |
| Continuous Orders | No intervention | –For participants in this arm, no clinical decision support or alerts were displayed to care team clinicians and the urinary catheter order was continuous. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to hospital
- At least 18 years old
- Has order placed for indwelling urinary catheter
Key exclusion criteria (1 listed)
- Indication for urinary catheter labeled as either "Chronic" or "Placed by urology"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical decision supportA 48 hour expiration on orders placed for indwelling urinary catheters. | Other | Stop Orders |
Primary outcome
Urinary catheter dwell time
Time frame: Measured from time of catheter insertion until catheter removal or hospital discharge if the catheter was not removed, up to 250 days.
The time between urinary catheter insertion and removal
3 secondary outcomes
Catheter Associate Urinary Tract Infection (CAUTI) rate
Time frame: The development of a CAUTI was assessed from time of catheter insertion until either catheter removal or hospital discharge if the catheter was not removed, up to 250 days.
CAUTI population rate
Time frame: The development of a CAUTI was assessed from time of catheter insertion until either catheter removal or hospital discharge if the catheter was not removed, up to 250 days.
CAUTI Free survival
Time frame: The development of a CAUTI was assessed from time of catheter insertion until either catheter removal or hospital discharge if the catheter was not removed, up to 250 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Adelman, MD, MS principal investigator
Columbia University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical decision support in people with Health Care Associated Infection and Catheter-associated Urinary Tract Infection, run by Columbia University at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary catheter dwell time (time frame: Measured from time of catheter insertion until catheter removal or hospital discharge if the catheter was not removed, up to 250 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.