Infection Due to Indwelling Urinary CatheterNCT02054065
Effect of CAUTI Prevention Alert - A Randomized Control Trial
A study testing CAUTI Decision Support in people with Infection Due to Indwelling Urinary Catheter, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This study proposes to expand upon previous research by studying the effects of a urinary-catheter removal alert on duration of urinary catheter use and frequency of CAUTIs with a large, randomized controlled trial within a three-hospital academic medical center. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Infection Due to Indwelling Urinary Catheter
- What is being tested?
- CAUTI Decision Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jun 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All admissions with an indwelling urinary catheter will be randomly assigned to intervention vs. control (usual care) conditions.
Who cannot join
- Neonatal Intensive Care Unit and pediatric patients
Trial locations and contacts
1 site in 1 country.
About this study
This study proposes to expand upon previous research by studying the effects of a urinary-catheter removal alert on duration of urinary catheter use and frequency of CAUTIs with a large, randomized controlled trial within a three-hospital academic medical center.
Hypothesis The proposed urinary-catheter removal alerts will decrease the number of catheter days and decrease the number of catheter associated urinary tract infections (CAUTIs), but will not affect the catheter re-insertion rate.
Read the detailed description
Primary Objectives
- Specific Aim 1: Investigate the effect of a urinary-catheter removal alert on the rate of catheter associated urinary tract infections (CAUTIs).
- Specific Aim 2: Investigate the effect of a urinary-catheter removal alert on the number of catheter days.
- Specific Aim 3: Evaluate the effect of a urinary-catheter removal alert on the rate of catheter re-insertion.
- Specific Aim 4: Evaluate the effect of a urinary-catheter removal alert on overall mortality in patients with indwelling catheters.
- Being tested
- CAUTI Decision Support
- Keywords
- Urinary Catheter, urinary tract infection
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAUTI Decision SupportOther
Decision support used to prevent Catheter Associated Urinary Tract Infections
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Normal care conditions, no computer-based physician alert. |
| CAUTI Decision Support | Experimental | Decision support aimed at preventing Catheter Associated Urinary Tract Infections (CAUTIs) Receives: Other: CAUTI Decision Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CAUTIs
Measured: One Year
Secondary outcomes (3)
Number of catheter days
Measured: One year
Rate of catheter re-insertion
Measured: One Year
Patient mortality due to CAUTI
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection Due to Indwelling Urinary CatheterStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason S Adelman, MD, MS, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054065
- Sponsor's protocol ID
- 12-06-225
- Status last verified
- Sep 2018
- First submitted
- 31 Jan 2014
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CAUTI Prevention Alert - A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02054065
- Acronym / sponsor ID
- 12-06-225
- Keywords
- Urinary Catheter, urinary tract infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Feb 2014 (estimated)
- 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.
This study proposes to expand upon previous research by studying the effects of a urinary-catheter removal alert on duration of urinary catheter use and frequency of CAUTIs with a large, randomized controlled trial within a three-hospital academic medical center.
Hypothesis The proposed urinary-catheter removal alerts will decrease the number of catheter days and decrease the number of catheter associated urinary tract infections (CAUTIs), but will not affect the catheter re-insertion rate.
Detailed description
Primary Objectives
- Specific Aim 1: Investigate the effect of a urinary-catheter removal alert on the rate of catheter associated urinary tract infections (CAUTIs).
- Specific Aim 2: Investigate the effect of a urinary-catheter removal alert on the number of catheter days.
- Specific Aim 3: Evaluate the effect of a urinary-catheter removal alert on the rate of catheter re-insertion.
- Specific Aim 4: Evaluate the effect of a urinary-catheter removal alert on overall mortality in patients with indwelling catheters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Normal care conditions, no computer-based physician alert. |
| CAUTI Decision Support | Experimental | Other: CAUTI Decision SupportDecision support aimed at preventing Catheter Associated Urinary Tract Infections (CAUTIs) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All admissions with an indwelling urinary catheter will be randomly assigned to intervention vs. control (usual care) conditions.
Key exclusion criteria (1 listed)
- Neonatal Intensive Care Unit and pediatric patients
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 |
|---|---|---|
| CAUTI Decision SupportDecision support used to prevent Catheter Associated Urinary Tract Infections | Other | CAUTI Decision Support |
Primary outcome
Number of CAUTIs
Time frame: One Year
3 secondary outcomes
Number of catheter days
Time frame: One year
Rate of catheter re-insertion
Time frame: One Year
Patient mortality due to CAUTI
Time frame: One year
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 11 Sep 2018.
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 S Adelman, MD, MS principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAUTI Decision Support in people with Infection Due to Indwelling Urinary Catheter, run by Montefiore Medical Center at 1 site 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 1 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 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of CAUTIs (time frame: One Year). 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 11 Sep 2018.