All Hospitalized PatientsCARENCT01797146
Effectiveness of Catheter Reminder and Evaluation Program
A study testing Catheter Reminder and Evaluation Program in people with All Hospitalized Patients and With and Without Catheter, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
The investigators will conduct a cluster randomized controlled trial to evaluate the efficacy of Catheter Reminder and Evaluation program (CARE) in reducing the duration of catheter use and the number of infection relating to catheter use. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- All Hospitalized Patients, With and Without Catheter
- What is being tested?
- Catheter Reminder and Evaluation Program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 874 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2013to Dec 2013
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All hospitalized adults in 6 general medical wards at Siriraj Hospital
- With or Without catheter
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Catheter Reminder and Evaluation (CARE) Program in Reducing the Catheter-day and Prevention of Catheter-associated Infections
The investigators will conduct a cluster randomized controlled trial to evaluate the efficacy of Catheter Reminder and Evaluation program (CARE) in reducing the duration of catheter use and the number of infection relating to catheter use.
- Being tested
- Catheter Reminder and Evaluation Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter Reminder and Evaluation ProgramProcedure or surgery
This intervention will be implemented by ward nurses and responsible physicians. The details of intervention are shown below.
- Nurse: Every morning, a ward nurse will check if any patient has a urinary catheter or a central venous catheter in place. An order sheet will be marked with a CARE-rubber stamp and the following information will be added by hand-writing.
- Type and duration of urinary catheter use.
- Indication of urinary catheter _________
- Type and duration of central venous catheter use
- Indication of urinary catheter _________
- Responsible physician: During a morning round, a physician needs to fill the indication of catheter use. If a given physician does not fill the indication of urinary catheter use, the catheter will be automatically removed. If a given physician does not fill the indication of central venous catheter, the CARE team will be notified.
| Study group | Role | What they receive |
|---|---|---|
| CARE | Active comparator | All patients in the intervention wards will receive the Catheter Reminder and Evaluation (CARE) intervention. Receives: Procedure: Catheter Reminder and Evaluation Program |
| Control | No intervention | All patients in the control wards will receive usual care without the CARE intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary catheter day
Total duration of urinary catheter use (day)
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes (1)
CA-UTI
Number of catheter-associated urinary tract infection episode
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Hospitalized PatientsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 874 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinyo Rattanaumpawan, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797146
- Sponsor's protocol ID
- 656/2555(EC1)
- Acronym
- CARE
- Status last verified
- Nov 2015
- First submitted
- 18 Feb 2013
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Catheter Reminder and Evaluation (CARE) Program in Reducing the Catheter-day and Prevention of Catheter-associated Infections
- ClinicalTrials.gov ID
- NCT01797146
- Acronym / sponsor ID
- CARE / 656/2555(EC1)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 874 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Feb 2013 (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.
The investigators will conduct a cluster randomized controlled trial to evaluate the efficacy of Catheter Reminder and Evaluation program (CARE) in reducing the duration of catheter use and the number of infection relating to catheter use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARE | Active comparator | Procedure: Catheter Reminder and Evaluation ProgramAll patients in the intervention wards will receive the Catheter Reminder and Evaluation (CARE) intervention. |
| Control | No intervention | –All patients in the control wards will receive usual care without the CARE intervention. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All hospitalized adults in 6 general medical wards at Siriraj Hospital
- With or Without catheter
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Catheter Reminder and Evaluation ProgramThis intervention will be implemented by ward nurses and responsible physicians. The details of intervention are shown below. 1. Nurse: Every morning, a ward nurse will check if any patient has a urinary catheter or a central venous catheter in place. An order sheet will be marked with a CARE-rubber stamp and the following information will be added by hand-writing. * Type and duration of urinary catheter use. * Indication of urinary catheter _________ * Type and duration of central venous catheter use * Indication of urinary catheter _________ 2. Responsible physician: During a morning round, a physician needs to fill the indication of catheter use. If a given physician does not fill the indication of urinary catheter use, the catheter will be automatically removed. If a given physician does not fill the indication of central venous catheter, the CARE team will be notified. | Procedure or surgery | CARE |
Primary outcome
Urinary catheter day
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Total duration of urinary catheter use (day)
1 secondary outcome
CA-UTI
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
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 Nov 2015.
Related trials for All Hospitalized Patients
Active, not recruitingPhase 3
The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD
Kidney Disease, Chronic, Renal Transplant Failure
RecruitingObservational study
The Erlanger Stroke Registry (ESPro) is the Only Ongoing Prospective Population-based Stroke Registry in Germany, Started in 1994. ESPro Includes All Hospitalized and Non-hospitalized Patients With Stroke in the Community of Erlangen (120.000 Inhabitants), With a Long-life Follow-up.
Intracerebral Haemorrhage (ICH), Cerebral Infarction
Recruiting
Evaluation of Pediatric eCART Implementation
Pediatric ALL, Sepsis
Not yet recruiting
AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Heart Failure
Recruiting
Massage Impact on Sleep in Pediatric Oncology
Cancer, Pediatric Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter Reminder and Evaluation Program in people with All Hospitalized Patients and With and Without Catheter, run by Siriraj Hospital at 1 site in Thailand.
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 2 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 Nov 2015. 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 Thailand. 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 day (time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks). 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 Nov 2015.