NCT01797146

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
874

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

10 months

First QC Date

February 18, 2013

Last Update Submit

November 18, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Urinary catheter day

    Total duration of urinary catheter use (day)

    participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Secondary Outcomes (1)

  • CA-UTI

    participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Study Arms (2)

CARE

ACTIVE COMPARATOR

All patients in the intervention wards will receive the Catheter Reminder and Evaluation (CARE) intervention.

Procedure: Catheter Reminder and Evaluation Program

Control

NO INTERVENTION

All patients in the control wards will receive usual care without the CARE intervention.

Interventions

This 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.

CARE

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All hospitalized adults in 6 general medical wards at Siriraj Hospital
  • With or Without catheter

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Interventions

Program Evaluation

Intervention Hierarchy (Ancestors)

Evaluation Studies as TopicInvestigative TechniquesQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 18, 2013

First Posted

February 22, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations