We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    ITNE01
Previous Study | Return to List | Next Study

Impact of an Infusion Therapy Nursing Expert Service on Length of Stay and Clinical Results of Venous Access Devices (ETI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01548365
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : September 23, 2013
Sponsor:
Collaborator:
KRONIKGUNE Cronicity Research Centre
Information provided by (Responsible Party):
Lucia Garate Echenique, Basque Health Service

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine whether an infusion therapy nursing expert service is effective in decreasing hospital length of stay, improving the clinical results of venous access devices and increasing patient satisfaction with venous access.

Condition or disease Intervention/treatment Phase
Patients With Prolonged Intravenous Therapy Other: Infusion therapy nursing expert service Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Impact of an Infusion Therapy Nursing Expert Service on Length of Stay, Clinical Results of Venous Access Devices and Satisfaction on Patients With Long Intravenous Therapy Prescription.
Study Start Date : March 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
No Intervention: Control Group
routine care for the selection, placement and maintenance of venous access devices (VAD).
Experimental: Infusion Therapy Nursing Expert
Patients in this group will receive the infusion therapy nursing expert (ITNE) service.
 Other: Infusion therapy nursing expert service

The ITNE will assess the patient and treatment characteristics and use an evidence based decision making algorithm for the selection of the most suitable VAD.

If the VAD needed is a PICC or a midline ITNE will place it following hospital's protocols. If needed, ITNE will also educate and support patients and next of keens in the maintenance of the device at home.

If other devices such as peripheral catheters, central venous catheters (jugular or subclavian) or venous subcutaneous reservoirs are the preferable VADs for patients and treatment conditions, ITNE will work together with health professionals in charge of patients to activate the usual procedures to place the according device.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Hospital Length of Stay [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Venous Access Devices reaching end of treatment [ Time Frame: 3 months ]
  2. Incidence of complications derived from VAD [ Time Frame: 3 months ]
  3. Patients receiving intravenous therapy at home [ Time Frame: 3 months ]
  4. Patient satisfaction with VAD [ Time Frame: 3 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Require an estimated long prescription of intravenous treatment. These treatments may be of fluid therapy, pharmacological, nutritional or hemotherapy.

    • Estimation of 7 days or more of continuous intravenous therapy.
    • Estimation of an intermittent intravenous therapy of less than a week, but on a monthly basis or less and a total estimated duration superior to 3 months.
  • Be patient at Araba University Hospital

Exclusion Criteria:

  • To have a central venous catheter indwelled
  • MRSA (Methicillin Resistant Staphylococcus Aureus)
  • Younger than 18 years old
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548365


Locations
Layout table for location information
Spain
Araba University Hospital
Vitoria-Gasteiz, Araba, Spain, 01009
Sponsors and Collaborators
Basque Health Service
KRONIKGUNE Cronicity Research Centre
Investigators
Layout table for investigator information
Principal Investigator: Lucia Garate, MsC Basque Health Service
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Lucia Garate Echenique, Nursing Research Supervisor, Basque Health Service
ClinicalTrials.gov Identifier: NCT01548365    
Other Study ID Numbers: ITNE01
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: September 23, 2013
Last Verified: September 2013
Keywords provided by Lucia Garate Echenique, Basque Health Service:
Nursing Services
Catheterization, Central Venous
Catheters Indwelling
Catheterization, Peripheral