- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01548365
Impact of an Infusion Therapy Nursing Expert Service on Length of Stay and Clinical Results of Venous Access Devices (ETI)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Araba
-
Vitoria-Gasteiz, Araba, Spain, 01009
- Araba University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hospital Length of Stay
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Venous Access Devices reaching end of treatment
Time Frame: 3 months
|
3 months
|
|
Incidence of complications derived from VAD
Time Frame: 3 months
|
3 months
|
|
Patients receiving intravenous therapy at home
Time Frame: 3 months
|
3 months
|
|
Patient satisfaction with VAD
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lucia Garate, MsC, Basque Health Service
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ITNE01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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