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

This study is currently recruiting participants.
Verified March 2012 by Basque Health Service
Sponsor:
Collaborator:
KRONIKGUNE Cronicity Research Centre
Information provided by (Responsible Party):
Lucia Garate Echenique, Basque Health Service
ClinicalTrials.gov Identifier:
NCT01548365
First received: March 5, 2012
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Patients With Prolonged Intravenous Therapy
 Other: Infusion therapy nursing expert service

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • Hospital Length of Stay [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Venous Access Devices reaching end of treatment [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Incidence of complications derived from VAD [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Patients receiving intravenous therapy at home [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Patient satisfaction with VAD [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 82
Study Start Date: March 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548365

Contacts
Contact: Lucia Garate, MsC 945007413 ext 5132 lucia.garateechenique@osakidetza.net

Locations
Spain
Araba University Hospital Recruiting
Vitoria-Gasteiz, Araba, Spain, 01009
Principal Investigator: Lucia Garate, MsC            
Sponsors and Collaborators
Basque Health Service
KRONIKGUNE Cronicity Research Centre
Investigators
Principal Investigator: Lucia Garate, MsC Basque Health Service
  More Information

No publications provided

Responsible Party: Lucia Garate Echenique, Nursing Research Supervisor, Basque Health Service
ClinicalTrials.gov Identifier: NCT01548365     History of Changes
Other Study ID Numbers: ITNE01
Study First Received: March 5, 2012
Last Updated: March 15, 2012
Health Authority: Spain: Ethics Committee

Keywords provided by Basque Health Service:
Nursing Services
Catheterization, Central Venous
Catheters Indwelling
Catheterization, Peripheral

ClinicalTrials.gov processed this record on June 13, 2013