Patients With Prolonged Intravenous TherapyETINCT01548365
Impact of an Infusion Therapy Nursing Expert Service on Length of Stay and Clinical Results of Venous Access Devices
A study testing Infusion therapy nursing expert service in people with Patients With Prolonged Intravenous Therapy, run by Basque Health Service at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Prolonged Intravenous Therapy
- What is being tested?
- Infusion therapy nursing expert service
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2012to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- To have a central venous catheter indwelled
- MRSA (Methicillin Resistant Staphylococcus Aureus)
- Younger than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Being tested
- Infusion therapy nursing expert service
- Keywords
- Nursing Services, Catheterization, Central Venous, Catheters Indwelling, Catheterization, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion therapy nursing expert serviceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | routine care for the selection, placement and maintenance of venous access devices (VAD). |
| Infusion Therapy Nursing Expert | Experimental | Patients in this group will receive the infusion therapy nursing expert (ITNE) service. Receives: Other: Infusion therapy nursing expert service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
Measured: 3 months
Secondary outcomes (4)
Venous Access Devices reaching end of treatment
Measured: 3 months
Incidence of complications derived from VAD
Measured: 3 months
Patients receiving intravenous therapy at home
Measured: 3 months
Patient satisfaction with VAD
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Prolonged Intravenous TherapyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Collaborators
- KRONIKGUNE Cronicity Research Centre
- Responsible party
- Principal investigator, Lucia Garate Echenique, Basque Health Service
- Investigators
- Lucia Garate, MsC, Principal investigator, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548365
- Sponsor's protocol ID
- ITNE01
- Acronym
- ETI
- Status last verified
- Sep 2013
- First submitted
- 5 Mar 2012
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01548365
- Acronym / sponsor ID
- ETI / ITNE01
- Keywords
- Nursing Services, Catheterization, Central Venous, Catheters Indwelling, Catheterization, Peripheral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Collaborators
- KRONIKGUNE Cronicity Research Centre
- Study start
- Mar 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Mar 2012 (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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –routine care for the selection, placement and maintenance of venous access devices (VAD). |
| Infusion Therapy Nursing Expert | Experimental | Other: Infusion therapy nursing expert servicePatients in this group will receive the infusion therapy nursing expert (ITNE) service. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Require an estimated long prescription of intravenous treatment. These treatments may be of fluid therapy, pharmacological, nutritional or hemotherapy.
- Be patient at Araba University Hospital
Key exclusion criteria (3 listed)
- To have a central venous catheter indwelled
- MRSA (Methicillin Resistant Staphylococcus Aureus)
- Younger than 18 years old
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 |
|---|---|---|
| Infusion therapy nursing expert serviceThe 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. | Other | Infusion Therapy Nursing Expert |
Primary outcome
Hospital Length of Stay
Time frame: 3 months
4 secondary outcomes
Venous Access Devices reaching end of treatment
Time frame: 3 months
Incidence of complications derived from VAD
Time frame: 3 months
Patients receiving intravenous therapy at home
Time frame: 3 months
Patient satisfaction with VAD
Time frame: 3 months
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 23 Sep 2013.
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.
Lucia Garate, MsC principal investigator
Basque Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infusion therapy nursing expert service in people with Patients With Prolonged Intravenous Therapy, run by Basque Health Service at 1 site in Spain.
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 4 inclusion and 3 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 23 Sep 2013. 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 Spain. 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?
Hospital Length of Stay (time frame: 3 months). 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 23 Sep 2013.