Intravenous Treatment in Nursing Homes

Infections Clinical Trial

— 3IV  

Official title:

Can a Structured Training Program in Intravenous Treatment of Infections in Nursing Homes Lead to a Better Patient Trajectory and Reduced Hospital Admittance?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023763
• Other study ID #: 2009/1584a
• Status: Completed
• Phase: Phase 2
• First received: December 1, 2009
• Last updated: May 12, 2016
• Start date: November 2009
• Est. completion date: December 2012

Study information

• Verified date: May 2016
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection AuthorityNorway: Ministry of Health and Care ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

The primary objective for the project is to evaluate whether nursing home residents who require intravenous fluids and intravenous antibiotics, can be treated just as well or even better in the nursing home as in the hospital. In Vestfold, Norway, a structured training program in the intravenous treatment of dehydration and infections in nursing homes is planned. The 3IV study will evaluate if this leads to an equal or better patient trajectory and reduced hospital admittance.

Description:

1. Can a structured training program in administration of intravenous fluids and antibiotics lead to a reduced number of admissions and days in hospitals among nursing home residents?

2. Can treatment with intravenous fluids or antibiotics in nursing homes provide an equally good or better patient trajectory compared to patients hospitalized for the same treatment? We will look at duration of symptoms, direct and indirect complications, and mortality rates.

3. Can treatment costs for the public health service be reduced when patients are treated with intravenous fluids and /or antibiotics in the nursing home instead of being admitted to the hospital?

4. Can treatment for dehydration and infections in the nursing home rather than in a hospital provide an equally or better satisfaction in patients, next of kin and staff?

5. How are difficult ethical issues handeld by medical staff at the nursing homes and the hospital when nursing home patients receive intravenous treatment?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Nursing home residents in need of intravenous fluids or antibiotics

Exclusion Criteria:

• Patients who needs hospitalization due to either co-morbidity or seriousness of disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dehydration
• Infections

Intervention

Other:
• A structured training program
A structured training program in nursing homes in the intravenous treatment of dehydration and infections.

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause morbidity and mortality		Within 30 days after disease onset	Yes
Secondary	Number of admissions and days in hospitals among nursing home residents		Primarily within 30 days after disease onset	Yes
Secondary	Patient trajectory		Primarily within 30 days after disease onset	Yes
Secondary	Satisfaction in patients, next of kin and staff		Primarily within 30 days after disease onset	Yes