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Intravenous Treatment in Nursing Homes (3IV)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Oslo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Oslo
ClinicalTrials.gov Identifier:
NCT01023763
First received: December 1, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Infections
Dehydration
 Other: A structured training program
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • All cause morbidity and mortality [ Time Frame: Within 30 days after disease onset ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of admissions and days in hospitals among nursing home residents [ Time Frame: Primarily within 30 days after disease onset ] [ Designated as safety issue: Yes ]
  • Patient trajectory [ Time Frame: Primarily within 30 days after disease onset ] [ Designated as safety issue: Yes ]
  • Total treatment costs (public health perspective) [ Time Frame: Primarily within 30 days after disease onset ] [ Designated as safety issue: Yes ]
  • Satisfaction in patients, next of kin and staff [ Time Frame: Primarily within 30 days after disease onset ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1400
Study Start Date: November 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Hospital treatment
Nursing home residents who require intravenous fluids and intravenous antibiotics and who are treated in hospital.
Active Comparator: Nursing home treatment
Nursing home residents who require intravenous fluids and intravenous antibiotics and who are treated in the nursing home.
 Other: A structured training program
A structured training program in nursing homes in the intravenous treatment of dehydration and infections.

Detailed 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?
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023763

Locations
Norway
University of Oslo Recruiting
Oslo, Norway
Contact: Maria Romoren, MD PhD     +47 22 85 06 48     maria.romoren@medisin.uio.no    
Sponsors and Collaborators
University of Oslo
  More Information

No publications provided

Responsible Party: MD PhD Maria Romoren, University of Oslo
ClinicalTrials.gov Identifier: NCT01023763     History of Changes
Other Study ID Numbers: 2009/1584a
Study First Received: December 1, 2009
Last Updated: December 1, 2009
Health Authority: Norway: Data Protection Authority
Norway: Ministry of Health and Care Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Oslo:
Nursing homes
Intravenous
Treatment
Patient trajectory
Hospital admissions

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013