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Intravenous Treatment in Nursing Homes (3IV)

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ClinicalTrials.gov Identifier: NCT01023763
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Morten Lindbaek, University of Oslo

Brief 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.

Condition or disease Intervention/treatment Phase
Infections Dehydration Other: A structured training program Phase 2

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?

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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?
Study Start Date : November 2009
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Usual care

Nursing home residents who require intravenous fluids and intravenous antibiotics was treated as usual (hospital admissions for intravenous treatment).

In control nursing homes that had not completed the training program (intervention period), nursing home residents who require intravenous fluids and intravenous antibiotics was treated as usual. The majority of these patients were admitted to hospital for intravenous treatment. A few nursing homes or nursing home departments had sufficient expertise and capacity to provide treatment locally.

A training program in iv treatment

A structured training program in intravenous treatment in nursing homes:

Each of 30 participating nursing homes sequentially received theory and practical training in intravenous treatment. In nursing homes that had completed the training program (intervention period), and had sufficient expertise and capacity, nursing home residents in need of intravenous fluids or antibiotics were treated locally; otherwise they were hospitalized.

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



Primary Outcome Measures :
  1. All cause morbidity and mortality [ Time Frame: Within 30 days after disease onset ]

Secondary Outcome Measures :
  1. Number of admissions and days in hospitals among nursing home residents [ Time Frame: Primarily within 30 days after disease onset ]
  2. Patient trajectory [ Time Frame: Primarily within 30 days after disease onset ]
  3. Satisfaction in patients, next of kin and staff [ Time Frame: Primarily within 30 days after disease onset ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023763


Locations
Norway
University of Oslo
Oslo, Norway
Sponsors and Collaborators
University of Oslo

Responsible Party: Morten Lindbaek, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01023763     History of Changes
Other Study ID Numbers: 2009/1584a
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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