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Intravenous Treatment in Nursing Homes (3IV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 1, 2009
First Posted Date  ICMJE December 2, 2009
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE November 2009
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
All cause morbidity and mortality [ Time Frame: Within 30 days after disease onset ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
  • Number of admissions and days in hospitals among nursing home residents [ Time Frame: Primarily within 30 days after disease onset ]
  • Patient trajectory [ Time Frame: Primarily within 30 days after disease onset ]
  • Satisfaction in patients, next of kin and staff [ Time Frame: Primarily within 30 days after disease onset ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
  • Number of admissions and days in hospitals among nursing home residents [ Time Frame: Primarily within 30 days after disease onset ]
  • Patient trajectory [ Time Frame: Primarily within 30 days after disease onset ]
  • Total treatment costs (public health perspective) [ Time Frame: Primarily within 30 days after disease onset ]
  • Satisfaction in patients, next of kin and staff [ Time Frame: Primarily within 30 days after disease onset ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Treatment in Nursing Homes
Official Title  ICMJE Can a Structured Training Program in Intravenous Treatment of Infections in Nursing Homes Lead to a Better Patient Trajectory and Reduced Hospital Admittance?
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Infections
  • Dehydration
Intervention  ICMJE Other: A structured training program
A structured training program in nursing homes in the intravenous treatment of dehydration and infections.
Study Arms  ICMJE
  • 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.

    Intervention: Other: A structured training program
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2016)
330
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2009)
1400
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01023763
Other Study ID Numbers  ICMJE 2009/1584a
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Morten Lindbaek, University of Oslo
Study Sponsor  ICMJE University of Oslo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Oslo
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP