Back to resultsIntravenous Treatment in Nursing Homes (3IV)
Primary Purpose
Infections, Dehydration
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
A structured training program
Sponsored by
About this trial
This is an interventional treatment trial for Infections focused on measuring Nursing homes, Intravenous, Treatment, Patient trajectory, Hospital admissions
Eligibility 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
Sites / Locations
- University of Oslo
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Usual care
A training program in iv treatment
Arm Description
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 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.
Outcomes
Primary Outcome Measures
All cause morbidity and mortality
Secondary Outcome Measures
Number of admissions and days in hospitals among nursing home residents
Patient trajectory
Satisfaction in patients, next of kin and staff
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01023763
Brief Title
Intravenous Treatment in Nursing Homes
Acronym
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?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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?
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.
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?
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?
How are difficult ethical issues handeld by medical staff at the nursing homes and the hospital when nursing home patients receive intravenous treatment?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Dehydration
Keywords
Nursing homes, Intravenous, Treatment, Patient trajectory, Hospital admissions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Arm Title
A training program in iv treatment
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
A structured training program
Intervention Description
A structured training program in nursing homes in the intravenous treatment of dehydration and infections.
Primary Outcome Measure Information:
Title
All cause morbidity and mortality
Time Frame
Within 30 days after disease onset
Secondary Outcome Measure Information:
Title
Number of admissions and days in hospitals among nursing home residents
Time Frame
Primarily within 30 days after disease onset
Title
Patient trajectory
Time Frame
Primarily within 30 days after disease onset
Title
Satisfaction in patients, next of kin and staff
Time Frame
Primarily within 30 days after disease onset
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Oslo
City
Oslo
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29739393
Citation
Klomstad K, Pedersen R, Forde R, Romoren M. Involvement in decisions about intravenous treatment for nursing home patients: nursing homes versus hospital wards. BMC Med Ethics. 2018 May 8;19(1):34. doi: 10.1186/s12910-018-0258-5.
Results Reference
derived
PubMed Identifier
28927372
Citation
Nyborg G, Brekke M, Straand J, Gjelstad S, Romoren M. Potentially inappropriate medication use in nursing homes: an observational study using the NORGEP-NH criteria. BMC Geriatr. 2017 Sep 19;17(1):220. doi: 10.1186/s12877-017-0608-z.
Results Reference
derived
Learn more about this trial
Intravenous Treatment in Nursing Homes
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