Intravenous Treatment in Nursing Homes

NCT01023763 | Completed Phase 2

• 1 other identifier: 2009/1584a
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections; Dehydration

Keywords

Nursing homes; Intravenous; Treatment; Patient trajectory; Hospital admissions

Outcome Measures

Primary Outcomes (1)

• All cause morbidity and mortality

  Within 30 days after disease onset

Secondary Outcomes (3)

• Number of admissions and days in hospitals among nursing home residents

  Primarily within 30 days after disease onset

• Patient trajectory

  Primarily within 30 days after disease onset

• Satisfaction in patients, next of kin and staff

  Primarily within 30 days after disease onset

Study Arms (2)

Usual care

NO INTERVENTION

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

OTHER

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

Interventions

A structured training program OTHER

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

A training program in iv treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Nursing home residents in need of intravenous fluids or antibiotics

You may not qualify if:

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

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (1)

University of Oslo

Oslo, Norway

Location

Related Publications (2)

• 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.

  PMID: 29739393 DERIVED

• 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.

  PMID: 28927372 DERIVED

MeSH Terms

Conditions

Infections; Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 13, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)