Intravenous Treatment in Nursing Homes

NCT ID: NCT01023763

Last Updated: 2016-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infections Dehydration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type OTHER

A structured training program

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

A structured training program

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oslo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Morten Lindbaek

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Oslo

Oslo, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29739393 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28927372 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009/1584a

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Skilled Nursing Facility Care at Home
NCT06416670 ACTIVE_NOT_RECRUITING NA