Interventional Study of Videoconferences Between Hospital and Municipality - a Randomized Controlled Trial (Tele-hjem)

January 9, 2015 updated by: Zealand University Hospital

Interventional Study of Videoconferences Between Hospital and Municipality After Discharge From Roskilde and Køge Hospitals - a Randomized Controlled Trial

The study aims to assess whether the review of discharge planning followed by a cross-sectoral video conference in connection with discharge of medical and geriatric patients at Roskilde and Køge hospitals as well as patients from the Emergency Department at Køge Hospital reduces the proportion of patients who are readmitted within 180 days.

Project nurses at the two hospitals identifies all patients fulfilling the inclusion criteria (above 55 years of age, discharged to their own home), get informed consent and performs the video conferences. Within a few hours after discharge a video conference is held in the patient´s home including the patient,the municipal nurse and the project nurse at the hospital. During the video conference the discharge is reviewed using a structured assessment.

The survey is conducted as an open, randomized intervention study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study consists of two parts: First, the project nurse reviews the patients discharge together with the nurse from the hospital ward. Next, the patient is discharged from the hospital and meets the nurse from the municipality at home. Together with the patient the nurse form the municipality reviews:

  • Documents from the hospital
  • Medicine
  • Nutrition
  • Mobility
  • Assessment of the need for health care services from the municipality

All patients in the project - both patients in the intervention group and patients in the control group - will receive treatment and care equivalent to normally applicable quality standards.

In 2011 4387 patients were discharged Monday to Friday from the Medical and Geriatric Departments at Roskilde and Køge Hospital to one of the seven municipalities. Of these, 1204 persons (27%) were readmitted (in any department) within 180 days. It is expected that the study demonstrates a reduction of ≥ 6 percentage points (from 27% to 21%) with a power of 80% and a significance level of 5%. There will be a need for 792 patients in both control and intervention group, ie 1584 in total.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1387

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Køge, Denmark
        • Region Zealand, Roskilde and Køge Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Discharge from the Medical Department and Geriatric Department at Roskilde and Køge hospitals or the Emergency Department at Køge Hospital.

Address in Køge, Greve, Faxe, Solrød, Lejre, Stevns or Roskilde municipalities. Discharges between 8 am and 4 pm Monday-Friday. Acute/subacute admission to the hospital

Exclusion Criteria:

  • Patients who cannot give consent to participation. Discharge to a nursing home or relief care home. Patients with planned readmission. Former participant in the study. Patients who are included in the Sub Acute Project. Patients who needs terminal care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Review of discharges and cross-sectoral video conferencing immediately after discharge
Other: Review of discharges and cross-sectoral video conferencing immediately after discharge
The intervention is video conference which is randomized and is an intervention that is assigned by the investigator.
No Intervention: Control
Standard health care services

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The proportion of patients who are readmitted
Time Frame: 180 days
Acute readmissions to any hospital in Denmark
180 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Use of municipal services (nursing, practical help, personal care)
Time Frame: 4 months
4 months
Time to readmission
Time Frame: 180 days
180 days
Total number of readmissions
Time Frame: 180 days
180 days
Total number of days of readmission
Time Frame: 180 days
180 days
The number of contacts with general practitioner
Time Frame: 180 days
180 days
Death
Time Frame: 180 days
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zealand University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Region Zealand
Roskilde Municipality
Køge Municipality
Stevns Municipality
Solrød Municipality
Lejre Municipality
Faxe Municipality
Greve Municipality

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Solvejg Henneberg Pedersen, dr., Region Zealand
  • Principal Investigator: Birgitte Dreyer Sørensen, cand. scient. san. publ., Region Zealand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SJ-337

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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