A Virtual Ward to Reduce Readmissions After Hospital Discharge

December 6, 2013 updated by: Irfan Dhalla, Unity Health Toronto
The purpose of this study is to see whether a Virtual Ward reduces readmissions after hospital discharge.

Study Overview

Status

Status

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

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

We will conduct a pragmatic, randomized controlled trial to evaluate a new model of care for high-risk medical patients after discharge from hospital. This new model of care has two key elements. First, we will use the LACE index (see citation below for details) to identify patients who are at high risk of readmission or death after hospital discharge. These patients will be randomized to either the Virtual Ward or usual care on the day of discharge. Although patients being cared for in the Virtual Ward will reside at home, they will benefit from a hospital-like interdisciplinary team, a shared set of notes, a single point of contact, round-the-clock physician availability and increased co-ordination of specialist, primary and home-based community care for several weeks after hospital discharge.

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 (Anticipated)

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.
1928

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada
        • University Health Network
      • Toronto, Ontario, Canada
        • Toronto Central Community Care Access Centre
      • Toronto, Ontario, Canada
        • Women's College Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Discharge from medical service
  • LACE score greater than or equal to 10
  • Age greater than or equal or 18
  • Resident in Toronto Central Local Health Integration Network catchment area
  • Patient or designate able to speak English well enough for follow up telephone calls

Exclusion Criteria:

  • Previously enrolled in study
  • Discharged to a rehabilitation or complex continuing care facility

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Active Comparator: Usual Care
Other: Usual care
The usual care provided to patients after discharge from hospital
Experimental: Virtual Ward
Other: Virtual Ward
A multidisciplinary team to optimize medical and social care for patients residing in their own homes

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
Composite of readmission to hospital or death.
Time Frame: 30 days after hospital discharge
A binary outcome variable for each patient, representing either readmission to hospital or death within 30 days of hospital discharge. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
30 days after hospital discharge

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
Measure Description
Time Frame
Composite of readmission or death
Time Frame: 90 days after discharge
A binary outcome variable for each patient, representing either readmission to hospital or death within the time periods noted above. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
90 days after discharge
Composite of readmission or death
Time Frame: 6 months after discharge
A binary outcome variable for each patient, representing readmission to hospital within the time periods noted above. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
6 months after discharge
Composite of readmission or death
Time Frame: One year after discharge
A binary outcome variable for each patient, representing either readmission to hospital or death within the time periods noted above. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
One year after discharge
Emergency department visits
Time Frame: 30 days after discharge
A binary outcome variable for each patient, representing an emergency department visit within the time periods noted above. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
30 days after discharge
Emergency department visits
Time Frame: 90 days after discharge
A binary outcome variable for each patient, representing an emergency department visit within the time periods noted above. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
90 days after discharge
Emergency department visits
Time Frame: 6 months after discharge
A binary outcome variable for each patient, representing an emergency department visit within the time periods noted above. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
6 months after discharge
Emergency department visits
Time Frame: One year after discharge
A binary outcome variable for each patient, representing an emergency department visit within the time periods noted above. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
One year after discharge
Long-term care admission
Time Frame: 30 days after discharge
A binary outcome variable for each patient, representing a long-term care admission within the time periods noted above. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
30 days after discharge
Long-term care admission
Time Frame: 90 days after discharge
A binary outcome variable for each patient, representing a long-term care admission within the time periods noted above. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
90 days after discharge
Long-term care admission
Time Frame: 6 months after discahrge
A binary outcome variable for each patient, representing a long-term care admission within the time periods noted above. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
6 months after discahrge
Long-term care admission
Time Frame: One year after discharge
A binary outcome variable for each patient, representing a long-term care admission within the time periods noted above. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
One year after discharge
Death
Time Frame: 90 days after discharge
A binary outcome variable for each patient, representing death within the time periods noted above. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences
90 days after discharge
Death
Time Frame: 6 months after discharge
A binary outcome variable for each patient, representing death within the time periods noted above. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences
6 months after discharge
Death
Time Frame: One year after discharge
A binary outcome variable for each patient, representing death within the time periods noted above. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences
One year after discharge
Death
Time Frame: 30 days after discharge
A binary outcome variable for each patient, representing death within the time periods noted above. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences
30 days after discharge
Composite of readmission to hospital or death.
Time Frame: One year after discharge
Time to the composite outcome of either readmission to hospital or death. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Data will be censored on the date of the last follow up (i.e., 30 days, 90 days or 6 months). Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
One year after discharge
Readmission
Time Frame: One year after discharge
Time to readmission to hospital. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Data will be censored on the date of the last follow up (i.e., 30 days, 90 days or 6 months), or on death. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
One year after discharge
Emergency department visits
Time Frame: One year after discharge
Time to emergency department visit. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Data will be censored on the date of the last follow up (i.e., 30 days, 90 days or 6 months), or on readmission or death. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
One year after discharge
Long-term care admission
Time Frame: One year after discharge
Time to long-term care admission. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Data will be censored on the date of the last follow up (i.e., 30 days, 90 days or 6 months), or on death. Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
One year after discharge
Death
Time Frame: One year after discharge
Time to death. A research assistant blinded to the assignment will ascertain this information via telephone using a standardized script. Data will be censored on the date of the last follow up (i.e., 30 days, 90 days or 6 months). Second, we may also ascertain this information by linking the data we collect to administrative databases housed at the Institute for Clinical Evaluative Sciences.
One year after discharge

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.
Unity Health Toronto

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.
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
Ontario Ministry of Health and Long Term Care
Women's College Hospital
Toronto Central Local Health Integration Network
Toronto Central Community Care Access Centre

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.
  • Principal Investigator: Irfan Dhalla, MD, MSc, St. Michael's Hospital/University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
June 1, 2010

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.
June 1, 2013

Study Completion (Anticipated)

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.
June 1, 2014

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).
April 13, 2010

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.
April 19, 2010

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.
April 21, 2010

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.
December 9, 2013

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.
December 6, 2013

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.
December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 216852-PHE-CEAJ-25173

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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