A Virtual Ward to Reduce Readmissions After Hospital Discharge
Primary Purpose
Acute Disease
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Ward
Usual care
Sponsored by
About this trial
This is an interventional health services research trial for Acute Disease
Eligibility Criteria
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
Sites / Locations
- St. Michael's Hospital
- Sunnybrook Health Sciences Centre
- Toronto Central Community Care Access Centre
- University Health Network
- Women's College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual Care
Virtual Ward
Arm Description
Outcomes
Primary Outcome Measures
Composite of readmission to hospital or death.
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.
Secondary Outcome Measures
Composite of readmission or death
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.
Composite of readmission or death
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.
Composite of readmission or death
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.
Emergency department visits
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.
Emergency department visits
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.
Emergency department visits
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.
Emergency department visits
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.
Long-term care admission
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.
Long-term care admission
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.
Long-term care admission
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.
Long-term care admission
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.
Death
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
Death
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
Death
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
Death
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
Composite of readmission to hospital or death.
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.
Readmission
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.
Emergency department visits
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.
Long-term care admission
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.
Death
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.
Full Information
NCT ID
NCT01108172
First Posted
April 13, 2010
Last Updated
December 6, 2013
Sponsor
Unity Health Toronto
Collaborators
Canadian Institutes of Health Research (CIHR), Toronto Central Local Health Integration Network, Ontario Ministry of Health and Long Term Care, Toronto Central Community Care Access Centre, Women's College Hospital, University Health Network, Toronto, Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT01108172
Brief Title
A Virtual Ward to Reduce Readmissions After Hospital Discharge
Official Title
A Virtual Ward to Reduce Readmissions After Hospital Discharge
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Unity Health Toronto
Collaborators
Canadian Institutes of Health Research (CIHR), Toronto Central Local Health Integration Network, Ontario Ministry of Health and Long Term Care, Toronto Central Community Care Access Centre, Women's College Hospital, University Health Network, Toronto, Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to see whether a Virtual Ward reduces readmissions after hospital discharge.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1928 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Title
Virtual Ward
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Virtual Ward
Intervention Description
A multidisciplinary team to optimize medical and social care for patients residing in their own homes
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
The usual care provided to patients after discharge from hospital
Primary Outcome Measure Information:
Title
Composite of readmission to hospital or death.
Description
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.
Time Frame
30 days after hospital discharge
Secondary Outcome Measure Information:
Title
Composite of readmission or death
Description
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.
Time Frame
90 days after discharge
Title
Composite of readmission or death
Description
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.
Time Frame
6 months after discharge
Title
Composite of readmission or death
Description
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.
Time Frame
One year after discharge
Title
Emergency department visits
Description
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.
Time Frame
30 days after discharge
Title
Emergency department visits
Description
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.
Time Frame
90 days after discharge
Title
Emergency department visits
Description
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.
Time Frame
6 months after discharge
Title
Emergency department visits
Description
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.
Time Frame
One year after discharge
Title
Long-term care admission
Description
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.
Time Frame
30 days after discharge
Title
Long-term care admission
Description
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.
Time Frame
90 days after discharge
Title
Long-term care admission
Description
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.
Time Frame
6 months after discahrge
Title
Long-term care admission
Description
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.
Time Frame
One year after discharge
Title
Death
Description
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
Time Frame
90 days after discharge
Title
Death
Description
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
Time Frame
6 months after discharge
Title
Death
Description
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
Time Frame
One year after discharge
Title
Death
Description
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
Time Frame
30 days after discharge
Title
Composite of readmission to hospital or death.
Description
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.
Time Frame
One year after discharge
Title
Readmission
Description
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.
Time Frame
One year after discharge
Title
Emergency department visits
Description
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.
Time Frame
One year after discharge
Title
Long-term care admission
Description
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.
Time Frame
One year after discharge
Title
Death
Description
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.
Time Frame
One year after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irfan Dhalla, MD, MSc
Organizational Affiliation
St. Michael's Hospital/University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto Central Community Care Access Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
20194559
Citation
van Walraven C, Dhalla IA, Bell C, Etchells E, Stiell IG, Zarnke K, Austin PC, Forster AJ. Derivation and validation of an index to predict early death or unplanned readmission after discharge from hospital to the community. CMAJ. 2010 Apr 6;182(6):551-7. doi: 10.1503/cmaj.091117. Epub 2010 Mar 1.
Results Reference
background
PubMed Identifier
25268437
Citation
Dhalla IA, O'Brien T, Morra D, Thorpe KE, Wong BM, Mehta R, Frost DW, Abrams H, Ko F, Van Rooyen P, Bell CM, Gruneir A, Lewis GH, Daub S, Anderson GM, Hawker GA, Rochon PA, Laupacis A. Effect of a postdischarge virtual ward on readmission or death for high-risk patients: a randomized clinical trial. JAMA. 2014 Oct 1;312(13):1305-12. doi: 10.1001/jama.2014.11492.
Results Reference
derived
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A Virtual Ward to Reduce Readmissions After Hospital Discharge
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