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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01108172
Other study ID # 216852-PHE-CEAJ-25173
Secondary ID
Status Unknown status
Phase N/A
First received April 13, 2010
Last updated December 6, 2013
Start date June 2010
Est. completion date June 2014

Study information

Verified date December 2013
Source St. Michael's Hospital, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to see whether a Virtual Ward reduces readmissions after hospital discharge.


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.


Recruitment information / eligibility

Status Unknown status
Enrollment 1928
Est. completion date June 2014
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada St. Michael's Hospital Toronto Ontario
Canada Sunnybrook Health Sciences Centre Toronto Ontario
Canada Toronto Central Community Care Access Centre Toronto Ontario
Canada University Health Network Toronto Ontario
Canada Women's College Hospital Toronto Ontario

Sponsors (8)

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

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 days after hospital discharge
Secondary 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. 90 days after discharge
Secondary 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. 6 months after discharge
Secondary 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. One year after discharge
Secondary 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. 30 days after discharge
Secondary 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. 90 days after discharge
Secondary 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. 6 months after discharge
Secondary 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. One year after discharge
Secondary 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. 30 days after discharge
Secondary 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. 90 days after discharge
Secondary 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. 6 months after discahrge
Secondary 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. One year after discharge
Secondary 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 90 days after discharge
Secondary 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 6 months after discharge
Secondary 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 One year after discharge
Secondary 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 30 days after discharge
Secondary 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. One year after discharge
Secondary 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. One year after discharge
Secondary 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. One year after discharge
Secondary 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. One year after discharge
Secondary 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. One year after discharge
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