Acute DiseaseNCT01108172
A Virtual Ward to Reduce Readmissions After Hospital Discharge
A study testing Virtual Ward in people with Acute Disease, run by Unity Health Toronto at 5 sites in Canada.
Trial summary
The purpose of this study is to see whether a Virtual Ward reduces readmissions after hospital discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Disease
- What is being tested?
- Virtual Ward
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,928 participants
- Where
- 5 sitesCanada
- Study dates
- Jun 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previously enrolled in study
- Discharged to a rehabilitation or complex continuing care facility
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Sunnybrook Health Sciences Centre
Toronto, Ontario
Toronto Central Community Care Access Centre
Toronto, Ontario
University Health Network
Toronto, Ontario
Women's College Hospital
Toronto, Ontario
About this study
The purpose of this study is to see whether a Virtual Ward reduces readmissions after hospital discharge.
Read the 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.
- Conditions
- Acute Disease
- Being tested
- Virtual Ward, Usual care
- Medical subject headings
- Acute Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual WardOther
A multidisciplinary team to optimize medical and social care for patients residing in their own homes
Usual careOther
The usual care provided to patients after discharge from hospital
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Not described Receives: Other: Usual care |
| Virtual Ward | Experimental | Not described Receives: Other: Virtual Ward |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after hospital discharge
Secondary outcomes (20)
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.
Measured: 90 days after discharge
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.
Measured: 6 months after discharge
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.
Measured: One year after discharge
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.
Measured: 30 days after discharge
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.
Measured: 90 days after discharge
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.
Measured: 6 months after discharge
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.
Measured: One year after discharge
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.
Measured: 30 days after discharge
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.
Measured: 90 days after discharge
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.
Measured: 6 months after discahrge
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.
Measured: One year after discharge
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
Measured: 90 days after discharge
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
Measured: 6 months after discharge
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
Measured: One year after discharge
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
Measured: 30 days after discharge
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.
Measured: One year after discharge
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.
Measured: One year after discharge
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.
Measured: One year after discharge
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.
Measured: One year after discharge
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.
Measured: One year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2013
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute DiseaseStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,928 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Irfan Dhalla, Unity Health Toronto
- Investigators
- Irfan Dhalla, MD, MSc, Principal investigator, St. Michael's Hospital/University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108172
- Sponsor's protocol ID
- 216852-PHE-CEAJ-25173
- Status last verified
- Dec 2013
- First submitted
- 13 Apr 2010
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20194559Dhalla 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.
PubMed 25268437
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Ward to Reduce Readmissions After Hospital Discharge
- ClinicalTrials.gov ID
- NCT01108172
- Acronym / sponsor ID
- 216852-PHE-CEAJ-25173
- Conditions
- Acute Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,928 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- 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
- Study start
- Jun 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2014 (estimated)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual care |
| Virtual Ward | Experimental | Other: Virtual Ward |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Previously enrolled in study
- Discharged to a rehabilitation or complex continuing care facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual WardA multidisciplinary team to optimize medical and social care for patients residing in their own homes | Other | Virtual Ward |
| Usual careThe usual care provided to patients after discharge from hospital | Other | Usual Care |
Primary outcome
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.
20 secondary outcomes
Composite of readmission or death
Time frame: 90 days after discharge
Composite of readmission or death
Time frame: 6 months after discharge
Composite of readmission or death
Time frame: One year after discharge
Emergency department visits
Time frame: 30 days after discharge
Emergency department visits
Time frame: 90 days after discharge
Emergency department visits
Time frame: 6 months after discharge
Emergency department visits
Time frame: One year after discharge
Long-term care admission
Time frame: 30 days after discharge
Long-term care admission
Time frame: 90 days after discharge
Long-term care admission
Time frame: 6 months after discahrge
Long-term care admission
Time frame: One year after discharge
Death
Time frame: 90 days after discharge
Death
Time frame: 6 months after discharge
Death
Time frame: One year after discharge
Death
Time frame: 30 days after discharge
Composite of readmission to hospital or death.
Time frame: One year after discharge
Readmission
Time frame: One year after discharge
Emergency department visits
Time frame: One year after discharge
Long-term care admission
Time frame: One year after discharge
Death
Time frame: One year after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
- Background: PubMed 20194559van 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.
- Derived from this study: PubMed 25268437Dhalla 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irfan Dhalla, MD, MSc principal investigator
St. Michael's Hospital/University of Toronto
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Ward in people with Acute Disease, run by Unity Health Toronto at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of readmission to hospital or death. (time frame: 30 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01108172, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2013.