Chronic DiseasesNCT02325752
A Prospective Randomised Control Trial to Study the Effectiveness of a Health Service Innovation Using a Modified Virtual Ward Model to Prevent Unscheduled Readmission of High Risk Patients
A study testing Intervention in people with Chronic Diseases, run by Singapore General Hospital.
Trial summary
The investigators conducted an open randomized control study of patients who received the transitional care program versus patients who received usual care at the Singapore General Hospital from Aug 2011 to Sept 2012. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Diseases
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Jan 2013
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with 2 or more unscheduled admission in the last 90 days to selected medical departments
- LACE score of ≥10.
Who cannot join
- Non-residents
- No telephone contact or a resident address
- Residing in long term care facilities.
About this study
The investigators conducted an open randomized control study of patients who received the transitional care program versus patients who received usual care at the Singapore General Hospital from Aug 2011 to Sept 2012.
Read the detailed description
The investigators conducted an open randomized control study of patients who received the transitional care program versus patients who received usual care at the Singapore General Hospital from Aug 2011 to Sept 2012.
- Conditions
- Chronic Diseases
- Being tested
- Intervention
- Keywords
- readmission, chronic diseases
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
A multidisciplinary team delivered the transitional care program.
Our transitional care program focused on four key areas:
- Post discharge surveillance of the patient to ensure adherence to care plans.
- Coordination of follow-up visits with specialist care providers.
- Patent education and care giver training.
- Activation of community and social services.
Upon recruitment, the patients were interviewed and assessed by the team nurse prior to their discharge. Intervention starts upon discharge from the hospital. The duration of the intervention program was 3 months. A follow-up by telephone was made within 72 hours after discharge to assess patient's condition and adherence to treatment plan. Home visits were made within 2 weeks after discharge.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in the control group received usual care by the hospital. There was no contact between the patients in the control group and the study team throughout the 3 months interval. A scheduled telephone call was made at the end of 3 months when they were invited to participate in a telephone survey. |
| Intervention | Active comparator | Intervention Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of readmission
Any hospital admission after randomisation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startAug 2011
- Primary completionOct 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseasesStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Integrated Care, Singapore, Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
- Investigators
- Kheng Hock Lee, MBBS, Principal investigator, Singhealth Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325752
- Sponsor's protocol ID
- 2011/380/E
- Status last verified
- Feb 2017
- First submitted
- 21 Dec 2014
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee KH, Low LL, Allen J, Barbier S, Ng LB, Ng MJ, Tay WY, Tan SY. Transitional care for the highest risk patients: findings of a randomised control study. Int J Integr Care. 2015 Oct 22;15:e039. doi: 10.5334/ijic.2003. eCollection 2015 Oct-Dec.
PubMed 27118956
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Control Trial to Study the Effectiveness of a Health Service Innovation Using a Modified Virtual Ward Model to Prevent Unscheduled Readmission of High Risk Patients
- ClinicalTrials.gov ID
- NCT02325752
- Acronym / sponsor ID
- 2011/380/E
- Conditions
- Chronic Diseases
- Keywords
- readmission, chronic diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Agency for Integrated Care, Singapore, Duke-NUS Graduate Medical School
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Dec 2014 (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 investigators conducted an open randomized control study of patients who received the transitional care program versus patients who received usual care at the Singapore General Hospital from Aug 2011 to Sept 2012.
Detailed description
The investigators conducted an open randomized control study of patients who received the transitional care program versus patients who received usual care at the Singapore General Hospital from Aug 2011 to Sept 2012.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in the control group received usual care by the hospital. There was no contact between the patients in the control group and the study team throughout the 3 months interval. A scheduled telephone call was made at the end of 3 months when they were invited to participate in a telephone survey. |
| Intervention | Active comparator | Other: InterventionIntervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with 2 or more unscheduled admission in the last 90 days to selected medical departments
- LACE score of ≥10.
Key exclusion criteria (3 listed)
- Non-residents
- No telephone contact or a resident address
- Residing in long term care facilities.
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 |
|---|---|---|
| InterventionA multidisciplinary team delivered the transitional care program. Our transitional care program focused on four key areas: 1. Post discharge surveillance of the patient to ensure adherence to care plans. 2. Coordination of follow-up visits with specialist care providers. 3. Patent education and care giver training. 4. Activation of community and social services. Upon recruitment, the patients were interviewed and assessed by the team nurse prior to their discharge. Intervention starts upon discharge from the hospital. The duration of the intervention program was 3 months. A follow-up by telephone was made within 72 hours after discharge to assess patient's condition and adherence to treatment plan. Home visits were made within 2 weeks after discharge. | Other | Intervention |
Primary outcome
Rate of readmission
Time frame: 30 days
Any hospital admission after randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Derived from this study: PubMed 27118956Lee KH, Low LL, Allen J, Barbier S, Ng LB, Ng MJ, Tay WY, Tan SY. Transitional care for the highest risk patients: findings of a randomised control study. Int J Integr Care. 2015 Oct 22;15:e039. doi: 10.5334/ijic.2003. eCollection 2015 Oct-Dec.
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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.
Kheng Hock Lee, MBBS principal investigator
Singhealth Foundation
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Chronic Diseases, run by Singapore General Hospital.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of readmission (time frame: 30 days). 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 NCT02325752, which also lists 1 linked publication.
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 10 Feb 2017.