Post-cardiac SurgeryNCT03353155
Effectiveness of Transitional Care Services
A study testing CareHub in people with Post-cardiac Surgery, run by Johns Hopkins University at 1 site in Singapore.
Trial summary
The National University Hospital System has designed and is piloting an improved post-discharge care programme called CareHub for patients undergoing cardiac surgery. CareHub is a post-discharge care programme that is designed to streamline and better coordinate current programmes for patients at high risk of… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Post-cardiac Surgery
- What is being tested?
- CareHub
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2016to 1 Oct 2017
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted to the cardiac inpatient service post-cardiac surgery
Who cannot join
- Patients that do not consent or are unable to consent to be included into CareHub
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Refinements to Effective Transitional Care Services Improve Outcomes? Results From a Pragmatic, Randomized Controlled Trial.
The National University Hospital System has designed and is piloting an improved post-discharge care programme called CareHub for patients undergoing cardiac surgery. CareHub is a post-discharge care programme that is designed to streamline and better coordinate current programmes for patients at high risk of readmission.
To assess the clinical and cost-effectiveness of CareHub, our team will randomly assign patients to a usual care setting or CareHub setting, and measure clinical outcomes, patient satisfaction, readmissions, and length of stay through 6 months post-discharge in both groups.Patients enrolled in both groups will receive post-discharge care for six months after discharge. CareHub patients will receive a single point of contact for access to usual care services. Recruitment for this pilot will be from 20 April 2016 - approximately late October 2016, and the CareHub team will provide 6 months of post-discharge support. The entire pilot will thus run from 20 April 2016 - April / May 2017, with data collection extending 6 months after the last patient is enrolled.
Read the detailed description
Today, the National University Hospital System has a variety of transitional / post-discharge care programmes, and patients may be enrolled in more than one. Each of these programmes is run by a different hospital team, so a patient may have to liaise with many parties for their post-discharge care.
The National University Hospital System has designed and is piloting an improved post-discharge care programme called CareHub for patients undergoing cardiac surgery. Recruitment for this pilot will be from 20 April 2016 - approximately late October 2016, and the CareHub team will provide 6 months of post-discharge support. The entire pilot will thus run from 20 April 2016 - April / May 2017.
CareHub is a post-discharge care programme that is designed to streamline and better coordinate current programmes for patients at high risk of readmission. Patients enrolled in CareHub and usual care will receive post-discharge care for six months after discharge. However, patients in CareHub will experience:
(i) Provision of a single point of contact for all the patient's needs, to help patients and their families navigate the healthcare system as well as various programmes available in the hospital and community. Care Coordinator identifies patients and starts working with care team during the inpatient phase, and follows patient through to the post-discharge phase.
(ii) More structured and regular telephone support and checks, to help ease the hospital-to-home transition, as well as to provide more opportunity to verify that patients are adhering to their recommended treatment (which may include e.g. checking that patients have made use of the daycare services CareHub recommended).
(iii) A call center which will operate during office hours, where tele-consult will be available from and nurses/care coordinators.
(iv) A consolidated multi-disciplinary discharge plan, based on the input of all healthcare workers caring for the patient. These include the CareHub coordinator, ward doctor and nurse, heart failure care manager, and allied health professionals, as required.
(v) Early identification and preparation for post-discharge care. Healthcare workers listed in (iv) will participate in a daily in-patient multi-disciplinary ward huddle, to discuss the patient's condition and start early preparation for post-discharge care.
To assess the clinical and cost-effectiveness of CareHub, our team will randomly assign patients to a usual care setting or CareHub setting, and measure clinical outcomes, patient satisfaction, readmissions, and length of stay through 6 months post-discharge in both groups.
- Conditions
- Post-cardiac Surgery
- Being tested
- Usual Care, CareHub
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
CareHubBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Telephone and/or home visits at 1 week, and thereafter, monthly for 6 months, to check on medication compliance and/or medical social problems and/or physical therapy needs and/or health-related financial challenges by the relevant service departments as recommended by the discharging physician. Receives: Behavioral: Usual Care |
| CareHub | Active comparator | Telephone follow-up by a nurse care coordinator acting as single point of contact for medication compliance and/or medical social problems and/or physical therapy needs and/or health-related financial challenges based on automatic enrollment using ACE score cut-off at admission. Receives: Behavioral: CareHub |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-discharge length of stay
Patient's length of stay for any readmissions following index admission
Measured: 6 months
Unplanned readmissions
Whether patients were admitted for a cardiac complaint after index admission
Measured: 6 months
Cardiac-related specialist outpatient clinic visits
The number of post-index admission visits to an outpatient clinic for cardiac consults
Measured: 6 months
Emergency department visits
The number of emergency department visits post-index admission
Measured: 6 months
Secondary outcomes (1)
Net cost of service utilization
CareHub cost/patient minus Usual Care cost/patient
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start1 Jul 2016
- Primary completion30 Nov 2016
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post-cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Model description
- Patients are randomly assigned to one of two groups. Group 1 is usual care, in which patients are followed up after surgery by the ambulatory clinic assigned to their case. Patients in usual care have access to occupational and physical therapy, and medical social work, if they choose to use them. Group 2 is CareHub, in which patients are followed up by a dedicated care coordinator who proactively calls patients at home and schedules their clinic appointments, and consults with therapists and medical social workers.
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National University Health System, Singapore
- Responsible party
- Sponsor
- Investigators
- John Wong, MD, PhD, Principal investigator, National University Hospital SystemPhillip Phan, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353155
- Sponsor's protocol ID
- NUHSCareHub
- Status last verified
- Aug 2018
- First submitted
- 12 Nov 2017
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participate data has been de-identified. There are currently no plans to share the data.
Publications
Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi: 10.1056/NEJMsa0803563.
PubMed 19339721Coleman EA. Falling through the cracks: challenges and opportunities for improving transitional care for persons with continuous complex care needs. J Am Geriatr Soc. 2003 Apr;51(4):549-55. doi: 10.1046/j.1532-5415.2003.51185.x.
PubMed 12657078Greysen SR, Harrison JD, Kripalani S, Vasilevskis E, Robinson E, Metlay J, Schnipper JL, Meltzer D, Sehgal N, Ruhnke GW, Williams MV, Auerbach AD. Understanding patient-centred readmission factors: a multi-site, mixed-methods study. BMJ Qual Saf. 2017 Jan;26(1):33-41. doi: 10.1136/bmjqs-2015-004570. Epub 2016 Jan 14.
PubMed 26769841Wee SL, Loke CK, Liang C, Ganesan G, Wong LM, Cheah J. Effectiveness of a national transitional care program in reducing acute care use. J Am Geriatr Soc. 2014 Apr;62(4):747-53. doi: 10.1111/jgs.12750. Epub 2014 Mar 17.
PubMed 24635373Coleman EA, Smith JD, Frank JC, Min SJ, Parry C, Kramer AM. Preparing patients and caregivers to participate in care delivered across settings: the Care Transitions Intervention. J Am Geriatr Soc. 2004 Nov;52(11):1817-25. doi: 10.1111/j.1532-5415.2004.52504.x.
PubMed 15507057Naylor M, Brooten D, Jones R, Lavizzo-Mourey R, Mezey M, Pauly M. Comprehensive discharge planning for the hospitalized elderly. A randomized clinical trial. Ann Intern Med. 1994 Jun 15;120(12):999-1006. doi: 10.7326/0003-4819-120-12-199406150-00005.
PubMed 8185149Allen J, Hutchinson AM, Brown R, Livingston PM. Quality care outcomes following transitional care interventions for older people from hospital to home: a systematic review. BMC Health Serv Res. 2014 Aug 15;14:346. doi: 10.1186/1472-6963-14-346.
PubMed 25128468
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Refinements to Effective Transitional Care Services Improve Outcomes? Results From a Pragmatic, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03353155
- Acronym / sponsor ID
- NUHSCareHub
- Conditions
- Post-cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National University Health System, Singapore
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 27 Nov 2017 (actual)
- 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 National University Hospital System has designed and is piloting an improved post-discharge care programme called CareHub for patients undergoing cardiac surgery. CareHub is a post-discharge care programme that is designed to streamline and better coordinate current programmes for patients at high risk of readmission.
To assess the clinical and cost-effectiveness of CareHub, our team will randomly assign patients to a usual care setting or CareHub setting, and measure clinical outcomes, patient satisfaction, readmissions, and length of stay through 6 months post-discharge in both groups.Patients enrolled in both groups will receive post-discharge care for six months after discharge. CareHub patients will receive a single point of contact for access to usual care services. Recruitment for this pilot will be from 20 April 2016 - approximately late October 2016, and the CareHub team will provide 6 months of post-discharge support. The entire pilot will thus run from 20 April 2016 - April / May 2017, with data collection extending 6 months after the last patient is enrolled.
Detailed description
Today, the National University Hospital System has a variety of transitional / post-discharge care programmes, and patients may be enrolled in more than one. Each of these programmes is run by a different hospital team, so a patient may have to liaise with many parties for their post-discharge care.
The National University Hospital System has designed and is piloting an improved post-discharge care programme called CareHub for patients undergoing cardiac surgery. Recruitment for this pilot will be from 20 April 2016 - approximately late October 2016, and the CareHub team will provide 6 months of post-discharge support. The entire pilot will thus run from 20 April 2016 - April / May 2017.
CareHub is a post-discharge care programme that is designed to streamline and better coordinate current programmes for patients at high risk of readmission. Patients enrolled in CareHub and usual care will receive post-discharge care for six months after discharge. However, patients in CareHub will experience:
(i) Provision of a single point of contact for all the patient's needs, to help patients and their families navigate the healthcare system as well as various programmes available in the hospital and community. Care Coordinator identifies patients and starts working with care team during the inpatient phase, and follows patient through to the post-discharge phase.
(ii) More structured and regular telephone support and checks, to help ease the hospital-to-home transition, as well as to provide more opportunity to verify that patients are adhering to their recommended treatment (which may include e.g. checking that patients have made use of the daycare services CareHub recommended).
(iii) A call center which will operate during office hours, where tele-consult will be available from and nurses/care coordinators.
(iv) A consolidated multi-disciplinary discharge plan, based on the input of all healthcare workers caring for the patient. These include the CareHub coordinator, ward doctor and nurse, heart failure care manager, and allied health professionals, as required.
(v) Early identification and preparation for post-discharge care. Healthcare workers listed in (iv) will participate in a daily in-patient multi-disciplinary ward huddle, to discuss the patient's condition and start early preparation for post-discharge care.
To assess the clinical and cost-effectiveness of CareHub, our team will randomly assign patients to a usual care setting or CareHub setting, and measure clinical outcomes, patient satisfaction, readmissions, and length of stay through 6 months post-discharge in both groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomly assigned to one of two groups. Group 1 is usual care, in which patients are followed up after surgery by the ambulatory clinic assigned to their case. Patients in usual care have access to occupational and physical therapy, and medical social work, if they choose to use them. Group 2 is CareHub, in which patients are followed up by a dedicated care coordinator who proactively calls patients at home and schedules their clinic appointments, and consults with therapists and medical social workers.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual CareTelephone and/or home visits at 1 week, and thereafter, monthly for 6 months, to check on medication compliance and/or medical social problems and/or physical therapy needs and/or health-related financial challenges by the relevant service departments as recommended by the discharging physician. |
| CareHub | Active comparator | Behavioral: CareHubTelephone follow-up by a nurse care coordinator acting as single point of contact for medication compliance and/or medical social problems and/or physical therapy needs and/or health-related financial challenges based on automatic enrollment using ACE score cut-off at admission. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to the cardiac inpatient service post-cardiac surgery
Key exclusion criteria (1 listed)
- Patients that do not consent or are unable to consent to be included into CareHub
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 |
|---|---|---|
| Usual Care | Behavioural | Usual Care |
| CareHub | Behavioural | CareHub |
Primary outcome
Post-discharge length of stay
Time frame: 6 months
Patient's length of stay for any readmissions following index admission
Unplanned readmissions
Time frame: 6 months
Whether patients were admitted for a cardiac complaint after index admission
Cardiac-related specialist outpatient clinic visits
Time frame: 6 months
The number of post-index admission visits to an outpatient clinic for cardiac consults
Emergency department visits
Time frame: 6 months
The number of emergency department visits post-index admission
1 secondary outcome
Net cost of service utilization
Time frame: 6 months
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 24 Aug 2018.
- Background: PubMed 19339721Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi: 10.1056/NEJMsa0803563.
- Background: PubMed 12657078Coleman EA. Falling through the cracks: challenges and opportunities for improving transitional care for persons with continuous complex care needs. J Am Geriatr Soc. 2003 Apr;51(4):549-55. doi: 10.1046/j.1532-5415.2003.51185.x.
- Background: PubMed 26769841Greysen SR, Harrison JD, Kripalani S, Vasilevskis E, Robinson E, Metlay J, Schnipper JL, Meltzer D, Sehgal N, Ruhnke GW, Williams MV, Auerbach AD. Understanding patient-centred readmission factors: a multi-site, mixed-methods study. BMJ Qual Saf. 2017 Jan;26(1):33-41. doi: 10.1136/bmjqs-2015-004570. Epub 2016 Jan 14.
- Background: PubMed 24635373Wee SL, Loke CK, Liang C, Ganesan G, Wong LM, Cheah J. Effectiveness of a national transitional care program in reducing acute care use. J Am Geriatr Soc. 2014 Apr;62(4):747-53. doi: 10.1111/jgs.12750. Epub 2014 Mar 17.
- Background: PubMed 15507057Coleman EA, Smith JD, Frank JC, Min SJ, Parry C, Kramer AM. Preparing patients and caregivers to participate in care delivered across settings: the Care Transitions Intervention. J Am Geriatr Soc. 2004 Nov;52(11):1817-25. doi: 10.1111/j.1532-5415.2004.52504.x.
- Background: PubMed 8185149Naylor M, Brooten D, Jones R, Lavizzo-Mourey R, Mezey M, Pauly M. Comprehensive discharge planning for the hospitalized elderly. A randomized clinical trial. Ann Intern Med. 1994 Jun 15;120(12):999-1006. doi: 10.7326/0003-4819-120-12-199406150-00005.
- Background: PubMed 25128468Allen J, Hutchinson AM, Brown R, Livingston PM. Quality care outcomes following transitional care interventions for older people from hospital to home: a systematic review. BMC Health Serv Res. 2014 Aug 15;14:346. doi: 10.1186/1472-6963-14-346.
- Individual participant dataSharing planned: No. Individual participate data has been de-identified. There are currently no plans to share the data.
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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.
John Wong, MD, PhD principal investigator
National University Hospital System
Phillip Phan, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CareHub in people with Post-cardiac Surgery, run by Johns Hopkins University at 1 site in Singapore.
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 1 inclusion and 1 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 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
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?
Post-discharge length of stay (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT03353155, which also lists 7 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 24 Aug 2018; AzTrials last refreshed its copy on 4 Nov 2026.