- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03353155
Effectiveness of Transitional Care Services
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore
- National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients admitted to the cardiac inpatient service post-cardiac surgery
Exclusion Criteria:
- Patients that do not consent or are unable to consent to be included into CareHub
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual Care
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.
|
|
Active Comparator: CareHub
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-discharge length of stay
Time Frame: 6 months
|
Patient's length of stay for any readmissions following index admission
|
6 months
|
Unplanned readmissions
Time Frame: 6 months
|
Whether patients were admitted for a cardiac complaint after index admission
|
6 months
|
Cardiac-related specialist outpatient clinic visits
Time Frame: 6 months
|
The number of post-index admission visits to an outpatient clinic for cardiac consults
|
6 months
|
Emergency department visits
Time Frame: 6 months
|
The number of emergency department visits post-index admission
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Net cost of service utilization
Time Frame: 6 months
|
CareHub cost/patient minus Usual Care cost/patient
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: John Wong, MD, PhD, National University Hospital System
- Principal Investigator: Phillip Phan, PhD, Johns Hopkins University
Publications and helpful links
General Publications
- Naylor 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.
- Coleman 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.
- Coleman 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.
- 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. Erratum In: N Engl J Med. 2011 Apr 21;364(16):1582.
- Greysen 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.
- Wee 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.
- Allen 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NUHSCareHub
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post-cardiac Surgery
-
Heart Center Leipzig - University HospitalRecruiting
-
Riphah International UniversityCompletedPost-cardiac SurgeryPakistan
-
EarlySense Ltd.Completed
-
St George's, University of LondonCompleted
-
Erasmus Medical CenterVentinovaCompleted
-
Pentracor GmbHCompleted
-
Riphah International UniversityCompletedPost-cardiac SurgeryPakistan
-
Riphah International UniversityCompletedPost-cardiac SurgeryPakistan
-
Al-Shifa Trust Eye HospitalCompletedPost-cardiac SurgeryPakistan
-
Transonic Systems Inc.CompletedPost Cardiac SurgerySweden
Clinical Trials on Usual Care
-
Charite University, Berlin, GermanyCompletedMultiple Sclerosis | FatigueGermany
-
Centers for Disease Control and PreventionCompleted
-
Charite University, Berlin, GermanyMammazentrum Hamburg am Krankenhaus Jerusalem, Germany; Dorit und Alexander...Completed
-
European Institute for Evidence Based Osteopathic...Unknown
-
Suzanna ZickUniversity of MichiganTerminatedQuality of Life | Fatigue | Lupus Erythematosus, Systemic | Sleep | Pain, ChronicUnited States
-
The Miriam HospitalNational Institute on Aging (NIA)RecruitingHeart FailureUnited States
-
Lawson Health Research InstituteUnknownDepression | Quality of Life | Sleep | Anxiety | Dry EyeCanada
-
U.S. Wound RegistryRecruitingWounds and Injuries | Diabetic Foot | Leg Ulcer | Skin Ulcer | Diabetes Complications | Diabetic Neuropathies | Lymphedema | Peripheral Arterial Disease | Vasculitis | Venous Insufficiency | Varicose Ulcer | Pressure Ulcer | Pyoderma | Surgical Wound Dehiscence | Amputation StumpUnited States
-
University Hospital, MontpellierCompletedOsteoarthritis | Mindfulness | MBSRFrance
-
Gachon University Gil Oriental Medical HospitalKorea Health Industry Development InstituteCompletedKnee Replacement | AcupunctureKorea, Republic of