Hospital ReadmissionNCT01440907
Study of the Impact of a Hospital Discharge Care Coordination Program in an Elderly Population
A study testing Care Coordination Program in people with Hospital Readmission, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
The purpose of this research study is to evaluate the effect of a health information exchange (HIE)-supported care coordination package on 30-day readmission rates in a frail elderly population. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hospital Readmission
- What is being tested?
- Care Coordination Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2011to Jul 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Weill Cornell Investigators will be receiving a HIPAA-compliant de-identified dataset from the Brooklyn Health Information Exchange (BHIX) that includes:
- Demographic data information
- Diagnoses (admission, discharge, readmission)
- Whether the patient was readmitted readmission, # of inpatients days if the patients was readmitted
- Care coordination program statistics (e.g. usage of the personal health record, and frequency of contact with nursing support staff).
- The data set will include data of the following individuals:
- Intervention Dataset (Group 1): Those age 65 or older who are discharged from Maimonides to home during the study period and enrolled in the Care Coordination Program.
- Control Dataset (Group 2): Those age 65 or older who are discharged from Maimonides to home during the study period.
Who cannot join
- The exclusion criteria for this study for both the intervention \& control dataset is anybody who does not fall into the above inclusion category and anybody who was:
- Transferred on the day of discharge to another acute care hospital, admitted to a hospital specialty unit, admitted to an inpatient rehabilitation facility, or admitted to a long-term care hospital;
- Approached and declined to participate in the Care Coordination Program.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Maimonides Medical Center
Brooklyn, New York, 11219
Brooklyn Health Information Exchange (BHIX)
Brooklyn, New York, 11220
About this study
Official title: The Effect of an HIE-Supported Care Coordination Package on Hospital Re-Admission Rates in an Elderly Population
The purpose of this research study is to evaluate the effect of a health information exchange (HIE)-supported care coordination package on 30-day readmission rates in a frail elderly population.
Read the detailed description
BACKGROUND
Reducing hospital readmission rates is a top national priority. Unplanned hospital readmission is estimated to have accounted for more than $17 billion of the roughly $103 billion hospital payments made by Medicare in 2004.1 For patients in Medicare fee-for-service programs, the 30-day hospital readmission rates was recently found to be 19.6% nationally, and 20.7% in New York State (Jencks et al., 2009). Hospitals have urgent incentives to address readmission rates: readmission rates have been added to the National Quality Forum performance metrics (National Quality Forum, 2007); readmission rate comparisons are posted on www.hospitalcompare.hss.gov as public indicators of hospital quality; and provisions in health care reform legislation will soon mean that hospitals will not receive payment for many readmissions within 30 days of discharge.
Targeted transitional programs and better coordination of care between inpatient and outpatient settings have the potential to reduce hospital readmission rates (Naylor et al, 2004; Coleman et al, 2006; Peikes et al, 2009). Successful care coordination measures depend upon the effective transmission of health information between the inpatient and outpatient settings.
The Brooklyn Health Information Exchange (BHIX) is a regional health information organization (RHIO) that provides secure health information exchange (HIE) services among participating health-care organizations in Brooklyn, Queens, and other parts of New York City. HIE allows the meaningful sharing of health information of locations where a patients may receive care or healthcare services and can be used to help improve the effective transmission of health information between inpatient and outpatient settings. Maimonides Medical Center is working with BHIX to offer a health information technology- and HIE-based care coordination program (CCP) to help improve the care of frail elderly patients upon discharge. The CCP includes: (1) access to a secure online personal health record (PHR) that people can logon and manage their health information, as well as receive alerts and reminders about action items for them to take on their healthcare; and (2) depending on the patient's health care needs, nursing support (either in-person or by phone).
The main objective of this study to determine the impact of the CCP in a frail elderly population.
SPECIFIC AIMS
Weill Cornell Investigators will be analyzing a HIPAA-defined de-identified dataset from BHIX to evaluate the impact of the CCP. The two main outcomes we will be addressing in our data analysis are:
- Readmission to any BHIX hospital within 30 days of hospital discharge from Maimonides;
- Number of inpatient days within 30 days after being discharged from Maimonides Hospital.
See CITATIONS, for references.
- Conditions
- Hospital Readmission
- Being tested
- Care Coordination Program
- Keywords
- Health Information Technology, Health Records, Personal, Hospital Information Systems, Patient Access to Records, Medical Records, Medical Record Systems, Computerized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Coordination ProgramOther
Also called Safe at Home Project
The Care Coordination Program includes: (1) access to a secure online personal health record (PHR) that people can logon and manage their health information, as well as receive alerts and reminders about action items for them to take on their healthcare; and (2) depending on the patient's health care needs, nursing support (either in-person or by phone).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Those age 65 or older who are discharged from Maimonides Medical Center to home during the study period and enrolled in the Care Coordination Program Receives: Other: Care Coordination Program |
| Control Group | No intervention | Those age 65 or older who are discharged from Maimonides Medical Center to home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Readmission Rates Post 30-day Discharge
To determine the impact of a health information exchange (HIE) care coordination program on reducing hospital readmissions rates post 30-day discharge from Maimonides Medical Center.
Measured: 1 year
Secondary outcomes (1)
Number of inpatient hospital days within 30 days of discharge
To determine the impact of a health information exchange (HIE) care coordination program on reducing the number of inpatient days patients experience within 30 days after being discharged from Maimonides Medical Center.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hospital ReadmissionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Department of Health, Maimonides Medical Center
- Responsible party
- Sponsor
- Investigators
- Jessica S Ancker, MPH, PhD, Principal investigator, Weill Medical College of Cornell UniversityMelissa C Miller, MPH, Study chair, Weill Medical College of Cornell UniversityRainu Kaushal, MD, MPH, Study director, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440907
- Sponsor's protocol ID
- C023699-22
- Status last verified
- Jan 2017
- First submitted
- 23 Sep 2011
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A fully deidentified data set listing outcomes for the included patients is available by contacting the study PI (Jessica Ancker, jsa7002@med.cornell.edu)
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 19339721Naylor MD, Brooten DA, Campbell RL, Maislin G, McCauley KM, Schwartz JS. Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial. J Am Geriatr Soc. 2004 May;52(5):675-84. doi: 10.1111/j.1532-5415.2004.52202.x.
PubMed 15086645Coleman EA, Parry C, Chalmers S, Min SJ. The care transitions intervention: results of a randomized controlled trial. Arch Intern Med. 2006 Sep 25;166(17):1822-8. doi: 10.1001/archinte.166.17.1822.
PubMed 17000937Peikes D, Chen A, Schore J, Brown R. Effects of care coordination on hospitalization, quality of care, and health care expenditures among Medicare beneficiaries: 15 randomized trials. JAMA. 2009 Feb 11;301(6):603-18. doi: 10.1001/jama.2009.126.
PubMed 19211468
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an HIE-Supported Care Coordination Package on Hospital Re-Admission Rates in an Elderly Population
- ClinicalTrials.gov ID
- NCT01440907
- Acronym / sponsor ID
- C023699-22
- Conditions
- Hospital Readmission
- Keywords
- Health Information Technology, Health Records, Personal, Hospital Information Systems, Patient Access to Records, Medical Records, Medical Record Systems, Computerized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- New York State Department of Health, Maimonides Medical Center
- Study start
- May 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Sep 2011 (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 research study is to evaluate the effect of a health information exchange (HIE)-supported care coordination package on 30-day readmission rates in a frail elderly population.
Detailed description
BACKGROUND
Reducing hospital readmission rates is a top national priority. Unplanned hospital readmission is estimated to have accounted for more than $17 billion of the roughly $103 billion hospital payments made by Medicare in 2004.1 For patients in Medicare fee-for-service programs, the 30-day hospital readmission rates was recently found to be 19.6% nationally, and 20.7% in New York State (Jencks et al., 2009). Hospitals have urgent incentives to address readmission rates: readmission rates have been added to the National Quality Forum performance metrics (National Quality Forum, 2007); readmission rate comparisons are posted on www.hospitalcompare.hss.gov as public indicators of hospital quality; and provisions in health care reform legislation will soon mean that hospitals will not receive payment for many readmissions within 30 days of discharge.
Targeted transitional programs and better coordination of care between inpatient and outpatient settings have the potential to reduce hospital readmission rates (Naylor et al, 2004; Coleman et al, 2006; Peikes et al, 2009). Successful care coordination measures depend upon the effective transmission of health information between the inpatient and outpatient settings.
The Brooklyn Health Information Exchange (BHIX) is a regional health information organization (RHIO) that provides secure health information exchange (HIE) services among participating health-care organizations in Brooklyn, Queens, and other parts of New York City. HIE allows the meaningful sharing of health information of locations where a patients may receive care or healthcare services and can be used to help improve the effective transmission of health information between inpatient and outpatient settings. Maimonides Medical Center is working with BHIX to offer a health information technology- and HIE-based care coordination program (CCP) to help improve the care of frail elderly patients upon discharge. The CCP includes: (1) access to a secure online personal health record (PHR) that people can logon and manage their health information, as well as receive alerts and reminders about action items for them to take on their healthcare; and (2) depending on the patient's health care needs, nursing support (either in-person or by phone).
The main objective of this study to determine the impact of the CCP in a frail elderly population.
SPECIFIC AIMS
Weill Cornell Investigators will be analyzing a HIPAA-defined de-identified dataset from BHIX to evaluate the impact of the CCP. The two main outcomes we will be addressing in our data analysis are:
- Readmission to any BHIX hospital within 30 days of hospital discharge from Maimonides;
- Number of inpatient days within 30 days after being discharged from Maimonides Hospital.
See CITATIONS, for references.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Care Coordination ProgramThose age 65 or older who are discharged from Maimonides Medical Center to home during the study period and enrolled in the Care Coordination Program |
| Control Group | No intervention | –Those age 65 or older who are discharged from Maimonides Medical Center to home |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Weill Cornell Investigators will be receiving a HIPAA-compliant de-identified dataset from the Brooklyn Health Information Exchange (BHIX) that includes:
- The data set will include data of the following individuals:
Key exclusion criteria (3 listed)
- The exclusion criteria for this study for both the intervention \& control dataset is anybody who does not fall into the above inclusion category and anybody who was:
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 |
|---|---|---|
| Care Coordination ProgramAlso: Safe at Home ProjectThe Care Coordination Program includes: (1) access to a secure online personal health record (PHR) that people can logon and manage their health information, as well as receive alerts and reminders about action items for them to take on their healthcare; and (2) depending on the patient's health care needs, nursing support (either in-person or by phone). | Other | Intervention Group |
Primary outcome
Hospital Readmission Rates Post 30-day Discharge
Time frame: 1 year
To determine the impact of a health information exchange (HIE) care coordination program on reducing hospital readmissions rates post 30-day discharge from Maimonides Medical Center.
1 secondary outcome
Number of inpatient hospital days within 30 days of discharge
Time frame: 1 year
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 Jan 2017.
- 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 15086645Naylor MD, Brooten DA, Campbell RL, Maislin G, McCauley KM, Schwartz JS. Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial. J Am Geriatr Soc. 2004 May;52(5):675-84. doi: 10.1111/j.1532-5415.2004.52202.x.
- Background: PubMed 17000937Coleman EA, Parry C, Chalmers S, Min SJ. The care transitions intervention: results of a randomized controlled trial. Arch Intern Med. 2006 Sep 25;166(17):1822-8. doi: 10.1001/archinte.166.17.1822.
- Background: PubMed 19211468Peikes D, Chen A, Schore J, Brown R. Effects of care coordination on hospitalization, quality of care, and health care expenditures among Medicare beneficiaries: 15 randomized trials. JAMA. 2009 Feb 11;301(6):603-18. doi: 10.1001/jama.2009.126.
- Individual participant dataSharing planned: Yes. A fully deidentified data set listing outcomes for the included patients is available by contacting the study PI (Jessica Ancker, jsa7002@med.cornell.edu)
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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.
Jessica S Ancker, MPH, PhD principal investigator
Weill Medical College of Cornell University
Melissa C Miller, MPH study chair
Weill Medical College of Cornell University
Rainu Kaushal, MD, MPH study director
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Coordination Program in people with Hospital Readmission, run by Weill Medical College of Cornell University at 2 sites in United States.
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 8 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Hospital Readmission Rates Post 30-day Discharge (time frame: 1 year). 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 NCT01440907, which also lists 4 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 Jan 2017.