HospitalizationPhase 1NCT01292096
Intervening With and Improving Care for Patients at Risk for Frequent Hospital Admissions
A Phase 1 study testing Provision of extra (care coordination and management) services in people with Hospitalization and Patient Readmission, run by NYU Langone Health at 1 site in United States.
Trial summary
Patients with frequent hospital admissions account for a disproportionate share of visits and costs. An intervention that can bridge the gap between hospital and community based care for a population of patients with frequent hospital admissions may offer both improved care and cost savings if hospital admissions can… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Hospitalization, Patient Readmission
- What is being tested?
- Provision of extra (care coordination and management) services
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Mar 2009
- Phase
- Phase 1
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients identified at the time of a current hospital admission by a predictive algorithm (algorithmic risk score of 50 or greater) as being at high risk for hospital readmission in the following 12 months
- English or Spanish speaking
- Fee-for-service Medicaid or uninsured patients
- Ages 18-64
Who cannot join
- Neither English or Spanish-speaking,
- Institutionalized when not admitted to the hospital
- Unable to communicate
- HIV positive (because HIV positive patients have resources available to them from different and unrelated funding streams, and receive primary care at an off-site location)
Trial locations and contacts
1 site in 1 country.
United States1 site
Bellevue Hospital Center Department of Emergency Medicine, A345
New York, New York, 10016
About this study
Patients with frequent hospital admissions account for a disproportionate share of visits and costs. An intervention that can bridge the gap between hospital and community based care for a population of patients with frequent hospital admissions may offer both improved care and cost savings if hospital admissions can be appropriately reduced. We are now using data from our previous research to inform the development and implementation of an intervention at Bellevue Hospital, which will bridge the gap between hospital and community based care for a population of patients with frequent hospital admissions.
We hypothesize that such an intervention can offer both improved care and cost savings if hospital admissions can be appropriately reduced.
In this protocol we outline a strategy to pilot a small-scale intervention on a small subset of patients admitted to an urban public tertiary care safety net hospital who are defined by our study criteria as at high risk for future readmission. By piloting components of the intervention, we aim to assure the intervention functions as planned, and can deliver the needed services to high risk patients in a seamless and patient-centered manner. The purpose of this "feasibility study" is to ensure that when our intervention is implemented on a larger scale, it appropriately serves enrolled patients needs, and that we are able to effectively follow patients during the intervention period.
Read the detailed description
In pilot research, we found that high users at Bellevue Hospital Center had varied indications for admission to the hospital, but also shared many risk factors that have been traditionally difficult for the health care system to address, including homelessness, social isolation, substance use, depression and anxiety, and fragmented primary care. Coordination of the multiple service types required to improve care for such patients across hospitals, clinics, and community-based organizations is hindered by financial disincentives, restrictive funding streams, and poor communication among service providers Intervention model and team: The pilot intervention will begin at the patient's bedside in the hospital and continue after his/her discharge into the community, utilizing a flexible and intensive care management model with a multi-disciplinary team approach. Community Based Care Managers (CBCMs) overseen by a social worker, will connect patients to needed community services including housing for homeless patients, accompany patients to appointments and facilitate transportation to medical, benefits enrollment, and perform other services based in the hospital and community.
So that the intervention can address the multitude of complex medical and social needs of high risk patients, in addition to our community partners that address the needs of homeless patients, we will partner with additional community providers of mental health, substance use, and home medical services who will assist our intervention team staff in managing patients' care after hospital discharge. In addition, we will build upon existing specialized health and social services within Bellevue Hospital (e.g. provision of prompt outpatient clinic appointments) so that this population is better and more effectively served.
Specific Aims
- evaluate the patient and provider experience with various potential components of a pilot intervention plan for high risk, high cost patients, (identified using a predictive case-finding algorithm) conducted in partnership with community providers of homeless, mental health, substance use, and other key services, and 2) evaluate the feasibility of several aspects of the intervention. By piloting and evaluating components of the intervention, we aim to assure the intervention functions as planned, and can deliver the needed services to high risk patients.
Outcomes:
Ability of intervention team to:
- Function effectively (e.g. communicate and coordinate with one another and with other departments in the hospital)
- Match patients to appropriate services
- Obtain supportive housing for homeless patients with Common Ground partner
- Maintain contact with patients after initial hospital discharge
- Facilitate patient adherence to outpatient appointments
- Link patients with no usual source of care to PMD
- Conditions
- Hospitalization, Patient Readmission
- Being tested
- Provision of extra (care coordination and management) services
- Keywords
- homelessness, substance use, frequent hospitalization, frequent users of health services, enhanced care management, coordination services p, high risk for frequent hospitalization
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of extra (care coordination and management) servicesOther
The pilot intervention begins at the patient's bedside in the hospital and continue after his/her discharge into the community, utilizing a flexible and intensive care management model with a multi-disciplinary team approach. Community Based Care Managers (CBCMs) overseen by a social worker, will connect patients to needed community services including housing for homeless patients, accompany patients to appointments and facilitate transportation to medical, benefits enrollment, and perform other services based in the hospital and community.
What is being measured
The primary outcome is the main question the study is designed to answer.
Housing placement
Number of eligible chronically homeless patients placed in transitional or permanent housing
Measured: 1 year
Secondary outcomes (2)
Patient retention in program
Number of subjects lost to follow-up and who did not engage after program enrollment
Measured: 1 year
Linkage to primary care provider
Number of patients without a primary care provider who were successfully linked to primary care (at least two visits)
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 posted9 Feb 2011 (estimated)
- Study startAug 2007
- Primary completionMar 2009
- Study completionMar 2009
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 HospitalizationStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- United Hospital Fund, The New York Community Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292096
- Sponsor's protocol ID
- 07-649
- Status last verified
- Feb 2016
- First submitted
- 31 Jan 2011
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Raven MC, Doran KM, Kostrowski S, Gillespie CC, Elbel BD. An intervention to improve care and reduce costs for high-risk patients with frequent hospital admissions: a pilot study. BMC Health Serv Res. 2011 Oct 13;11:270. doi: 10.1186/1472-6963-11-270.
PubMed 21995329
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening With and Improving Care for Patients at Risk for Frequent Hospital Admissions
- ClinicalTrials.gov ID
- NCT01292096
- Acronym / sponsor ID
- 07-649
- Conditions
- Hospitalization, Patient Readmission
- Keywords
- homelessness, substance use, frequent hospitalization, frequent users of health services, enhanced care management, coordination services p, high risk for frequent hospitalization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- United Hospital Fund, The New York Community Trust
- Study start
- Aug 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 9 Feb 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.
Patients with frequent hospital admissions account for a disproportionate share of visits and costs. An intervention that can bridge the gap between hospital and community based care for a population of patients with frequent hospital admissions may offer both improved care and cost savings if hospital admissions can be appropriately reduced. We are now using data from our previous research to inform the development and implementation of an intervention at Bellevue Hospital, which will bridge the gap between hospital and community based care for a population of patients with frequent hospital admissions.
We hypothesize that such an intervention can offer both improved care and cost savings if hospital admissions can be appropriately reduced.
In this protocol we outline a strategy to pilot a small-scale intervention on a small subset of patients admitted to an urban public tertiary care safety net hospital who are defined by our study criteria as at high risk for future readmission. By piloting components of the intervention, we aim to assure the intervention functions as planned, and can deliver the needed services to high risk patients in a seamless and patient-centered manner. The purpose of this "feasibility study" is to ensure that when our intervention is implemented on a larger scale, it appropriately serves enrolled patients needs, and that we are able to effectively follow patients during the intervention period.
Detailed description
In pilot research, we found that high users at Bellevue Hospital Center had varied indications for admission to the hospital, but also shared many risk factors that have been traditionally difficult for the health care system to address, including homelessness, social isolation, substance use, depression and anxiety, and fragmented primary care. Coordination of the multiple service types required to improve care for such patients across hospitals, clinics, and community-based organizations is hindered by financial disincentives, restrictive funding streams, and poor communication among service providers Intervention model and team: The pilot intervention will begin at the patient's bedside in the hospital and continue after his/her discharge into the community, utilizing a flexible and intensive care management model with a multi-disciplinary team approach. Community Based Care Managers (CBCMs) overseen by a social worker, will connect patients to needed community services including housing for homeless patients, accompany patients to appointments and facilitate transportation to medical, benefits enrollment, and perform other services based in the hospital and community.
So that the intervention can address the multitude of complex medical and social needs of high risk patients, in addition to our community partners that address the needs of homeless patients, we will partner with additional community providers of mental health, substance use, and home medical services who will assist our intervention team staff in managing patients' care after hospital discharge. In addition, we will build upon existing specialized health and social services within Bellevue Hospital (e.g. provision of prompt outpatient clinic appointments) so that this population is better and more effectively served.
Specific Aims
- evaluate the patient and provider experience with various potential components of a pilot intervention plan for high risk, high cost patients, (identified using a predictive case-finding algorithm) conducted in partnership with community providers of homeless, mental health, substance use, and other key services, and 2) evaluate the feasibility of several aspects of the intervention. By piloting and evaluating components of the intervention, we aim to assure the intervention functions as planned, and can deliver the needed services to high risk patients.
Outcomes:
Ability of intervention team to:
- Function effectively (e.g. communicate and coordinate with one another and with other departments in the hospital)
- Match patients to appropriate services
- Obtain supportive housing for homeless patients with Common Ground partner
- Maintain contact with patients after initial hospital discharge
- Facilitate patient adherence to outpatient appointments
- Link patients with no usual source of care to PMD
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients identified at the time of a current hospital admission by a predictive algorithm (algorithmic risk score of 50 or greater) as being at high risk for hospital readmission in the following 12 months
- English or Spanish speaking
- Fee-for-service Medicaid or uninsured patients
- Ages 18-64
Key exclusion criteria (4 listed)
- Neither English or Spanish-speaking,
- Institutionalized when not admitted to the hospital
- Unable to communicate
- HIV positive (because HIV positive patients have resources available to them from different and unrelated funding streams, and receive primary care at an off-site location)
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 |
|---|---|---|
| Provision of extra (care coordination and management) servicesThe pilot intervention begins at the patient's bedside in the hospital and continue after his/her discharge into the community, utilizing a flexible and intensive care management model with a multi-disciplinary team approach. Community Based Care Managers (CBCMs) overseen by a social worker, will connect patients to needed community services including housing for homeless patients, accompany patients to appointments and facilitate transportation to medical, benefits enrollment, and perform other services based in the hospital and community. | Other | – |
Primary outcome
Housing placement
Time frame: 1 year
Number of eligible chronically homeless patients placed in transitional or permanent housing
2 secondary outcomes
Patient retention in program
Time frame: 1 year
Linkage to primary care provider
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 2 Mar 2016.
- Derived from this study: PubMed 21995329Raven MC, Doran KM, Kostrowski S, Gillespie CC, Elbel BD. An intervention to improve care and reduce costs for high-risk patients with frequent hospital admissions: a pilot study. BMC Health Serv Res. 2011 Oct 13;11:270. doi: 10.1186/1472-6963-11-270.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Provision of extra (care coordination and management) services in people with Hospitalization and Patient Readmission, run by NYU Langone Health at 1 site 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 4 inclusion and 4 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 2 Mar 2016. 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Housing placement (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 NCT01292096, 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 2 Mar 2016.