Intervening With and Improving Care for Patients at Risk for Frequent Hospital Admissions

February 29, 2016 updated by: NYU Langone Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

1) 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:

  1. Function effectively (e.g. communicate and coordinate with one another and with other departments in the hospital)
  2. Match patients to appropriate services
  3. Obtain supportive housing for homeless patients with Common Ground partner
  4. Maintain contact with patients after initial hospital discharge
  5. Facilitate patient adherence to outpatient appointments
  6. Link patients with no usual source of care to PMD

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Bellevue Hospital Center Department of Emergency Medicine, A345

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Housing placement
Time Frame: 1 year
Number of eligible chronically homeless patients placed in transitional or permanent housing
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient retention in program
Time Frame: 1 year
Number of subjects lost to follow-up and who did not engage after program enrollment
1 year
Linkage to primary care provider
Time Frame: 1 year
Number of patients without a primary care provider who were successfully linked to primary care (at least two visits)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The New York Community Trust
United Hospital Fund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 07-649

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.

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