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Hospital Outcomes: Intervention in Moderately III Patients

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ClinicalTrials.gov Identifier: NCT00256659
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : April 3, 2008
Sponsor:
Information provided by:
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE November 17, 2005
First Posted Date  ICMJE November 21, 2005
Last Update Posted Date April 3, 2008
Study Start Date  ICMJE September 1998
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2005)
To evaluate the utility of real time prognostic data and in the improvement of hospitalization morbidity, mortality, iatrogenic complications, and length of stay.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00256659 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2005)
To evaluate resource allocation and efficiency of ancillary service delivery in aggregate cost and 3 month follow up in regards to hospital readmission, living environment, and utilization of social services.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hospital Outcomes: Intervention in Moderately III Patients
Official Title  ICMJE Hospital Outcomes: Intervention in Moderately III Patients
Brief Summary To evaluate the utility of real time prognostic data (illness severity, stability and function) in the improvement of hospitalization morbidity, mortality, iatrogenic complications and length of stay.
Detailed Description

To evaluate resource allocation and efficiency of ancillary service delivery in aggregate cost and 3 month follow up in regards to hospital readmission, living environment, and utilization of social services.

This is a randomized study which will compare the current Standard of Care in hospital to EARLY assessment and referrals with respect to social work services, rehabilitation, psychiatry, and nursing. In this study, the control group will receive the hospital support services provided under current system of delivery and allocation. The intervention group will not receive any new or different services not already provided to all patients at New York Presbyterian Hospital. The difference between the 2 groups will be the uniformity of screening to identify the needs of the patient in the respective area of social services, rehabilitation, psychiatric assistance, and nursing care, and the timeliness by which the referrals for support services will be placed.

Potential interventions: (In both control and experimental group)

  1. Social work: Discharge planning (homecare, visiting nursing services, skilled nursing facility placement).
  2. Rehabilitation: Physical Therapy (improve ADLs-activities of daily living).
  3. Psychiatry: Diagnosis and Assistance in management of Depression.
  4. Nursing: Prevention of in hospital falls and decubitus ulcer formation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Moderately Ill Medical Inpatients at the Cornell Campus of the New York-Presbyterian Hospital
Intervention  ICMJE Behavioral: Early assessment and referral to ancillary care services vs. standard care
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 17, 2005)
444
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE April 1999
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. All medical in-patients who are coded moderately ill with fair to poor function in the SIGNOUT program will be asked to participate in our study.
  2. Patients who are able to provide verbal consent for their participation will be enrolled.

Exclusion Criteria:

  1. Any patient not coded in the SIGNOUT system as moderately ill with fair to poor function.
  2. Patients who refuses not to participate in the study.
  3. Patients who are unable to give written informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00256659
Other Study ID Numbers  ICMJE 9808003482
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mary E. Charlson, MD, Weill Cornell Medical College
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary E Charlson, MD Weill Medical College of Cornell University
Principal Investigator: James Hollenberg, MD Weill Medical College of Cornell University
Principal Investigator: Mark Pecker, MD Weill Medical College of Cornell University
Principal Investigator: Sona Euster, MSW Weill Medical Center of Cornell University
Principal Investigator: Delia Gorga, PhD Weill Medical Center of Cornell University
Principal Investigator: Mary Cooper, MD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP