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Prevention of Early Readmission in Elderly Congestive Heart Failure Patients

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
health education
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

70 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

Men and women, ages 70 or older, with documented congestive heart failure.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000475
    Brief Title
    Prevention of Early Readmission in Elderly Congestive Heart Failure Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1990 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 1995 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To assess the impact of a multidisciplinary treatment program on three-month readmission-free survival in elderly congestive heart failure patients.
    Detailed Description
    BACKGROUND: The prevalence of congestive heart failure increases progressively with advancing age, and congestive heart failure is a major cause of mortality, morbidity, and diminished quality of life in the elderly. Not only is congestive heart failure the most common cardiovascular indication for hospitalization in patients 65 years or older, but frequent repetitive hospitalizations, occurring in 30-50 percent of patients within three to six months of initial discharge, create an imposing cost burden in caring for these patients. A pilot study conducted at the grantee institution has shown that elderly congestive heart failure patients at risk for early readmission can be identified at the time of initial hospitalization, that up to 50 percent of readmissions are potentially preventable, and that a non-pharmacologic treatment strategy consisting of patient education, medication analysis, discharge planning, and enhanced follow-up is feasible and may reduce readmissions by 30 to 50 percent. DESIGN NARRATIVE: In the feasibility study, patients were randomly assigned to receive intervention or standard care over a four year period. Patients were stratified into readmission risk categories of high or moderate based on the presence of four independent risk factors for readmission defined in a prior study at Jewish Hospital in St. Louis. The risk factors included: four or more prior hospitalizations within the preceding five-year interval, previous history of congestive heart failure, hypocholesterolemia, and right bundle-branch block on the admitting electrocardiogram. The study intervention consisted of individualized patient education using teaching materials specifically designed for the study; a careful review of medications with specific recommendations designed to eliminate unnecessary drugs, decrease the number of dosing intervals, improve compliance, and minimize side effects; early discharge planning; and enhanced post-discharge follow-up. The primary endpoints were rehospitalization within 90 days after initial hospital discharge and the cumulative number of days hospitalized during follow-up. Principal secondary endpoints included analyses of the effect of the study intervention on compliance with prescribed medications, dietary sodium intake, incidence of adverse drug reactions, patient knowledge and understanding of congestive heart failure, patient-assessed quality of life, and the overall cost of medical care. In the full-scale trial, 140 patients were assigned to the control group which received all standard treatments and services ordered by their physicians. A total of 142 patients were assigned to the treatment group which received intensive education about congestive heart failure and its treatment by an experienced cardiovascular research nurse, using a teaching booklet developed by study investigators for geriatric patients with heart failure. Treatment group patients also received individualized dietary assessment and instruction given by a registered dietitian; consultation with social-service personnel to facilitate discharge planning and care after discharge; an analysis of medications by a geriatric cardiologist who made specific recommendations to eliminate unnecessary medications and simplify the overall regimen; and intensive follow-up after discharge. The goals of follow-up were to reinforce the patient's education, ensure compliance with medications and diet, and identify recurrent symptoms amenable to treatment on an outpatient basis. The primary outcome measure was survival for 90 days without hospital readmission. Secondary endpoints included the number of readmissions for any cause, the number of readmissions for congestive heart failure, the cumulative number of days of hospitalization during follow-up, quality-of-life scores, and the overall cost of medical care. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive, Heart Failure

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    health education

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Men and women, ages 70 or older, with documented congestive heart failure.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Rich
    Organizational Affiliation
    Jewish Hospital and St. Mary's Healthcare

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    7565975
    Citation
    Rich MW, Beckham V, Wittenberg C, Leven CL, Freedland KE, Carney RM. A multidisciplinary intervention to prevent the readmission of elderly patients with congestive heart failure. N Engl J Med. 1995 Nov 2;333(18):1190-5. doi: 10.1056/NEJM199511023331806.
    Results Reference
    background
    PubMed Identifier
    8289096
    Citation
    Rich MW, Vinson JM, Sperry JC, Shah AS, Spinner LR, Chung MK, Davila-Roman V. Prevention of readmission in elderly patients with congestive heart failure: results of a prospective, randomized pilot study. J Gen Intern Med. 1993 Nov;8(11):585-90. doi: 10.1007/BF02599709.
    Results Reference
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    Prevention of Early Readmission in Elderly Congestive Heart Failure Patients

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