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

About this trial
This is an interventional prevention trial for Cardiovascular Diseases
Eligibility Criteria
Men and women, ages 70 or older, with documented congestive heart failure.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000475
First Posted
October 27, 1999
Last Updated
February 17, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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
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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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Learn more about this trial
Prevention of Early Readmission in Elderly Congestive Heart Failure Patients
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