Prevention of Early Readmission in Elderly Congestive Heart Failure Patients
|First Received Date ICMJE||October 27, 1999|
|Last Updated Date||January 3, 2006|
|Start Date ICMJE||April 1990|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00000475 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Prevention of Early Readmission in Elderly Congestive Heart Failure Patients|
|Official Title ICMJE||Not Provided|
To assess the impact of a multidisciplinary treatment program on three-month readmission-free survival in elderly congestive heart failure patients.
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Prevention
|Intervention ICMJE||Behavioral: health education|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||March 1995|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Men and women, ages 70 or older, with documented congestive heart failure.
|Ages||70 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00000475|
|Other Study ID Numbers ICMJE||64|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Heart, Lung, and Blood Institute (NHLBI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Heart, Lung, and Blood Institute (NHLBI)|
|Verification Date||December 2005|
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