Cardiovascular DiseasesPhase 2NCT00000475
Prevention of Early Readmission in Elderly Congestive Heart Failure Patients
A Phase 2 study testing health education in people with Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To assess the impact of a multidisciplinary treatment program on three-month readmission-free survival in elderly congestive heart failure patients. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive
- What is being tested?
- health education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1990to Mar 1995
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Men and women, ages 70 or older, with documented congestive heart failure.
About this study
To assess the impact of a multidisciplinary treatment program on three-month readmission-free survival in elderly congestive heart failure patients.
Read the 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.
- Being tested
- health education
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health educationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startApr 1990
- Study completionMar 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Michael Rich, Jewish Hospital and St. Mary's Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000475
- Sponsor's protocol ID
- 64
- Other IDs
- R29HL044739
- Status last verified
- Dec 2005
- First submitted
- 27 Oct 1999
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
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.
PubMed 7565975Rich 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.
PubMed 8289096
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Early Readmission in Elderly Congestive Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00000475
- Acronym / sponsor ID
- 64
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1990
- Study completion
- Mar 1995 (actual)
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health education | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 7565975Rich 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.
- Background: PubMed 8289096Rich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Rich
Jewish Hospital and St. Mary's Healthcare
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing health education in people with Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000475, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.