Congestive Heart FailureEPSEEIC2004NCT00519038
Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways
A study testing Clinical Pathways in people with Congestive Heart Failure, run by Agenzia Regionale Sanitaria delle Marche.
Trial summary
The purpose of this study is to determine whether the use of clinical pathways improves the quality of the hospital care of decompensated heart failure patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Clinical Pathways
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Dec 2006
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- principal diagnosis of heart failure (all ICD-9 codes included in 428.xx code)
Who cannot join
- current acute myocardial infarction (AMI)
- current unstable angina
About this study
The purpose of this study is to determine whether the use of clinical pathways improves the quality of the hospital care of decompensated heart failure patients.
Read the detailed description
In Europe approximately 5% of all acute medical admissions relate to heart failure and in the United States heart failure is responsible for almost 1 million hospitalizations annually. Almost three quarters of these admissions are unplanned and worsening heart failure is responsible for half of these admissions.
The Acute Decompensated Heart Failure National Registry (ADHERE) showed that the hospital treatment of heart failure frequently does not follow published guidelines or conform to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) core performance measures, potentially contributing to the high morbidity, mortality and economic cost of this disorder. ADHERE findings also suggested that the wide variations in conformity may reflect differences in training, guideline familiarity, and implementation of tools and systems to ensure that recommended care is provided and documented. Consequently the development of educational and quality improvement programs has the potential to considerably reduce the current variability in care, enhance guideline adherence, and improve outcomes for patients.
Clinical pathways has become a popular tool to achieve such goals. Clinical pathways are a methodology for the mutual decision making and organization of care for a well-defined group of patients during a well-defined period with the aim to enhance the quality of care by improving patient outcomes, promoting patient safety, increasing patient satisfaction, and optimizing the use of resources. They are also developed by multi-professional teams. Despite enthusiasm and diffusion, the widespread acceptance of clinical pathways remain questionable because very little prospective controlled data demonstrated their effectiveness.
The Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways was designed in order to conduct a rigorous evaluation of a clinical pathway in hospital treatment of decompensated heart failure.
- Conditions
- Congestive Heart Failure
- Being tested
- Clinical Pathways, Usual Care
- Keywords
- Critical Pathways, Congestive Heart Failure, Randomized Controlled Trial, Effectiveness
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical PathwaysOther
Clinical pathways are a methodology for the mutual decision making and organization of care for a well-defined group of patients during a well-defined period with the aim to enhance the quality of care by improving patient outcomes, promoting patient safety, increasing patient satisfaction, and optimizing the use of resources. They are also developed by multi-professional teams
Usual CareOther
Usual care is the current practice actually performed in the hospital
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients treated according to clinical pathways Receives: Other: Clinical Pathways |
| 2 | Other | Patients treated according to usual care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Measured: during the stay
Secondary outcomes (1)
Appropriateness of the stay; Rate of unscheduled readmissions; Length of the stay; Cost of the admission; Patients' satisfaction score; Use of diagnostic procedures; Use of medical treatments.
Measured: during the stay or at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startMar 2003
- Study completionDec 2006
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 Congestive Heart FailureStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agenzia Regionale Sanitaria delle Marche
- Sponsor type
- Other government
- Investigators
- Andrea Gardini, MD, Study chair, Agenzia Regionale Sanitaria delle Marche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519038
- Sponsor's protocol ID
- EPSEEIC2004-EXART12MARCHE
- Acronym
- EPSEEIC2004
- Status last verified
- Aug 2007
- First submitted
- 20 Aug 2007
- Last updated
- 21 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Panella M, Marchisio S, Demarchi ML, Manzoli L, Di Stanislao F. Reduced in-hospital mortality for heart failure with clinical pathways: the results of a cluster randomised controlled trial. Qual Saf Health Care. 2009 Oct;18(5):369-73. doi: 10.1136/qshc.2008.026559.
PubMed 19812099Panella M, Marchisio S, Gardini A, Di Stanislao F. A cluster randomized controlled trial of a clinical pathway for hospital treatment of heart failure: study design and population. BMC Health Serv Res. 2007 Nov 7;7:179. doi: 10.1186/1472-6963-7-179.
PubMed 17986361
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways
- ClinicalTrials.gov ID
- NCT00519038
- Acronym / sponsor ID
- EPSEEIC2004 / EPSEEIC2004-EXART12MARCHE
- Conditions
- Congestive Heart Failure
- Keywords
- Critical Pathways, Congestive Heart Failure, Randomized Controlled Trial, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- Agenzia Regionale Sanitaria delle MarcheOther government
- Study start
- Mar 2003
- Study completion
- Dec 2006 (actual)
- First posted
- 21 Aug 2007 (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.
The purpose of this study is to determine whether the use of clinical pathways improves the quality of the hospital care of decompensated heart failure patients.
Detailed description
In Europe approximately 5% of all acute medical admissions relate to heart failure and in the United States heart failure is responsible for almost 1 million hospitalizations annually. Almost three quarters of these admissions are unplanned and worsening heart failure is responsible for half of these admissions.
The Acute Decompensated Heart Failure National Registry (ADHERE) showed that the hospital treatment of heart failure frequently does not follow published guidelines or conform to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) core performance measures, potentially contributing to the high morbidity, mortality and economic cost of this disorder. ADHERE findings also suggested that the wide variations in conformity may reflect differences in training, guideline familiarity, and implementation of tools and systems to ensure that recommended care is provided and documented. Consequently the development of educational and quality improvement programs has the potential to considerably reduce the current variability in care, enhance guideline adherence, and improve outcomes for patients.
Clinical pathways has become a popular tool to achieve such goals. Clinical pathways are a methodology for the mutual decision making and organization of care for a well-defined group of patients during a well-defined period with the aim to enhance the quality of care by improving patient outcomes, promoting patient safety, increasing patient satisfaction, and optimizing the use of resources. They are also developed by multi-professional teams. Despite enthusiasm and diffusion, the widespread acceptance of clinical pathways remain questionable because very little prospective controlled data demonstrated their effectiveness.
The Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways was designed in order to conduct a rigorous evaluation of a clinical pathway in hospital treatment of decompensated heart failure.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Clinical PathwaysPatients treated according to clinical pathways |
| 2 | Other | Other: Usual CarePatients treated according to usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- principal diagnosis of heart failure (all ICD-9 codes included in 428.xx code)
Key exclusion criteria (2 listed)
- current acute myocardial infarction (AMI)
- current unstable angina
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 |
|---|---|---|
| Clinical PathwaysClinical pathways are a methodology for the mutual decision making and organization of care for a well-defined group of patients during a well-defined period with the aim to enhance the quality of care by improving patient outcomes, promoting patient safety, increasing patient satisfaction, and optimizing the use of resources. They are also developed by multi-professional teams | Other | 1 |
| Usual CareUsual care is the current practice actually performed in the hospital | Other | 2 |
Primary outcome
In-hospital mortality
Time frame: during the stay
1 secondary outcome
Appropriateness of the stay; Rate of unscheduled readmissions; Length of the stay; Cost of the admission; Patients' satisfaction score; Use of diagnostic procedures; Use of medical treatments.
Time frame: during the stay or at discharge
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 21 Aug 2007.
- Derived from this study: PubMed 19812099Panella M, Marchisio S, Demarchi ML, Manzoli L, Di Stanislao F. Reduced in-hospital mortality for heart failure with clinical pathways: the results of a cluster randomised controlled trial. Qual Saf Health Care. 2009 Oct;18(5):369-73. doi: 10.1136/qshc.2008.026559.
- Derived from this study: PubMed 17986361Panella M, Marchisio S, Gardini A, Di Stanislao F. A cluster randomized controlled trial of a clinical pathway for hospital treatment of heart failure: study design and population. BMC Health Serv Res. 2007 Nov 7;7:179. doi: 10.1186/1472-6963-7-179.
Related trials for Congestive Heart Failure
RecruitingObservational study
Heart Failure and Aortic Stenosis Transcriptome
Heart Failure, Aortic Stenosis
Active, not recruiting
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Left Ventricular Ejection Fraction, Heart Failure (HF)
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
Recruiting
Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
Heart Failure, Cardiovascular Risk Factors
RecruitingPhase 3
Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction
Heart Failure, Heart Failure With Reduced Ejection Fraction
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.
Andrea Gardini, MD study chair
Agenzia Regionale Sanitaria delle Marche
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pathways in people with Congestive Heart Failure, run by Agenzia Regionale Sanitaria delle Marche.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. 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 21 Aug 2007. 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.
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.
What does the primary outcome measure?
In-hospital mortality (time frame: during the stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00519038, 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 21 Aug 2007.