Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways

NCT00519038 | Completed DMC

• 1 other identifier: EPSEEIC2004-EXART12MARCHE
• Study Type: interventional
• Target: 424
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Congestive Heart Failure

Keywords

Critical Pathways; Congestive Heart Failure; Randomized Controlled Trial; Effectiveness

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  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.

  during the stay or at discharge

Study Arms (2)

1

EXPERIMENTAL

Patients treated according to clinical pathways

Other: Clinical Pathways

2

OTHER

Patients treated according to usual care

Other: Usual Care

Interventions

Clinical Pathways OTHER

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

1

Usual Care OTHER

Usual care is the current practice actually performed in the hospital

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• principal diagnosis of heart failure (all ICD-9 codes included in 428.xx code)

You may not qualify if:

• current acute myocardial infarction (AMI)
• current unstable angina

Sponsors & Collaborators

• Agenzia Regionale Sanitaria delle Marche: lead

Related Publications (2)

• 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.

  PMID: 19812099 DERIVED

• Panella 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.

  PMID: 17986361 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Critical Pathways

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Andrea Gardini, MD

  Agenzia Regionale Sanitaria delle Marche

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 20, 2007
• First Posted: August 21, 2007
• Study Start: March 1, 2003
• Study Completion: December 1, 2006
• Last Updated: August 21, 2007

Record last verified: 2007-08