Study to Evaluate the Care Process and the Quality of STEMI Care

Myocardial Infarction Clinical Trial

— CP4ACS  

Official title:

Study to Evaluate the Care Process and the Quality of Care for Adult Patients With ST Elevated Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02961777
• Other study ID #: CP4ACS\2013\2
• Status: Completed
• Start date: January 2014
• Est. completion date: January 2018

Study information

• Verified date: July 2018
• Source: European Pathway Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Cardiovascular diseases, and more precisely patients with ST - elevated myocardial infarction are globally responsible for a large number of hospitalizations and deaths. Monitoring the quality of care for these patients is very relevant topic. Investigators developed indicators from the scientific literature on the quality of care for patients with STEMI at both the patient level and hospital level. The indicators were subsequently validated by a RAND modified Delphi - study of multidisciplinary experts in the care of patients with STEMI.

In this study, the following objectives are set:

1. ) Study of the quality of care for patients with STEMI in 16 Flemish hospitals with cardiology department by retrospective and prospective audit of 20 patient records per participating hospital .

2. ) Study of the interdisciplinary relationships and communication within teams involved in the care of patients with STEMI in the participating hospitals 3) Study of perceived organization of care for patients with STEMI in the participating hospitals

In accordance with the objectives of the research, the study consists of three phases:

1. ) A retrospective observational audit of 20 patient records of patients with STEMI each participating hospital.

2. ) A prospective observational audit of 20 patient records of patients with STEMI each participating hospital.

3. ) A survey using validated instruments of interdisciplinary relationships and communication on the one hand and on the other by the teams involved in the care of patients with STEMI perceived organization of care .

Data collection is performed by local researchers and remains their property. The data is coded and kept confidential. Only the local researcher has access to the encryption key. The data are protected by the Belgian law on privacy and medical confidentiality, only to be used in the context of this study. The results are published anonymously.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients admitted with STEMI within 24 hours after symptom onset and

• eligible for reperfusion according to ESC STEMI guidelines

Exclusion Criteria:

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Other:
• implementation of care pathway
implementation of a care pathway

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
European Pathway Association	KU Leuven, Universitaire Ziekenhuizen Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	performance on quality indicators at patient level as defined by the CP4ACS Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium (NCT02030210)	This study evaluates quality indicators at patient level as defined by the CP4ACS Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium. The study is limited to the period in which the patients are hospitalized; No data is gathered before or after hospitalization.	through study completion, an average of 1 year
Primary	performance on quality indicators at hospital level as defined by the CP4ACS Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium (NCT02030210)	This study evaluates quality indicators at hospital level as defined by the CP4ACS Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium. The study is limited to the period in which the patients are hospitalized. No data is gathered before or after hospitalization.	through study completion, an average of 1 year