Study to Evaluate the Care Process and the Quality of STEMI Care (CP4ACS)

July 23, 2018 updated by: Dr. Kris Vanhaecht, European Pathway Association

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

640

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients admitted with STEMI within 24 hours after symptom onset and eligble for reperfusion according to ESC STEMI guidelines

Description

Inclusion Criteria:

  • patients admitted with STEMI within 24 hours after symptom onset and
  • eligible for reperfusion according to ESC STEMI guidelines

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Time 1
retrospective evaluation of patient record. no intervention
Time 2
retrospective evaluation of patient record. no intervention
Other: implementation of care pathway
implementation of a care pathway
Time 3
retrospective evaluation of patient record. no intervention
Other: implementation of care pathway
implementation of a care pathway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
performance on quality indicators at patient level as defined by the CP4ACS Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium (NCT02030210)
Time Frame: through study completion, an average of 1 year
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
performance on quality indicators at hospital level as defined by the CP4ACS Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium (NCT02030210)
Time Frame: through study completion, an average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Pathway Association

Collaborators

Universitaire Ziekenhuizen KU Leuven
KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 9, 2016

First Posted (Estimate)

November 11, 2016

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 23, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP4ACS\2013\2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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