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Improving the Quality of Patient Care by Using a Clinical Expert System. (CLEOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dominik M. Alscher, MD, Robert Bosch Gesellschaft für Medizinische Forschung mbH
ClinicalTrials.gov Identifier:
NCT00430755
First received: January 31, 2007
Last updated: November 15, 2015
Last verified: November 2015
  Purpose

Aim:

To investigate the quality of history taking by physician and computer-based system.

Patients:

100 inpatients presenting at the RBK for the first time and treated in the departments of nephrology and cardiology.

Methods:

The information obtained by the computer based system is compared with the information acquired by conventional history taking. Study endpoint is the comparison of historical data organized according to the elements in a standard medical history on a patient-by-patient basis.

Study procedure History taking is performed by physicians according to the guidelines of the RBK. Within 2 days thereafter the patient is interviewed with help of the CLEOS system with the support of a study nurse.


Condition Intervention
Hypertension
Diabetes
Hypercholesterolemia
Vasculitis
Coronary Heart Diseases
Device: Computer-assisted history
Procedure: physician taken history
Other: Computer-assisted history taking

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Quality Assessment for History Taking With or Without an Knowledge Based Interview System.

Further study details as provided by Robert Bosch Gesellschaft für Medizinische Forschung mbH:

Primary Outcome Measures:
  • Detection of Medical Problems (by Number of Problems Reported by Computer Assisted History, That Were Not Reported by Physician Taken History) [ Time Frame: participants were followed for the duration of hospital stay, an average of 8 days ] [ Designated as safety issue: No ]
    Data were extracted from hospital charts by to experienced physicians.; data from the computer histories were extracted by a senior physician, who tabulated comparisons between the 2 sets of records. We used the number of problems reported by Computer Assisted History that were not reported by Physician. Nurses at Robert Bosch Krankenhaus do not take medical histories in regard to allergies or adverse drug reactions. Pharmacists make no entries into charts and have no separate records of drug allergies or history of adverse drug reactions. Data on these issues either are obtained only by physician interview of the patient.


Enrollment: 98
Study Start Date: August 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Inpatients of hospital

All patients who were admitted to the departments of nephrology or cardiology in a tertiary hospital in Germany.

The intervention was use of an expert system to acquire medical histories by direct interview of patients.

Description of the software program - The program tested in this study consisted of a data acquisition [history-taking] component and a data analysis component. The data acquisition component was constructed on the basis of established principles of pathophysiology. Medical knowledge was formalized as software algorithms that were machine-readable by representing the knowledge as branched chain decision trees.

Device: Computer-assisted history

Methods The intervention was use of an expert system to acquire medical histories by direct interview of patients.

Description of the software program - The program tested in this study consisted of a data acquisition [history-taking] component and a data analysis component. The data acquisition component was constructed on the basis of established principles of pathophysiology. Medical knowledge was formalized as software algorithms that were machine-readable by representing the knowledge as branched chain decision trees.

Other Name: CLEOS
Procedure: physician taken history
Convential history taking by physicians
Other Name: Traditional history taking
Other: Computer-assisted history taking

Detailed Description:

Aim:

To compare the completeness of history taking by physicians and by a computerized system interacting directly with the patients. Historical data recorded in the patient record, including the discharge letter, were compared with the history acquired by computer-based interview of each patient.

Patients:

100 inpatients presenting at the RBK for the first time and treated in the departments of nephrology and cardiology.

Methods:

The information obtained by the computer based system is compared with the information acquired by conventional history taking. Study endpoint is the comparison of historical data organized according to the elements in a standard medical history on a patient-by-patient basis.

Study procedure After informed consent of the patients the procedure of history taking is performed by the physician according to the guidelines of the RBK. Within 2 days thereafter the patient is interviewed with help of the CLEOS system [a computer-based, history-taking program] with the support of a study nurse. The physician will be informed about the results immediately after completion of the questionnaire.

Data of medical significance were extracted from the official hospital chart and the computerized history by clinically experienced physicians and tabulated on a patient-by-patient basis. data elements were compared across each category of the history for each patient interviewed. The relevance of the differences of the information obtained by the two systems was rated by an independent reviewer.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All inpatients in a hospital environment

Exclusion Criteria:

  • Inability to give an informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430755

Locations
Germany
Robert-Bosch-Hospital
Stuttgart, Germany, 70376
Sponsors and Collaborators
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Investigators
Principal Investigator: Dominik M Alscher, MD Robert Bosch Gesellschaft für Medizinische Forschung mbH
  More Information

Responsible Party: Dominik M. Alscher, MD, Chief Medical Officer, Robert Bosch Gesellschaft für Medizinische Forschung mbH
ClinicalTrials.gov Identifier: NCT00430755     History of Changes
Other Study ID Numbers: RBK080 
Study First Received: January 31, 2007
Results First Received: September 24, 2010
Last Updated: November 15, 2015
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Heart Diseases
Hypercholesterolemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Vasculitis
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on December 02, 2016