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

Hypertension Clinical Trial

— CLEOS  

Official title:

Quality Assessment for History Taking With or Without an Knowledge Based Interview System.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430755
• Other study ID #: RBK080
• Status: Completed
• Phase: N/A
• First received: January 31, 2007
• Last updated: November 15, 2015
• Start date: August 2005
• Est. completion date: December 2008

Study information

• Verified date: November 2015
• Source: Robert Bosch Gesellschaft für Medizinische Forschung mbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All inpatients in a hospital environment

Exclusion Criteria:

• Inability to give an informed consent

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Diseases
• Diabetes
• Hypercholesterolemia
• Hypertension
• Myocardial Ischemia
• Vasculitis

Intervention

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.

Procedure:
• physician taken history
Convential history taking by physicians

Other:
• Computer-assisted history taking

Locations

Country	Name	City	State
Germany	Robert-Bosch-Hospital	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
Robert Bosch Gesellschaft für Medizinische Forschung mbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of Medical Problems (by Number of Problems Reported by Computer Assisted History, That Were Not Reported by Physician Taken History)	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.	participants were followed for the duration of hospital stay, an average of 8 days	No