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

Primary Purpose

Hypertension, Diabetes, Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Computer-assisted history
physician taken history
Computer-assisted history taking
Sponsored by
Robert Bosch Gesellschaft für Medizinische Forschung mbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All inpatients in a hospital environment

Exclusion Criteria:

  • Inability to give an informed consent

Sites / Locations

  • Robert-Bosch-Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Inpatients of hospital

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2007
Last Updated
November 15, 2015
Sponsor
Robert Bosch Gesellschaft für Medizinische Forschung mbH
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1. Study Identification

Unique Protocol Identification Number
NCT00430755
Brief Title
Improving the Quality of Patient Care by Using a Clinical Expert System.
Acronym
CLEOS
Official Title
Quality Assessment for History Taking With or Without an Knowledge Based Interview System.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Robert Bosch Gesellschaft für Medizinische Forschung mbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes, Hypercholesterolemia, Vasculitis, Coronary Heart Diseases

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inpatients of hospital
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Computer-assisted history
Other Intervention Name(s)
CLEOS
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
physician taken history
Other Intervention Name(s)
Traditional history taking
Intervention Description
Convential history taking by physicians
Intervention Type
Other
Intervention Name(s)
Computer-assisted history taking
Primary Outcome Measure Information:
Title
Detection of Medical Problems (by Number of Problems Reported by Computer Assisted History, That Were Not Reported by Physician Taken History)
Description
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.
Time Frame
participants were followed for the duration of hospital stay, an average of 8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All inpatients in a hospital environment Exclusion Criteria: Inability to give an informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominik M Alscher, MD
Organizational Affiliation
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert-Bosch-Hospital
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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