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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00430755
Acronym
CLEOS
Enrollment
98
Registered
2007-02-02
Start date
2005-08-31
Completion date
2008-12-31
Last updated
2015-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Diseases, Diabetes, Hypercholesterolemia, Hypertension, Vasculitis

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.

Interventions

DEVICEComputer-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.

Convential history taking by physicians

OTHERComputer-assisted history taking

Sponsors

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All inpatients in a hospital environment

Exclusion criteria

* Inability to give an informed consent

Design outcomes

Primary

MeasureTime frameDescription
Detection of Medical Problems (by Number of Problems Reported by Computer Assisted History, That Were Not Reported by Physician Taken History)participants were followed for the duration of hospital stay, an average of 8 daysData 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.

Countries

Germany

Participant flow

Recruitment details

Patients who were interviewed had been admitted emergently. Patient charts were not consulted prior to any interview; and the study nurse, who picked patients randomly for interview, had no knowledge of these patients before an interview and carried on no discussions with floor staff about a patient's clinical state.

Pre-assignment details

Acquisition of clinical data in the history-taking program is based on the principles of pathophysiology formalized as software algorithms representing medical knowledge as branched chain decision trees.

Participants by arm

ArmCount
Inpatients With the Need for History Taking
Every patient, who needs to get a medical history taken
98
Total98

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyWithdrawal by Subject53

Baseline characteristics

CharacteristicInpatients With the Need for History Taking
Age, Continuous58 years
STANDARD_DEVIATION 16
Region of Enrollment
Germany
98 participants
Sex: Female, Male
Female
41 Participants
Sex: Female, Male
Male
57 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 98
serious
Total, serious adverse events
0 / 98

Outcome results

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.

Time frame: participants were followed for the duration of hospital stay, an average of 8 days

Population: The rest did not end the history tool

ArmMeasureValue (NUMBER)
Inpatients With the Need for History TakingDetection of Medical Problems (by Number of Problems Reported by Computer Assisted History, That Were Not Reported by Physician Taken History)98 medical problems

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026