NCT00430755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Aug 2005

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
7 years until next milestone

Results Posted

Study results publicly available

December 18, 2015

Completed
Last Updated

December 18, 2015

Status Verified

November 1, 2015

Enrollment Period

3.3 years

First QC Date

January 31, 2007

Results QC Date

September 24, 2010

Last Update Submit

November 15, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Inpatients of hospital

OTHER

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 historyProcedure: physician taken historyOther: Computer-assisted history taking

Interventions

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.

Also known as: CLEOS
Inpatients of hospital

Convential history taking by physicians

Also known as: Traditional history taking
Inpatients of hospital
Inpatients of hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All inpatients in a hospital environment

You may not qualify if:

  • Inability to give an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert-Bosch-Hospital

Stuttgart, 70376, Germany

Location

MeSH Terms

Conditions

HypertensionDiabetes MellitusHypercholesterolemiaVasculitisCoronary Disease

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMyocardial IschemiaHeart Diseases

Results Point of Contact

Title
Prof. Dr. Mark Dominik Alscher
Organization
Robert-Bosch-Hospital

Study Officials

  • Dominik M Alscher, MD

    Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Medical Officer

Study Record Dates

First Submitted

January 31, 2007

First Posted

February 2, 2007

Study Start

August 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 18, 2015

Results First Posted

December 18, 2015

Record last verified: 2015-11

Locations