HypertensionCLEOSNCT00430755
Improving the Quality of Patient Care by Using a Clinical Expert System.
A study testing Computer-assisted history, physician taken history and Computer-assisted history taking in people with Hypertension and Diabetes, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes, Hypercholesterolemia
- What is being tested?
- Computer-assisted history, physician taken history and Computer-assisted history taking
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2005to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All inpatients in a hospital environment
Who cannot join
- Inability to give an informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality Assessment for History Taking With or Without an Knowledge Based Interview System.
Aim:
To investigate the quality of history taking by physician and computer-based system.
Read more
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.
Read the 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.
- Being tested
- Computer-assisted history, physician taken history, Computer-assisted history taking
- Medical subject headings
- Hypertension, Diabetes Mellitus, Hypercholesterolemia, Vasculitis, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-assisted historyDevice
Also called CLEOS
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.
physician taken historyProcedure or surgery
Also called Traditional history taking
Convential history taking by physicians
Computer-assisted history takingOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Computer-assisted history; Procedure: physician taken history; Other: Computer-assisted history taking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: participants were followed for the duration of hospital stay, an average of 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startAug 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominik M. Alscher, MD, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Investigators
- Dominik M Alscher, MD, Principal investigator, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430755
- Sponsor's protocol ID
- RBK080
- Acronym
- CLEOS
- Status last verified
- Nov 2015
- First submitted
- 31 Jan 2007
- Last updated
- 18 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Assessment for History Taking With or Without an Knowledge Based Interview System.
- ClinicalTrials.gov ID
- NCT00430755
- Acronym / sponsor ID
- CLEOS / RBK080
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)University, hospital or other
- Study start
- Aug 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 2 Feb 2007 (estimated)
- Results
- Posted 18 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatients of hospital | Other | Device: Computer-assisted history, Procedure: physician taken history, Other: Computer-assisted history takingAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All inpatients in a hospital environment
Key exclusion criteria (1 listed)
- Inability to give an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-assisted historyAlso: CLEOSMethods 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 | Inpatients of hospital |
| physician taken historyAlso: Traditional history takingConvential history taking by physicians | Procedure or surgery | Inpatients of hospital |
| Computer-assisted history taking | Other | Inpatients of hospital |
Primary outcome
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominik M Alscher, MD principal investigator
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-assisted history, physician taken history and Computer-assisted history taking in people with Hypertension and Diabetes, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2015.