Patient ComplianceNCT03076398
Development of Anaesthesia Electronic Medical Record
An observational study of Patient Compliance, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
Normally, anaesthesia personnel make a record patients' information during the surgical procedure. Pre and post-operatively, they visit patients to make sure that their customers are well informed regarding the whole process and satisfied with the service as well as any complications that might be existed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patient Compliance
- How many people
- 397 participants
- Where
- 1 siteThailand
- Study dates
- 19 Feb 2015to 19 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing general or regional anaesthesia
Who may be able to join
- patients undergoing anaesthesia
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Phongthara Vichitvejpaisal
Bangkok Noi, Bangkok, 10700
Phongthara Vichitvejpaisal, 24134558, phongthara@gmail.com
About this study
Official title: Feasibility Study and Prototype Computerised Program Development of Anaesthesia Electronic Medical Record
Normally, anaesthesia personnel make a record patients' information during the surgical procedure. Pre and post-operatively, they visit patients to make sure that their customers are well informed regarding the whole process and satisfied with the service as well as any complications that might be existed.
The investigators would like to develop an anaesthesia electronic medical record at the point of care. The objectives are to record peri-operative patients' information in a real-time fashion, manage all administrative tasks as annual reports, and operate data as search engine for research and educational purpose.
Read the detailed description
Department of Anaesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University provides services to patients undergoing operative procedures in many fields; such as Traumatic surgery, Orthopaedics surgery, Eye surgery, Ear, Nose and Throat surgery, Plastics surgery, Cardio-thoracic surgery, Neurosurgery, General surgery, Urological surgery, Head and Neck surgery, Paediatric surgery, Obstetrics surgery, Gynaecological surgery, Electro-convulsive therapy, Radiological services, Endoscopic centre, Intensive Care Unit, Acute Pain service, Pain Clinic and Pre Anaesthesia Assessment Centre.
Normally, anaesthesia personnel make a patient information record during the surgical procedure. Pre and post-operatively, they visit patients to make sure that their customers are well informed regarding the whole process and satisfied with the service as well as any complications that might be existed.
The patient data, a crucial document for both medical and official terms, has been developed and improved continuously by the department. Daily, about 250 informations are transferred from paper-pencil to electronic, computerised format for statistical purpose and further reference. Still, the department has to face the data problem in many aspects.
- Daily, an abundant of information needs to be transferred to computer by non-medical personnel. This results in time consuming, data loss and piles of document.
- Unclear peri-operative handwriting of medical or technical terms, particularly on copied files results in untrustworthy and disgraceful of patients' evidence.
- Scanned files results in difficulties of data retrieval for assignments in research, education, administrative policy and finance. Consequently, a hospital becomes an unfaithful and treacherous organisation.
The investigators would like to develop an anaesthesia electronic medical record at the point of care. The objectives are to record peri-operative patients' information in a real-time fashion, manage all administrative tasks as annual reports, and operate data as search engine for research and educational purpose.
- Conditions
- Patient Compliance
- Medical subject headings
- Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaesthesia Electronic Medical Record
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start19 Feb 2015
- Primary completion19 Apr 2017 (estimated)
- Study completion19 Apr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ComplianceStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 397 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phongthara Vichitvejpaisal, Siriraj Hospital
- Investigators
- Chairat Shayakul, Study chair, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076398
- Sponsor's protocol ID
- Si 140/2016
- Status last verified
- Mar 2017
- First submitted
- 7 Mar 2017
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study and Prototype Computerised Program Development of Anaesthesia Electronic Medical Record
- ClinicalTrials.gov ID
- NCT03076398
- Acronym / sponsor ID
- Si 140/2016
- Conditions
- Patient Compliance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 397 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 19 Feb 2015 (actual)
- Primary completion
- 19 Apr 2017 (estimated)
- Study completion
- 19 Apr 2017 (estimated)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Normally, anaesthesia personnel make a record patients' information during the surgical procedure. Pre and post-operatively, they visit patients to make sure that their customers are well informed regarding the whole process and satisfied with the service as well as any complications that might be existed.
The investigators would like to develop an anaesthesia electronic medical record at the point of care. The objectives are to record peri-operative patients' information in a real-time fashion, manage all administrative tasks as annual reports, and operate data as search engine for research and educational purpose.
Detailed description
Department of Anaesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University provides services to patients undergoing operative procedures in many fields; such as Traumatic surgery, Orthopaedics surgery, Eye surgery, Ear, Nose and Throat surgery, Plastics surgery, Cardio-thoracic surgery, Neurosurgery, General surgery, Urological surgery, Head and Neck surgery, Paediatric surgery, Obstetrics surgery, Gynaecological surgery, Electro-convulsive therapy, Radiological services, Endoscopic centre, Intensive Care Unit, Acute Pain service, Pain Clinic and Pre Anaesthesia Assessment Centre.
Normally, anaesthesia personnel make a patient information record during the surgical procedure. Pre and post-operatively, they visit patients to make sure that their customers are well informed regarding the whole process and satisfied with the service as well as any complications that might be existed.
The patient data, a crucial document for both medical and official terms, has been developed and improved continuously by the department. Daily, about 250 informations are transferred from paper-pencil to electronic, computerised format for statistical purpose and further reference. Still, the department has to face the data problem in many aspects.
- Daily, an abundant of information needs to be transferred to computer by non-medical personnel. This results in time consuming, data loss and piles of document.
- Unclear peri-operative handwriting of medical or technical terms, particularly on copied files results in untrustworthy and disgraceful of patients' evidence.
- Scanned files results in difficulties of data retrieval for assignments in research, education, administrative policy and finance. Consequently, a hospital becomes an unfaithful and treacherous organisation.
The investigators would like to develop an anaesthesia electronic medical record at the point of care. The objectives are to record peri-operative patients' information in a real-time fashion, manage all administrative tasks as annual reports, and operate data as search engine for research and educational purpose.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing general or regional anaesthesia
Key inclusion criteria (1 listed)
- patients undergoing anaesthesia
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anaesthesia Electronic Medical Record
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Chairat Shayakul study chair
Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Compliance, run by Siriraj Hospital at 1 site in Thailand.
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: status not confirmed, as of the sponsor's last update on 13 Mar 2017. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Phongthara Vichitvejpaisal (24134558, phongthara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anaesthesia Electronic Medical Record (time frame: 2 year). 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 13 Mar 2017.