Mobile ApplicationsPreanestes@sNCT04259268
Evaluation of the Quality of Preoperative Information Obtained Through Preanestes@s, a Web Based Application
An observational study of Mobile Applications and Internet-Based Intervention, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
In this prospective and paired study, the investigators evaluate whether the preoperative information recorded through a web based questionnaire together with a virtual non face to face patient assessment based on the information recorded by the questionnaire and the electronic records of patients is of a comparable… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mobile Applications, Internet-Based Intervention, Preoperative Period
- What is being tested?
- Quality of preoperative information register and Suitability of information contained in the informed consent
- How many people
- 318 participants
- Where
- 1 siteSpain
- Study dates
- 7 Feb 2020to 25 May 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients submitted to programmed interventions under anesthetic care in Hospital Universitario Virgen del Rocío
Who may be able to join
- Adult patients submitted to programmed interventions under anesthetic care in Hospital Universitario Virgen del Rocío
Who cannot join
- Patients unable to fully understand the informed consent
- Urgent or emergent surgery
- Patients submitted to cataract surgery, as far as this procedure is attended by specific clinical pathway
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Quality of Preoperative Information Obtained Through Preanestes@s, a Web Based Application: Paired Comparison of a Web Based Questionnaire, a Virtual Non Face to Face Assessment and Outpatient Visit
In this prospective and paired study, the investigators evaluate whether the preoperative information recorded through a web based questionnaire together with a virtual non face to face patient assessment based on the information recorded by the questionnaire and the electronic records of patients is of a comparable quality to that obtained with the traditional outpatient interview.
Read the detailed description
Preanestes@s is a web based application conceived to lead patients through the preoperative period. The application includes a patient interface which offers general and individualized information on the perioperative process, with the possibility of generating a dynamic interaction between patients and medical staff. Patient interface incorporates a web based preoperative questionnaire that once fully completed, will automatically indicate which preoperative tests are necessary and will address patients to a virtual (non face to face) consultation or to traditional outpatient assessment. Both virtual and outpatient assessment will be performed by an anesthesiologist. The web based questionnaire will automatically assign patients an ASA grade (from the American Society of Anesthesia Physical Status Classification); this being the determining variable, although not the only one, when directing patients to the virtual or face-to-face consultation.The questionnaire therefore serves both for collection of clinical information, and as a patient classification tool as well.
Virtual assessment will be the performed by evaluating both the filled web based questionnaire together with participants´ electronic records. Face to face assessment will be performed in the traditional way by means of an interview with the participant together with the consultation of participant´s previous electronic records.
The virtual assessment will be reserved for participants without significant comorbidity, which would correspond to patients classified as grade ASA 1-2; this means participants without diseases or with diseases that do not significantly compromise the integrity of the participant: well-controlled hypertension, active smoking without major lung disease, non-morbid obesity, etcetera. Participants with significant comorbidity (grade ASA ≥ 3), will always be referred to a face-to-face consultation.
This study has been approved by the local Ethics Committee -Comité de Ética e Investigación de Huelva-and signed by its Secretary María Dolores Santos Rubio, date 18.12.2019.
The investigators´objective is to evaluate whether the information recorded through the web based questionnaire and the virtual assessment is of a comparable quality to that obtained with the gold standard, the traditional face to face outpatient interview.To answer this question, the investigators have designed a prospective paired stud. After obtaining the correspondent informed consent, the investigators will ask participants to fill the web based questionnaire. In participants submitted to virtual assessment after completing the questionnaire, an investigator will perform the virtual preoperative evaluation; these participants will also be submitted to traditional outpatient evaluation in order to compare both types of evaluation. In participants submitted to outpatient assessment, the investigators will compare traditional face to face visit with the questionnaire information.
The investigators will study the degree of concordance in the recording of preoperative variables between different methods (web based questionnaire, virtual assessment and outpatient assessment). The variables to be analysed are described in the Outcomes Measure section.
The investigators will also compare the suitability of information recorded in the anesthetic paper based informed consent (pIC) versus the electronic informed consent (eIC) included in the application. The investigators hypothesis is that Preanestes@s web based questionnaire together with the virtual assessment allows a collection of preoperative information at least as reliable as the classic face to face interview format.
Statistical analysis: the investigators will analyze the agreement between observers (Interrater reliability) for the qualitative variables selected, making comparisons between the different methods of recording information for each variable included in the analysis (study of paired samples). The investigators will use the Fleiss Kappa coefficient to study the concordance in the measurement of the categorical variables.
For the estimation of the sample size, the investigators will group the categories ASA grade 1-2 versus ASA grade 3 and 4, since in the model proposed , the ASA grade ≥ 3 leads patients to a face-to-face outpatient visit. The investigators assume, therefore, the ASA grade as a dichotomous variable (ASA ≥ 3 present or absent). With these considerations, and based on the Table of Concordance of the work of Sankar et al and their results (Kappa index 0.68 (95% CI 0.67-0.69)), the investigators estimate a sample size of 318 patients for a Kappa index of 0.68 with a precision level of 0.08 and an 95% CI. The investigators will recruit, in principle, a total of 382 participants, assuming a potential loss of 20% of the patients initially included.
- Being tested
- Quality of preoperative information register, Suitability of information contained in the informed consent
- Keywords
- Patient Health Questionnaire, Electronic Health Records
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of preoperative information registerOther
Register of principal (grade ASA classification) and secondary variables (allergies, antiplatelet or blood thinners prescriptions, cardiovascular diseases, present medication)
Suitability of information contained in the informed consentOther
Register of information regarding specific individual risks and personal data (patient and doctor identification and signature)
| Study group | Role | What they receive |
|---|---|---|
| Web based questionnaire | Information registered by patient in the web based questionnaire Receives: Other: Quality of preoperative information register | |
| Outpatient assessment | Information registered by the anesthesiologist and based on the web based questionnaire, the electronic records of patient and the "face to face" interview Receives: Other: Quality of preoperative information register; Other: Suitability of information contained in the informed consent | |
| Virtual assessment | Information registered by the anesthesiologist and based on the web based questionnaire and the electronic records of patient Receives: Other: Quality of preoperative information register; Other: Suitability of information contained in the informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ASA grade classification
Comparison of the ASA grade assigned automatically when patients fill the web based questionnaire versus that assigned by the anesthesiologist following the virtual or outpatient assessment
Measured: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)
Secondary outcomes (5)
Change in the register of any allergies
Comparison of the presence of any allergies registered by patient in the web based questionnaire those included in patient´s electronic records or registered by the anesthesiologist following the virtual or outpatient assessment
Measured: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)
Change in the register of antiplatelet or blood thinners
Comparison in the register of antiplatelet or blood thinners either by patient through the web based questionnaire versus those registered in patient´s electronic records or by the anesthesiologist following the virtual or outpatient assessment
Measured: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)
Change in the register of cardiovascular diseases
Comparison in the register of cardiovascular diseases registered either by patient through the web based questionnaire or by the anesthesiologist following the virtual or outpatient assessment
Measured: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)
Register of the ASA grade in the informed consent form
Comparison in the register of the ASA grade either in the paper based informed consent versus the electronic informed consent
Measured: The day of intervention
Register of personal name and surname in the informed consent form
Comparison in the register of the names and surnames of both patient and anesthesiologist either in the paper based informed consent versus the electronic informed consent
Measured: The day of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start7 Feb 2020
- Primary completion31 Mar 2021
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Mobile ApplicationsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel de la Matta, MD, Principal investigator, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259268
- Sponsor's protocol ID
- PIN-0224-2018
- Acronym
- Preanestes@s
- Status last verified
- May 2021
- First submitted
- 2 Jan 2020
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Hert S, Staender S, Fritsch G, Hinkelbein J, Afshari A, Bettelli G, Bock M, Chew MS, Coburn M, De Robertis E, Drinhaus H, Feldheiser A, Geldner G, Lahner D, Macas A, Neuhaus C, Rauch S, Santos-Ampuero MA, Solca M, Tanha N, Traskaite V, Wagner G, Wappler F. Pre-operative evaluation of adults undergoing elective noncardiac surgery: Updated guideline from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2018 Jun;35(6):407-465. doi: 10.1097/EJA.0000000000000817.
PubMed 29708905Katz RI, Dexter F, Rosenfeld K, Wolfe L, Redmond V, Agarwal D, Salik I, Goldsteen K, Goodman M, Glass PS. Survey study of anesthesiologists' and surgeons' ordering of unnecessary preoperative laboratory tests. Anesth Analg. 2011 Jan;112(1):207-12. doi: 10.1213/ANE.0b013e31820034f0. Epub 2010 Nov 16.
PubMed 21081771Zaballos M, Lopez-Alvarez S, Argente P, Lopez A; Grupo de Trabajo de Pruebas Preoperatorias. Preoperative tests recommendations in adult patients for ambulatory surgery. Rev Esp Anestesiol Reanim. 2015 Jan;62(1):29-41. doi: 10.1016/j.redar.2014.07.007. Epub 2014 Aug 18. English, Spanish.
PubMed 25146773Arias A, Benitez S, Canosa D, Borbolla D, Staccia G, Plazzotta F, Casais M, Michelangelo H, Luna D, Bernaldo de Quiros FG. Computerization of a preanesthetic evaluation and user satisfaction evaluation. Stud Health Technol Inform. 2010;160(Pt 2):1197-201.
PubMed 20841873Applegate RL 2nd, Gildea B, Patchin R, Rook JL, Wolford B, Nyirady J, Dawes TA, Faltys J, Ramsingh DS, Stier G. Telemedicine pre-anesthesia evaluation: a randomized pilot trial. Telemed J E Health. 2013 Mar;19(3):211-6. doi: 10.1089/tmj.2012.0132. Epub 2013 Feb 5.
PubMed 23384334Blanco Vargas D, Faura Messa A, Izquierdo Tugas E, Santa-Olalla Bergua M, Noguera Sopena MM, Manoso Noriego M. [Online versus non-standard face to face preoperative assessment: cost effectiveness]. Rev Esp Anestesiol Reanim. 2012 Aug-Sep;59(7):350-6. doi: 10.1016/j.redar.2012.05.039. Epub 2012 Jul 10. Spanish.
PubMed 22784647de la Matta Martin M, Forastero Rodriguez A, Lopez Romero JL. [Evaluation of a new computerized recording system for preoperative assessment data]. Rev Esp Anestesiol Reanim. 2011 Oct;58(8):485-92. doi: 10.1016/s0034-9356(11)70123-2. Spanish.
PubMed 22141216Ludbrook G, Seglenieks R, Osborn S, Grant C. A call centre and extended checklist for pre-screening elective surgical patients - a pilot study. BMC Anesthesiol. 2015 May 19;15:77. doi: 10.1186/s12871-015-0057-1.
PubMed 25985775Law TT, Suen DT, Tam YF, Cho SY, Chung HP, Kwong A, Yuen WK. Telephone pre-anaesthesia assessment for ambulatory breast surgery. Hong Kong Med J. 2009 Jun;15(3):179-82.
PubMed 19494372Lozada MJ, Nguyen JT, Abouleish A, Prough D, Przkora R. Patient preference for the pre-anesthesia evaluation: Telephone versus in-office assessment. J Clin Anesth. 2016 Jun;31:145-8. doi: 10.1016/j.jclinane.2015.12.040. Epub 2016 Apr 15.
PubMed 27185698Goodhart IM, Andrzejowski JC, Jones GL, Berthoud M, Dennis A, Mills GH, Radley SC. Patient-completed, preoperative web-based anaesthetic assessment questionnaire (electronic Personal Assessment Questionnaire PreOperative): Development and validation. Eur J Anaesthesiol. 2017 Apr;34(4):221-228. doi: 10.1097/EJA.0000000000000545.
PubMed 27798453Sankar A, Johnson SR, Beattie WS, Tait G, Wijeysundera DN. Reliability of the American Society of Anesthesiologists physical status scale in clinical practice. Br J Anaesth. 2014 Sep;113(3):424-32. doi: 10.1093/bja/aeu100. Epub 2014 Apr 11.
PubMed 24727705ASA House of Delegates/Executive Committee. ASA Satandards and Guidelines. ASA Physical Status Classification System.2014. https://www.asahq.org/standards-and-guidelines/asa-physical-status-classification-system
Kinley H, Czoski-Murray C, George S, McCabe C, Primrose J, Reilly C, Wood R, Nicolson P, Healy C, Read S, Norman J, Janke E, Alhameed H, Fernandes N, Thomas E. Effectiveness of appropriately trained nurses in preoperative assessment: randomised controlled equivalence/non-inferiority trial. BMJ. 2002 Dec 7;325(7376):1323. doi: 10.1136/bmj.325.7376.1323.
PubMed 12468478de la Matta M, Alonso-Gonzalez M, Moreno-Conde J, Salas-Fernandez S, Lopez-Romero JL; Preanestesas study investigators. Development and patient acceptance of Preanestes@s, a web-based application and electronic questionnaire for preoperative assessment. A prospective cohort study. Rev Esp Anestesiol Reanim (Engl Ed). 2022 Aug-Sep;69(7):383-392. doi: 10.1016/j.redare.2022.01.002. Epub 2022 Jul 20.
PubMed 35871145
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Quality of Preoperative Information Obtained Through Preanestes@s, a Web Based Application: Paired Comparison of a Web Based Questionnaire, a Virtual Non Face to Face Assessment and Outpatient Visit
- ClinicalTrials.gov ID
- NCT04259268
- Acronym / sponsor ID
- Preanestes@s / PIN-0224-2018
- Keywords
- Patient Health Questionnaire, Electronic Health Records
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 6 Feb 2020 (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.
In this prospective and paired study, the investigators evaluate whether the preoperative information recorded through a web based questionnaire together with a virtual non face to face patient assessment based on the information recorded by the questionnaire and the electronic records of patients is of a comparable quality to that obtained with the traditional outpatient interview.
Detailed description
Preanestes@s is a web based application conceived to lead patients through the preoperative period. The application includes a patient interface which offers general and individualized information on the perioperative process, with the possibility of generating a dynamic interaction between patients and medical staff. Patient interface incorporates a web based preoperative questionnaire that once fully completed, will automatically indicate which preoperative tests are necessary and will address patients to a virtual (non face to face) consultation or to traditional outpatient assessment. Both virtual and outpatient assessment will be performed by an anesthesiologist. The web based questionnaire will automatically assign patients an ASA grade (from the American Society of Anesthesia Physical Status Classification); this being the determining variable, although not the only one, when directing patients to the virtual or face-to-face consultation.The questionnaire therefore serves both for collection of clinical information, and as a patient classification tool as well.
Virtual assessment will be the performed by evaluating both the filled web based questionnaire together with participants´ electronic records. Face to face assessment will be performed in the traditional way by means of an interview with the participant together with the consultation of participant´s previous electronic records.
The virtual assessment will be reserved for participants without significant comorbidity, which would correspond to patients classified as grade ASA 1-2; this means participants without diseases or with diseases that do not significantly compromise the integrity of the participant: well-controlled hypertension, active smoking without major lung disease, non-morbid obesity, etcetera. Participants with significant comorbidity (grade ASA ≥ 3), will always be referred to a face-to-face consultation.
This study has been approved by the local Ethics Committee -Comité de Ética e Investigación de Huelva-and signed by its Secretary María Dolores Santos Rubio, date 18.12.2019.
The investigators´objective is to evaluate whether the information recorded through the web based questionnaire and the virtual assessment is of a comparable quality to that obtained with the gold standard, the traditional face to face outpatient interview.To answer this question, the investigators have designed a prospective paired stud. After obtaining the correspondent informed consent, the investigators will ask participants to fill the web based questionnaire. In participants submitted to virtual assessment after completing the questionnaire, an investigator will perform the virtual preoperative evaluation; these participants will also be submitted to traditional outpatient evaluation in order to compare both types of evaluation. In participants submitted to outpatient assessment, the investigators will compare traditional face to face visit with the questionnaire information.
The investigators will study the degree of concordance in the recording of preoperative variables between different methods (web based questionnaire, virtual assessment and outpatient assessment). The variables to be analysed are described in the Outcomes Measure section.
The investigators will also compare the suitability of information recorded in the anesthetic paper based informed consent (pIC) versus the electronic informed consent (eIC) included in the application. The investigators hypothesis is that Preanestes@s web based questionnaire together with the virtual assessment allows a collection of preoperative information at least as reliable as the classic face to face interview format.
Statistical analysis: the investigators will analyze the agreement between observers (Interrater reliability) for the qualitative variables selected, making comparisons between the different methods of recording information for each variable included in the analysis (study of paired samples). The investigators will use the Fleiss Kappa coefficient to study the concordance in the measurement of the categorical variables.
For the estimation of the sample size, the investigators will group the categories ASA grade 1-2 versus ASA grade 3 and 4, since in the model proposed , the ASA grade ≥ 3 leads patients to a face-to-face outpatient visit. The investigators assume, therefore, the ASA grade as a dichotomous variable (ASA ≥ 3 present or absent). With these considerations, and based on the Table of Concordance of the work of Sankar et al and their results (Kappa index 0.68 (95% CI 0.67-0.69)), the investigators estimate a sample size of 318 patients for a Kappa index of 0.68 with a precision level of 0.08 and an 95% CI. The investigators will recruit, in principle, a total of 382 participants, assuming a potential loss of 20% of the patients initially included.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Web based questionnaire | – | Other: Quality of preoperative information registerInformation registered by patient in the web based questionnaire |
| Outpatient assessment | – | Other: Quality of preoperative information register, Other: Suitability of information contained in the informed consentInformation registered by the anesthesiologist and based on the web based questionnaire, the electronic records of patient and the "face to face" interview |
| Virtual assessment | – | Other: Quality of preoperative information register, Other: Suitability of information contained in the informed consentInformation registered by the anesthesiologist and based on the web based questionnaire and the electronic records of patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients submitted to programmed interventions under anesthetic care in Hospital Universitario Virgen del Rocío
Key inclusion criteria (1 listed)
- Adult patients submitted to programmed interventions under anesthetic care in Hospital Universitario Virgen del Rocío
Key exclusion criteria (3 listed)
- Patients unable to fully understand the informed consent
- Urgent or emergent surgery
- Patients submitted to cataract surgery, as far as this procedure is attended by specific clinical pathway
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 |
|---|---|---|
| Quality of preoperative information registerRegister of principal (grade ASA classification) and secondary variables (allergies, antiplatelet or blood thinners prescriptions, cardiovascular diseases, present medication) | Other | Outpatient assessment, Virtual assessment, Web based questionnaire |
| Suitability of information contained in the informed consentRegister of information regarding specific individual risks and personal data (patient and doctor identification and signature) | Other | Outpatient assessment, Virtual assessment |
Primary outcome
Change in ASA grade classification
Time frame: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)
Comparison of the ASA grade assigned automatically when patients fill the web based questionnaire versus that assigned by the anesthesiologist following the virtual or outpatient assessment
5 secondary outcomes
Change in the register of any allergies
Time frame: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)
Change in the register of antiplatelet or blood thinners
Time frame: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)
Change in the register of cardiovascular diseases
Time frame: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)
Register of the ASA grade in the informed consent form
Time frame: The day of intervention
Register of personal name and surname in the informed consent form
Time frame: The day of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Background: PubMed 29708905De Hert S, Staender S, Fritsch G, Hinkelbein J, Afshari A, Bettelli G, Bock M, Chew MS, Coburn M, De Robertis E, Drinhaus H, Feldheiser A, Geldner G, Lahner D, Macas A, Neuhaus C, Rauch S, Santos-Ampuero MA, Solca M, Tanha N, Traskaite V, Wagner G, Wappler F. Pre-operative evaluation of adults undergoing elective noncardiac surgery: Updated guideline from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2018 Jun;35(6):407-465. doi: 10.1097/EJA.0000000000000817.
- Background: PubMed 21081771Katz RI, Dexter F, Rosenfeld K, Wolfe L, Redmond V, Agarwal D, Salik I, Goldsteen K, Goodman M, Glass PS. Survey study of anesthesiologists' and surgeons' ordering of unnecessary preoperative laboratory tests. Anesth Analg. 2011 Jan;112(1):207-12. doi: 10.1213/ANE.0b013e31820034f0. Epub 2010 Nov 16.
- Background: PubMed 25146773Zaballos M, Lopez-Alvarez S, Argente P, Lopez A; Grupo de Trabajo de Pruebas Preoperatorias. Preoperative tests recommendations in adult patients for ambulatory surgery. Rev Esp Anestesiol Reanim. 2015 Jan;62(1):29-41. doi: 10.1016/j.redar.2014.07.007. Epub 2014 Aug 18. English, Spanish.
- Background: PubMed 20841873Arias A, Benitez S, Canosa D, Borbolla D, Staccia G, Plazzotta F, Casais M, Michelangelo H, Luna D, Bernaldo de Quiros FG. Computerization of a preanesthetic evaluation and user satisfaction evaluation. Stud Health Technol Inform. 2010;160(Pt 2):1197-201.
- Background: PubMed 23384334Applegate RL 2nd, Gildea B, Patchin R, Rook JL, Wolford B, Nyirady J, Dawes TA, Faltys J, Ramsingh DS, Stier G. Telemedicine pre-anesthesia evaluation: a randomized pilot trial. Telemed J E Health. 2013 Mar;19(3):211-6. doi: 10.1089/tmj.2012.0132. Epub 2013 Feb 5.
- Background: PubMed 22784647Blanco Vargas D, Faura Messa A, Izquierdo Tugas E, Santa-Olalla Bergua M, Noguera Sopena MM, Manoso Noriego M. [Online versus non-standard face to face preoperative assessment: cost effectiveness]. Rev Esp Anestesiol Reanim. 2012 Aug-Sep;59(7):350-6. doi: 10.1016/j.redar.2012.05.039. Epub 2012 Jul 10. Spanish.
- Background: PubMed 22141216de la Matta Martin M, Forastero Rodriguez A, Lopez Romero JL. [Evaluation of a new computerized recording system for preoperative assessment data]. Rev Esp Anestesiol Reanim. 2011 Oct;58(8):485-92. doi: 10.1016/s0034-9356(11)70123-2. Spanish.
- Background: PubMed 25985775Ludbrook G, Seglenieks R, Osborn S, Grant C. A call centre and extended checklist for pre-screening elective surgical patients - a pilot study. BMC Anesthesiol. 2015 May 19;15:77. doi: 10.1186/s12871-015-0057-1.
- Background: PubMed 19494372Law TT, Suen DT, Tam YF, Cho SY, Chung HP, Kwong A, Yuen WK. Telephone pre-anaesthesia assessment for ambulatory breast surgery. Hong Kong Med J. 2009 Jun;15(3):179-82.
- Background: PubMed 27185698Lozada MJ, Nguyen JT, Abouleish A, Prough D, Przkora R. Patient preference for the pre-anesthesia evaluation: Telephone versus in-office assessment. J Clin Anesth. 2016 Jun;31:145-8. doi: 10.1016/j.jclinane.2015.12.040. Epub 2016 Apr 15.
- Background: PubMed 27798453Goodhart IM, Andrzejowski JC, Jones GL, Berthoud M, Dennis A, Mills GH, Radley SC. Patient-completed, preoperative web-based anaesthetic assessment questionnaire (electronic Personal Assessment Questionnaire PreOperative): Development and validation. Eur J Anaesthesiol. 2017 Apr;34(4):221-228. doi: 10.1097/EJA.0000000000000545.
- Background: PubMed 24727705Sankar A, Johnson SR, Beattie WS, Tait G, Wijeysundera DN. Reliability of the American Society of Anesthesiologists physical status scale in clinical practice. Br J Anaesth. 2014 Sep;113(3):424-32. doi: 10.1093/bja/aeu100. Epub 2014 Apr 11.
- 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.
Manuel de la Matta, MD principal investigator
Hospitales Universitarios Virgen del Rocío
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 Mobile Applications and Internet-Based Intervention, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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 3 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 26 May 2021. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in ASA grade classification (time frame: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04259268, which also lists 15 linked publications.
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 26 May 2021.