An observational study in Mobile Applications, Internet-Based Intervention and Preoperative Period, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-26.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Observational
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.
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.
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 119 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients submitted to programmed interventions under anesthetic care in Hospital Universitario Virgen del Rocío
Exclusion Criteria:
Information registered by patient in the web based questionnaire
Other: Quality of preoperative information register
Information registered by the anesthesiologist and based on the web based questionnaire, the electronic records of patient and the "face to face" interview
Other: Quality of preoperative information register · Other: Suitability of information contained in the informed consent
Information registered by the anesthesiologist and based on the web based questionnaire and the electronic records of patient
Other: Quality of preoperative information register · Other: Suitability of information contained in the informed consent
Register of principal (grade ASA classification) and secondary variables (allergies, antiplatelet or blood thinners prescriptions, cardiovascular diseases, present medication)
Register of information regarding specific individual risks and personal data (patient and doctor identification and signature)
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
Time frame: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)
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
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
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
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
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
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
Comparison in the register of the ASA grade either in the paper based informed consent versus the electronic informed consent
Time frame: 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
Time frame: The day of intervention
Plan to share: No
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla