Clinical trial NCT04259268: Evaluation of the Quality of Preoperative Information Obtained Through Preanestes@s, a Web Based Application
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mobile Applications
Internet-Based Intervention
Preoperative Period
Keywords: Patient Health Questionnaire
Electronic Health Records
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients submitted to programmed interventions under anesthetic care in Hospital Universitario Virgen del Rocío

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients submitted to programmed interventions under anesthetic care in Hospital Universitario Virgen del Rocío

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in ASA grade classification
timeFrame: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)
Secondary outcomes:
measure: Change in the register of any allergies
timeFrame: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)
measure: Change in the register of antiplatelet or blood thinners
timeFrame: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)
measure: Change in the register of cardiovascular diseases
timeFrame: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)
measure: Register of the ASA grade in the informed consent form
timeFrame: The day of intervention
measure: Register of personal name and surname in the informed consent form
timeFrame: The day of intervention
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: Hospitales Universitarios Virgen del Rocío
name: Manuel de la Matta, MD
role: PRINCIPAL_INVESTIGATOR
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