Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04787783
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2021-03-04
Brief Title:
Evaluation of the Utility of Preanestess a Web Based Application for Preoperative Assessment
Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Organization:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study Overview
Official Title:
Preanestess Phase 2 Evaluation of the Utility of a Web Based Application for Preoperative Care Comparison of the Rate of Suboptimal Web-Based Assessments Versus the Outpatient Visit
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Preanestess
Brief Summary:
In this prospective two-arm study the investigators will evaluate the incidence of suboptimal preoperative assessments when the participants are evaluated through a web based application Preanestess versus the traditional outpatient interview
Detailed Description:
Preanestess 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 automatically indicates which preoperative tests are necessary and addresses patients to a virtual non face to face consultation or to traditional outpatient assessment Both virtual and outpatient assessment are performed by an anesthesiologist The web based questionnaire automatically assigns patients an ASA from the American Society of Anesthesia Physical Status Classification grade this being a determining variable although not the only one when directing patients to the virtual or face-to-face consultationThe questionnaire therefore serves both for collection of clinical information and as a patient classification tool as well
Virtual assessment is performed by evaluating both the filled web based questionnaire together with patients electronic records Face to face assessment is performed in the traditional way by means of a clinical interview together with the consultation of patients previous electronic records
The virtual assessment is reserved for participants without significant comorbidity which would correspond to patients classified as grade ASA 1-2 this means without diseases or with diseases that do not significantly compromise the integrity of the patient well-controlled hypertension active smoking without major lung disease non-morbid obesity etc Patients with significant comorbidity grade ASA 3 are 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 18122019 and corresponds to the Phase 2 of the study Evaluation of the utility and quality of the clinical information obtained through Preanestess a web based application for preoperative assessment Comparison of the virtual preanesthetic visit and the outpatient face-to-face visit Phase 2 is independent of Phase 1 entitled Evaluation of the Quality of Preoperative Information Obtained Through Preanestess a Web Based Application Paired Comparison of a Web Based Questionnaire a Virtual Non Face to Face Assessment and Outpatient Visit registered in Clinical Trials with number of reference NCT04259268 Primary completion of Phase 1 have been concluded with date February 19 2021 and preliminary analysis of data is currently being conducted by investigators
In this study the objective of the investigators is to assess whether the use of a web based application for the preoperative assessment allows an adequate completion of the preoperative process when compared to traditional face to face outpatient interview The quality of the information recorded by this web based application has been previously tested by the investigators showing promising results in terms of security and accuracy
The investigators have designed a prospective two-arm study to compare the performance of the two modalities of preoperative assessment web based versus face to face outpatient visit
The investigators will base their evaluation of performance on previously published criteria the Andalusian Regional Government Health Council defines a suboptimal preoperative assessment SOPA as one that potentially generates inadequate preparation of the patient that may affect the expected results Specific criteria defining SOPA are detailed in the Outcomes Measures section of the present document
Allocation of participants to each study arm will be consecutive and based on daily distribution of the clinics participants submitted to one of two surgeries of any of the following Orthopedics General Surgery ENT will be allocated to either web based preoperative assessment or traditional face to face outpatient visit Written informed consent will be obtained of all participants prior to their recruitment
Statistical analysis Data collection and subsequent analysis will be performed by the investigators team Qualitative variables will be represented through the absolute and marginal frequencies The investigators will analyze the incidence of SOPA in both groups using Chi square to study the difference between the proportions in the case of normal distribution or failing that the Mann-Whitney U In the same way the investigators will study the differences for each of the defining criteria of SOPA
Sample Size Following the model of Kinley et al in the study comparing the quality of the pre-anesthesia record carried out by anesthesia trainees versus trained nurses the investigators will use the variable incomplete studies that could have affected perioperative management for the calculation of the sample size This variable would be equivalent to the variable SOPA in present work Based on Kinley data the investigators will use an incomplete study rate of 15 a figure that coincides with the standard inadequate assessment in the Guide for the Perioperative Process published by the Andalusian Regional Government Health Council which establishes a maximum acceptable rate of inadequate completion of the preoperative protocols in 15 In this study of equivalence between the two formats the investigators will assume equivalence if a maximum difference of 25 between both formats is observed which represents a differential of 375 over the initial 15 Thus for a two-sided calculation and assuming an alpha error of 005 and a beta error of 02 80 power it would be necessary to include 1127 participants per group
Virtual assessment is performed by evaluating both the filled web based questionnaire together with patients electronic records Face to face assessment is performed in the traditional way by means of a clinical interview together with the consultation of patients previous electronic records
The virtual assessment is reserved for participants without significant comorbidity which would correspond to patients classified as grade ASA 1-2 this means without diseases or with diseases that do not significantly compromise the integrity of the patient well-controlled hypertension active smoking without major lung disease non-morbid obesity etc Patients with significant comorbidity grade ASA 3 are 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 18122019 and corresponds to the Phase 2 of the study Evaluation of the utility and quality of the clinical information obtained through Preanestess a web based application for preoperative assessment Comparison of the virtual preanesthetic visit and the outpatient face-to-face visit Phase 2 is independent of Phase 1 entitled Evaluation of the Quality of Preoperative Information Obtained Through Preanestess a Web Based Application Paired Comparison of a Web Based Questionnaire a Virtual Non Face to Face Assessment and Outpatient Visit registered in Clinical Trials with number of reference NCT04259268 Primary completion of Phase 1 have been concluded with date February 19 2021 and preliminary analysis of data is currently being conducted by investigators
In this study the objective of the investigators is to assess whether the use of a web based application for the preoperative assessment allows an adequate completion of the preoperative process when compared to traditional face to face outpatient interview The quality of the information recorded by this web based application has been previously tested by the investigators showing promising results in terms of security and accuracy
The investigators have designed a prospective two-arm study to compare the performance of the two modalities of preoperative assessment web based versus face to face outpatient visit
The investigators will base their evaluation of performance on previously published criteria the Andalusian Regional Government Health Council defines a suboptimal preoperative assessment SOPA as one that potentially generates inadequate preparation of the patient that may affect the expected results Specific criteria defining SOPA are detailed in the Outcomes Measures section of the present document
Allocation of participants to each study arm will be consecutive and based on daily distribution of the clinics participants submitted to one of two surgeries of any of the following Orthopedics General Surgery ENT will be allocated to either web based preoperative assessment or traditional face to face outpatient visit Written informed consent will be obtained of all participants prior to their recruitment
Statistical analysis Data collection and subsequent analysis will be performed by the investigators team Qualitative variables will be represented through the absolute and marginal frequencies The investigators will analyze the incidence of SOPA in both groups using Chi square to study the difference between the proportions in the case of normal distribution or failing that the Mann-Whitney U In the same way the investigators will study the differences for each of the defining criteria of SOPA
Sample Size Following the model of Kinley et al in the study comparing the quality of the pre-anesthesia record carried out by anesthesia trainees versus trained nurses the investigators will use the variable incomplete studies that could have affected perioperative management for the calculation of the sample size This variable would be equivalent to the variable SOPA in present work Based on Kinley data the investigators will use an incomplete study rate of 15 a figure that coincides with the standard inadequate assessment in the Guide for the Perioperative Process published by the Andalusian Regional Government Health Council which establishes a maximum acceptable rate of inadequate completion of the preoperative protocols in 15 In this study of equivalence between the two formats the investigators will assume equivalence if a maximum difference of 25 between both formats is observed which represents a differential of 375 over the initial 15 Thus for a two-sided calculation and assuming an alpha error of 005 and a beta error of 02 80 power it would be necessary to include 1127 participants per group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None