Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602310
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Utility of Preanestess20 a Web Based Application for Preoperative Assessment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Utility of the Preanestess20 a Web Based Application for Preoperative Assessment Comparison of the Rate of Suboptimal Web Based Telematic Assessments Versus the Outpatient Visit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Preanestess
Brief Summary:
The use of web based self-assessment questionnaires as a complementary tool for conducting preoperative assessment POA is gaining increasing acceptance Preanestess20 is a web based application fully developed by the investigators team which potentially allows for remote non-telephonic POA It has already been evaluated as a feasible tool in terms of patient acceptance and quality of the information recorded In this prospective two-arm study the investigators will evaluate the incidence of suboptimal POA when the participants are evaluated through Preanestess20 versus the traditional outpatient face to face visit The investigators will consider as suboptimal any POA that potentially may generate an inadequate preparation of the patient which may affect the expected results A total 1127 participants will be evaluated through Preanestess20 intervention arm and compared to a cohort of 1127 patients evaluated by traditional face-to-face interview non-intervention arm The comparison will be made by means of a propensity score matching study Patients included in both arms of the study will be recruited throughout the same period of time
Detailed Description:
Preoperative evaluation models that integrate the use of electronic health records and telephone or electronic questionnaires are evolving aiming to optimize the preoperative assessment process In 2018 the investigators developed Preanestess a web based application conceived to allow for remote preoperative assessment and guide patients through the preoperative period The application includes a patient interface which offers general and individualized information on the preoperative process with the possibility of generating a dynamic interaction between patients and medical staff Patient interface incorporates a smart web based preoperative questionnaire PreQuest which once fully completed automatically classifies patients as per their American ASA grade from the American Society of Anesthesia Physical Status Classification and suggests the convenience of a face-to-face visit f-visit versus a virtual non-face-to-face non-telephonic visit v-visit according to the assigned ASA grade patients with ASA grade3 are systematically recommended for f-visit and the presence of predefined comorbidities or physical conditions not necessarily related to a specific ASA grade ie current or persistent cough or dyspnea Both virtual and f-visit are performed by an anesthesiologist Preanestess also determines the preoperative tests that should be conducted according to the patients condition and offers individualized health advice and recommendations on treatment with the option of electronically signing an experimental model of electronic informed consent
In its original version Preanestess has been evaluated both in terms of user acceptance and usability as well as in terms of the quality of information recording this last by means of a paired study which compared the information recorded through PreQuest with that recorded by the anesthesiologist when performing the v-visit and the f-visit The results have been favorable to the model both in terms of user acceptance and of the quality of the information recording
On april 2021 the investigators launched a prospective study to evaluate the feasibility and utility of the model this estimated by comparing the rate of suboptimal preoperative studies carried out using the application versus the traditional outpatient f-visit Evaluation of the Utility of Preanestess a Web Based Application for Preoperative Assessment NCT04787783 Unfortunately the study recruitment rate has been lower than expected partly due to the difficulties derived from the limited collaboration of the surgeons the actors initially proposed to lead the recruiting process recruitment should preferably take place at the time of the surgical indication at the surgeons office Once the investigators detected the difficulties in recruiting by surgeons they considered filling this shortage through the figure of a recruiting agent but the investigators were forced to discontinue this task due to lack of funding what finally led them to seek alternatives to improve the effectiveness and efficiency of the model From that moment on the investigators began to work with the objective of achieving automatic patient recruitment This is how the Preanestess20 version came about
Preanestess20 incorporates a new automatic recruitment interface so that information that previously had to be entered by the surgeon or in its defect by a recruiting agent is now filled in automatically Similarly the new patient management interface has also been improved in automatism and simplified so that the information that previously had to be managed by the administrative staff is now managed automatically
On the other hand the f-visit has been replaced by a telephone visit t-visit so that the options available in the model would be the v-visit non face-to-face non-telephone and the t-visit non face-to-face but telephone regardless of the fact that the anesthesiologist evaluating each case may request a f-visit on demand for specific cases
Preanestess20 also automates the patient appointment process thus reducing the administrative workload and improving the efficiency of the model
Finally Preanestess20 also improves its capabilities when communicating with the patient with the incorporation among others of WhatsApp messaging
Assuming the improvements of the model and taking into account that they represent a relevant modification to the conditions of the original study the investigators designed a new prospective work aimed at comparing the rate of adequate preoperative assessments using the Preanestesas20 application versus the traditional face-to-face model
This study Internal code SICEIA-2024-001682 has been approved by the local Ethics Committee -Comité de Ética e Investigación de los Hospitales Universitarios Virgen Macarena y Virgen del Rocío-and signed by its Secretary José Carlos García Pérez date 26072024
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 an 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
A total 1127 participants will be evaluated through Preanestess20 Intervention arm and compared to a cohort of 1127 patients evaluated by traditional face-to-face interview Non-intervention arm
Allocation of participants to Intervention arm will be consecutive and based on daily distribution of the clinics Orthopedics General Surgery and Urology Participants in the Non-intervention group will be recruited ex-post using the propensity score methodology among patients assessed by the traditional face to face format throughout the study periodWritten informed consent will be obtained of all participants in the Intervention group 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 Siz 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
In its original version Preanestess has been evaluated both in terms of user acceptance and usability as well as in terms of the quality of information recording this last by means of a paired study which compared the information recorded through PreQuest with that recorded by the anesthesiologist when performing the v-visit and the f-visit The results have been favorable to the model both in terms of user acceptance and of the quality of the information recording
On april 2021 the investigators launched a prospective study to evaluate the feasibility and utility of the model this estimated by comparing the rate of suboptimal preoperative studies carried out using the application versus the traditional outpatient f-visit Evaluation of the Utility of Preanestess a Web Based Application for Preoperative Assessment NCT04787783 Unfortunately the study recruitment rate has been lower than expected partly due to the difficulties derived from the limited collaboration of the surgeons the actors initially proposed to lead the recruiting process recruitment should preferably take place at the time of the surgical indication at the surgeons office Once the investigators detected the difficulties in recruiting by surgeons they considered filling this shortage through the figure of a recruiting agent but the investigators were forced to discontinue this task due to lack of funding what finally led them to seek alternatives to improve the effectiveness and efficiency of the model From that moment on the investigators began to work with the objective of achieving automatic patient recruitment This is how the Preanestess20 version came about
Preanestess20 incorporates a new automatic recruitment interface so that information that previously had to be entered by the surgeon or in its defect by a recruiting agent is now filled in automatically Similarly the new patient management interface has also been improved in automatism and simplified so that the information that previously had to be managed by the administrative staff is now managed automatically
On the other hand the f-visit has been replaced by a telephone visit t-visit so that the options available in the model would be the v-visit non face-to-face non-telephone and the t-visit non face-to-face but telephone regardless of the fact that the anesthesiologist evaluating each case may request a f-visit on demand for specific cases
Preanestess20 also automates the patient appointment process thus reducing the administrative workload and improving the efficiency of the model
Finally Preanestess20 also improves its capabilities when communicating with the patient with the incorporation among others of WhatsApp messaging
Assuming the improvements of the model and taking into account that they represent a relevant modification to the conditions of the original study the investigators designed a new prospective work aimed at comparing the rate of adequate preoperative assessments using the Preanestesas20 application versus the traditional face-to-face model
This study Internal code SICEIA-2024-001682 has been approved by the local Ethics Committee -Comité de Ética e Investigación de los Hospitales Universitarios Virgen Macarena y Virgen del Rocío-and signed by its Secretary José Carlos García Pérez date 26072024
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 an 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
A total 1127 participants will be evaluated through Preanestess20 Intervention arm and compared to a cohort of 1127 patients evaluated by traditional face-to-face interview Non-intervention arm
Allocation of participants to Intervention arm will be consecutive and based on daily distribution of the clinics Orthopedics General Surgery and Urology Participants in the Non-intervention group will be recruited ex-post using the propensity score methodology among patients assessed by the traditional face to face format throughout the study periodWritten informed consent will be obtained of all participants in the Intervention group 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 Siz 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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None