Preoperative Risk Assessment in the Elderly

Preoperative Risk Assessment Clinical Trial

— PrepTAB  

Official title:

Web-based Preoperative Risk Assessment in the Elderly: a Pilot-study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04160234
• Other study ID #: EK 342/19
• Status: Recruiting
• Start date: November 22, 2019
• Est. completion date: January 2022

Study information

• Verified date: February 2021
• Source: RWTH Aachen University
• Contact: Ana Kowark, MD
• Phone: +49241800
• Email: akowark[@]ukaachen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

PrepTAB aims to determine whether elderly patients are able to complete 4 preoperative risk assessment questionnaires within a web-based survey.

Description:

Elderly patients are the most rapidly increasing group among surgical admissions. They are prone to a higher risk, because of predisposing risk factors. A comprehensive preoperative risk assessment is recommended by the European Society of Anaesthesiologists guideline, but time-consuming and usually not performed at present. A telemedical approach would enable an out-of hospital risk assessment before hospital admission and provide important information without the need for additional in-hospital resources. The feasibility of the completion of a web-based questionnaire by elderly patients, within a controlled in-hospital setting is required, as a base for a telemedical approach.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Legally competent patients

• Written informed consent

• Age = 65, male, female, diverse

• Multimorbid patients (= 2 comorbidities (according to the Charlson Comorbidity Index)

• Major elective surgery (such as total abdominal hysterectomy, endoscopic resection of prostate, lumbar discectomy, thyroidectomy, total joint replacement, lung operations, colon resection, radical neck dissection etc.)

Exclusion Criteria:

• Blind or deaf patients

• Patient/ Proxy not able to use electronic devices e.g. computer, tablet or smart phone

• Non-fluency in local language

• Alcohol and/ or drugs abuse

• Ambulatory surgery

• Repeated surgery, with previous participation

• Patients with severe neurological or psychiatric disorder

• Refusal of study participation by the patient

Related Conditions & MeSH terms

• Preoperative Risk Assessment

Intervention

Other:
• web-based questionnaires
Patients will be asked to complete web-based questionnaires on a tablet computer

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, University Hospital Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rate	The completion rate of the total number of questions of the web-based questionnaires	1 day
Secondary	Frequency of patient's requests for help to the accompanying next of kin	The study team member, who is present during the study treatment, will assess the frequency of the patient's requests for help to the accompanying next of kin	1 day
Secondary	Assessment of the kind of patient's requests for help to the accompanying next of kin	The study team member, who is present during the study treatment, will assess the kind of the patient's requests for help to the accompanying next of kin, divided into: technical request or request regarding the content of the web-based questions	1 day
Secondary	Assessment of the kind of patient's requests for help to the study team member	The study team member, who is present during the study treatment, will assess the kind of the patient's requests for help to himself, divided into: technical request or request regarding the content of the web-based questions	1 day
Secondary	Frequency of patient's requests for help to the study team member	The study team member, who is present during the study treatment, will assess the frequency of the patient's requests for help to him	1 day
Secondary	Elapsed time for questionnaire completion	The survey software will automatically count the elapsed time for completion of the questionnaires. The time will start in the moment, when the patient accesses the website and it will end when he presses the finish button	1 day
Secondary	Ranking of unanswered questions	We will analyse which questions where not answered by the most patients.	1 day
Secondary	Patient satisfaction	Analysis of patient satisfaction about the web-based questionnaires. A paper-based satisfaction questionnaire is provided to the patient after the completion of the web-based survey. The satisfaction questionnaire will consist of a 5-point Likert scale. It will consist of the items: Strongly disagree; Disagree; Neither agree nor disagree; Agree; Strongly agree	1 day
Secondary	Frequency of technical problems	The frequency of technical problems (i.e. internet connection, black screen etc.) will be assessed by the present study team member	1 day