Preoperative Risk Assessment in the Elderly (PrepTAB)

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

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

Study Overview

• Status: Unknown
• Conditions: Preoperative Risk Assessment
• Intervention / Treatment: Other: web-based questionnaires

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Ana Kowark, MD; Phone Number: +49241800; Email: akowark@ukaachen.de

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • Recruiting
      • Department of Anesthesiology, University Hospital Aachen
      • Contact: Ana Kowark, MD; Phone Number: +4924180-88179; Email: anaesthesiologie@ukaachen.de
      • Contact: Sebastian Ziemann, MD; Phone Number: +4924180-88179; Email: anaesthesiologie@ukaachen.de
      • Principal Investigator: Ana Kowark, MD
      • Sub-Investigator: Mark Coburn, Prof.
      • Sub-Investigator: Sebastian Ziemann, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A convenient sample of patients, meeting all inclusion and none exclusion criteria, will be enrolled in the study. The patients will be recruited from the anaesthesia ambulance in the University hospital RWTH Aachen, where they have an appointment with the anaesthetist before their planned surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elderly patient; Preoperative elderly patients, who are planned for a surgical intervention	Other: web-based questionnaires; Patients will be asked to complete web-based questionnaires on a tablet computer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion rate	The completion rate of the total number of questions of the web-based questionnaires	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Ranking of unanswered questions	We will analyse which questions where not answered by the most patients.	1 day
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
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

Collaborators and Investigators

• Sponsor: RWTH Aachen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 22, 2019
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (ACTUAL): November 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: surgery; elderly; preoperative risk
• Other Study ID Numbers: EK 342/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No