Clinical trial NCT04160234: Preoperative Risk Assessment in the Elderly
Official title: Web-based Preoperative Risk Assessment in the Elderly: a Pilot-study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preoperative Risk Assessment
Keywords: elderly
surgery
preoperative risk
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Completion rate
timeFrame: 1 day
Secondary outcomes:
measure: Frequency of patient's requests for help to the accompanying next of kin
timeFrame: 1 day
measure: Assessment of the kind of patient's requests for help to the accompanying next of kin
timeFrame: 1 day
measure: Assessment of the kind of patient's requests for help to the study team member
timeFrame: 1 day
measure: Frequency of patient's requests for help to the study team member
timeFrame: 1 day
measure: Elapsed time for questionnaire completion
timeFrame: 1 day
measure: Ranking of unanswered questions
timeFrame: 1 day
measure: Patient satisfaction
timeFrame: 1 day
measure: Frequency of technical problems
timeFrame: 1 day
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Anesthesiology, University Hospital Aachen
state: NRW
Study officials:
References: