DENIM-trial: Digital prE-operative patieNt guIdance systeM

Jeroen Bosch Ziekenhuis

Status: Completed

Conditions: Patient Adherence to Preoperative Instructions; Patient Satisfaction; Care Givers Satisfaction; Rate of Late Cancellation

Treatments: Device: Mobile application and standard care; Device: Mobile application for preoperative patient guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT07065201

2022.04.04.02

Details and patient eligibility

About

The goal of this RCT is to assess the effectiveness of a mobile application in enhancing the preoperative preparation of patients scheduled for elective surgery under anesthesia or procedural sedation. The main object is to evaluate the effect of preoperative instructions, delivered through reminders and push notifications, on the rate of late cancellations. Secondary outcomes are adherence to preoperative instructions, patient satisfaction, and care provider satisfaction.

Full description

Participants will be randomly assigned to one of two groups: 1) Intervention group: patients will be asked to download a mobile application specifically designed for preoperative guidance. Through this app they will receive all relevant preoperative instructions via automated reminders and push notifications (e.g., fasting and medication adjustment). In addition, they will be asked to complete a short questionnaire via the app. 2) Control group: patients will download the same mobile application and will be asked to fill out the same questionnaire. However, they will not receive any preoperative instructions through the app. All patients in both groups will continue to receive the standard written instructions. App access will be maintained until five days after surgery.

Enrollment: 10,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age >18 years
• patients scheduled for elective surgery under anesthesia or procedural sedation
• Possession of a mobile phone or tablet
• Access to a valid email address for study communication

Exclusion criteria

• age < 18 years
• emergency surgery
• language barrier
• no consent

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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10,000 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

Patients in the intervention arm are individuals scheduled for elective surgery who will be asked to download a mobile application specifically designed for preoperative guidance. Through this app they will receive all relevant preoperative instructions via automated reminders and push notifications (e.g., fasting, medication adjustment). In addition, they will be asked to complete a short questionnaire via the app.

Treatment:

Device: Mobile application for preoperative patient guidance

Control group

Placebo Comparator group

Description:

Patients in the control group are individuals scheduled for elective surgery who will be asked to download the same mobile application as the intervention group. However, they will not receive any preoperative instructions through the app. They will be asked to fill out the same questionnaire as the control group.

Treatment:

Device: Mobile application and standard care