Quality of Recovery After Day Care Surgery With App Controlled Remote Monitoring: a Randomized Controlled Trial (QuReMo)

Non blinded randomized controlled trial with mixed methods design. To assess the experienced quality of recovery after day care surgery between patients provided with remote home monitoring and patients receiving standard discharge care

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Nausea; Vomiting
• Intervention / Treatment: Other: Remote monitoring

Detailed Description

Rationale: To date the majority of surgical interventions is performed in day care and patients are being discharged soon after the first critical postoperative period. At home, patients have limited options to contact the hospital in case of severe pain and nausea. We have provided day care surgical patients with a smartphone application for remote monitoring that is configured to self-record postoperative pain and nausea after being discharged from hospital. Furthermore, it provides a messaging service to contact the hospital in case of (severe) pain or nausea. Despite the promising initial patient experiences of such an application, we do not know whether remote monitoring with a smartphone application improves the patient's experience during the recovery period.

Objective: To evaluate the experienced quality of recovery after day care surgery between patients provided with a smartphone application for remote monitoring and patients receiving standard of care (no remote monitoring).

Study design: (Non-blinded) randomized controlled trial with mixed methods design Study population: Adult patients (aged 18 years or older) scheduled for day care surgery Intervention (if applicable): The intervention group receives the smartphone application for remote monitoring during weekdays from 8 am to 17 pm up to 7 days after surgery. With this application, patients are able to record experienced pain and nausea. In addition, they can send messages to the hospital. Daily monitoring is performed by an anaesthesia professional who will contact the patient in case severe pain or nausea is reported in the app. The control group receives standard of care (with post-discharge verbal and paper instructions).

Main study parameters/endpoints: The main study endpoint is the difference between patients using remote monitoring and patients not using remote monitoring in perceived quality of recovery measured with the QoR-15 questionnaire on the 7th day after day care surgery. Secondary endpoints are 1) the overall score on the Quality of Recovery-15 at day 1, 4 and 7 post discharge, 2) the perceived quality of hospital aftercare and 3) experienced psychological effects of remote monitoring during postoperative recovery from day care surgery.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participating in this study does not pose any additional risks either for patients allocated to the intervention group with remote monitoring or for patients allocated tothe standard of care group. Patients in the remote monitoring group are being asked to use a smartphone application to record pain and nausea daily for up to 7 days post discharge. Recording pain and nausea will take 2 minutes daily. Patients from both groups are being asked to fill in the validated QoR-15 questionnaire one day before admission and on the 1st, 4th and 7th day post discharge and this will take 2.5 minutes. No extra hospital visits, physical examinations or tests are required. Patients in the remote monitoring group could benefit from participating in the study because they are monitored daily by a healthcare professional. Therefore, severe pain, nausea and possibly other complications can be noticed and managed earlier.

• Study Type: Interventional
• Enrollment (Anticipated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bram Thiel, MSc; Phone Number: 0031 20 5994773; Email: b.thiel@olvg.nl
• Study Contact Backup: Name: Marc Godfried, PhD; Phone Number: 0031 20 5999111; Email: m.b.godfried@olvg.nl

Study Locations

• Netherlands
  • Limburg
    • Nijmegen, Limburg, Netherlands, 6532 SZ
      • CWZ Hospital
      • Contact: Will Gerrits, MD; Phone Number: 0031 24 3657657; Email: w.gerrits@cwz.nl
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1091AC
      • OLVG Hospital
      • Contact: Bram Thiel, MSc; Phone Number: 0031 02 5994773; Email: b.thiel@olvg.nl
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3079 DZ
      • Maasstad Hospital
      • Contact: Seppe Koopman, PhD; Phone Number: 0031 01 2911911; Email: KoopmanJ@maasstadziekenhuis.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Age: older than or equal to 18 years
• Pre-anaesthesia conclusion: ASA I to III
• Scheduled for day care surgery for one of the following surgical specialties:

gynaecology, eye-nose and throat, oral and maxillofacial, orthopaedics, general and vascular, trauma and urology -In possession of a smartphone

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• Not able to speak or understand the Dutch language
• Mentally impaired (e.g. dementia, retardation)

During study:

-Patients who experience a unexpected post-operative complication or prolonged recovery with the result that discharge on the same day of the surgical intervention is not possible will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote monitoring; At discharge, patients in the remote monitoring group receive verbal and paper care- and recovery instructions from a day care ward nurse and in adittion they will have a monitoring application installed on theirpersonal smartphone. Once they are back home, they can start recording pain and nausea and ask questions about their recovery with the application and report back the anaesthesia backoffice.	Other: Remote monitoring; Remote monitoring with a smartphone application of pain and nausea after day care surgery
No Intervention: Standard care; At discharge, patients in the standard care group receive verbal and paper care- and recovery instructions from a day care ward nurse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery	To assess the difference between patients using remote monitoring and patients not using remote monitoring in perceived quality of recovery measured with the QoR-15 questionnaire on the 7th day after day care surgey	7th day after day care surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	To assess the experienced postoperative pain (POP) between patients provided with a smartphone application for remote monitoring and patients receiving standard of care (no remote monitoring) after day care surgery.	1st, 4th and 7th day after day care surgery
Post discharge nausea and vomiting	To assess the experienced post discharge nausea and vomiting (PDNV) between patients provided with a smartphone application for remote monitoring and patients receiving standard of care (no remote monitoring) after day care surgery.	1st, 4th and 7th day after day care surgey
Surgical complications	To assess the difference in the number of surgical complications rated with the Clavien Dindo classification of surgical complication between patients provided with a smartphone application for remote monitoring and patients receiving standard of care (no remote monitoring) after day care surgery.	1st 4th and 7th day after day care surgey
Re-admissions	To assess the difference in the number of re-admissions between patients provided with a smartphone application for remote monitoring and patients receiving standard of care (no remote monitoring) after day care surgery.	1st, 4th and 7th day after day care surgery
Contact with healthcare professionals	To assess the difference in the number of hospital contacts / general practitioner between patients provided with a smartphone application for remote monitoring and patients receiving standard of care (no remote monitoring) after day care surgery.	1st, 4th and 7th day after day care surgey
Experienced communication	To assess the difference in experienced quality of communication with the hospital staff between patients provided with a smartphone application for remote monitoring and patients receiving standard of care (no remote monitoring) after day care surgery.	1st, 4th and 7th day after day care surgey
Experienced psychological effects	o assess the experienced psychological effects remote monitoring in patients recovering from day care surgery.	1st, 4th and 7th day after day care surgey

Collaborators and Investigators

• Sponsor: Onze Lieve Vrouwe Gasthuis
• Investigators: Principal Investigator: Marc Godfried, PhD, OLVG Hospital; Principal Investigator: Seppe Koopman, PhD, Maasstad Hospital; Principal Investigator: Robert van Dongen, PhD, CWZ Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: eHealth; Anaesthesia; Remote monitoring; Day care surgery
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting
• Other Study ID Numbers: NL78144.100.21 / WO21.083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study will be registered before inclusion of the first patient on www.clinicaltrials.gov. The results of the study will find their way into (inter-) national scientific journals and guidelines. We will submit analyses to scientific journals in the field of anaesthesiology.
• IPD Sharing Time Frame: Available december 2022
• IPD Sharing Access Criteria: Request for information can be adressed to b.thiel@olvg.nl.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

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