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

Pain Clinical Trial

— QuReMo  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05244772
• Other study ID #: NL78144.100.21 / WO21.083
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: December 2022

Study information

• Verified date: February 2022
• Source: Onze Lieve Vrouwe Gasthuis
• Contact: Bram Thiel, MSc
• Phone: 0031 20 5994773
• Email: b.thiel[@]olvg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Pain
• Vomiting

Intervention

Other:
• Remote monitoring
Remote monitoring with a smartphone application of pain and nausea after day care surgery

Locations

Country	Name	City	State
Netherlands	OLVG Hospital	Amsterdam	Noord Holland
Netherlands	CWZ Hospital	Nijmegen	Limburg
Netherlands	Maasstad Hospital	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Onze Lieve Vrouwe Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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