Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05244772
Acronym
QuReMo
Enrollment
230
Registered
2022-02-17
Start date
2022-03-31
Completion date
2022-12-31
Last updated
2022-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea, Pain, Vomiting

Keywords

eHealth, Remote monitoring, Anaesthesia, Day care surgery

Brief 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

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.

Interventions

OTHERRemote monitoring

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

Sponsors

Onze Lieve Vrouwe Gasthuis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Recovery7th day after day care surgeryTo 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

Secondary

MeasureTime frameDescription
Post discharge nausea and vomiting1st, 4th and 7th day after day care surgeyTo 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.
Surgical complications1st 4th and 7th day after day care surgeyTo 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.
Re-admissions1st, 4th and 7th day after day care surgeryTo 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.
Postoperative pain1st, 4th and 7th day after day care surgeryTo 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.
Experienced communication1st, 4th and 7th day after day care surgeyTo 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.
Experienced psychological effects1st, 4th and 7th day after day care surgeyo assess the experienced psychological effects remote monitoring in patients recovering from day care surgery.
Contact with healthcare professionals1st, 4th and 7th day after day care surgeyTo 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.

Countries

Netherlands

Contacts

Primary ContactBram Thiel, MSc
b.thiel@olvg.nl0031 20 5994773
Backup ContactMarc Godfried, PhD
m.b.godfried@olvg.nl0031 20 5999111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026