Clinical trial NCT05244772: Quality of Recovery After Day Care Surgery With App Controlled Remote Monitoring: a Randomized Controlled Trial
Official title: Quality of Recovery After Day Care Surgery With App Controlled Remote Monitoring: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Nausea
Vomiting
Keywords: eHealth
Remote monitoring
Anaesthesia
Day care surgery
Lead sponsor: Onze Lieve Vrouwe Gasthuis
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Recovery
timeFrame: 7th day after day care surgery
Secondary outcomes:
measure: Postoperative pain
timeFrame: 1st, 4th and 7th day after day care surgery
measure: Post discharge nausea and vomiting
timeFrame: 1st, 4th and 7th day after day care surgey
measure: Surgical complications
timeFrame: 1st 4th and 7th day after day care surgey
measure: Re-admissions
timeFrame: 1st, 4th and 7th day after day care surgery
measure: Contact with healthcare professionals
timeFrame: 1st, 4th and 7th day after day care surgey
measure: Experienced communication
timeFrame: 1st, 4th and 7th day after day care surgey
measure: Experienced psychological effects
timeFrame: 1st, 4th and 7th day after day care surgey
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: CWZ Hospital
state: Limburg
city: Amsterdam
country: Netherlands
facility: OLVG Hospital
state: Noord Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
state: Zuid-Holland
Study officials:
affiliation: OLVG Hospital
name: Marc Godfried, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maasstad Hospital
name: Seppe Koopman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CWZ Hospital
name: Robert van Dongen, PhD
role: PRINCIPAL_INVESTIGATOR
References: