Quality of Recovery After Day Care Surgery With App Controlled Remote Monitoring: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 230
- 试验地点
- 3
- 主要终点
- Quality of Recovery
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Remote monitoring (Other)
Standard care
At discharge, patients in the standard care group receive verbal and paper care- and recovery instructions from a day care ward nurse.
结局指标
主要结局
Quality of Recovery
时间窗: 7th day after day care surgery
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
次要结局
- Re-admissions(1st, 4th and 7th day after day care surgery)
- Post discharge nausea and vomiting(1st, 4th and 7th day after day care surgey)
- Postoperative pain(1st, 4th and 7th day after day care surgery)
- Surgical complications(1st 4th and 7th day after day care surgey)
- Experienced communication(1st, 4th and 7th day after day care surgey)
- Experienced psychological effects(1st, 4th and 7th day after day care surgey)
- Contact with healthcare professionals(1st, 4th and 7th day after day care surgey)
研究者
M.B. Godfried
Anesthesiologist
Onze Lieve Vrouwe Gasthuis