Development and Application of an Intelligent Whole-course Case Management Model for Patients With Microtia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Incidence of postoperative complications after ear reconstruction
研究概览
简要总结
The aim of this study is to develop an intelligent, full-course case management model for patients with microtia, enabling them to receive continuous, individualized nursing and health management services across the stages from diagnosis and treatment to rehabilitation.
The study seeks to address the following questions:
What practical needs do patients with microtia and their families have throughout the treatment process? How can case management and an information-based platform be used to provide continuous, personalized health management for these patients? Does implementation of an intelligent case management model improve patient health education, follow-up management and care experience?
What will participants be asked to do? During microtia-related diagnosis and treatment,
Participants will:
Establish a personal health record documenting disease- and treatment-related information; Receive stage-specific, individualized health education and nursing guidance; Obtain treatment reminders, follow-up notifications and rehabilitation tasks via an information platform; Complete corresponding health management tasks under the guidance of healthcare professionals; Communicate online with healthcare providers through the platform and provide timely feedback on treatment and rehabilitation; Undergo scheduled follow-up and outcome assessments. Through these procedures, the research team will integrate patients' fragmented needs for diagnosis, treatment, nursing and rehabilitation at different stages, forming a continuous management process that spans the entire course of care.
详细描述
This study comprises two phases. In phase I, a case-management platform for patients with microtia will be developed. Semi-structured interviews with patients, family members, plastic surgeons, anaesthesiologists, clinical nurses and social workers, together with a literature review and expert meetings, will be conducted to inform platform design. Phase II is the effectiveness evaluation. Patients admitted for ear reconstruction surgery at the Eye, Ear, Nose and Throat Hospital of Fudan University between January and June 2026 will be assigned to the control group and receive routine care. Patients admitted between July and December 2026 will be assigned to the intervention group and receive care supported by the microtia case-management platform. Recruitment for the intervention cohort will begin after completion of control cohort enrolment, with no overlap. No randomisation will be performed. Primary and secondary outcomes will be compared between the two cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 6-40 years
- •Meeting the diagnostic criteria for microtia as defined in Plastic Surgery of China, presenting typical microtia morphology and undergoing auricular reconstruction
- •Patients undergoing staged total ear reconstruction (including first-stage framework placement and ear elevation) or expander-based total ear reconstruction (expander implantation and semi-covered technique); temporoparietal fascia flap surgery; external auditory canal surgery
排除标准
- •Abnormal coagulation or other laboratory findings
- •Absence of normal fascial coverage of the affected ear, or presence of eczema, infection or other local pathology on the affected side
- •Severe cognitive impairment or psychiatric disorders
- •Concomitant major organ dysfunction
- •Refusal by the patient or family to participate in the study
研究组 & 干预措施
Control group
The control group will receive standard care according to current departmental practice, including routine perioperative nursing, conventional health education, discharge guidance and standard follow-up, without use of the intelligent case-management platform.
Intervention group
In addition to standard care, the intervention group will use the microtia case-management platform.
干预措施: Microtia case-management platform (Other)
结局指标
主要结局
Incidence of postoperative complications after ear reconstruction
时间窗: Assessed 3 months postoperatively
This study includes common complications after ear reconstruction, namely haematoma, infection, flap necrosis, framework exposure and pressure injury. The incidence of postoperative complications is calculated as: incidence = (number of patients with complications / total number of patients) × 100%.
次要结局
- Health education awareness rate(Assessed 1 day before discharge)
- Patients' anxiety symptoms(Assessed 1 month after discharge)
- Caregivers' anxiety symptoms(Assessed 1 month after discharge)
- Patient follow-up rate(Assessed at 1 and 3 months after discharge)
- Quality of life of patients(Assessed 1 month after discharge)
- Patient satisfaction(Assessed 1 month after discharge)
研究者
Jing Xu
Charge Nurse Practitioner
Eye & ENT Hospital of Fudan University