Case Management for Microtia
Development and Application of an Intelligent Whole-course Case Management Model for Patients With Microtia
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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Jiaying Gao
- Telefonní číslo: +86 13795315458
- E-mail: 1254091997@qq.com
Studijní místa
-
-
-
Shanghai, Čína, 201112
- Nábor
- EYE & ENT Hospital, Fudan University
-
Kontakt:
- Jing Xu
- Telefonní číslo: +86 34233106
- E-mail: xujing10126@163.com
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Nerandomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Singl
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Žádný zásah: 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. |
|
|
Experimentální: Intervention group
In addition to standard care, the intervention group will use the microtia case-management platform. |
An intelligent, whole-course case-management model will be implemented for patients with microtia. Continuous electronic health records will be established, and stage-specific individualized health education, rehabilitation guidance and follow-up tasks will be provided. The platform will enable health information updates, task check-ins, message-based communication and online follow-up. |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of postoperative complications after ear reconstruction
Časové okno: 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%. |
Assessed 3 months postoperatively
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Health education awareness rate
Časové okno: Assessed 1 day before discharge
|
A self-developed questionnaire on health education awareness will be used. The questionnaire covers eight domains: postoperative disease knowledge, diet, precautions for postoperative activity, postoperative medication, catheter- and pain-related education, postoperative wound observation and discharge health education. Each item has three response options (aware, partly aware, and unaware), with "partly aware" and "unaware" both classified as unaware. Health education awareness rates will be calculated for the control and intervention groups using the formula: health education awareness rate = (number of unaware items / total number of items) × 100%. |
Assessed 1 day before discharge
|
|
Patients' anxiety symptoms
Časové okno: Assessed 1 month after discharge
|
The Screen for Child Anxiety Related Emotional Disorders (SCARED) is a self-report instrument for children and adolescents that assesses anxiety disorders across five factors: somatic/panic, generalized anxiety, separation anxiety, social phobia and school phobia. It comprises 41 items, each rated on a three-point scale from 0 to 2 (0: not true; 1: somewhat true; 2: very true). Higher scores indicate more severe anxiety. |
Assessed 1 month after discharge
|
|
Caregivers' anxiety symptoms
Časové okno: Assessed 1 month after discharge
|
SAS is used to assess the subjective experience of anxiety and consists of 20 items, each scored on a four-point scale. Five items are positively worded (items 5, 9, 13, 17 and 19), and 15 items are negatively worded (all remaining items). Family members of patients are assessed using the SAS: scores <50 indicate no anxiety, 50-59 mild anxiety, 60-69 moderate anxiety and >69 severe anxiety. Higher scores denote greater anxiety severity. In this study, the SAS is used to evaluate anxiety in patients aged 16 years or older and their caregivers. |
Assessed 1 month after discharge
|
|
Patient follow-up rate
Časové okno: Assessed at 1 and 3 months after discharge
|
The follow-up rates of patients in the control and intervention groups at 1 and 3 months after discharge were calculated as: patient follow-up rate = (number of patients who actually participated in follow-up / total number of patients scheduled for follow-up) × 100%. |
Assessed at 1 and 3 months after discharge
|
|
Quality of life of patients
Časové okno: Assessed 1 month after discharge
|
Quality of life was assessed using the Quality of Life Scale for Patients with Congenital Middle and External Ear Malformation. This scale evaluates three dimensions-physical functioning, psychological status and social relationships-with 18 items in total. Each item is scored on a five-point scale from 0 to 4; higher scores indicate poorer quality of life. |
Assessed 1 month after discharge
|
|
Patient satisfaction
Časové okno: Assessed 1 month after discharge
|
Evaluated using a self-designed satisfaction questionnaire comprising 15 items across five domains: consultation process and environment, quality of medical and nursing services, attitude of medical and nursing staff, health education and use of the information platform. Each item is rated on a three-point Likert scale (3 = satisfied, 2 = basically satisfied, 1 = dissatisfied), yielding a total score of 15-45. The sum of item scores represents overall satisfaction, with higher scores indicating greater patient satisfaction. |
Assessed 1 month after discharge
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- Reinisch JF, van Hovell Tot Westerflier CVA, Gould DJ, Tahiri YT. Secondary Salvage of the Unsatisfactory Microtia Reconstruction. Plast Reconstr Surg. 2020 May;145(5):1252-1261. doi: 10.1097/PRS.0000000000006766.
- Deng K, Dai L, Yi L, Deng C, Li X, Zhu J. Epidemiologic characteristics and time trend in the prevalence of anotia and microtia in China. Birth Defects Res A Clin Mol Teratol. 2016 Feb;106(2):88-94. doi: 10.1002/bdra.23462. Epub 2015 Dec 17.
- Fan Y, Liu W, Fan X, Niu X, Chen X. Psychosocial status of patients with unilateral and bilateral microtia before auricular reconstruction surgery. Int J Pediatr Otorhinolaryngol. 2021 Dec;151:110928. doi: 10.1016/j.ijporl.2021.110928. Epub 2021 Sep 25.
- Li Q, Zhou X, Wang Y, Qian J, Zhang Q. Auricular reconstruction of congenital microtia by using the modified Nagata method: Personal 10-Year experience with 1350 cases. J Plast Reconstr Aesthet Surg. 2018 Oct;71(10):1462-1468. doi: 10.1016/j.bjps.2018.05.036. Epub 2018 Jun 19.
- Patel KR, Benchetrit L, Ronner EA, Occhiogrosso J, Hadlock T, Shaye D, Quesnel AM, Cohen MS. Development of an interdisciplinary microtia-atresia care model: A single-center 20-year experience. Laryngoscope Investig Otolaryngol. 2022 Nov 16;7(6):2103-2111. doi: 10.1002/lio2.896. eCollection 2022 Dec.
- Behrens B, Swetlitz C, Pine DS, Pagliaccio D. The Screen for Child Anxiety Related Emotional Disorders (SCARED): Informant Discrepancy, Measurement Invariance, and Test-Retest Reliability. Child Psychiatry Hum Dev. 2019 Jun;50(3):473-482. doi: 10.1007/s10578-018-0854-0.
- Ren YY, Zhao SQ. [Development and evaluation of a quality of life scale specific to patients with congenital external and middle ear malformation]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2010 Aug;45(8):623-7. Chinese.
- Dunstan DA, Scott N, Todd AK. Screening for anxiety and depression: reassessing the utility of the Zung scales. BMC Psychiatry. 2017 Sep 8;17(1):329. doi: 10.1186/s12888-017-1489-6.
- Perera S, Dabney BW. Case management service quality and patient-centered care. J Health Organ Manag. 2020 Jun 24;ahead-of-print(ahead-of-print). doi: 10.1108/JHOM-12-2019-0347.
- Zhou Y, Li X, Zhang M, Lv G, Duan B, Tang Z. Effect of Multimedia Health Education on Psychological Burden, Quality of Life Ability, and Self-Efficacy of Congenital Microtia. Comput Math Methods Med. 2022 Aug 11;2022:1482865. doi: 10.1155/2022/1482865. eCollection 2022.
- Kim HAJ, Namavarian A, Khan U, Levy BB, Ziai H, Talei B, Gantous AM. Reconstructive Techniques in Pediatric Congenital Microtia: A Systematic Review and Meta-analysis. Facial Plast Surg. 2025 Apr;41(2):204-211. doi: 10.1055/a-2247-5109. Epub 2024 Jan 17.
- Torres I, Martinez JDC, Sanabria R, Gonzalez LV, Diaz-Baez D. Postoperative Safety and Satisfaction in Patients With Microtia. J Oral Maxillofac Surg. 2021 Feb;79(2):472.e1-472.e9. doi: 10.1016/j.joms.2020.09.004. Epub 2020 Sep 8.
- Asirova GV, Wynands J, Almeida DL. Improvement of Quality of Life After Microtia Reconstruction Using a Modified Firmin Technique-Case Series of 130 Patients. Aesthetic Plast Surg. 2025 Jul;49(13):3528-3537. doi: 10.1007/s00266-025-04697-z. Epub 2025 Feb 7.
- Hilewitz D, Olshinka A. Early Non-Surgical Treatment For Microtia Types 1 and 2. J Craniofac Surg. 2024 Jul-Aug 01;35(5):1509-1512. doi: 10.1097/SCS.0000000000010279. Epub 2024 May 14.
- Turhan Damar H, Ogce Aktas F. Anxiety, Depression, Stress, and Self-Esteem in Turkish Parents of Children with Microtia. Cleft Palate Craniofac J. 2024 Dec;61(12):1981-1990. doi: 10.1177/10556656231190046. Epub 2023 Jul 24.
- Luquetti DV, Heike CL, Hing AV, Cunningham ML, Cox TC. Microtia: epidemiology and genetics. Am J Med Genet A. 2012 Jan;158A(1):124-39. doi: 10.1002/ajmg.a.34352. Epub 2011 Nov 21.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- Case management for microtia
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Individual participant data will not be shared with external researchers due to patient privacy protection and institutional data policy. Aggregated study results will be reported in publications.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .