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Case Management for Microtia

23. september 2026 opdateret af: Jing Xu

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

188

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Shanghai, Kina, 201112
        • Rekruttering
        • EYE & ENT Hospital, Fudan University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år til 40 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.

Eksperimentel: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of postoperative complications after ear reconstruction
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Health education awareness rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. august 2027

Datoer for studieregistrering

Først indsendt

23. september 2026

Først indsendt, der opfyldte QC-kriterier

23. september 2026

Først opslået (Faktiske)

29. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • Case management for microtia

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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