Clinical trial NCT06171763: The Multi-stakeholder Assessment of Economic and Managerial Determinants and Impacts of Telemedicine
Official title: The Multi-stakeholder Assessment of Economic and Managerial Determinants and Impacts of Telemedicine: a Comparison Between a Tele-homecare Solution and Traditional Care Models.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Lead sponsor: Buzzi Children's Hospital
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study aims to conduct a comprehensive evaluation involving multiple stakeholders to assess the factors influencing and the consequences of telehomecare in comparison to traditional care models. The integration of technology into the healthcare sector necessitates significant changes in care of patients, organizational structures, production processes, organizational responsibilities, and the management of service delivery processes.

The delivery of telemedicine services through integrated devices represents a method of service production that demands active involvement from patients or, in the case of pediatric patients, their caregivers. This collaborative process of patient engagement in healthcare services is referred to as "co-production." In this research, telehomecare will be examined as an illustrative instance of co-producing healthcare services.

Co-production implies that the inputs into a production process are contributed not only by the organization producing a good or service but also by the users. In the case study, co-production occurs through the interaction between patients/caregivers and professionals during telehealth visits for device-mediated monitoring activities. Throughout the televisit, patients/caregivers play a crucial role in collecting and sharing the necessary parameters with professionals using the device, thereby serving as essential actors in the care process.

The investigators explored the impact of a transitional care program, utilizing an user-friendly mobile medical device, to support an early discharges in a pediatric setting. Clinical outcome and economic advantages are considered. This study will contribute to implement knowledge on the role of telemedicine on HaH healthcare in pediatrics.

Detailed description: This is a single-center, two-arm, randomized, open-label, parallel-group study that was conducted at Buzzi Children's Hospital, a hospital in a metropolis located in Milan (Italy). The different arms consisted of an experimental group with an early discharge adopting telehomecare and a standard care group with in-person physical care until the end of hospitalization.

Eligibility criteria: Inclusion criteria:

* Age: 0-18 years.
* Gender: Both males and females
* Patients: Hospitalized at the end of treatment.
* Stable Vital Signs (heart rate, respiratory rate, oxygen saturation)
* Stable/Improving/Resolved biochemical Tests.
* Absence of Fever
* Consent/Assent: Willingness to participate with appropriate consent or assent based on age.
* Proximity to Domicile: Residence within a maximum distance of 45 minutes.
* Adequate Home Facilities.
* Language Proficiency: Adequate knowledge of the Italian language.
* Possession of Compatible Device

Exclusion criteria:

* Refusal to Participate
* Vital Signs Instability
* Presence of Fever
* Deteriorating biochemical Test Results
* Residence More Than 45 Minutes Away
* Inadequate Home Facilities
* Language Barrier
* Lack of a Compatible Device
* Not owning a device with an operating system suitable for supporting the Tytocare app.

Primary outcomes:
measure: Early discharge utilizing an user-friendly mobile medical device
timeFrame: 12 months
Secondary outcomes:
measure: Length of stay
timeFrame: 12 months
measure: Economic impact
timeFrame: 12 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Buzzi Children's Hospital
Study officials:
References: