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NCT Number: NCT06171763

The Multi-stakeholder Assessment of Economic and Managerial Determinants and Impacts of Telemedicine

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.

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Key information

Conditions

Telemedicine

Age range

12 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Buzzi Children's Hospital

Milan, 20154, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemedicine

Other

The telehomecare solution involves an early discharge with continued home monitoring through the use of telemedicine utilizing an user-friendly mobile. Additionally, there were a clinical reassessment in person 72 hours after discharge to evaluate the outcomes and results of the intervention.

Primary outcomes

  1. Early discharge utilizing an user-friendly mobile medical device

    Time frame: 12 months

    Considering in-person visit as the standard care procedure, the primary objective of this study is to obtain concordance with complete resolution of the disease from in-person physical care, without re-admission to the hospital. The investigators expect non-readmission in a minimum of 90 % of cases.

    Outcome measure: count and percentage of patients readmitted to the hospital after early discharge

Secondary outcomes

  1. Length of stay

    Time frame: 12 months

    To record a lower length of stay in interventional group compared to standard care group Outcome measure: days of hospitalization

  2. Economic impact

    Time frame: 12 months

    To compare costs of hospitalization between interventional group compared to standard care group Outcome measure: direct and indirect costs (in euros)

Sponsors and collaborators

Lead sponsor

Buzzi Children's Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 15, 2023
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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