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

The Multi-stakeholder Assessment of Economic and Managerial Determinants and Impacts of Telemedicine: a Comparison Between a Tele-homecare Solution and Traditional Care Models.

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.

Study Overview

• Status: Completed
• Conditions: Telemedicine
• Intervention / Treatment: Other: Telemedicine

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20154
    • Buzzi Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telehome care; For patients/caregivers assigned to the tele-homecare group, before discharge, instruction on the use of the TytoCareTM system was provided by healthcare personnel trained in the use of the system. Subsequently, each patient give the device they used until the scheduled post-discharge clinical assessment. A parent/caregiver was invited to participate for each pediatric patient. Every 24 hours, the patient was assessed remotely in synchronous teleconsultation by medical staff; during tele-visit, the physician performed the complete routine procedure, including medical history and physical examination with user friendly medical device and completed the data collection sheet. At 72 hours after discharge, an in-person clinical assessment was scheduled for outcome evaluation. In particular, during the visit, the complete resolution of the disease state was assessed through the post-discharge objective examination.	Other: Telemedicine; 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.
No Intervention: Standard care; Patients remained hospitalized for the continuation of the treatment. Every 24 hours, the patient was assessed in person by medical staff; the traditional physical examination involved assessment of the clinical parameters using standard equipment such as a digital thermometer, conventional stethoscope, and otoscope and completed the same data collection sheet. After 72 hours of hospital observation, an in-person clinical examination was conducted to evaluate the outcome. In particular, during the visit, the complete resolution of the disease state was assessed through the post-discharge objective examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early discharge utilizing an user-friendly mobile medical device	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	To record a lower length of stay in interventional group compared to standard care group Outcome measure: days of hospitalization	12 months
Economic impact	To compare costs of hospitalization between interventional group compared to standard care group Outcome measure: direct and indirect costs (in euros)	12 months

Collaborators and Investigators

• Sponsor: Buzzi Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): November 8, 2023

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 0033846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No