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

NCT06171763 | Completed

• 1 other identifier: 0033846
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Telemedicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Length of stay

  12 months

• Economic impact

  12 months

Study Arms (2)

Telehome care

EXPERIMENTAL

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

Standard care

NO INTERVENTION

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.

Interventions

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.

Telehome care

Eligibility Criteria

• Age: 12 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Buzzi Children's Hospital: lead

Study Sites (1)

Buzzi Children's Hospital

Milan, 20154, Italy

Location

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 15, 2023
• Study Start: August 8, 2022
• Primary Completion: September 30, 2023
• Study Completion: November 8, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)