Open Label Randomized Clinical Trial to Assess the Safety of Teleconsultation (ECASeT)

Open Label Randomized Clinical Trial to Assess the Safety of Teleconsultation, Compared to the Traditional Clinical Consultation

Randomized-controlled trial to assess the safety of remote consultations (both video and teleconsultation) in the follow-up of patients in the hospital setting. A total of 2136 patients will be randomly allocated into one of the three study arms: A) face-to-face consultation (control) B) Remote consultation (telephone or video consultation). Primary outcome will be the frequency of complications of the underlying disease, including adverse reactions to the treatment of the underlying disease.

To be eligible for remote consultation, patients have to have adequate digital literacy at physician discretion, technological capacity to use the video conferencing software, and undergo a type of follow-up that, due to the moderate complexity of the pathology, do not require physical examinations. Patients followed up in more than three departments, those with visual or hearing impairments that may hamper patient-physician communication, and those enrolled in another clinical trial that requires an experimental intervention during the follow-up will be excluded from the study.

Physicians can schedule and cancel appointments at their discretion. At least three visits should be scheduled in the study setting: the baseline visit (i.e., screening visit), intermediate visits (pre-defined by the physician based on the follow-up needed for managing the baseline condition), and the final visit (i.e., either the follow-up visit closest to 12 ± 2 months after enrollment or before in case of discharge or early discontinuation).

The primary objective will be assessed using a non-inferiority analysis of the cumulative incidence of complications of the baseline disease between remote consultation (video and teleconsultation arms) and face-to-face consultation, using a non-inferiority margin of 2%. The analysis will be based on a modified binomial test to assess the non-inferiority of an experimental intervention vs. a control group in a three-arm trial. The primary analysis will be conducted on a per-protocol study sample, which will include all participants who have finished the study and have not been withdrawn because of non-allowed visits using modalities other than scheduled.

Study Overview

• Status: Recruiting
• Conditions: Various Clinical Conditions Commonly Followed up in a Secondary Hospital
• Intervention / Treatment: Other: Face-to-face appointment; Other: Remote consultation (telephone or video consultation mode)

• Study Type: Interventional
• Enrollment (Estimated): 2136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alejandro Rodríguez-Molinero, PhD; Phone Number: 47158 938960025; Email: arodriguez@csapg.cat

Study Locations

• Spain
  • Barcelona
    • Sant Pere De Ribes, Barcelona, Spain, 08810
      • Recruiting
      • Hospital Residència Sant Camil
      • Contact: Alejandro Rodríguez-Molinero
    • Vilafranca Del Penedès, Barcelona, Spain, 08720
      • Recruiting
      • Hospital Comarcal de l'Alt Penedès
    • Vilanova I La Geltrú, Barcelona, Spain, 08800
      • Not yet recruiting
      • Centre de Rehabilitació
      • Contact: Alejandro Rodríguez-Molinero

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men and women of any age.
• Possibility of making consultations by telephone, at the discretion of the investigator, taking into account the severity and complexity of the baseline pathology and the objective of health care.
• Forecast to carry out follow-up in external consultation.
• Agreement to be attended through a non-face-to-face system.
• Ability to connect to the video consultation system.
• Device compatible with the video consultation system.
• Possibility of collaborating in the necessary evaluations.
• Legal capacity to give informed consent.
• Signature of the informed consent for inclusion of the study.

Exclusion Criteria:

• Need to carry out physical examinations, visualize the patient in person or perform techniques that involve face-to-face visits.
• Need for face-to-face consultation due patient's clinical situation.
• Follow-up by more than three medical specialists.
• Visual, hearing or functional impairments that may hamper patient-physician communication.
• Patients enrolled in another clinical trial that requires an experimental intervention during the follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Face-to-face consultation	Other: Face-to-face appointment; Participants will be scheduled with face-to-face appointments as usual (control arm). All phone calls (except reminders for scheduled visits) performed by the physician during the study will be recorded. Per protocol, participants allocated in the control arm can receive up to 25% of physician-doctor interactions by phone (that is, one phone call allowed for three face-to-face appointments).
Active Comparator: Remote consultation (telephone or video consultation mode)	Other: Remote consultation (telephone or video consultation mode); Patients will be seen through one of the two remote consultation modalities: video consultation or telephone. Patients will receive a reminder by text or call before the appointment. In the case of telephone consultation, patients will be informed of the date and time slot in which they must wait for the doctor's call. At the time of the appointment, the doctor will call the contact phone number of the patients and/or their family members, starting with the first contact number that appears in the patient's medical history, and using the rest of the contacts available if there is no response. . In the case of video consultation, at the time of the appointment, patients will receive a link to the application that manages the teleconsultation. Once in the application, they will remain in the virtual waiting room until the doctor switches to the videoconference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications of the underlying disease	Frequency of complications of the underlying disease, including adverse reactions to the treatment of the underlying disease	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe complications of the baseline disease	Frequency of severe complications of the underlying disease.	12 months
Treatment Serious Adverse Event	Frequency of Serious Adverse Events related to the underlying disease's treatment	12 months
Avoidable hospitalizations	Total and avoidable hospitalizations, secondary to ambulatory care sensitive conditions	12 months
Number of unscheduled medical contacts	Count of unscheduled medical contacts (phone calls, unscheduled visits, ER visits, and admissions) registered in the hospital information system	12 months
Care process indicators	Number of consultations made in a format different from the one initially foreseen (face-to-face, telephone consultation or video consultation) Number of empty consultations (the patient does not attend) Number of patients who interrupt their outpatient follow-up Number of prescriptions and type of prescription	12 months
Healthcare expenditure	Estimated healthcare expenditure associated with each of the three interventions	12 months
Usability of video consultation system	Usability of video consultation system, measured by using the Computer System Usability Questionnaire	12 months
Satisfaction of users (health professionals and patients) with the process of clinical care	Degree of satisfaction of users (health professionals and patients) with the process of clinical care, measured by using the satisfaction questionary of the Pla d'enquestes de satisfacció del CatSalut	12 months

Collaborators and Investigators

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
• Collaborators: Institut Català de la Salut

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 3, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CSAPG-15

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