Open Label Randomized Clinical Trial to Assess the Safety of Teleconsultation

Official title

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

Overview

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on a per-protocol study sample, which will include all participants who have finished the study and have not been withdrawn because of non-allowed visits using modalities other than scheduled.

Interventions

• 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).
• 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

Primary outcome measures

• Complications of the underlying disease [Time frame: 12 months]

Secondary outcome measures (8)

• Severe complications of the baseline disease [Time frame: 12 months]
• Treatment Serious Adverse Event [Time frame: 12 months]
• Avoidable hospitalizations [Time frame: 12 months]
• Number of unscheduled medical contacts [Time frame: 12 months]
• Care process indicators [Time frame: 12 months]
• Healthcare expenditure [Time frame: 12 months]
• Usability of video consultation system [Time frame: 12 months]
• Satisfaction of users (health professionals and patients) with the process of clinical care [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Spain · 3 centers

• Hospital Residència Sant Camil — Sant Pere de Ribes
• Hospital Comarcal de l'Alt Penedès — Vilafranca del Penedès
• Centre de Rehabilitació — Vilanova i la Geltrú

Publications

• Rodriguez-Molinero A, Carot-Sans G, Escrig R, Tebe C, Arce J, Perez-Lopez C, Ballesta S, Verdejo G, Cedeno A, Riera-Pagespetit M, Vivas-Angeles S, Alarcon JL, Navarro I, Toro S, Mateo L, Torres AJ, Delmas G, Camell H, Chamero A, Gasol M, Piera-Jimenez J; ECASeT Research Group. Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultati PMID 38066614

Identifiers

NCT: NCT05094180 · CSAPG-15

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗