Clinical trial NCT05094180: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Various Clinical Conditions Commonly Followed up in a Secondary Hospital
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
Collaborators: name: Institut Català de la Salut
First posted: 2021-10-26
Enrollment: 2136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


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.

Primary outcomes:
measure: Complications of the underlying disease
timeFrame: 12 months
Secondary outcomes:
measure: Severe complications of the baseline disease
timeFrame: 12 months
measure: Treatment Serious Adverse Event
timeFrame: 12 months
measure: Avoidable hospitalizations
timeFrame: 12 months
measure: Number of unscheduled medical contacts
timeFrame: 12 months
measure: Care process indicators
timeFrame: 12 months
measure: Healthcare expenditure
timeFrame: 12 months
measure: Usability of video consultation system
timeFrame: 12 months
measure: Satisfaction of users (health professionals and patients) with the process of clinical care
timeFrame: 12 months
Other outcomes:
Locations:
city: Sant Pere De Ribes
country: Spain
facility: Hospital Residència Sant Camil
state: Barcelona
city: Vilafranca Del Penedès
country: Spain
facility: Hospital Comarcal de l'Alt Penedès
state: Barcelona
city: Vilanova I La Geltrú
country: Spain
facility: Centre de Rehabilitació
state: Barcelona
Study officials:
References: