Open Label Randomized Clinical Trial to Assess the Safety of Teleconsultation
- Conditions
- Various Clinical Conditions Commonly Followed up in a Secondary Hospital
- Interventions
- Other: Face-to-face appointmentOther: Remote consultation (telephone or video consultation mode)
- Registration Number
- NCT05094180
- Lead Sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2136
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Face-to-face consultation Face-to-face appointment - Remote consultation (telephone or video consultation mode) Remote consultation (telephone or video consultation mode) -
- Primary Outcome Measures
Name Time Method Complications of the underlying disease 12 months Frequency of complications of the underlying disease, including adverse reactions to the treatment of the underlying disease
- Secondary Outcome Measures
Name Time Method Number of unscheduled medical contacts 12 months Count of unscheduled medical contacts (phone calls, unscheduled visits, ER visits, and admissions) registered in the hospital information system
Healthcare expenditure 12 months Estimated healthcare expenditure associated with each of the three interventions
Severe complications of the baseline disease 12 months Frequency of severe complications of the underlying disease.
Treatment Serious Adverse Event 12 months Frequency of Serious Adverse Events related to the underlying disease's treatment
Avoidable hospitalizations 12 months Total and avoidable hospitalizations, secondary to ambulatory care sensitive conditions
Care process indicators 12 months 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
Usability of video consultation system 12 months Usability of video consultation system, measured by using the Computer System Usability Questionnaire
Satisfaction of users (health professionals and patients) with the process of clinical care 12 months 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
Trial Locations
- Locations (3)
Hospital Residència Sant Camil
🇪🇸Sant Pere De Ribes, Barcelona, Spain
Centre de Rehabilitació
🇪🇸Vilanova I La Geltrú, Barcelona, Spain
Hospital Comarcal de l'Alt Penedès
🇪🇸Vilafranca Del Penedès, Barcelona, Spain