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Better Communication, Better Care Using SICG Assistant Based on Artificial Intelligence

NCT07753668 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-08-07

No results posted yet for this study

Summary

The project 'Better Communication, Better Care' has as its main objective to evaluate the effectiveness of the implementation of the 'Guide to conversation in serious illness (SICG)' by means of a significant reduction in anxiety and depression index in patients with serious illness and their families. Additionally, it aims to explore the perceived utility of this guide from the perspective of patients, families, and healthcare professionals involved in Palliative Care. Another important objective is to assess the effectiveness of the training program to improve communicative competencies of healthcare professionals in real clinical contexts. Furthermore, the project is structured around a pragmatic randomized clinical trial by clusters, where healthcare professionals will be randomized into intervention and control groups, with patients being the unit of analysis. In parallel, a feasibility and usability study of the mobile application and virtual assistant that will support the implementation of the guide will be conducted, evaluating parameters such as learning facility, satisfaction, efficiency, and errors through validated instruments. Finally, a cost-benefit analysis will be carried out to determine the economic efficiency of the program in terms of resource optimization and improvement in care quality.

Conditions

  • Cancer Care Providers

Interventions

DEVICE

Intervention Group

The intervention combines a structured serious illness communication guide with an AI-powered virtual assistant app. Unlike standard communication training, the app provides real-time support during clinical encounters: it records conversations automatically, suggests unexplored topics to the clinician, and enables post-visit discourse analysis to anticipate patient needs and predict clinical events. Healthcare professionals receive training in the use of the guide and app. Effectiveness is evaluated through a pragmatic cluster-randomized controlled trial (unit of randomization: HCP; unit of analysis: patient), a before-after design assessing HCP communication skills and satisfaction, a feasibility study using SUS and MAUQ questionnaires, and a cost-utility analysis over a one-year horizon. Qualitative data are collected via narrative interviews with HCPs and patient/family key informants to capture implementation experiences and emergent causal pathways.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Cudeca Hospice Foundation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-10-31
Completion
2028-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07753668 on ClinicalTrials.gov