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

NCT07753668 | Active Not Recruiting DMC

• 1 other identifier: PI25/01603
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Palliative Care; Cancer Care Facilities; Artificial Intelligence; Interdisciplinary Communication; Decision Making, Shared; Machine Learning

Outcome Measures

Primary Outcomes (1)

• Change in patient anxiety and depression

  Change from baseline in Hospital Anxiety and Depression Scale (HADS) score in patients with serious illness, comparing intervention arm (care delivered by HCPs trained in the Serious Illness Conversation Guide \[SICG\]) vs. control arm (standard care). HADS comprises 14 items (7 anxiety, 7 depression), each scored 0-3; subscale range 0-21. Higher scores indicate worse symptoms. A between-group difference of 2.5 points is considered clinically relevant.

  Baseline, 1 month, 3 months, and 6 months after SICG conversation (or equivalent index visit in the control arm).

Secondary Outcomes (11)

• Change in family-caregiver anxiety and depression

  Baseline, 3 months, and 6 months after the patient's SICG conversation.

• Patient health-related quality of life (EuroQoL-5D-5L)

  Baseline, 3 months, and 6 months.

• Patient cancer-specific quality of life (EORTC QLQ-C15-PAL)

  Baseline, 3 months, and 6 months.

• Family-caregiver health-related quality of life (EuroQoL-5D-5L)

  Baseline, 3 months, and 6 months.

• Patient symptom burden (ESAS)

  Baseline, 1 month, 3 months, and 6 months.

Study Arms (2)

Usual Care group

NO INTERVENTION

Usual care. the subject recieve the usual care

SICG Group

EXPERIMENTAL

The SICG Group recieved the intervention of the study. As this is a cluster trial, the intervention operates at two levels. In the case of healthcare professionals, the experimental arm receives training in the use of the SICG for subsequent use with their patients. For patients, the experimental group receives the intervention through healthcare professionals' use of the SICG to explore their wishes and expectations regarding their care.

Device: Intervention Group

Interventions

Intervention Group DEVICE

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.

SICG Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-80 years.
• Diagnosis of a serious illness, defined as an illness carrying a high risk of mortality that negatively impacts quality of life or daily functioning, and that typically causes significant emotional distress in caregivers.
• Karnofsky Performance Status ≥ 50 or Performance Status ≤ 2 or Palliative Performance Scale ≥ 50.
• Spanish as native/fluent language, sufficient to complete the study questionnaires.
• Cared for by an HCP enrolled in the study (intervention or control arm).
• Able and willing to provide written informed consent.

You may not qualify if:

• Cognitive or perceptual impairment that prevents reliable completion of the study questionnaires.
• Inability to communicate in Spanish to the level required by the assessment instruments.
• Any condition that, in the investigator's judgment, makes participation unsafe or unfeasible (e.g., clinical instability incompatible with follow-up).

Sponsors & Collaborators

• Cudeca Hospice Foundation: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (2)

CUDECA Institute/CUDECA Foundation

Benalmádena, Málaga, 29631, Spain

Location

Fundación CUDECA

Benalmádena, Málaga, 29631, Spain

Location

Related Publications (10)

• Paladino J, Brannen E, Benotti E, Henrich N, Ritchie C, Sanders J, Lakin JR. Implementing Serious Illness Communication Processes in Primary Care: A Qualitative Study. Am J Hosp Palliat Care. 2021 May;38(5):459-466. doi: 10.1177/1049909120951095. Epub 2020 Aug 14.

  PMID: 32794412 BACKGROUND

• Jain N, Bernacki RE. Goals of Care Conversations in Serious Illness: A Practical Guide. Med Clin North Am. 2020 May;104(3):375-389. doi: 10.1016/j.mcna.2019.12.001.

  PMID: 32312404 BACKGROUND

• Paladino J, Koritsanszky L, Nisotel L, Neville BA, Miller K, Sanders J, Benjamin E, Fromme E, Block S, Bernacki R. Patient and clinician experience of a serious illness conversation guide in oncology: A descriptive analysis. Cancer Med. 2020 Jul;9(13):4550-4560. doi: 10.1002/cam4.3102. Epub 2020 May 4.

  PMID: 32363775 BACKGROUND

• Paladino J, Koritsanszky L, Neal BJ, Lakin JR, Kavanagh J, Lipsitz S, Fromme EK, Sanders J, Benjamin E, Block S, Bernacki R. Effect of the Serious Illness Care Program on Health Care Utilization at the End of Life for Patients with Cancer. J Palliat Med. 2020 Oct;23(10):1365-1369. doi: 10.1089/jpm.2019.0437. Epub 2020 Jan 3.

  PMID: 31904304 BACKGROUND

• Andrady AL, Pandey KK, Heikkila AM. Interactive effects of solar UV radiation and climate change on material damage. Photochem Photobiol Sci. 2019 Mar 1;18(3):804-825. doi: 10.1039/c8pp90065e. Epub 2019 Feb 27.

  PMID: 30810563 BACKGROUND

• Bernacki RE, Block SD; American College of Physicians High Value Care Task Force. Communication about serious illness care goals: a review and synthesis of best practices. JAMA Intern Med. 2014 Dec;174(12):1994-2003. doi: 10.1001/jamainternmed.2014.5271.

  PMID: 25330167 BACKGROUND

• Bernacki R, Hutchings M, Vick J, Smith G, Paladino J, Lipsitz S, Gawande AA, Block SD. Development of the Serious Illness Care Program: a randomised controlled trial of a palliative care communication intervention. BMJ Open. 2015 Oct 6;5(10):e009032. doi: 10.1136/bmjopen-2015-009032.

  PMID: 26443662 BACKGROUND

• Paladino J, Kilpatrick L, O'Connor N, Prabhakar R, Kennedy A, Neal BJ, Kavanagh J, Sanders J, Block S, Fromme E. Training Clinicians in Serious Illness Communication Using a Structured Guide: Evaluation of a Training Program in Three Health Systems. J Palliat Med. 2020 Mar;23(3):337-345. doi: 10.1089/jpm.2019.0334. Epub 2019 Sep 17.

  PMID: 31503520 BACKGROUND

• Lakin JR, Desai M, Engelman K, O'Connor N, Teuteberg WG, Coackley A, Kilpatrick LB, Gawande A, Fromme EK. Earlier identification of seriously ill patients: an implementation case series. BMJ Support Palliat Care. 2020 Dec;10(4):e31. doi: 10.1136/bmjspcare-2019-001789. Epub 2019 Jun 28.

  PMID: 31253734 BACKGROUND

• Steinhauser KE, Christakis NA, Clipp EC, McNeilly M, McIntyre L, Tulsky JA. Factors considered important at the end of life by patients, family, physicians, and other care providers. JAMA. 2000 Nov 15;284(19):2476-82. doi: 10.1001/jama.284.19.2476.

  PMID: 11074777 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: August 7, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)