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.
Communication is a cornerstone of person-centered care, and takes on particular importance in serious illness, defined here as a condition carrying a high risk of mortality that negatively affects quality of life or daily functioning and that commonly produces significant emotional distress in caregivers. Inadequate, delayed, or infrequent communication contributes to avoidable patient and family suffering, and clinicians often lack structured tools and training to conduct high-quality conversations about goals, values, and preferences in serious illness. The Serious Illness Conversation Guide (SICG), originally developed and validated internationally, provides a structured framework that clinicians can use throughout the course of an illness to elicit patient values and preferences and align care accordingly. This project - conducted by a research team that collaborates directly with the guide's original international developer group - will implement the SICG in routine clinical practice across primary care and hospital-based palliative care services in the province of Málaga, Spain, supported by a purpose-built mobile application and virtual assistant designed to facilitate documentation and continuity of the conversation across multiple involved clinicians. The study combines four complementary components: Cluster-randomized controlled trial (quantitative, confirmatory): Healthcare professionals (HCPs) are randomized (block randomization, blocks of 4) into an intervention arm (trained in and using the SICG, supported by the app/virtual assistant) or a control arm (usual care). Patients and families are recruited by their assigned HCP and constitute the unit of analysis (multilevel/mixed-model analysis accounting for clustering at the HCP level). Before-after evaluation of HCP communication skills and satisfaction following SICG training. Feasibility and usability study of the mobile application and virtual assistant, using the System Usability Scale (SUS, Spanish-validated) and the mHealth App Usability Questionnaire (MAUQ). Cost-utility analysis from the funder's perspective (1-year time horizon), estimating incremental cost-effectiveness based on training costs, implementation costs, and healthcare resource utilization (emergency and hospital admissions, palliative care referrals). A parallel qualitative strand (individual/group narrative interviews with HCPs, patients, and family key informants) will explore perceived utility of the SICG and document emergent experiences during implementation, analyzed thematically using an iterative, constructionist approach (NVivo). Ethical approval for evaluation of the SICG implementation has been granted by the Comité de Ética de Investigación Provincial de Málaga (session of 30/09/2021); an amendment is planned to extend approval to cover use of the supporting mobile application (feasibility study component). Study Design Field Value Study Type Interventional Study Design Pragmatic cluster-randomized controlled trial (mixed-methods) Allocation Randomized (block randomization at HCP level, blocks of 4) Intervention Model Parallel assignment Randomization Unit Healthcare professional (cluster) Unit of Analysis Patient Masking None (open-label; not feasible to blind HCPs to guide use) Primary Purpose Supportive care / Health services research Estimated Cluster Size \~5 patients per HCP Number of Clusters 40 HCPs (20 intervention / 20 control) Condition/Disease Serious illness (advanced/life-limiting disease with high mortality risk and significant impact on quality of life); Palliative Care Intervention Experimental arm: Complex two-phase intervention - (1) Training of HCPs in use of the SICG (structured communication skills course); (2) Use of the SICG by trained HCPs with patients and their families (approx. 5 patients/families per HCP), supported by a dedicated mobile application and virtual assistant. Control arm: Standard/usual care (no SICG training or use). Eligibility Criteria Patients: Serious illness as defined above Age 18-80 years Spanish as native language Karnofsky Performance Status ≥50, or ECOG Performance Status ≤2, or Palliative Performance Scale (PPS) ≥50 Signed informed consent Family members: Family member of an eligible patient with serious illness Age 18-80 years Spanish as native language Signed informed consent Exclusion criteria (patients and family members): Cognitive or perceptual impairment precluding completion of study questionnaires. Healthcare professionals (HCPs): Inclusion: Specialists in Palliative Care, Oncology, Hematology, or Primary Care, affiliated with Fundación CUDECA, Servicio Andaluz de Salud, or Institut Català d'Oncologia Exclusion: Any professional not meeting inclusion criteria Sample Size 190 patients with serious illness, calculated to detect a between-group difference of 2.5 points in anxiety/depression scores, with 95% confidence and 80% power, accounting for a design effect of 1.2 and an intracluster correlation coefficient (ICC) of 0.05. Patients recruited via 40 HCPs, average cluster size of 5. Outcome Measures Primary Outcome: Change in anxiety and depression levels (Hospital Anxiety and Depression Scale, HADS) in patients and family members, intervention vs. control group. Secondary Outcomes: Perceived usefulness of the SICG (patients, families, HCPs) HCP communication skills and self-efficacy (validated communication self-confidence and expected-outcomes scales; psychosocial aspects of patient care scale) SICG implementation process fidelity and reach (patient identification/referral criteria; number of eligible vs. enrolled patients) Quality of life (EuroQoL-5D-5L; QLQ-C15-PAL) Cost-utility of SICG implementation (incremental cost-effectiveness ratio) Additional patient measures: Karnofsky Index, PPS, PS, Edmonton Symptom Assessment Scale (ESAS), Distress Thermometer App/virtual assistant usability and feasibility (SUS, MAUQ; learnability, efficiency, error rate, user satisfaction, engagement) Data Collection \& Analysis Quantitative data collected via electronic case report form (REDCap, hosted by Instituto IBIMA). Qualitative data collected via audio-recorded interviews, transcribed and analyzed in NVivo. Quantitative analysis by intention-to-treat; multilevel modeling to account for clustering at the HCP level; ICC calculated for the primary outcome; repeated-measures ANOVA for within-group change over time; multivariate imputation for missing data; significance threshold p\<0.05 (two-sided); SPSS v25.0. Estimated Timeline Recruitment of HCPs and training: approx. 8 months SICG implementation and follow-up: minimum 12 months per participating HCP Utility interviews: two time points during implementation Total estimated project duration: 36 months Data Sharing / Repository De-identified data intended for deposit in a public repository (RIUMA - Universidad de Málaga institutional repository) following FAIR principles, subject to data protection regulations (GDPR; Spanish LOPDGDD 3/2018). Minimum 10-year data availability guaranteed by the research team.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
190
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.
CUDECA Institute/CUDECA Foundation
Benalmádena, Málaga, Spain
Fundación CUDECA
Benalmádena, Málaga, Spain
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.
Time frame: Baseline, 1 month, 3 months, and 6 months after SICG conversation (or equivalent index visit in the control arm).
Change in family-caregiver anxiety and depression
Change from baseline in HADS score among family caregivers of enrolled patients. Same scoring as above (range 0-21 per subscale; higher = worse).
Time frame: Baseline, 3 months, and 6 months after the patient's SICG conversation.
Patient health-related quality of life (EuroQoL-5D-5L)
Change in EQ-5D-5L index value (utility score, range -0.594 to 1.000; higher = better QoL) and EQ-VAS (0-100). Used both as a clinical outcome and as the utility metric for the cost-utility analysis (QALYs).
Time frame: Baseline, 3 months, and 6 months.
Patient cancer-specific quality of life (EORTC QLQ-C15-PAL)
Change in QLQ-C15-PAL, the 15-item palliative-care short form of the QLQ-C30. Functional and symptom subscales linearly transformed to 0-100.
Time frame: Baseline, 3 months, and 6 months.
Family-caregiver health-related quality of life (EuroQoL-5D-5L)
Change in EQ-5D-5L index and EQ-VAS in family caregivers.
Time frame: Baseline, 3 months, and 6 months.
Patient symptom burden (ESAS)
Change in Edmonton Symptom Assessment System total distress score (10 symptoms, each 0-10; total 0-100; higher = worse).
Time frame: Baseline, 1 month, 3 months, and 6 months.
Patient and caregiver distress (Distress Thermometer)
Change in NCCN Distress Thermometer score (single-item visual analogue, 0-10; ≥4 = clinically significant distress).
Time frame: Baseline, 1 month, 3 months, and 6 months.
Patient functional status (Karnofsky Performance Status / Palliative Performance Scale)
Change in Karnofsky Performance Status (0-100, higher = better function) and Palliative Performance Scale (0-100% in 10% decrements). Used both as descriptive variables and as eligibility-confirmation measures (KPS ≥50 or PPS ≥50 at enrolment).
Time frame: Baseline, 3 months, and 6 months.
Patient and family satisfaction with SICG
Ad-hoc satisfaction questionnaire on the use and perceived helpfulness of the Serious Illness Conversation, administered after the index conversation. more satisfaction better care.
Time frame: Within 2 weeks after the SICG conversation.
HCP communication self-efficacy and attitudes (pre-post training)
Change in three validated scales administered to participating healthcare professionals: (a) Self-Efficacy in Communication Skills scale; (b) Expected Outcomes of Communication scale; (c) Psychosocial Aspects of Patient Care scale. Higher scores indicate greater confidence, more positive expectations, and greater attention to psychosocial care, respectively.
Time frame: Baseline (pre-training), immediately post-training, and 6 and 12 months after training.
HCP satisfaction with SICP training and implementation
Ad-hoc satisfaction questionnaire on the SICP training programme and on the experience of implementing the SICG in routine practice. Better score better satisfaction.
Time frame: Immediately after training and 12 months after the start of SICG implementation.
Healthcare resource utilization
Number and type of contacts with healthcare services during the 6 months following the index conversation, extracted from electronic health records: emergency-department visits, hospital admissions and length of stay, outpatient visits, and referrals to specialist palliative care.
Time frame: From index conversation through 6 months of follow-up.
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