NCT06726447

Brief Summary

This multicenter cluster-randomized study evaluates the impact of an artificial intelligence (AI) tool on the satisfaction of healthcare professionals and patients in outpatient consultations, measuring its effect on perceived satisfaction (through a visual analog scale), the duration of consultations, and the quality and quantity of clinical data recorded. Adult patients (18-80 years) seen in outpatient centers will participate, comparing those using the AI tool with centers following the usual procedure. The tool is expected to reduce the administrative burden, improve user satisfaction and increase the efficiency and quality of the clinical registry. Recruitment will take place between December 2024 and May 2025, with final analysis planned for the end of 2025.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Dec 2024Dec 2026

First Submitted

Initial submission to the registry

November 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

November 26, 2024

Last Update Submit

February 25, 2026

Conditions

Keywords

Artificial IntelligencePatient SatisfactionMedical Records Systems, ComputerizedHealth Care Quality, Access, and Evaluation

Outcome Measures

Primary Outcomes (1)

  • Satisfaction with the consultation

    measured using a 10 cm Visual Analog Scale (VAS) of satisfaction, which assesses the degree of satisfaction perceived by patients and health professionals. From no satisfaction in the left side to Completely satisfied in the right side.

    From enrrolment to the end of the consultation the same day.

Secondary Outcomes (4)

  • Duration of the consultation

    From enrrolment to the end of the consultation the same day.

  • Number of clinical data recorded

    From enrrolment to the end of the consultation the same day.

  • Patient Experience (Patient Expectation Questionnaire - PEQ)

    at the begining and at the end of the consultation

  • Likelihood of recommendation (Net Promoter Score - NPS)

    From enrrolment to the end of the consultation the same day.

Other Outcomes (7)

  • Sociodemographic variables

    at the begining of the consultation, Just after enrrollment.

  • Sociodemographic variables

    at the begining of the consultation, Just after enrrollment.

  • Sociodemographic variables

    at the begining of the consultation, Just after enrrollment.

  • +4 more other outcomes

Study Arms (2)

Artificial Intelligence Tool

EXPERIMENTAL

The health centers assigned to this group will implement an artificial intelligence (AI) tool for clinical registration during outpatient consultations. Healthcare professionals will activate the tool at the beginning of the consultation and deactivate it at the end. The tool will be used to document interactions in real time, generating more detailed records and reducing the administrative burden.

Device: Artificial Intelligence Tool

Standard of care

NO INTERVENTION

In the centers assigned to this group, consultations will be carried out in the usual way, using traditional clinical recording methods, without additional technological intervention. This group will serve as a reference to compare differences in satisfaction, duration of consultations and quality of the clinical record.

Interventions

The intervention in this study consists of the implementation of an artificial intelligence tool for clinical registration during outpatient consultations. This technology facilitates the documentation of interactions in real time, optimizing the workflow of professionals and enabling more patient-centered care.

Artificial Intelligence Tool

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 18 and 80 years of age.
  • Patients consulting for any health reason in the outpatient clinics of the centers participating in the study.
  • Patients who sign the informed consent to participate in the study.

You may not qualify if:

  • Patients who are unable to understand or complete the questionnaires, due to:
  • Language barriers.
  • Cognitive disabilities.
  • Any other reason that prevents their adequate participation.
  • Patients who are currently participating in other clinical trials or research studies that may interfere with the results of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ACES Centers

Barcelona, Catalonia, 28500, Spain

RECRUITING

CSEU La Salle - UAM

Madrid, Madrid, 28018, Spain

NOT YET RECRUITING

Related Publications (1)

  • Topol EJ. High-performance medicine: the convergence of human and artificial intelligence. Nat Med. 2019 Jan;25(1):44-56. doi: 10.1038/s41591-018-0300-7. Epub 2019 Jan 7.

    PMID: 30617339BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Raul Ferrer, PhD

    Senior Lecturer and Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raúl Ferrer-Peña, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The masking is single-blind and patient-centered, which is appropriate for this type of intervention where it is not feasible to blind healthcare professionals. This helps to reduce bias in measurements related to patient satisfaction and experience.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Clusters
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. in Pain Research

Study Record Dates

First Submitted

November 26, 2024

First Posted

December 10, 2024

Study Start

December 1, 2024

Primary Completion

June 30, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

The study data will not be shared to ensure the confidentiality and privacy of the participants, in accordance with current regulations such as the General Data Protection Regulation (GDPR). In addition, sensitive health-related data are handled, the disclosure of which could compromise the privacy of individuals. Although the data will be anonymized, the team has decided to limit its access to authorized personnel only in order to protect the integrity of the study and minimize ethical or legal risks associated with the distribution of personal information.

Locations