Artificial Intelligence Satisfaction in Professionals and Patients (sAItisfACES)

February 25, 2026 updated by: Raúl Ferrer-Peña, Universidad Autonoma de Madrid

sAItisfACES - Impact of an Artificial Intelligence Tool on the Satisfaction of Professionals and Patients in Ambulatory Consultations: A Randomized Cluster Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This multicenter cluster-randomized study aims to evaluate the impact of an artificial intelligence (AI) tool designed to optimize real-time clinical registration during outpatient consultations. Its effect on patient and healthcare professional satisfaction will be analyzed, measured using a visual analog scale (VAS) and validated tools such as the Patient Experience Questionnaire (PEQ) and the Net Promoter Score (NPS). In addition, the duration of consultations and the quantity and quality of clinical data recorded in the intervention and control groups will be compared. The intervention group will use the AI tool, while the control group will continue with the usual recording without AI. Participants will be adult patients (18-80 years) seen in health centers linked to the study, recruited by prior informed consent. AI is expected to reduce the administrative burden on professionals, allowing them to devote more time to direct care, improving both the quality of the clinical record and the patient experience. Recruitment will take place between December 2024 and May 2025, and will follow the ethical guidelines set out in the Declaration of Helsinki. This project seeks to provide evidence on the implementation of AI-based technologies in the outpatient setting and their impact on the quality of healthcare.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 28500
    • Madrid
      • Madrid, Madrid, Spain, 28018

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Artificial Intelligence Tool
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
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.
No Intervention: Standard of care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Satisfaction with the consultation
Time Frame: From enrrolment to the end of the consultation the same day.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of the consultation
Time Frame: From enrrolment to the end of the consultation the same day.
Total time of the consultation, measured manually from the time of entry to the time of departure of the patient.
From enrrolment to the end of the consultation the same day.
Number of clinical data recorded
Time Frame: From enrrolment to the end of the consultation the same day.
Total number of words documented in the clinical history generated during the consultation, excluding headings
From enrrolment to the end of the consultation the same day.
Patient Experience (Patient Expectation Questionnaire - PEQ)
Time Frame: at the begining and at the end of the consultation
Assessment of selected domains of the Patient Expectation Questionnaire (Health Service Process and Professional-Patient Communication). Format: 5-point Likert scale.
at the begining and at the end of the consultation
Likelihood of recommendation (Net Promoter Score - NPS)
Time Frame: From enrrolment to the end of the consultation the same day.
Patient's assessment of the likelihood of recommending the service received. Range: 0 (very unlikely) to 10 (very likely).
From enrrolment to the end of the consultation the same day.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sociodemographic variables
Time Frame: at the begining of the consultation, Just after enrrollment.
Age (years)
at the begining of the consultation, Just after enrrollment.
Sociodemographic variables
Time Frame: at the begining of the consultation, Just after enrrollment.
Sex (Male/Female)
at the begining of the consultation, Just after enrrollment.
Sociodemographic variables
Time Frame: at the begining of the consultation, Just after enrrollment.
Nationality (Spanish/Other).
at the begining of the consultation, Just after enrrollment.
Sociodemographic variables
Time Frame: at the begining of the consultation, Just after enrrollment.
Municipality of residence (Rural/Non-rural).
at the begining of the consultation, Just after enrrollment.
Sociodemographic variables
Time Frame: at the begining of the consultation, Just after enrrollment.
Marital status (Single, Married, Divorced, Widowed).
at the begining of the consultation, Just after enrrollment.
Sociodemographic variables
Time Frame: at the begining of the consultation, Just after enrrollment.
Employment status (Active/Not active/Pensioner/Employed/Other).
at the begining of the consultation, Just after enrrollment.
Sociodemographic variables
Time Frame: at the begining of the consultation, Just after enrrollment.
Educational level (None, Primary, Secondary, Vocational training, University, Doctorate).
at the begining of the consultation, Just after enrrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Autonoma de Madrid

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raul Ferrer, PhD, Senior Lecturer and Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • sAItisfACES - IA satisfaction

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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