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Enhancing Readability of Lay Abstracts and Summaries for Medical Knowledge Using Generative Artificial Intelligence (BRIDGE AI 3)

4. maj 2026 opdateret af: Giovanni Cacciamani, University of Southern California

Enhancing Readability of Lay Abstracts and Summaries for Medical Knowledge Using Generative Artificial Intelligence: A Randomized Controlled Trial (BRIDGE AI 3)

This trial tests if AI can help make medical info clear and readable. Many patients struggle to find medical informations that easy to read and understand from verified medical sources. The study tests if an AI tool can assist health providers to craft clear text for patients more fast than what they do now. Health providers are split at random into two groups-one uses the AI tool and one does not. The trial tests how clear the text is, how correct it is, and how much time is saved. The aim is to see if AI can close the gap between complex research and what patients can grasp.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Afsluttet

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

This study evaluates whether a generative artificial intelligence (AI) tool can improve the readability and accessibility of lay summaries derived from scientific medical abstracts. Many patients encounter difficulty understanding medical literature due to technical language and complexity, which can limit informed decision-making and engagement with healthcare information.

The BRIDGE-AI (Provider Perspective) initiative aims to address this gap by enabling healthcare professionals and researchers to generate patient-friendly summaries of scientific content using AI-assisted tools. The intervention leverages a generative AI framework (pub2people) designed to translate complex medical terminology into language that is understandable to a general audience.

In this randomized controlled study, participants with experience in scientific publishing will be assigned to either an AI-assisted group or a control group using conventional methods. Participants will be asked to transform scientific abstracts into layperson-friendly summaries. The study compares AI-assisted and manually generated outputs in terms of readability, accuracy, and efficiency.

The primary objective is to determine whether AI-assisted generation improves the readability of lay summaries compared to standard approaches. Secondary objectives include evaluating the accuracy of AI-generated summaries relative to source material and assessing potential time savings associated with AI use.

This study contributes to ongoing efforts to improve health communication by evaluating scalable tools that may enhance the translation of complex medical information into patient-accessible formats.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
120

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 91100
        • University of Southern California

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Provider Participants

Inclusion:

  • Corresponding authors who have been published in the top 10 journals of urology and medicine
  • All genders
  • Any profession
  • 18+ years of age

Exclusion:

  • Anyone under the age of 18
  • Participants that have not published in the top 10 journals of urology and medicine

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Ingen indgriben: Gold Standard
Eksperimentel: Pub2Post
Andet: Pub2Post
Pub2Post, a generative artificial intelligence agent which helps in drafting the layperson abstracts and summaries

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Readability Change
Tidsramme: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.

Flesch Reading Ease Score

Description: Measures text readability based on sentence length and word syllables.

Scale: 0 to 100 Interpretation: Higher scores indicate easier readability (better outcome).
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Readability Change
Tidsramme: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Flesch-Kincaid Grade Level Description: Estimates U.S. school grade level required to understand the text. Scale: Typically ranges from ~0 to 18+ Interpretation: Lower scores indicate easier readability (better outcome).
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Readability Change
Tidsramme: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.

Gunning Fog Index Description: Estimates years of formal education needed to understand the text on first reading.

Scale: Typically 0 to 20+ Interpretation: Lower scores indicate easier readability (better outcome).
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Readability Change
Tidsramme: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
SMOG Index (Simple Measure of Gobbledygook) Description: Estimates years of education required to comprehend the text. Scale: Typically 0 to 20+ Interpretation: Lower scores indicate easier readability (better outcome).
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Readability Change
Tidsramme: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.

Coleman-Liau Index Description: Readability formula based on characters per word and sentence length.

Scale: Typically 0 to 18+ (grade level equivalent) Interpretation: Lower scores indicate easier readability (better outcome).
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Readability Change
Tidsramme: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.

Automated Readability Index (ARI) Description: Estimates grade level required for comprehension using characters and word counts.

Scale: Typically 0 to 14+ Interpretation: Lower scores indicate easier readability (better outcome).
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time Saving
Tidsramme: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.

To evaluate the time savings achieved by using generative AI compared to traditional methods for generating layperson abstracts and summaries. Time will be recorded in hours, minutes, and seconds. We will collect and compare the total time spent drafting the complete layperson abstract and summaries, as well as the time spent on each individual section - background, methods, results, conclusion, and short summaries. The comparison will be made between summaries created by humans alone versus those created with GAI assistance.

Time will be reported in minutes
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Correctness and meaning retention
Tidsramme: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.

Accuracy Score of Layperson Abstract Sections Description: Degree to which each section (Background, Methods, Results, Conclusion, Short Summary) reflects key information from the original scientific abstract.

Scale: 5-point Likert scale (1 = very inaccurate, 5 = highly accurate) Assessment Method: Two independent reviewers score each section Interpretation: Higher scores indicate better accuracy (better outcome).
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Correctness and meaning retention
Tidsramme: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.

Completeness Score of Layperson Abstract Sections Description: Extent to which essential information from the original abstract is included in each section.

Scale: 5-point Likert scale (1 = very incomplete, 5 = fully complete) Assessment Method: Two independent reviewers evaluate each section. Interpretation: Higher scores indicate greater completeness (better outcome).
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Correctness and meaning retention
Tidsramme: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.

Clarity Score for Layperson Readability Description: Evaluates simplicity, avoidance of jargon, and coherence for lay audiences.

Scale: 5-point Likert scale (1 = very unclear, 5 = very clear and understandable) Assessment Method: Two independent reviewers evaluate each section. Interpretation: Higher scores indicate better clarity (better outcome).
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Correctness and meaning retention
Tidsramme: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.

Section-Level Correctness Rate Description: Proportion of sections rated as "correct," defined as receiving scores ≥4 from both reviewers on accuracy, completeness, and clarity simultaneously.

Scale: 0 to 1 (proportion) or 0% to 100% Interpretation: Higher values indicate better overall section quality.
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Correctness and meaning retention
Tidsramme: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.

Hallucination Rate Description: Frequency of false or misleading content in generated layperson abstracts, defined as information not supported by the original abstract.

Scale: Proportion of sections or documents containing hallucinations (0 to 1 or %) Assessment Method: Evaluated separately by reviewers using predefined criteria. Interpretation: Lower values indicate better performance (fewer hallucinations).
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Perceived Task Difficulty
Tidsramme: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment

Description: Participant-reported difficulty of completing the lay abstract summarization task.

Scale: 5-point Likert scale (1 = very easy, 5 = very difficult) (adjust anchors if different in your instrument) Assessment Timing: Immediately after task completion Interpretation: Lower scores indicate less perceived difficulty (better outcome)
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment
Perceived Task Duration
Tidsramme: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment
Description: Participant perception of time required to complete the task. Scale: 5-point Likert scale (1 = very short, 5 = very long) Assessment Timing: Post-task Interpretation: Lower scores indicate shorter perceived duration (better outcome)
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment
Perceived Helpfulness of the intervention
Tidsramme: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment

Description: Participant-reported usefulness of the generative AI tool in assisting lay abstract creation.

Scale: 5-point Likert scale (1 = not helpful at all, 5 = extremely helpful) Assessment Timing: Post-task Interpretation: Higher scores indicate greater perceived helpfulness (better outcome)
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment
System Usability Scale (SUS) Score
Tidsramme: Immediately after completing the system/task (post-use assessment)

Description: Standardized assessment of system usability using the System Usability Scale.

Scale: 0 to 100 Interpretation: Higher scores indicate better usability

  • 70: acceptable usability
  • 90: superior usability
Immediately after completing the system/task (post-use assessment)
Perceived Usefulness (Technology Acceptance Model)
Tidsramme: Immediately after completing the system/task (post-use assessment)

Description: Degree to which participants believe the GAI tool enhances task performance.

Scale: Likert scale (typically 1-5 or 1-7; specify exact instrument version) Interpretation: Higher scores indicate greater perceived usefulness (better outcome)
Immediately after completing the system/task (post-use assessment)
Perceived Ease of Use (Technology Acceptance Model)
Tidsramme: Immediately after completing the system/task (post-use assessment)
Description: Degree to which participants find the GAI tool easy to use. Scale: Likert scale (typically 1-5 or 1-7; must match instrument used) Interpretation: Higher scores indicate greater ease of use (better outcome)
Immediately after completing the system/task (post-use assessment)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
University of Southern California

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
16. januar 2025

Primær færdiggørelse (Faktiske)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
22. januar 2025

Studieafslutning (Faktiske)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
27. februar 2025

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
12. marts 2025

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
30. april 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
4. maj 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • UP-24-01142

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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