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WorkloadAI ScribeNCT06691724

Ambient Scribe in General Practice: a Multi-perspective Before-after Longitudinal Mixed-methods Study

An observational study of Workload, run by Erasmus Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

General practitioners (GPs) in the Netherlands are under unsustainable pressure. Recent surveys show that 68% of general practitioners find the workload too high and 18% find their work extremely or very stressful. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Workload
What is being tested?
LLM-based transcription and reporting tool
How many people
800 participants
Where
1 siteNetherlands
Study dates
9 Dec 2024to 2 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: * General practitioners (in training) in the Southwest of the Netherlands * Patients seeing general practitioners (in training) in the Southwest of the Netherlands

Who may be able to join

  • Planning to implement the AI-based transcription and reporting tool
  • Give informed consent for observation and/or interview and/or questionnaire
  • Give informed consent for questionnaire and/or interview
  • For questionnaire: had a consultation with the GP
  • For interview: had a consultation with the GP in which the tool was used

Who cannot join

  • Insufficient knowledge of the Dutch language to be interviewed
  • Patients:
  • Insufficient knowledge of the Dutch language to be interviewed

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Erasmus MC

    Rotterdam, South Holland, 3015GD

Other trials in Netherlands

About this study

General practitioners (GPs) in the Netherlands are under unsustainable pressure. Recent surveys show that 68% of general practitioners find the workload too high and 18% find their work extremely or very stressful. The pressure on GPs significantly harms patient care, as reduced physician well-being can negatively impact patient experiences, treatment adherence, patient-provider communication, healthcare costs, care quality, and patient safety.

A key contributor to the stress is the increasing time commitment associated with clinical documentation. The documentation process has evolved into a time-intensive task, which is a significant obstacle to efficient patient care. Large language models (LLMs) are promising artificial intelligence (AI) solutions to reduce the documentation in general practice. In this project, the investigators aim to study an AI-based transcription and reporting tool in general practice.

Read the detailed description

Introduction Over the years the introduction of the electronic health record (EHR) and escalating demands for documentation have led to a mounting burden on GPs. Clinical documentation is a major barrier to efficient patient care as last year more than half the GPs spend more than 20% of their time on administrative duties. This burden leads to reduced job satisfaction and well-being, increased rates of burnout, and employee attrition. The documentation burden also negatively influences patient-provider communication. It leads to GPs making less eye contact, having a more closed body posture, and conveying less information to their patients. The documentation in the EHR however also has positive effects, such as reduced cognitive load and improvements in patient safety and care. Reducing the provider-computer interaction during the consultation may improve patient-provider interaction and provider well-being while retaining the benefits of EHRs.

In fact, studies showed that employing medical assistants for documentation during consultations leads to an increase in face-to-face time and improves patient satisfaction. Moreover, speech-to-text technologies for dictation after the consultation alleviated the documentation burden by increasing documentation speed, patient experience, and provider satisfaction. These interventions may lower burnout and attrition rates, strengthening the well-being of the providers as well as that of the healthcare sector.

The rapid advancement of large language models (LLMs) has opened new avenues to reduce documentation burden. LLMs, such as ChatGPT, are artificial intelligence (AI) models that can interpret and generate text. These models can transcribe and summarize a consultation with the GP in real-time removing the need for medical assistants or dictation after the consultation. However, if the LLM makes mistakes, this may lead to increased administrative workload. The investigators aim to assess the effect of a AI-based transcription and reporting tool in general practice.

Objectives Our primary objective is to assess the effect of a transcription and reporting tool on time spent on clinical documentation in general practice.

Secondary objectives are to assess the effect of a transcription and reporting tool in general practice on

  • Total consultation time
  • GP experience
  • Patient experience
  • Documentation length and quality

To assess the usage rates of the tool To assess the acceptability of use of the tool

Design This is a longitudinal before-after study. For each GP the investigators will observe two days of consultations without the tool. This will be done two weeks before implementation of the tool (baseline period). The investigators will also observe two days of consultations with the tool. This occurs two weeks after implementation of the tool (intervention period). Consultations from the intervention period will be compared with the baseline period to assess effectiveness of tool on the various outcomes.

Sample size A sample size simulation showed the investigators would need 30 observations to have enough power for the primary outcome. To improve the generalizability of our research and increase the sample for the qualitative outcomes, the investigators aim to observe in total four days of consultations for 12 GPs from at least five different practices. Practices will be sampled purposively for differences in patient population and practice organization.

Outcomes The investigators will measure time outcomes through continuous observation. An observer will monitor the time spent on various tasks during a consultation, including taking the medical history, conducting the physical examination, explaining the diagnosis or treatment plan, consulting a colleague, clinical documentation, and administrative duties like prescribing or referring.

Patient experience of the consultation will be measured with a validated patient experience questionnaire (PEQ) for general practice. Patient attitude on the use of the tool during the consultation will be expanded upon with a semi-structured interview based on prior research. The experiences of the GP with and impact of the tool on clinical duties will be measured with semi-structured interviews based on prior research. The acceptability and use of the tool by GPs will be assessed according to the unified theory of acceptance and use of technology (UTAUT).

Usage rates of the tool will be measured by assessing the proportion of consultations in which the tool is used. Documentation volume will be measured by determining the length of documentation in words. The documentation's information quantity will be measured by the number of relevant clinical variables in the note.

Conditions
Workload
Being tested
LLM-based transcription and reporting tool
Keywords
general practice, workload, large language model, artificial intelligence, documentation, electronic health record, transcription

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LLM-based transcription and reporting toolOther

    Also called Juvoly QuickConsult

    The LLM-based transcription and reporting tool works in three steps:

    1. The conversation between patient and GP is transcribed to text with a speech-to-text LLM
    2. The text is summarized according to the Subjective, Objective, Assessment, Plan (SOAP) rules
    3. The SOAP summary is imported in the electronic health record of the GP
Study groups in NCT06691724
Study groupRoleWhat they receive
GP 01General practitioner working with/without the tool
Receives: Other: LLM-based transcription and reporting tool
GP 02General practitioner working with/without the tool
Receives: Other: LLM-based transcription and reporting tool
GP 03General practitioner working with/without the tool
Receives: Other: LLM-based transcription and reporting tool
GP 04General practitioner working with/without the tool
Receives: Other: LLM-based transcription and reporting tool
GP 05General practitioner working with/without the tool
Receives: Other: LLM-based transcription and reporting tool
GP 06General practitioner working with/without the tool
Receives: Other: LLM-based transcription and reporting tool
GP 07General practitioner working with/without the tool
Receives: Other: LLM-based transcription and reporting tool
GP 08General practitioner working with/without the tool
Receives: Other: LLM-based transcription and reporting tool
GP 09General practitioner working with/without the tool
Receives: Other: LLM-based transcription and reporting tool
GP 10General practitioner working with/without the tool
Receives: Other: LLM-based transcription and reporting tool
GP 11General practitioner working with/without the tool
Receives: Other: LLM-based transcription and reporting tool
GP 12General practitioner working with/without the tool
Receives: Other: LLM-based transcription and reporting tool

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time spent on documentation

    This outcome refers to the time spent on documentation for a clinical consultation. The investigators will measure time outcomes through continuous observation. An external observer will monitor the time spent on various tasks during a consultation, including taking the medical history, conducting the physical examination, explaining the diagnosis or treatment plan, consulting a colleague, clinical documentation, and administrative duties like prescribing or referring.

    Measured: Measured during the consultation (baseline and intervention)

Secondary outcomes (8)
  1. Total consultation time

    This outcome refers to the total time spent on the clinical consultation. The investigators will measure time outcomes through continuous observation. An external observer will monitor the time spent on various tasks during a consultation, including taking the medical history, conducting the physical examination, explaining the diagnosis or treatment plan, consulting a colleague, clinical documentation, and administrative duties like prescribing or referring.

    Measured: Measured during the consultation (baseline and intervention)

  2. GP experience with the tool

    The experiences of the GP and impact of the tool on clinical duties will be measured with semi-structured interviews based on prior research with the following topic guide:

    • What do you think about Juvoly QuickConsult?
    • Does the system help you? How? Workload? Focus? Job satisfaction?
    • Does the system help the patient? How? More time to explain or ask questions?
    • Does the system hinder the you? How? Distraction?
    • Does the system hinder the patient? Distraction? Don't want to talk about certain issues/share certain information? Less room for asking questions?

    Measured: Measured within one week after the two-day intervention period

  3. Patient experience with the consultation

    Patient experience of the consultation and communication with the GP will be measured with a patient experience questionnaire (PEQ) for general practice (doi: 10.1093/fampra/18.4.410).

    The PEQ contains five scales:

    • Outcomes of the visit (4-20, higher is better)
    • Communication experiences (4-20, higher is better)
    • Communication barriers (4-20, higher is worse)
    • Experience with the auxiliary staff (2-10, higher is better)
    • Emotions (4-28, higher is better)

    Measured: Measured within 1 week after the consultation

  4. Patient experience with the tool

    Patient experience and attitude with the tool will be assessed using a semi-structured interview based on prior research with the following topic guide:

    • How did you experience the consultation?
    • What do you think about the system the GP used to write down the consultation?
    • Does the system help the GP? How? More explanation time?
    • Does the system help you? How? More elaboration time?
    • Does the system hinder the GP? How? Distraction for the GP?
    • Does the system hinder you? Distraction? Don't want to talk about certain issues/share certain information? Less room for asking questions?

    Measured: Measured within 1 week after the consultation

  5. Usage rates

    Usage rates of the tool will be measured by assessing the proportion of consultations in which the tool is used.

    Measured: Measured directly after the consultation

  6. Documentation volume

    Documentation volume will be measured by determining the length of documentation in words.

    Measured: Measured directly after the consultation

  7. Documentation information density

    The documentation's information quantity will be measured by the number of relevant clinical variables in the note. They will be categorized according to their type:

    • Signs and related variables such as site, onset, character, or time course
    • Contextual factors such as self-care, risk behavior or family history
    • Symptoms
    • (Differential) diagnosis
    • Plan

    Measured: Measured directly after the consultation

  8. GP acceptability and use of the tool

    The acceptability and use of the tool by GPs will be assessed according to the unified theory of acceptance and use of technology (UTAUT). The questionnaire has five domains.

    Performance expectancy: 4-20 points, higher is better Effort expectancy: 4-20 points, higher is better Social influence: 4-20 points, higher is better Facilitating conditions: 4-20 points, higher is better Behavioral intention: 3-15 points, no value judgement

    Measured: Measured 1 week before the baseline period, 1 week before the start of the intervention period, and 1 week after intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2024
  2. Study start9 Dec 2024
  3. Primary completion2 Jul 2025
  4. Study completion2 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06691724
Sponsor's protocol ID
PaNaMa-12075
Other IDs
MEC-2024-0286
Acronym
AI Scribe
Status last verified
Dec 2025
First submitted
25 Oct 2024
Last updated
11 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Participants will be asked whether their data may be used in future research projects. Metadata of the project will be shared on a data repository. External investigators can apply for use of the data through this data repository. Only data of participants that allow for re-use of their data will be eligible for sharing.

Questions about this trial

What is this clinical trial studying?

An observational study of Workload, run by Erasmus Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time spent on documentation (time frame: Measured during the consultation (baseline and intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.

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