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.
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.
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:
- The conversation between patient and GP is transcribed to text with a speech-to-text LLM
- The text is summarized according to the Subjective, Objective, Assessment, Plan (SOAP) rules
- The SOAP summary is imported in the electronic health record of the GP
| Study group | Role | What they receive |
|---|---|---|
| GP 01 | General practitioner working with/without the tool Receives: Other: LLM-based transcription and reporting tool | |
| GP 02 | General practitioner working with/without the tool Receives: Other: LLM-based transcription and reporting tool | |
| GP 03 | General practitioner working with/without the tool Receives: Other: LLM-based transcription and reporting tool | |
| GP 04 | General practitioner working with/without the tool Receives: Other: LLM-based transcription and reporting tool | |
| GP 05 | General practitioner working with/without the tool Receives: Other: LLM-based transcription and reporting tool | |
| GP 06 | General practitioner working with/without the tool Receives: Other: LLM-based transcription and reporting tool | |
| GP 07 | General practitioner working with/without the tool Receives: Other: LLM-based transcription and reporting tool | |
| GP 08 | General practitioner working with/without the tool Receives: Other: LLM-based transcription and reporting tool | |
| GP 09 | General practitioner working with/without the tool Receives: Other: LLM-based transcription and reporting tool | |
| GP 10 | General practitioner working with/without the tool Receives: Other: LLM-based transcription and reporting tool | |
| GP 11 | General practitioner working with/without the tool Receives: Other: LLM-based transcription and reporting tool | |
| GP 12 | General 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.
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)
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)
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
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
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
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
Documentation volume
Documentation volume will be measured by determining the length of documentation in words.
Measured: Measured directly after the consultation
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
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.
- First posted15 Nov 2024
- Study start9 Dec 2024
- Primary completion2 Jul 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WorkloadStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margreet Vlastuin, Erasmus Medical Center
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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambient Scribe in General Practice: a Multi-perspective Before-after Longitudinal Mixed-methods Study
- ClinicalTrials.gov ID
- NCT06691724
- Acronym / sponsor ID
- AI Scribe / PaNaMa-12075
- Conditions
- Workload
- Keywords
- general practice, workload, large language model, artificial intelligence, documentation, electronic health record, transcription
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| GP 01 | – | Other: LLM-based transcription and reporting toolGeneral practitioner working with/without the tool |
| GP 02 | – | Other: LLM-based transcription and reporting toolGeneral practitioner working with/without the tool |
| GP 03 | – | Other: LLM-based transcription and reporting toolGeneral practitioner working with/without the tool |
| GP 04 | – | Other: LLM-based transcription and reporting toolGeneral practitioner working with/without the tool |
| GP 05 | – | Other: LLM-based transcription and reporting toolGeneral practitioner working with/without the tool |
| GP 06 | – | Other: LLM-based transcription and reporting toolGeneral practitioner working with/without the tool |
| GP 07 | – | Other: LLM-based transcription and reporting toolGeneral practitioner working with/without the tool |
| GP 08 | – | Other: LLM-based transcription and reporting toolGeneral practitioner working with/without the tool |
| GP 09 | – | Other: LLM-based transcription and reporting toolGeneral practitioner working with/without the tool |
| GP 10 | – | Other: LLM-based transcription and reporting toolGeneral practitioner working with/without the tool |
| GP 11 | – | Other: LLM-based transcription and reporting toolGeneral practitioner working with/without the tool |
| GP 12 | – | Other: LLM-based transcription and reporting toolGeneral practitioner working with/without the tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Insufficient knowledge of the Dutch language to be interviewed
- Insufficient knowledge of the Dutch language to be interviewed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LLM-based transcription and reporting toolAlso: Juvoly QuickConsultThe 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 | Other | GP 01, GP 02, GP 03, GP 04, GP 05, GP 06, GP 07, GP 08, GP 09, GP 10, GP 11, GP 12 |
Primary outcome
Time spent on documentation
Time frame: Measured during the consultation (baseline and intervention)
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.
8 secondary outcomes
Total consultation time
Time frame: Measured during the consultation (baseline and intervention)
GP experience with the tool
Time frame: Measured within one week after the two-day intervention period
Patient experience with the consultation
Time frame: Measured within 1 week after the consultation
Patient experience with the tool
Time frame: Measured within 1 week after the consultation
Usage rates
Time frame: Measured directly after the consultation
Documentation volume
Time frame: Measured directly after the consultation
Documentation information density
Time frame: Measured directly after the consultation
GP acceptability and use of the tool
Time frame: Measured 1 week before the baseline period, 1 week before the start of the intervention period, and 1 week after intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.