COPDIMPL-AI-MENTNCT06410547
Using Large Language Models Such As GPT-4 to Assess Guideline Adherence in Patients With Chronic Obstructive Pulmonary Disease
A study testing LLM in people with COPD, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
According to studies in the US and the Netherlands, 33-40% of patients with chronic conditions receive care that does not follow guideline recommendations. These findings have also been demonstrated in the management of COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- LLM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2024to 1 Apr 2025
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosis of COPD
- Consent
- Discharge after hospitalization
Who cannot join
- Lack of Consent
Trial locations and contacts
1 site in 1 country.
About this study
According to studies in the US and the Netherlands, 33-40% of patients with chronic conditions receive care that does not follow guideline recommendations. These findings have also been demonstrated in the management of COPD. This leads to under- or over-treatment of patients and, in the case of COPD, to exacerbations and hospitalisations. These exacerbations are a significant clinical problem, affecting patient's lung function, quality of life and mortality. They are also a burden on the healthcare system. Technological advances in artificial intelligence offer the opportunity to address these issues in COPD management. In the past year, there have been remarkable innovations in the field of natural language processing, especially through large language models such as GPT-4 from OpenAI and Bard or Gemini from Google. These models offer an opportunity to improve the implementation of evidence-based care in clinical practice.
This study is a prospective, randomised trial that will compare therapy on discharge for patients with COPD. One arm will receive no intervention, while the other arm will receive a treatment recommendation from an LLM. The study will compare the percentage of patients treated according to the guideline.
- Conditions
- COPD
- Being tested
- LLM
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLMOther
A LLM-based comparison between treatment and guideline.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | No intervention | This arm will be treated as usual. No intervention will be performed. |
| LLM Assessement | Active comparator | During hospital stay and after written informed consent, an LLM is asked to indicate if the treatment the patient receives is guideline-concordant. The information is ascertained by two study physicians (human-in-the-loop) and later provided to the treating physician who can recommend a change in therapy to the patient (outside of the study). Receives: Other: LLM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to treatment guidelines at the time of hospital discharge
The primary endpoint will assess whether the treatment at the time of discharge is consistent with the guidelines' recommendations. This is a binary outcome measure of yes or no.
Measured: From date of admission (which is enrollment) to the date of discharge, assessed up to one month
Percentage of patients treated in concordance with treatment guidelines at the time of hospital discharge
This primary endpoint will assess the percentage of guideline-concordant treatments in each study arm.
Measured: From date of admission (which is enrollment) to the date of discharge, assessed up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start15 May 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Gröschel, Charite University, Berlin, Germany
- Investigators
- Matthias Gröschel, MD PhD, Principal investigator, Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410547
- Sponsor's protocol ID
- EA2/322/23
- Acronym
- IMPL-AI-MENT
- Status last verified
- Mar 2026
- First submitted
- 24 Apr 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Large Language Models Such As GPT-4 to Assess Guideline Adherence in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06410547
- Acronym / sponsor ID
- IMPL-AI-MENT / EA2/322/23
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 13 May 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.
According to studies in the US and the Netherlands, 33-40% of patients with chronic conditions receive care that does not follow guideline recommendations. These findings have also been demonstrated in the management of COPD. This leads to under- or over-treatment of patients and, in the case of COPD, to exacerbations and hospitalisations. These exacerbations are a significant clinical problem, affecting patient's lung function, quality of life and mortality. They are also a burden on the healthcare system. Technological advances in artificial intelligence offer the opportunity to address these issues in COPD management. In the past year, there have been remarkable innovations in the field of natural language processing, especially through large language models such as GPT-4 from OpenAI and Bard or Gemini from Google. These models offer an opportunity to improve the implementation of evidence-based care in clinical practice.
This study is a prospective, randomised trial that will compare therapy on discharge for patients with COPD. One arm will receive no intervention, while the other arm will receive a treatment recommendation from an LLM. The study will compare the percentage of patients treated according to the guideline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention | No intervention | –This arm will be treated as usual. No intervention will be performed. |
| LLM Assessement | Active comparator | Other: LLMDuring hospital stay and after written informed consent, an LLM is asked to indicate if the treatment the patient receives is guideline-concordant. The information is ascertained by two study physicians (human-in-the-loop) and later provided to the treating physician who can recommend a change in therapy to the patient (outside of the study). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of COPD
- Consent
- Discharge after hospitalization
Key exclusion criteria (1 listed)
- Lack of Consent
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 |
|---|---|---|
| LLMA LLM-based comparison between treatment and guideline. | Other | LLM Assessement |
Primary outcome
Adherence to treatment guidelines at the time of hospital discharge
Time frame: From date of admission (which is enrollment) to the date of discharge, assessed up to one month
The primary endpoint will assess whether the treatment at the time of discharge is consistent with the guidelines' recommendations. This is a binary outcome measure of yes or no.
Percentage of patients treated in concordance with treatment guidelines at the time of hospital discharge
Time frame: From date of admission (which is enrollment) to the date of discharge, assessed up to one month
This primary endpoint will assess the percentage of guideline-concordant treatments in each study arm.
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 20 Mar 2026.
- Individual participant dataSharing planned: Yes. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Related trials for COPD
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PRA-216 COPD Safety and Biomarker Study
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Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
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Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
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Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
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.
Matthias Gröschel, MD PhD principal investigator
Charité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LLM in people with COPD, run by Charite University, Berlin, Germany at 1 site in Germany.
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 3 inclusion and 1 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 20 Mar 2026. 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 Germany. 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?
Adherence to treatment guidelines at the time of hospital discharge (time frame: From date of admission (which is enrollment) to the date of discharge, assessed up to one month). The study lists 2 primary outcomes in all. 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 20 Mar 2026.