Stroke, AcuteCAST-AISNCT06941753
Off-script Diagnosis & Differential Diagnosis (D&D) Training and Residents' Stroke Knowledge
A study testing Off-script diagnosis & differential diagnosis (D&D) training in people with Stroke, Acute and Educational Problems, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study is a single-center, randomized, open-label, controlled, endpoint-blinded study to assess the effect of off-script diagnosis \& differential diagnosis (D\&D) training in improving the residents' knowledge of acute ischemic stroke in China. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute, Educational Problems, Clinical Course
- What is being tested?
- Off-script diagnosis & differential diagnosis (D&D) training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 10 Aug 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residents (physicians in postgraduate training).
- Currently in neurology wards
- Managing acute ischemic stroke (AIS) patients, defined as: 1)Time from onset to randomization ≤ 2 weeks; 2) If onset time is unknown, the last known well time is considered the onset time.
- Signed informed consent
Who cannot join
- Managing asymptomatic ischemic stroke patients.
- Residents who are currently participating or have participated in another interventional ischemic stroke training program within the past 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Effectiveness of Off-script Diagnosis & Differential Diagnosis (D&D) Training in Improving Residents' Competence in Acute Ischemic Stroke Diagnosis and Treatment
This study is a single-center, randomized, open-label, controlled, endpoint-blinded study to assess the effect of off-script diagnosis \& differential diagnosis (D\&D) training in improving the residents' knowledge of acute ischemic stroke in China. The investigators will enroll 22 residents and assess the score of mASMaQ 30 days after randomization.
Read the detailed description
Ischemic stroke is characterized by high incidence and disability rates, with a critical time window for reperfusion therapy, necessitating prompt recognition, diagnosis, and treatment by frontline physicians. In clinical practice, residents across all specialties may encounter acute ischemic stroke (AIS) patients in emergency departments, outpatient clinics, or inpatient wards. However, many residents face challenges in managing AIS cases, often leading to missed diagnoses, treatment delays, and non-adherence to clinical guidelines. A primary contributing factor is their insufficient mastery of key AIS management principles and inability to effectively apply stroke knowledge in clinical contexts.
Enhancing residents' AIS management competence represents a significant challenge in stroke education. Traditional "Initial Progress Note" training overemphasizes comprehensive differential diagnoses, with most residents relying on scripted presentations. The actual clinical application of stroke knowledge remains uncertain. This study aims to evaluate whether off-script diagnosis \& differential diagnosis (D\&D) training (i.e., "Structured off-script D\&D") can significantly improve residents' AIS management knowledge.
The investigators will enroll 22 neurology residents and randomly assign them to two groups: the off-script diagnosis \& differential diagnosis (D\&D) training group (n=11) and a blank control group (n=11). The modified Acute Stroke Management Questionnaire (mASMaQ) will be used to assess residents' AIS knowledge 30 days after randomization.
- Conditions
- Stroke, Acute, Educational Problems, Clinical Course
- Being tested
- Off-script diagnosis & differential diagnosis (D&D) training
- Keywords
- resident, stroke education
- Medical subject headings
- Stroke, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off-script diagnosis & differential diagnosis (D&D) trainingOther
- Training Timeline: Must be completed within 72 hours post-randomization; Requires standardized structured off-script D\&D analysis.
- Structured Analysis Framework: 1)Epidemiology: Incidence, mortality, and disability rates; 2) Etiologic Classification: TOAST classification system; 3) Vascular Mechanisms: Culprit vessel, vascular territory, pathophysiology; 4) Differential Diagnosis: Stroke mimics and stroke subtype differentiation; 5) Acute Management: Hyperacute interventions (thrombolysis/EVT), secondary prevention strategies, and evidence-based case analysis; 6) Patient Education: Stroke prevention education for patients/public; 7) Research Gaps: Current limitations and future directions.
- Presentation Requirements: 1)Mandatory off-script delivery (no prepared text); 2) Time limit: 15+3 minutes for complete analysis.
| Study group | Role | What they receive |
|---|---|---|
| Off-script D&D training group | Experimental | Off-script D\&D training is required within 72 hours after randomization. Receives: Other: Off-script diagnosis & differential diagnosis (D&D) training |
| No-Intervention Control Group | No intervention | Off-script D\&D training is not required within 72 hours after randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mASMaQ
Modified Acute Stroke Management Questionnaire (mASMaQ), with a range of 33-165 scores. Higher scores indicate superior acute ischemic stroke management knowledge.
Blinded Assessment Protocol:1) Participant Requirements: Strict 10-minute time limit for independent completion; External references are prohibited; 2) Assessment Supervision: certified neurologists as proctors, who are blinded to group assignment throughout the trial. 3) Centralized Adjudication: based on participants' questionnaire responses.
Note: Details of the modified ASMaQ has been on file with the ethics committee and cannot be changed. To prevent disclosure of the measures and bias in resident measurement, we do not disclose the scales until the trial is completed. Details of mASMaQ will be made public with the publication of the article.
Measured: 30 days
Secondary outcomes (3)
General stroke knowledge
Part of mASMaQ, with a range of 10-50. Higher scores indicate superior general stroke knowledge.
Measured: 30 days
Hyperacute stroke management
Part of mASMaQ, with a range of 9-45. Higher scores indicate superior hyperacute stroke management knowledge.
Measured: 30 days
Advanced stroke management
Part of mASMaQ, with a range of 14-70. Higher scores indicate superior advanced stroke management knowledge.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start20 Jun 2025
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Ni, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941753
- Sponsor's protocol ID
- CAST-AIS2025
- Acronym
- CAST-AIS
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Off-script Diagnosis & Differential Diagnosis (D&D) Training in Improving Residents' Competence in Acute Ischemic Stroke Diagnosis and Treatment
- ClinicalTrials.gov ID
- NCT06941753
- Acronym / sponsor ID
- CAST-AIS / CAST-AIS2025
- Conditions
- Stroke, Acute, Educational Problems, Clinical Course
- Keywords
- resident, stroke education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 24 Apr 2025 (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.
This study is a single-center, randomized, open-label, controlled, endpoint-blinded study to assess the effect of off-script diagnosis \& differential diagnosis (D\&D) training in improving the residents' knowledge of acute ischemic stroke in China. The investigators will enroll 22 residents and assess the score of mASMaQ 30 days after randomization.
Detailed description
Ischemic stroke is characterized by high incidence and disability rates, with a critical time window for reperfusion therapy, necessitating prompt recognition, diagnosis, and treatment by frontline physicians. In clinical practice, residents across all specialties may encounter acute ischemic stroke (AIS) patients in emergency departments, outpatient clinics, or inpatient wards. However, many residents face challenges in managing AIS cases, often leading to missed diagnoses, treatment delays, and non-adherence to clinical guidelines. A primary contributing factor is their insufficient mastery of key AIS management principles and inability to effectively apply stroke knowledge in clinical contexts.
Enhancing residents' AIS management competence represents a significant challenge in stroke education. Traditional "Initial Progress Note" training overemphasizes comprehensive differential diagnoses, with most residents relying on scripted presentations. The actual clinical application of stroke knowledge remains uncertain. This study aims to evaluate whether off-script diagnosis \& differential diagnosis (D\&D) training (i.e., "Structured off-script D\&D") can significantly improve residents' AIS management knowledge.
The investigators will enroll 22 neurology residents and randomly assign them to two groups: the off-script diagnosis \& differential diagnosis (D\&D) training group (n=11) and a blank control group (n=11). The modified Acute Stroke Management Questionnaire (mASMaQ) will be used to assess residents' AIS knowledge 30 days after randomization.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Off-script D&D training group | Experimental | Other: Off-script diagnosis & differential diagnosis (D&D) trainingOff-script D\&D training is required within 72 hours after randomization. |
| No-Intervention Control Group | No intervention | –Off-script D\&D training is not required within 72 hours after randomization. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Residents (physicians in postgraduate training).
- Currently in neurology wards
- Managing acute ischemic stroke (AIS) patients, defined as: 1)Time from onset to randomization ≤ 2 weeks; 2) If onset time is unknown, the last known well time is considered the onset time.
- Signed informed consent
Key exclusion criteria (2 listed)
- Managing asymptomatic ischemic stroke patients.
- Residents who are currently participating or have participated in another interventional ischemic stroke training program within the past 3 months.
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 |
|---|---|---|
| Off-script diagnosis & differential diagnosis (D&D) training1. Training Timeline: Must be completed within 72 hours post-randomization; Requires standardized structured off-script D\&D analysis. 2. Structured Analysis Framework: 1)Epidemiology: Incidence, mortality, and disability rates; 2) Etiologic Classification: TOAST classification system; 3) Vascular Mechanisms: Culprit vessel, vascular territory, pathophysiology; 4) Differential Diagnosis: Stroke mimics and stroke subtype differentiation; 5) Acute Management: Hyperacute interventions (thrombolysis/EVT), secondary prevention strategies, and evidence-based case analysis; 6) Patient Education: Stroke prevention education for patients/public; 7) Research Gaps: Current limitations and future directions. 3. Presentation Requirements: 1)Mandatory off-script delivery (no prepared text); 2) Time limit: 15+3 minutes for complete analysis. | Other | Off-script D&D training group |
Primary outcome
mASMaQ
Time frame: 30 days
Modified Acute Stroke Management Questionnaire (mASMaQ), with a range of 33-165 scores. Higher scores indicate superior acute ischemic stroke management knowledge. Blinded Assessment Protocol:1) Participant Requirements: Strict 10-minute time limit for independent completion; External references are prohibited; 2) Assessment Supervision: certified neurologists as proctors, who are blinded to group assignment throughout the trial. 3) Centralized Adjudication: based on participants' questionnaire responses. Note: Details of the modified ASMaQ has been on file with the ethics committee and cannot be changed. To prevent disclosure of the measures and bias in resident measurement, we do not disclose the scales until the trial is completed. Details of mASMaQ will be made public with the publication of the article.
3 secondary outcomes
General stroke knowledge
Time frame: 30 days
Hyperacute stroke management
Time frame: 30 days
Advanced stroke management
Time frame: 30 days
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 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Jun Ni, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Off-script diagnosis & differential diagnosis (D&D) training in people with Stroke, Acute and Educational Problems, run by Peking Union Medical College Hospital at 1 site in China.
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 4 inclusion and 2 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 12 Aug 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 China. 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?
mASMaQ (time frame: 30 days). 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 12 Aug 2026.