- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07914998
Visual Symptom Simulator (Vis_Sym_Sim)
A Web-based Visual Symptom Simulator as an Adjunct to Neuro-ophthalmologic Evaluation
Some patients presenting with visual symptoms may have difficulty accurately describing their visual experiences. Symptoms such as blurred vision, diplopia, visual field deficits, and transient visual disturbances are subjective and can be challenging to communicate using words alone. This can create communication barriers and contribute to variability in symptom interpretation, with potential implications for reduced patient satisfaction and uncertainty in clinical evaluation, especially among medical trainees.
This prospective, survey-based feasibility and usability study will have the primary objective of evaluating whether a visual symptom simulator (VSS) improves communication of visual symptoms during neuro-ophthalmology assessment compared with standard history-taking alone, and whether it can be feasibly integrated into routine clinical practice as an adjunct to standard history-taking.
Secondary objectives include: 1) assessing whether the use of a visual simulator improves the clarity of patient-reported visual symptoms and reduces ambiguity during clinical assessment; and 2) exploring its potential role in improving trainees' (medical students, residents, fellows) understanding and interpretation of subjective visual symptoms in neuro-ophthalmology.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Research design and methods In collaboration with BCIT, a web-based VSS platform will be developed, with the goal of presenting interactive visual symptom scenarios designed to simulate patient-reported visual experiences.
Participants will include patients 18 years or older who are referred to the Ophthalmology Clinic at St Paul's Hospital (SPH) and Vancouver General Hospital (VGH) Eye Care Center for assessment of one of the following visual complaints: transient visual loss, diplopia, or blurry vision. We will also recruit medical trainees rotating through neuro-ophthalmology services. A control group (standard of care) will be recruited first and will undergo standard clinical interview and neuro-ophthalmological assessment without the VSS. Following finalization of the VSS, patients will be recruited into the VSS intervention group.
Methods of analysis, instruments, and tools The VSS will be the primary intervention tool in the intervention group and will be delivered via a web-based platform. The control group will undergo the standard neuro-ophthalmological examination alone.
Data will be collected using post-clinical and post-intervention surveys completed by both patients and trainees. Surveys primarily consist of Likert-scale items assessing patient satisfaction, as well as trainees' perceived understanding of patient symptoms and confidence in clinical reasoning. A short section at the end of the questionnaires will be available to patients and trainees for qualitative feedback.
Quantitative data will be analyzed using descriptive statistics to compare outcomes between control and intervention groups. Where applicable, subgroup analyses may be performed based on level of training (trainees).
Qualitative data from open-ended survey responses will be reviewed and analyzed for recurring themes.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 18 years or older
- Referred for neuro-ophthalmology evaluation with assessment of one of the following visual complaints: transient visual loss, diplopia, or blurry vision.
Exclusion Criteria:
- Younger than 18 years
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Control
Standard of care |
|
|
Aktiv komparator: Intervention
Use of simulator |
Development of an online visual simulator, to allow accurate representation of visual symptoms |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient survey scores
Tidsram: Immediately, at the completion of the patient first clinical assessment
|
Outcome survey will include rating scales of: Overall participant experience, Participant perception of physician understanding, Participant ability to communicate symptoms, Perceived influence on treatment/follow-up/care |
Immediately, at the completion of the patient first clinical assessment
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Trainee survey
Tidsram: Immediately, at the completion of the patient consultation
|
Outcomes include survey ranking of: Overall Educational Value and Trainee rating of VSS educational usefulness |
Immediately, at the completion of the patient consultation
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- H26-01712
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