- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02204605
Video-based Consensus Opinion for Hand and Upper Extremity Problems
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Before visiting a specialist, patients have assumptions regarding diagnosis, etiology, prognosis, and preferred treatment for their condition. Naturally, some of these assumptions may be inaccurate or incomplete or there may be room for debate and disagreement even among specialists. We are looking for ways to make unexpected and indeterminate aspects of an illness less unsettling for patients. When the hand surgeon's advice doesn't ring true, the patient may lose confidence in that provider. Sometimes the interaction can feel disrespectful and even adversarial. We are curious whether patient's satisfaction with diagnosis, surgeon, and treatment plan would improve if they were able to get an opinion from many surgeons at once. One feasible way to do that would be to show an edited and anonymized video to a set of hand surgeons for their opinions on diagnosis and treatment.
Primary study question:
Among patients with initially puzzling pains, there is no difference in satisfaction with diagnosis between patients that receive a video based consensus opinion and those that receive routine care from a single hand surgeon controlling for psychological factors, demographics, and initial and final diagnosis.
Secondary study questions:
- Among patients with initially puzzling pains, there is no difference in pain intensity and disability one month after the initial visit between patient that receive a consensus diagnosis and those that receive routine care from a single surgeon.
- There is no variation in diagnosis between observers (Observers are hand surgeons viewing the visit video and consulting on the diagnosis).
Type d'étude
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- All patients (>18 years) presenting to Dr. David Ring with painful conditions that are puzzling (A puzzling pain condition is defined as Dr. Ring being puzzled about what is causing the pain. Subject eligibility based on this criterion will be determined by Dr. Ring).
- English fluency and literacy
- Able to provide informed consent
Exclusion Criteria:
- Pregnant Women
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Control
Visits are not videotaped
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|
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Expérimental: Videoed Patients
Patients will have their visit videotaped.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Likert Scale for Satisfaction
Délai: At enrollment
|
At enrollment
|
|
Likert Scale for Satisfaction
Délai: 4-6 weeks
|
4-6 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Patient Self-Efficacy Questionnaire (PSEQ-2)
Délai: At enrollment
|
At enrollment
|
|
Patient Self-Efficacy Questionnaire (PSEQ-2)
Délai: 4-6 weeks
|
4-6 weeks
|
|
Patient Health Questionnaire (PHQ-2)
Délai: at enrollment
|
at enrollment
|
|
Patient Health Questionnaire (PHQ-2)
Délai: 4-6 weeks
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4-6 weeks
|
|
QuickDASH (Disabilities of the Arm, Shoulder, and Hand)
Délai: At enrollment
|
At enrollment
|
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QuickDASH (Disabilities of the Arm, Shoulder, and Hand)
Délai: 4-6 weeks
|
4-6 weeks
|
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Numerical Rating Scale for Pain
Délai: at enrollment
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at enrollment
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Numerical Rating Scale for Pain
Délai: 4-6 weeks
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4-6 weeks
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2014P000132
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