- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02204605
Video-based Consensus Opinion for Hand and Upper Extremity Problems
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Control
Visits are not videotaped
|
|
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Eksperimentel: Videoed Patients
Patients will have their visit videotaped.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Likert Scale for Satisfaction
Tidsramme: At enrollment
|
At enrollment
|
|
Likert Scale for Satisfaction
Tidsramme: 4-6 weeks
|
4-6 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Patient Self-Efficacy Questionnaire (PSEQ-2)
Tidsramme: At enrollment
|
At enrollment
|
|
Patient Self-Efficacy Questionnaire (PSEQ-2)
Tidsramme: 4-6 weeks
|
4-6 weeks
|
|
Patient Health Questionnaire (PHQ-2)
Tidsramme: at enrollment
|
at enrollment
|
|
Patient Health Questionnaire (PHQ-2)
Tidsramme: 4-6 weeks
|
4-6 weeks
|
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QuickDASH (Disabilities of the Arm, Shoulder, and Hand)
Tidsramme: At enrollment
|
At enrollment
|
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QuickDASH (Disabilities of the Arm, Shoulder, and Hand)
Tidsramme: 4-6 weeks
|
4-6 weeks
|
|
Numerical Rating Scale for Pain
Tidsramme: at enrollment
|
at enrollment
|
|
Numerical Rating Scale for Pain
Tidsramme: 4-6 weeks
|
4-6 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2014P000132
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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