- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02204605
Video-based Consensus Opinion for Hand and Upper Extremity Problems
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: Control
Visits are not videotaped
|
|
Experimentell: Videoed Patients
Patients will have their visit videotaped.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Likert Scale for Satisfaction
Tidsram: At enrollment
|
At enrollment
|
Likert Scale for Satisfaction
Tidsram: 4-6 weeks
|
4-6 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Patient Self-Efficacy Questionnaire (PSEQ-2)
Tidsram: At enrollment
|
At enrollment
|
Patient Self-Efficacy Questionnaire (PSEQ-2)
Tidsram: 4-6 weeks
|
4-6 weeks
|
Patient Health Questionnaire (PHQ-2)
Tidsram: at enrollment
|
at enrollment
|
Patient Health Questionnaire (PHQ-2)
Tidsram: 4-6 weeks
|
4-6 weeks
|
QuickDASH (Disabilities of the Arm, Shoulder, and Hand)
Tidsram: At enrollment
|
At enrollment
|
QuickDASH (Disabilities of the Arm, Shoulder, and Hand)
Tidsram: 4-6 weeks
|
4-6 weeks
|
Numerical Rating Scale for Pain
Tidsram: at enrollment
|
at enrollment
|
Numerical Rating Scale for Pain
Tidsram: 4-6 weeks
|
4-6 weeks
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 2014P000132
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