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Video-based Consensus Opinion for Hand and Upper Extremity Problems

20. december 2016 opdateret af: David C. Ring, MD, Massachusetts General Hospital
The investigators would like to determine if there is a difference in patient satisfaction among patients who have puzzling pain conditions and receive one evaluation from their treating physician, and those that receive an evaluation from their treating physician and from a group of consulting physicians by video. The investigators expect to enroll 128 patients at Massachusetts General Hospital.

Studieoversigt

Status

Trukket tilbage

Betingelser

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:

  1. 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:

  2. 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.
  3. There is no variation in diagnosis between observers (Observers are hand surgeons viewing the visit video and consulting on the diagnosis).

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
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
QuickDASH (Disabilities of the Arm, Shoulder, and Hand)
Tidsramme: At enrollment
At enrollment
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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2014

Primær færdiggørelse (Faktiske)

1. januar 2016

Studieafslutning (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først indsendt

29. juli 2014

Først indsendt, der opfyldte QC-kriterier

29. juli 2014

Først opslået (Skøn)

30. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

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 .

Kliniske forsøg med Smerte

Kliniske forsøg med Video-based Consensus Opinion

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