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Optional Follow-up Visits for Common, Low-risk Arm Fractures

6. april 2015 oppdatert av: David C. Ring, MD, Massachusetts General Hospital

Many common arm fractures have an excellent prognosis with little more than symptomatic treatment. When studying these fractures, investigators find that a substantial number of patients do not attend follow-up appointments. The difficulty of maneuvering in big cities, the cost of parking, the co-pay for the visit and the wait times for x-ray and doctor are all inconveniences that some patients might prefer to avoid. Building on prior research, it is appropriate to offer patients with common minor upper extremity fractures that have an excellent prognosis optional follow-up after the first visit. The plan would be to be available by phone, email and subsequent appointment at the patient's discretion if they felt that the recovery was off course. Benefit to individual participants is unlikely. The study will benefit the society as a whole, by providing a better understanding of these common fractures. It can also affect the economics of our health system by avoiding further follow-up appointments.

Primary null hypothesis: There is no difference in patient outcome 2-6 months after injury between patients that return for a second visit, and patients that do not.

Secondary null hypothesis: There is no difference in patient satisfaction 2-6 months after injury between patients that return for a second visit, and patients that do not.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

This study will employ a prospective, non-randomized design. After the questionnaires are filled the patients choose whether or not to schedule a second appointment for evaluation of their fracture: The first group will be scheduled for a second visit (standard treatment). The alternative (Optional follow-up) will be to take a handout describing the recovery and providing instructions for how to contact us should they get off course.

Since it is up to the subject to decide whether or not he or she wants a second appointment or the brochure, it is observational rather than interventional.

Evaluation: 2-6 months after injury all patients (independent of group) will be contacted by either phone or email by a blinded research assistant and asked to provide the following: pain with NRS (scale 0-10); three satisfaction questions; disability with use of Quick DASH; and if they returned to modified and regular work.

Patients in the standard group A will return to the Hand and Upper Extremity Service for their usual practice follow-up examination 1-3 months after treatment.

Studietype

Observasjonsmessig

Registrering (Faktiske)

120

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Hand Service, Department of Orthopaedic Surgery, Massachusetts General Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

All adult, English-speaking patients presenting to our outpatient clinic, that meet the inclusion criteria for this study will be invited to enroll at the time of the first visit at the outpatient clinic.

Beskrivelse

Inclusion Criteria:

  • adult (>18 years)
  • English-speaking
  • fracture with an excellent prognosis such as:
  • nondisplaced mallet fracture
  • stable, well-aligned metacarpal fracture
  • all small finger metacarpal neck fractures
  • non- or minimally displaced distal radius fracture treated in a removable splint
  • isolated minimally displaced radial head fracture involving the radial neck or part of the articular surface

Exclusion Criteria:

  • pregnant women
  • no written informed consent

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Standard treatment
This study will employ a prospective, non-randomized design. After the questionnaires are filled the patients choose whether or not to schedule a second appointment for evaluation of their fracture: The first group will be scheduled for a second visit (standard treatment) as our daily practice after 1-3 months. They will be contacted after 2-6 months either by phone or email and will complete again some questionnaires (Quick DASH, satisfaction, return to work).
Optional follow-up group
The alternative (Optional follow-up group) will be to take a handout describing the recovery and providing instructions for how to contact us should they get off course. The questionnaires will be repeated either by phone or email in 2-6 months.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Disability with use of Quick DASH
Tidsramme: Change from baseline at enrollment to follow-up at 2-6 months

The Disabilities of Arm Shoulder and Hand (DASH) questionnaire is used frequently in hand and upper extremity research to assess disability. The Quick DASH is the short version of the DASH consisting of 11 questions.

http://www.dash.iwh.on.ca/system/files/quickdash_questionnaire_2010.pdf
Change from baseline at enrollment to follow-up at 2-6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Satisfaction
Tidsramme: Change from baseline at enrollment to follow-up at 2-6 months
The investigators measure the overall current patient satisfaction with an ordinal scale from 0 to 10, 0 being completely dissatisfied, 10 being completely satisfied.
Change from baseline at enrollment to follow-up at 2-6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Massachusetts General Hospital

Etterforskere

  • Hovedetterforsker: David Ring, MD, Massachusetts General Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2012

Primær fullføring (Faktiske)

1. januar 2015

Studiet fullført (Faktiske)

1. januar 2015

Datoer for studieregistrering

Først innsendt

27. mars 2012

Først innsendt som oppfylte QC-kriteriene

20. april 2012

Først lagt ut (Anslag)

24. april 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

7. april 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. april 2015

Sist bekreftet

1. april 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2012P000632

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