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A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery

20. september 2019 oppdatert av: Cassandra Mierisch, Carilion Clinic

A Standardized Patient Education Video Program for Improvement of Post-Operative Recovery After Outpatient Upper Extremity Surgery

Adult patients undergoing elective outpatient, upper extremity, orthopedic surgeries will be randomized to view one of two educational programs: 1) a 2-video series regarding post-operative pain management or 2) a video regarding wound care and activity. The effect of this educational program on pain medications used, pain control efficacy, and other measures of satisfaction and recovery will be assessed.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Four hundred (400) adult patients undergoing elective outpatient, upper extremity, orthopedic surgeries will be recruited by the surgeon-investigators. Patients will be randomized to view one of two educational programs: 1) a 2-video series regarding post-operative pain management or 2) a video regarding wound care and activity.

These patients will be encouraged to review the video online in the week before surgery. An intake enrollment form will be completed by an investigator using demographic information available in the chart.

Participants in both arms will complete their Patient Education Study Diary daily, for 7 days following their surgery. There are two versions of this diary: the Wound Education Version asks patients to report daily pain mediation use. The Pain Education Version does not include this section as patients in the pain management arm of the study record this information in their Recovery Diary.

The patient will be contacted again by phone and/or mail 1 year after surgery (12-14 months) using the contact information available in EPIC to determine the self-reported prevalence of chronic pain and pain medication use.

Studietype

Intervensjonell

Registrering (Faktiske)

221

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Virginia
      • Roanoke, Virginia, Forente stater, 24014
        • Institute for Orthopedics and Neurosciences

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

Beskrivelse

Inclusion Criteria:

  • Adult patients planning elective outpatient orthopedic surgery procedures by a Carilion Clinic hand surgeon will be eligible for the study.

Exclusion Criteria:

  1. Patients unable or unwilling to provide informed consent
  2. Patients unable to unwilling to participate in the trial (poor English language skills, blindness, cognitively disadvantaged, poor literacy skills, other barriers to participation)
  3. Patients who are or suspect they may be pregnant.
  4. Patients for whom the medical provider, in his professional judgment, does not feel that the study protocol would be appropriate. (to be tracked)

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Wound Care Video
Wound Care Patient Education Video
Atferdsmessig: Wound Care Patient Education Video
Patient education video that were created in-house specifically for this project.
Eksperimentell: Pain Management Video Group
Pain Management Patient Education Video
Atferdsmessig: Pain Management Patient Education Video
Patient education video that were created in-house specifically for this project.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quality of Recovery 15 Score
Tidsramme: 2 days after surgery

Score on the standardized Quality of Recovery 15 questionnaire How have you been feeling in the last 24 hours? (0 to 10, where 0= none of the time [poor] and 10=all of the time [excellent]) 0 1 2 3 4 5 6 7 8 9 10

  1. Able to breath easily
  2. Been able to enjoy food
  3. Feeling rested
  4. Have had a good sleep
  5. Able to look after personal toilet and hygiene unaided
  6. Able to communicate with family or friends
  7. Getting support from hospital doctors and nurses
  8. Able to return to work or usual home activities
  9. Feeling comfortable and in control

  10. Having a feeling of general well-being

    Have you had any of the following in the last 24 hours? (10 to 0, where: 10=none of the time [excellent] and 0=all of the time [poor]) 10 9 8 7 6 5 4 3 2 1 0

  11. Moderate pain
  12. severe pain
  13. Nausea or vomiting
  14. Feeling worried or anxious
  15. Feeling sad or depressed
2 days after surgery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
PROMIS
Tidsramme: 3 days after surgery
PROMIS short forms administered on POD 3 - (GI belly pain 5a, GI nausea and vomiting 4a, Pain Intensity 3a, Pain Interference 4a, Sleep Disturbance 4a, Cognitive Function 4a)
3 days after surgery
number of narcotic pills used
Tidsramme: 7 days after surgery
number of narcotic pills used
7 days after surgery
daily pain level
Tidsramme: 7 days after surgery
0-10 rating scale
7 days after surgery
patient-reported satisfaction and feeling of control - pain management
Tidsramme: 7 days after surgery

Today, I feel in control of my pain management.

  1. Strongly agree
  2. Agree
  3. Neither agree nor disagree
  4. Disagree
  5. Strongly disagree
7 days after surgery
patient-reported satisfaction and feeling of control- wound care
Tidsramme: 7 days after surgery

Today, I feel in confident about how I am caring for my wound.

  1. Strongly agree
  2. Agree
  3. Neither agree nor disagree
  4. Disagree
  5. Strongly disagree
7 days after surgery
patient-reported satisfaction and feeling of control - pain management satisfaction
Tidsramme: 7 days after surgery

Today, I would rate my satisfaction with my pain control as (circle)

  1. Very satisfied
  2. Somewhat satisfied
  3. Neutral
  4. Somewhat dissatisfied
  5. Very dissatisfied
7 days after surgery
number of pain-related calls/visits to a healthcare provider
Tidsramme: 7 days after surgery
patient-reported
7 days after surgery
use of non-narcotic adjunct pain relief medication and modalities
Tidsramme: 7 days after surgery
7 days after surgery
incidence of high risk activities - sedating medication polytherapy
Tidsramme: 7 days after surgery
combining narcotics with muscle relaxants/sedatives/alcohol, other sedating medications
7 days after surgery
incidence of high risk activities - NSAID polytherapy
Tidsramme: 7 days after surgery
combining prn NSAIDs with regularly dosed prescription NSAIDs
7 days after surgery
incidence of high risk activities - overdosing
Tidsramme: 7 days after surgery
exceeding daily recommended doses of pain medication
7 days after surgery
incidence of side effects and adverse events - Nausea/V omitting
Tidsramme: 7 days after surgery
Nausea/Vomiting
7 days after surgery
incidence of side effects and adverse events - Dizziness/balance problems
Tidsramme: 7 days after surgery
Dizziness/balance problems
7 days after surgery
incidence of side effects and adverse events - fatigue or sedation
Tidsramme: 7 days after surgery
fatigue or sedation
7 days after surgery
incidence of side effects and adverse events - headache
Tidsramme: 7 days after surgery
headache
7 days after surgery
incidence of side effects and adverse events - visual changes
Tidsramme: 7 days after surgery
visual changes
7 days after surgery
incidence of side effects and adverse events - stomach pain
Tidsramme: 7 days after surgery
stomach pain
7 days after surgery
incidence of side effects and adverse events - constipation
Tidsramme: 7 days after surgery
constipation
7 days after surgery
incidence of side effects and adverse events - diarrhea
Tidsramme: 7 days after surgery
diarrhea
7 days after surgery
incidence of side effects and adverse events - fever
Tidsramme: 7 days after surgery
fever
7 days after surgery
incidence of side effects and adverse events - rash
Tidsramme: 7 days after surgery
rash
7 days after surgery
incidence of side effects and adverse events - hives
Tidsramme: 7 days after surgery
hives
7 days after surgery
incidence of side effects and adverse events - swelling
Tidsramme: 7 days after surgery
swelling
7 days after surgery
incidence of side effects and adverse events - difficulty breathing/shortness of breath
Tidsramme: 7 days after surgery
difficulty breathing/shortness of breath
7 days after surgery
incidence of side effects and adverse events - heart palpitations/arrythmia/heart racing
Tidsramme: 7 days after surgery
heart palpitations/arrythmia/heart racing
7 days after surgery
incidence of side effects and adverse events - anaphylaxis
Tidsramme: 7 days after surgery
anaphylaxis
7 days after surgery
incidence of side effects and adverse events - ringing in ears
Tidsramme: 7 days after surgery
ringing in ears
7 days after surgery
incidence of side effects and adverse events - other
Tidsramme: 7 days after surgery
other
7 days after surgery
demonstrated patient knowledge
Tidsramme: 7 days after surgery
as measured by score on the follow-up quiz
7 days after surgery
prevalence of chronic opioid use
Tidsramme: 1 year after surgery
patient reported
1 year after surgery

Samarbeidspartnere og etterforskere

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

Sponsor

Carilion Clinic

Etterforskere

  • Hovedetterforsker: Cassandra Mierisch, MD, Carilion Clinic

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 (Faktiske)

30. november 2017

Primær fullføring (Faktiske)

29. november 2018

Studiet fullført (Forventet)

12. juni 2020

Datoer for studieregistrering

Først innsendt

29. november 2017

Først innsendt som oppfylte QC-kriteriene

7. desember 2017

Først lagt ut (Faktiske)

8. desember 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. september 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. september 2019

Sist bekreftet

1. september 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2266

Plan for individuelle deltakerdata (IPD)

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Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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