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

20. september 2019 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

221

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Virginia
      • Roanoke, Virginia, Forenede Stater, 24014
        • Institute for Orthopedics and Neurosciences

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:

  • 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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Wound Care Video
Wound Care Patient Education Video
Adfærdsmæssigt: Wound Care Patient Education Video
Patient education video that were created in-house specifically for this project.
Eksperimentel: Pain Management Video Group
Pain Management Patient Education Video
Adfærdsmæssigt: Pain Management Patient Education Video
Patient education video that were created in-house specifically for this project.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Carilion Clinic

Efterforskere

  • Ledende efterforsker: Cassandra Mierisch, MD, Carilion Clinic

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 (Faktiske)

30. november 2017

Primær færdiggørelse (Faktiske)

29. november 2018

Studieafslutning (Forventet)

12. juni 2020

Datoer for studieregistrering

Først indsendt

29. november 2017

Først indsendt, der opfyldte QC-kriterier

7. december 2017

Først opslået (Faktiske)

8. december 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. september 2019

Sidst verificeret

1. september 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2266

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