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

20 september 2019 uppdaterad 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

221

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Virginia
      • Roanoke, Virginia, Förenta staterna, 24014
        • Institute for Orthopedics and Neurosciences

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Quality of Recovery 15 Score
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
PROMIS
Tidsram: 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
Tidsram: 7 days after surgery
number of narcotic pills used
7 days after surgery
daily pain level
Tidsram: 7 days after surgery
0-10 rating scale
7 days after surgery
patient-reported satisfaction and feeling of control - pain management
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 7 days after surgery
patient-reported
7 days after surgery
use of non-narcotic adjunct pain relief medication and modalities
Tidsram: 7 days after surgery
7 days after surgery
incidence of high risk activities - sedating medication polytherapy
Tidsram: 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
Tidsram: 7 days after surgery
combining prn NSAIDs with regularly dosed prescription NSAIDs
7 days after surgery
incidence of high risk activities - overdosing
Tidsram: 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
Tidsram: 7 days after surgery
Nausea/Vomiting
7 days after surgery
incidence of side effects and adverse events - Dizziness/balance problems
Tidsram: 7 days after surgery
Dizziness/balance problems
7 days after surgery
incidence of side effects and adverse events - fatigue or sedation
Tidsram: 7 days after surgery
fatigue or sedation
7 days after surgery
incidence of side effects and adverse events - headache
Tidsram: 7 days after surgery
headache
7 days after surgery
incidence of side effects and adverse events - visual changes
Tidsram: 7 days after surgery
visual changes
7 days after surgery
incidence of side effects and adverse events - stomach pain
Tidsram: 7 days after surgery
stomach pain
7 days after surgery
incidence of side effects and adverse events - constipation
Tidsram: 7 days after surgery
constipation
7 days after surgery
incidence of side effects and adverse events - diarrhea
Tidsram: 7 days after surgery
diarrhea
7 days after surgery
incidence of side effects and adverse events - fever
Tidsram: 7 days after surgery
fever
7 days after surgery
incidence of side effects and adverse events - rash
Tidsram: 7 days after surgery
rash
7 days after surgery
incidence of side effects and adverse events - hives
Tidsram: 7 days after surgery
hives
7 days after surgery
incidence of side effects and adverse events - swelling
Tidsram: 7 days after surgery
swelling
7 days after surgery
incidence of side effects and adverse events - difficulty breathing/shortness of breath
Tidsram: 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
Tidsram: 7 days after surgery
heart palpitations/arrythmia/heart racing
7 days after surgery
incidence of side effects and adverse events - anaphylaxis
Tidsram: 7 days after surgery
anaphylaxis
7 days after surgery
incidence of side effects and adverse events - ringing in ears
Tidsram: 7 days after surgery
ringing in ears
7 days after surgery
incidence of side effects and adverse events - other
Tidsram: 7 days after surgery
other
7 days after surgery
demonstrated patient knowledge
Tidsram: 7 days after surgery
as measured by score on the follow-up quiz
7 days after surgery
prevalence of chronic opioid use
Tidsram: 1 year after surgery
patient reported
1 year after surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Carilion Clinic

Utredare

  • Huvudutredare: Cassandra Mierisch, MD, Carilion Clinic

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 november 2017

Primärt slutförande (Faktisk)

29 november 2018

Avslutad studie (Förväntat)

12 juni 2020

Studieregistreringsdatum

Först inskickad

29 november 2017

Först inskickad som uppfyllde QC-kriterierna

7 december 2017

Första postat (Faktisk)

8 december 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 september 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 september 2019

Senast verifierad

1 september 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2266

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