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

20. September 2019 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

221

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Virginia
      • Roanoke, Virginia, Vereinigte Staaten, 24014
        • Institute for Orthopedics and Neurosciences

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Wound Care Video
Wound Care Patient Education Video
Verhalten: Wound Care Patient Education Video
Patient education video that were created in-house specifically for this project.
Experimental: Pain Management Video Group
Pain Management Patient Education Video
Verhalten: Pain Management Patient Education Video
Patient education video that were created in-house specifically for this project.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Quality of Recovery 15 Score
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Carilion Clinic

Ermittler

  • Hauptermittler: Cassandra Mierisch, MD, Carilion Clinic

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

30. November 2017

Primärer Abschluss (Tatsächlich)

29. November 2018

Studienabschluss (Voraussichtlich)

12. Juni 2020

Studienanmeldedaten

Zuerst eingereicht

29. November 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Dezember 2017

Zuerst gepostet (Tatsächlich)

8. Dezember 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. September 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. September 2019

Zuletzt verifiziert

1. September 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2266

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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