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

20 settembre 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

221

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Virginia
      • Roanoke, Virginia, Stati Uniti, 24014
        • Institute for Orthopedics and Neurosciences

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Wound Care Video
Wound Care Patient Education Video
Comportamentale: Wound Care Patient Education Video
Patient education video that were created in-house specifically for this project.
Sperimentale: Pain Management Video Group
Pain Management Patient Education Video
Comportamentale: Pain Management Patient Education Video
Patient education video that were created in-house specifically for this project.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of Recovery 15 Score
Lasso di tempo: 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

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Carilion Clinic

Investigatori

  • Investigatore principale: Cassandra Mierisch, MD, Carilion Clinic

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 novembre 2017

Completamento primario (Effettivo)

29 novembre 2018

Completamento dello studio (Anticipato)

12 giugno 2020

Date di iscrizione allo studio

Primo inviato

29 novembre 2017

Primo inviato che soddisfa i criteri di controllo qualità

7 dicembre 2017

Primo Inserito (Effettivo)

8 dicembre 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 settembre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 settembre 2019

Ultimo verificato

1 settembre 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2266

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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