A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery
20 septembre 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
221
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Virginia
-
Roanoke, Virginia, États-Unis, 24014
- Institute for Orthopedics and Neurosciences
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Adult patients planning elective outpatient orthopedic surgery procedures by a Carilion Clinic hand surgeon will be eligible for the study.
Exclusion Criteria:
- Patients unable or unwilling to provide informed consent
- Patients unable to unwilling to participate in the trial (poor English language skills, blindness, cognitively disadvantaged, poor literacy skills, other barriers to participation)
- Patients who are or suspect they may be pregnant.
- Patients for whom the medical provider, in his professional judgment, does not feel that the study protocol would be appropriate. (to be tracked)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Wound Care Video
Wound Care Patient Education Video
|
Patient education video that were created in-house specifically for this project.
|
|
Expérimental: Pain Management Video Group
Pain Management Patient Education Video
|
Patient education video that were created in-house specifically for this project.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Quality of Recovery 15 Score
Délai: 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
|
2 days after surgery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
PROMIS
Délai: 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
Délai: 7 days after surgery
|
number of narcotic pills used
|
7 days after surgery
|
|
daily pain level
Délai: 7 days after surgery
|
0-10 rating scale
|
7 days after surgery
|
|
patient-reported satisfaction and feeling of control - pain management
Délai: 7 days after surgery
|
Today, I feel in control of my pain management.
|
7 days after surgery
|
|
patient-reported satisfaction and feeling of control- wound care
Délai: 7 days after surgery
|
Today, I feel in confident about how I am caring for my wound.
|
7 days after surgery
|
|
patient-reported satisfaction and feeling of control - pain management satisfaction
Délai: 7 days after surgery
|
Today, I would rate my satisfaction with my pain control as (circle)
|
7 days after surgery
|
|
number of pain-related calls/visits to a healthcare provider
Délai: 7 days after surgery
|
patient-reported
|
7 days after surgery
|
|
use of non-narcotic adjunct pain relief medication and modalities
Délai: 7 days after surgery
|
7 days after surgery
|
|
|
incidence of high risk activities - sedating medication polytherapy
Délai: 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
Délai: 7 days after surgery
|
combining prn NSAIDs with regularly dosed prescription NSAIDs
|
7 days after surgery
|
|
incidence of high risk activities - overdosing
Délai: 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
Délai: 7 days after surgery
|
Nausea/Vomiting
|
7 days after surgery
|
|
incidence of side effects and adverse events - Dizziness/balance problems
Délai: 7 days after surgery
|
Dizziness/balance problems
|
7 days after surgery
|
|
incidence of side effects and adverse events - fatigue or sedation
Délai: 7 days after surgery
|
fatigue or sedation
|
7 days after surgery
|
|
incidence of side effects and adverse events - headache
Délai: 7 days after surgery
|
headache
|
7 days after surgery
|
|
incidence of side effects and adverse events - visual changes
Délai: 7 days after surgery
|
visual changes
|
7 days after surgery
|
|
incidence of side effects and adverse events - stomach pain
Délai: 7 days after surgery
|
stomach pain
|
7 days after surgery
|
|
incidence of side effects and adverse events - constipation
Délai: 7 days after surgery
|
constipation
|
7 days after surgery
|
|
incidence of side effects and adverse events - diarrhea
Délai: 7 days after surgery
|
diarrhea
|
7 days after surgery
|
|
incidence of side effects and adverse events - fever
Délai: 7 days after surgery
|
fever
|
7 days after surgery
|
|
incidence of side effects and adverse events - rash
Délai: 7 days after surgery
|
rash
|
7 days after surgery
|
|
incidence of side effects and adverse events - hives
Délai: 7 days after surgery
|
hives
|
7 days after surgery
|
|
incidence of side effects and adverse events - swelling
Délai: 7 days after surgery
|
swelling
|
7 days after surgery
|
|
incidence of side effects and adverse events - difficulty breathing/shortness of breath
Délai: 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
Délai: 7 days after surgery
|
heart palpitations/arrythmia/heart racing
|
7 days after surgery
|
|
incidence of side effects and adverse events - anaphylaxis
Délai: 7 days after surgery
|
anaphylaxis
|
7 days after surgery
|
|
incidence of side effects and adverse events - ringing in ears
Délai: 7 days after surgery
|
ringing in ears
|
7 days after surgery
|
|
incidence of side effects and adverse events - other
Délai: 7 days after surgery
|
other
|
7 days after surgery
|
|
demonstrated patient knowledge
Délai: 7 days after surgery
|
as measured by score on the follow-up quiz
|
7 days after surgery
|
|
prevalence of chronic opioid use
Délai: 1 year after surgery
|
patient reported
|
1 year after surgery
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Cassandra Mierisch, MD, Carilion Clinic
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
30 novembre 2017
Achèvement primaire (Réel)
29 novembre 2018
Achèvement de l'étude (Anticipé)
12 juin 2020
Dates d'inscription aux études
Première soumission
29 novembre 2017
Première soumission répondant aux critères de contrôle qualité
7 décembre 2017
Première publication (Réel)
8 décembre 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
23 septembre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 septembre 2019
Dernière vérification
1 septembre 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2266
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .