A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery
20 de setembro de 2019 atualizado por: 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.
Visão geral do estudo
Status
Desconhecido
Condições
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Real)
221
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Virginia
-
Roanoke, Virginia, Estados Unidos, 24014
- Institute for Orthopedics and Neurosciences
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Wound Care Video
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
|
Patient education video that were created in-house specifically for this project.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quality of Recovery 15 Score
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
PROMIS
Prazo: 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
Prazo: 7 days after surgery
|
number of narcotic pills used
|
7 days after surgery
|
|
daily pain level
Prazo: 7 days after surgery
|
0-10 rating scale
|
7 days after surgery
|
|
patient-reported satisfaction and feeling of control - pain management
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 7 days after surgery
|
patient-reported
|
7 days after surgery
|
|
use of non-narcotic adjunct pain relief medication and modalities
Prazo: 7 days after surgery
|
7 days after surgery
|
|
|
incidence of high risk activities - sedating medication polytherapy
Prazo: 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
Prazo: 7 days after surgery
|
combining prn NSAIDs with regularly dosed prescription NSAIDs
|
7 days after surgery
|
|
incidence of high risk activities - overdosing
Prazo: 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
Prazo: 7 days after surgery
|
Nausea/Vomiting
|
7 days after surgery
|
|
incidence of side effects and adverse events - Dizziness/balance problems
Prazo: 7 days after surgery
|
Dizziness/balance problems
|
7 days after surgery
|
|
incidence of side effects and adverse events - fatigue or sedation
Prazo: 7 days after surgery
|
fatigue or sedation
|
7 days after surgery
|
|
incidence of side effects and adverse events - headache
Prazo: 7 days after surgery
|
headache
|
7 days after surgery
|
|
incidence of side effects and adverse events - visual changes
Prazo: 7 days after surgery
|
visual changes
|
7 days after surgery
|
|
incidence of side effects and adverse events - stomach pain
Prazo: 7 days after surgery
|
stomach pain
|
7 days after surgery
|
|
incidence of side effects and adverse events - constipation
Prazo: 7 days after surgery
|
constipation
|
7 days after surgery
|
|
incidence of side effects and adverse events - diarrhea
Prazo: 7 days after surgery
|
diarrhea
|
7 days after surgery
|
|
incidence of side effects and adverse events - fever
Prazo: 7 days after surgery
|
fever
|
7 days after surgery
|
|
incidence of side effects and adverse events - rash
Prazo: 7 days after surgery
|
rash
|
7 days after surgery
|
|
incidence of side effects and adverse events - hives
Prazo: 7 days after surgery
|
hives
|
7 days after surgery
|
|
incidence of side effects and adverse events - swelling
Prazo: 7 days after surgery
|
swelling
|
7 days after surgery
|
|
incidence of side effects and adverse events - difficulty breathing/shortness of breath
Prazo: 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
Prazo: 7 days after surgery
|
heart palpitations/arrythmia/heart racing
|
7 days after surgery
|
|
incidence of side effects and adverse events - anaphylaxis
Prazo: 7 days after surgery
|
anaphylaxis
|
7 days after surgery
|
|
incidence of side effects and adverse events - ringing in ears
Prazo: 7 days after surgery
|
ringing in ears
|
7 days after surgery
|
|
incidence of side effects and adverse events - other
Prazo: 7 days after surgery
|
other
|
7 days after surgery
|
|
demonstrated patient knowledge
Prazo: 7 days after surgery
|
as measured by score on the follow-up quiz
|
7 days after surgery
|
|
prevalence of chronic opioid use
Prazo: 1 year after surgery
|
patient reported
|
1 year after surgery
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Cassandra Mierisch, MD, Carilion Clinic
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
30 de novembro de 2017
Conclusão Primária (Real)
29 de novembro de 2018
Conclusão do estudo (Antecipado)
12 de junho de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
29 de novembro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de dezembro de 2017
Primeira postagem (Real)
8 de dezembro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
23 de setembro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de setembro de 2019
Última verificação
1 de setembro de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2266
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Não
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .