O estudo NOTICE: estudo de avaliação de comunicação em neurocirurgia e ortopedia após fusões lombares (NOTICE)
The purpose of this single-blind, randomized, controlled study is to assess the efficacy of "informative text messages" vs "traditional handouts" provided to lumbar spine surgery patients post-operatively.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
A total of 224 adult patients (18 years or older) undergoing spinal fusion surgery at Duke University Hospital, will be recruited from the Duke Department of Neurosurgery and the Duke Department of Orthopedics. Participants will be consented and will complete standard of care outcomes questionnaires (Visual Analogue Scale, Oswestry Disability Index and Euro-Quol 5D) at the pre-operative clinic visit for baseline comparison. Participants will be randomized, through REDCap, with equal probability to either: A) the control group, with standard post-surgery handouts, or B) the experimental group, which will receive text messages for a period of 2 weeks after surgery (daily for the first week, and every other day for the second week). Text messages were designed to be standardized and automated, with an embedded link to a video regarding at-home, post-surgery-care instructions. Patients will be directed not to respond to the text messages, but to call for any questions or concerns. The primary outcome will be a reduction in 30-days post-surgery readmission rates. The secondary outcomes will be a reduction in 30-days post-surgery ED visits rates, back and leg pain scores, and anxiety levels. These outcomes will be assessed via a phone interview at 30-days (up to max of 37 days) post-discharge for both groups.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Claudia E Pamanes, MPH
- Número de telefone: (919) 668-0897
- E-mail: claudia.pamanes@duke.edu
Locais de estudo
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Recrutamento
- Duke Neurosurgery and Duke Orthopedics
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Contato:
- Claudia E Pamanes, MPH
- Número de telefone: (919) 668-0897
- E-mail: claudia.pamanes@duke.edu
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Contato:
- Beth Perry, RN, CCRP
- Número de telefone: (919) 681-2695
- E-mail: beth.perry@duke.edu
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Investigador principal:
- Oren N Gottfried, MD FAANS
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
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Primary lumbar fusion 1-4 levels
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18 years or older
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Degenerative spine diagnosis
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Answers YES to all the following screening questions:
- Do you own a mobile phone that is capable of sending and receiving text messages?
- Do you know how to text and feel comfortable texting?
- Are you a regular (at least once a day) text-message user?
- Are you agreeable to regular contact?
Exclusion Criteria:
- Prior lumbar fusions
- Tumors/infection/trauma
- Prisoners or institutionalized patients
- Non-English speaking patients
- Patients who smokes or with uncontrolled diabetes
- Participants will be removed from study if discharged to a rehabilitation center or discharged beyond 7 days post-operatively (we are expecting ~15% of patients to be discharged to a rehabilitation center or discharged beyond 7 days post-operatively)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: ARM 1: Text Message Group
The intervention group will receive automated text messages every day for the first week, and every other day for the second week post-operatively. The text messages will follow a series of pre-defined standardized scripts (Appendix 3) with embedded hyperlinks to a video from the providers with further advice. The patient is directed not to respond to the text messages, but to call for any questions or concerns. The text message group will receive a 30-day post-operative phone call to evaluate: number of ED visits, hospital readmissions, and to re-administer the questionnaires completed at baseline visit. Other data to be collected may include the following: number of phone calls to provider, MyChart messages to provider, pain medications, and new problems like pain and infection. |
The intervention group will receive automated text messages every day for the first week, and every other day for the second week post-operatively. The text messages will follow a series of pre-defined standardized scripts (Appendix 3) with embedded hyperlinks to a video from the providers with further advice. The patient is directed not to respond to the text messages, but to call for any questions or concerns. The text message group will receive a 30-day post-operative phone call to evaluate: number of ED visits, hospital readmissions, and to re-administer the questionnaires completed at baseline visit. Other data to be collected may include the following: number of phone calls to provider, MyChart messages to provider, pain medications, and new problems like pain and infection.
Outros nomes:
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Sem intervenção: ARM 2: Control group
The control group will be given the standard post-op packet that includes detailed instructions on proper wound care and signs and symptoms of infection. They will not receive text messages. The same outcomes will be assessed in both groups through a 30-day post-operative phone call. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in readmission rates within 30 days post-lumbar spine surgery.
Prazo: Baseline, 30 days
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Change in readmission rates within 30 days post-lumbar spine surgery as measured by questionnaire. |
Baseline, 30 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery.
Prazo: Baseline, 30 days
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Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery as measured by questionnaire. |
Baseline, 30 days
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Change in back and leg pain levels within 30 days post-lumbar spine surgery as measured by "Oswestry Disability Index" (ODI) questionnaire.
Prazo: Baseline, 30 days
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ODI questionnaire is a tool to evaluate a subjective level of functional disability in daily living activities in patients with low back pain. Scores go from 0% (no disability) to 100% (maximum disability possible). |
Baseline, 30 days
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Change in anxiety/depression levels within 30 days post-lumbar spine surgery as measured by "European Quality of Life-5 Dimension" (EQ-5D) questionnaire.
Prazo: Baseline, 30 days
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The EQ-5D is an instrument to quantify health-related quality of life. Scores can be reported as a five digit number in a range from 11111 (full health) to 55555 (worst health). |
Baseline, 30 days
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in patient satisfaction levels within 30 days post-lumbar spine surgery.
Prazo: Baseline, 30 days
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Change in patient satisfaction levels within 30 days post-lumbar spine surgery as measured by questionnaire. |
Baseline, 30 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Oren N Gottfried, MD FAANS, Duke Neurosurgery
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Pro00103904
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