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Идёт набор NCT04140344

The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions

Без фазы С лечением Lumbar Spine Degeneration Lumbar Spine Instability Lumbar Spondylosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Text Message Group.
Кому может быть актуально
Состояния в реестре: Lumbar Spine Degeneration, Lumbar Spine Instability, Lumbar Spondylosis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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:

Первичные конечные точки

  • Change in readmission rates within 30 days post-lumbar spine surgery. [Срок оценки: Baseline, 30 days]
Вторичные конечные точки (3)
  • Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery. [Срок оценки: Baseline, 30 days]
  • Change in back and leg pain levels within 30 days post-lumbar spine surgery as measured by "Oswestry Disability Index" (ODI) questionnaire. [Срок оценки: Baseline, 30 days]
  • Change in anxiety/depression levels within 30 days post-lumbar spine surgery as measured by "European Quality of Life-5 Dimension" (EQ-5D) questionnaire. [Срок оценки: Baseline, 30 days]

Критерии участия

Критерии включения

  • Primary lumbar fusion 1-4 levels
  • 18 years or older
  • Degenerative spine diagnosis
  • 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?

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Duke Neurosurgery and Duke Orthopedics — Durham

Идентификаторы

NCT: NCT04140344 · Pro00103904

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗