NOTICE 研究: 腰椎固定後の脳神経外科および OrThpedIcs 通信評価研究 (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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Claudia E Pamanes, MPH
- 電話番号：(919) 668-0897
- メール：claudia.pamanes@duke.edu
研究場所
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North Carolina
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Durham、North Carolina、アメリカ、27710
- 募集
- Duke Neurosurgery and Duke Orthopedics
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コンタクト：
- Claudia E Pamanes, MPH
- 電話番号：(919) 668-0897
- メール：claudia.pamanes@duke.edu
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コンタクト：
- Beth Perry, RN, CCRP
- 電話番号：(919) 681-2695
- メール：beth.perry@duke.edu
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主任研究者：
- Oren N Gottfried, MD FAANS
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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介入なし：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in readmission rates within 30 days post-lumbar spine surgery.
時間枠：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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery.
時間枠：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.
時間枠：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.
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in patient satisfaction levels within 30 days post-lumbar spine surgery.
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Oren N Gottfried, MD FAANS、Duke Neurosurgery
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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