A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery
A Standardized Patient Education Video Program for Improvement of Post-Operative Recovery After Outpatient Upper Extremity Surgery
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Virginia
-
Roanoke、Virginia、アメリカ、24014
- Institute for Orthopedics and Neurosciences
-
-
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:
- 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)
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：支持療法
- 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 |
|---|---|
|
アクティブコンパレータ：Wound Care Video
Wound Care Patient Education Video
|
Patient education video that were created in-house specifically for this project.
|
|
実験的：Pain Management Video Group
Pain Management Patient Education Video
|
Patient education video that were created in-house specifically for this project.
|
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 |
|---|---|---|
|
Quality of Recovery 15 Score
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PROMIS
時間枠：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
時間枠：7 days after surgery
|
number of narcotic pills used
|
7 days after surgery
|
|
daily pain level
時間枠：7 days after surgery
|
0-10 rating scale
|
7 days after surgery
|
|
patient-reported satisfaction and feeling of control - pain management
時間枠：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
時間枠：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
時間枠：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
時間枠：7 days after surgery
|
patient-reported
|
7 days after surgery
|
|
use of non-narcotic adjunct pain relief medication and modalities
時間枠：7 days after surgery
|
7 days after surgery
|
|
|
incidence of high risk activities - sedating medication polytherapy
時間枠：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
時間枠：7 days after surgery
|
combining prn NSAIDs with regularly dosed prescription NSAIDs
|
7 days after surgery
|
|
incidence of high risk activities - overdosing
時間枠：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
時間枠：7 days after surgery
|
Nausea/Vomiting
|
7 days after surgery
|
|
incidence of side effects and adverse events - Dizziness/balance problems
時間枠：7 days after surgery
|
Dizziness/balance problems
|
7 days after surgery
|
|
incidence of side effects and adverse events - fatigue or sedation
時間枠：7 days after surgery
|
fatigue or sedation
|
7 days after surgery
|
|
incidence of side effects and adverse events - headache
時間枠：7 days after surgery
|
headache
|
7 days after surgery
|
|
incidence of side effects and adverse events - visual changes
時間枠：7 days after surgery
|
visual changes
|
7 days after surgery
|
|
incidence of side effects and adverse events - stomach pain
時間枠：7 days after surgery
|
stomach pain
|
7 days after surgery
|
|
incidence of side effects and adverse events - constipation
時間枠：7 days after surgery
|
constipation
|
7 days after surgery
|
|
incidence of side effects and adverse events - diarrhea
時間枠：7 days after surgery
|
diarrhea
|
7 days after surgery
|
|
incidence of side effects and adverse events - fever
時間枠：7 days after surgery
|
fever
|
7 days after surgery
|
|
incidence of side effects and adverse events - rash
時間枠：7 days after surgery
|
rash
|
7 days after surgery
|
|
incidence of side effects and adverse events - hives
時間枠：7 days after surgery
|
hives
|
7 days after surgery
|
|
incidence of side effects and adverse events - swelling
時間枠：7 days after surgery
|
swelling
|
7 days after surgery
|
|
incidence of side effects and adverse events - difficulty breathing/shortness of breath
時間枠：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
時間枠：7 days after surgery
|
heart palpitations/arrythmia/heart racing
|
7 days after surgery
|
|
incidence of side effects and adverse events - anaphylaxis
時間枠：7 days after surgery
|
anaphylaxis
|
7 days after surgery
|
|
incidence of side effects and adverse events - ringing in ears
時間枠：7 days after surgery
|
ringing in ears
|
7 days after surgery
|
|
incidence of side effects and adverse events - other
時間枠：7 days after surgery
|
other
|
7 days after surgery
|
|
demonstrated patient knowledge
時間枠：7 days after surgery
|
as measured by score on the follow-up quiz
|
7 days after surgery
|
|
prevalence of chronic opioid use
時間枠：1 year after surgery
|
patient reported
|
1 year after surgery
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Cassandra Mierisch, MD、Carilion Clinic
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (予想される)
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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