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
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Virginia
-
Roanoke、Virginia、美国、24014
- Institute for Orthopedics and Neurosciences
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Wound Care Video
Wound Care Patient Education Video
|
Patient education video that were created in-house specifically for this project.
|
|
实验性的：Pain Management Video Group
Pain Management Patient Education Video
|
Patient education video that were created in-house specifically for this project.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of Recovery 15 Score
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PROMIS
大体时间：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
大体时间：7 days after surgery
|
number of narcotic pills used
|
7 days after surgery
|
|
daily pain level
大体时间：7 days after surgery
|
0-10 rating scale
|
7 days after surgery
|
|
patient-reported satisfaction and feeling of control - pain management
大体时间：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
大体时间：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
大体时间：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
大体时间：7 days after surgery
|
patient-reported
|
7 days after surgery
|
|
use of non-narcotic adjunct pain relief medication and modalities
大体时间：7 days after surgery
|
7 days after surgery
|
|
|
incidence of high risk activities - sedating medication polytherapy
大体时间：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
大体时间：7 days after surgery
|
combining prn NSAIDs with regularly dosed prescription NSAIDs
|
7 days after surgery
|
|
incidence of high risk activities - overdosing
大体时间：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
大体时间：7 days after surgery
|
Nausea/Vomiting
|
7 days after surgery
|
|
incidence of side effects and adverse events - Dizziness/balance problems
大体时间：7 days after surgery
|
Dizziness/balance problems
|
7 days after surgery
|
|
incidence of side effects and adverse events - fatigue or sedation
大体时间：7 days after surgery
|
fatigue or sedation
|
7 days after surgery
|
|
incidence of side effects and adverse events - headache
大体时间：7 days after surgery
|
headache
|
7 days after surgery
|
|
incidence of side effects and adverse events - visual changes
大体时间：7 days after surgery
|
visual changes
|
7 days after surgery
|
|
incidence of side effects and adverse events - stomach pain
大体时间：7 days after surgery
|
stomach pain
|
7 days after surgery
|
|
incidence of side effects and adverse events - constipation
大体时间：7 days after surgery
|
constipation
|
7 days after surgery
|
|
incidence of side effects and adverse events - diarrhea
大体时间：7 days after surgery
|
diarrhea
|
7 days after surgery
|
|
incidence of side effects and adverse events - fever
大体时间：7 days after surgery
|
fever
|
7 days after surgery
|
|
incidence of side effects and adverse events - rash
大体时间：7 days after surgery
|
rash
|
7 days after surgery
|
|
incidence of side effects and adverse events - hives
大体时间：7 days after surgery
|
hives
|
7 days after surgery
|
|
incidence of side effects and adverse events - swelling
大体时间：7 days after surgery
|
swelling
|
7 days after surgery
|
|
incidence of side effects and adverse events - difficulty breathing/shortness of breath
大体时间：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
大体时间：7 days after surgery
|
heart palpitations/arrythmia/heart racing
|
7 days after surgery
|
|
incidence of side effects and adverse events - anaphylaxis
大体时间：7 days after surgery
|
anaphylaxis
|
7 days after surgery
|
|
incidence of side effects and adverse events - ringing in ears
大体时间：7 days after surgery
|
ringing in ears
|
7 days after surgery
|
|
incidence of side effects and adverse events - other
大体时间：7 days after surgery
|
other
|
7 days after surgery
|
|
demonstrated patient knowledge
大体时间：7 days after surgery
|
as measured by score on the follow-up quiz
|
7 days after surgery
|
|
prevalence of chronic opioid use
大体时间：1 year after surgery
|
patient reported
|
1 year after surgery
|
合作者和调查者
调查人员
- 首席研究员：Cassandra Mierisch, MD、Carilion Clinic
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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