A Standardized Patient Education Video Program for Improvement of Post-Operative Recovery After Outpatient Upper Extremity Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 221
- 试验地点
- 2
- 主要终点
- Quality of Recovery 15 Score
研究概览
简要总结
Adult patients undergoing elective outpatient, upper extremity, orthopedic surgeries 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. The effect of this educational program on pain medications used, pain control efficacy, and other measures of satisfaction and recovery will be assessed.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
Care provider is not informed of which patient education video(s) the patient was provided, unless that patient initiates a conversation with the provider regarding the video.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients planning elective outpatient orthopedic surgery procedures by a Carilion Clinic hand surgeon will be eligible for the study.
排除标准
- •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)
结局指标
主要结局
Quality of Recovery 15 Score
时间窗: 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 1. Able to breath easily 2. Been able to enjoy food 3. Feeling rested 4. Have had a good sleep 5. Able to look after personal toilet and hygiene unaided 6. Able to communicate with family or friends 7. Getting support from hospital doctors and nurses 8. Able to return to work or usual home activities 9. Feeling comfortable and in control 10. Having a feeling of general well-being Have you had any of the following in the last 24 hours? (10 to 0, where: 10=none of the time \[excellent\] and 0=all of the time \[poor\]) 10 9 8 7 6 5 4 3 2 1 0 11. Moderate pain 12. severe pain 13. Nausea or vomiting 14. Feeling worried or anxious 15. Feeling sad or depressed
次要结局
- incidence of side effects and adverse events - fever(7 days after surgery)
- incidence of side effects and adverse events - swelling(7 days after surgery)
- number of narcotic pills used(7 days after surgery)
- incidence of side effects and adverse events - visual changes(7 days after surgery)
- incidence of side effects and adverse events - constipation(7 days after surgery)
- PROMIS(3 days after surgery)
- patient-reported satisfaction and feeling of control - pain management(7 days after surgery)
- patient-reported satisfaction and feeling of control- wound care(7 days after surgery)
- incidence of high risk activities - sedating medication polytherapy(7 days after surgery)
- patient-reported satisfaction and feeling of control - pain management satisfaction(7 days after surgery)
- incidence of side effects and adverse events - fatigue or sedation(7 days after surgery)
- incidence of side effects and adverse events - headache(7 days after surgery)
- incidence of side effects and adverse events - stomach pain(7 days after surgery)
- incidence of side effects and adverse events - rash(7 days after surgery)
- incidence of side effects and adverse events - hives(7 days after surgery)
- incidence of side effects and adverse events - difficulty breathing/shortness of breath(7 days after surgery)
- number of pain-related calls/visits to a healthcare provider(7 days after surgery)
- use of non-narcotic adjunct pain relief medication and modalities(7 days after surgery)
- incidence of high risk activities - overdosing(7 days after surgery)
- incidence of side effects and adverse events - Nausea/V omitting(7 days after surgery)
- incidence of side effects and adverse events - Dizziness/balance problems(7 days after surgery)
- incidence of side effects and adverse events - other(7 days after surgery)
- incidence of side effects and adverse events - anaphylaxis(7 days after surgery)
- daily pain level(7 days after surgery)
- incidence of high risk activities - NSAID polytherapy(7 days after surgery)
- incidence of side effects and adverse events - diarrhea(7 days after surgery)
- incidence of side effects and adverse events - heart palpitations/arrythmia/heart racing(7 days after surgery)
- incidence of side effects and adverse events - ringing in ears(7 days after surgery)
- demonstrated patient knowledge(7 days after surgery)
- prevalence of chronic opioid use(1 year after surgery)
研究者
Cassandra Mierisch
Orthopedic Surgeon
Carilion Clinic