A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Standardized Patient Education Video Program for Improvement of Post-Operative Recovery After Outpatient Upper Extremity Surgery

Conditions
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Analgesics, Opioid, Orthopedic Surgery, Ambulatory Surgery, Education, Patient, Injuries and Wounds

Intervention / Treatment
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* Behavioral: Pain Management Patient Education Video
* Behavioral: Wound Care Patient Education Video


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wound Care Video<br>Wound Care Patient Education Video | Behavioral: Wound Care Patient Education Video<br>* Patient education video that were created in-house specifically for this project.<br>|
| Experimental: Pain Management Video Group<br>Pain Management Patient Education Video | Behavioral: Pain Management Patient Education Video<br>* Patient education video that were created in-house specifically for this project.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery 15 Score | 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 Able to breath easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with family or friends Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control 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 Moderate pain severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed | 2 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS | 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 | number of narcotic pills used | 7 days after surgery | 
| daily pain level | 0-10 rating scale | 7 days after surgery | 
| patient-reported satisfaction and feeling of control - pain management | Today, I feel in control of my pain management. Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree | 7 days after surgery | 
| patient-reported satisfaction and feeling of control- wound care | Today, I feel in confident about how I am caring for my wound. Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree | 7 days after surgery | 
| patient-reported satisfaction and feeling of control - pain management satisfaction | Today, I would rate my satisfaction with my pain control as (circle) Very satisfied Somewhat satisfied Neutral Somewhat dissatisfied Very dissatisfied | 7 days after surgery | 
| number of pain-related calls/visits to a healthcare provider | patient-reported | 7 days after surgery | 
| use of non-narcotic adjunct pain relief medication and modalities |  | 7 days after surgery | 
| incidence of high risk activities - sedating medication polytherapy | combining narcotics with muscle relaxants/sedatives/alcohol, other sedating medications | 7 days after surgery | 
| incidence of high risk activities - NSAID polytherapy | combining prn NSAIDs with regularly dosed prescription NSAIDs | 7 days after surgery | 
| incidence of high risk activities - overdosing | exceeding daily recommended doses of pain medication | 7 days after surgery | 
| incidence of side effects and adverse events - Nausea/V omitting | Nausea/Vomiting | 7 days after surgery | 
| incidence of side effects and adverse events - Dizziness/balance problems | Dizziness/balance problems | 7 days after surgery | 
| incidence of side effects and adverse events - fatigue or sedation | fatigue or sedation | 7 days after surgery | 
| incidence of side effects and adverse events - headache | headache | 7 days after surgery | 
| incidence of side effects and adverse events - visual changes | visual changes | 7 days after surgery | 
| incidence of side effects and adverse events - stomach pain | stomach pain | 7 days after surgery | 
| incidence of side effects and adverse events - constipation | constipation | 7 days after surgery | 
| incidence of side effects and adverse events - diarrhea | diarrhea | 7 days after surgery | 
| incidence of side effects and adverse events - fever | fever | 7 days after surgery | 
| incidence of side effects and adverse events - rash | rash | 7 days after surgery | 
| incidence of side effects and adverse events - hives | hives | 7 days after surgery | 
| incidence of side effects and adverse events - swelling | swelling | 7 days after surgery | 
| incidence of side effects and adverse events - difficulty breathing/shortness of breath | difficulty breathing/shortness of breath | 7 days after surgery | 
| incidence of side effects and adverse events - heart palpitations/arrythmia/heart racing | heart palpitations/arrythmia/heart racing | 7 days after surgery | 
| incidence of side effects and adverse events - anaphylaxis | anaphylaxis | 7 days after surgery | 
| incidence of side effects and adverse events - ringing in ears | ringing in ears | 7 days after surgery | 
| incidence of side effects and adverse events - other | other | 7 days after surgery | 
| demonstrated patient knowledge | as measured by score on the follow-up quiz | 7 days after surgery | 
| prevalence of chronic opioid use | patient reported | 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid, analgesic, ambulatory, orthopedic, surgery, patient education, video, medication diary