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

Not Applicable

• Conditions: Analgesics, Opioid; Orthopedic Surgery; Ambulatory Surgery; Education, Patient; Injuries and Wounds
• Interventions: Behavioral: Wound Care Patient Education Video; Behavioral: Pain Management Patient Education Video

• Registration Number: NCT03366805
• Lead Sponsor: Carilion Clinic

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-11-29
• Study Start: 2017-11-30
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-08
• Primary Completion: 2018-11-29
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-20
• Last Update Posted: 2019-09-23
• Study Completion: 2020-06-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 221

Inclusion Criteria

• Adult patients planning elective outpatient orthopedic surgery procedures by a Carilion Clinic hand surgeon will be eligible for the study.

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Exclusion Criteria

1. Patients unable or unwilling to provide informed consent
2. Patients unable to unwilling to participate in the trial (poor English language skills, blindness, cognitively disadvantaged, poor literacy skills, other barriers to participation)
3. Patients who are or suspect they may be pregnant.
4. Patients for whom the medical provider, in his professional judgment, does not feel that the study protocol would be appropriate. (to be tracked)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wound Care Video	Wound Care Patient Education Video	Wound Care Patient Education Video
Pain Management Video Group	Pain Management Patient Education Video	Pain Management Patient Education Video

Primary Outcome Measures

Name	Time	Method
Quality of Recovery 15 Score	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

Secondary Outcome Measures

Name	Time	Method
number of narcotic pills used	7 days after surgery	number of narcotic pills used
incidence of side effects and adverse events - visual changes	7 days after surgery	visual changes
incidence of side effects and adverse events - constipation	7 days after surgery	constipation
incidence of side effects and adverse events - swelling	7 days after surgery	swelling
PROMIS	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)
patient-reported satisfaction and feeling of control - pain management	7 days after surgery	Today, I feel in control of my pain management.; 1. Strongly agree; 2. Agree; 3. Neither agree nor disagree; 4. Disagree; 5. Strongly disagree
patient-reported satisfaction and feeling of control- wound care	7 days after surgery	Today, I feel in confident about how I am caring for my wound.; 1. Strongly agree; 2. Agree; 3. Neither agree nor disagree; 4. Disagree; 5. Strongly disagree
incidence of high risk activities - sedating medication polytherapy	7 days after surgery	combining narcotics with muscle relaxants/sedatives/alcohol, other sedating medications
incidence of side effects and adverse events - fever	7 days after surgery	fever
patient-reported satisfaction and feeling of control - pain management satisfaction	7 days after surgery	Today, I would rate my satisfaction with my pain control as (circle); 1. Very satisfied; 2. Somewhat satisfied; 3. Neutral; 4. Somewhat dissatisfied; 5. Very dissatisfied
incidence of side effects and adverse events - fatigue or sedation	7 days after surgery	fatigue or sedation
incidence of side effects and adverse events - headache	7 days after surgery	headache
incidence of side effects and adverse events - stomach pain	7 days after surgery	stomach pain
incidence of side effects and adverse events - rash	7 days after surgery	rash
incidence of side effects and adverse events - hives	7 days after surgery	hives
incidence of side effects and adverse events - difficulty breathing/shortness of breath	7 days after surgery	difficulty breathing/shortness of breath
number of pain-related calls/visits to a healthcare provider	7 days after surgery	patient-reported
use of non-narcotic adjunct pain relief medication and modalities	7 days after surgery
incidence of high risk activities - overdosing	7 days after surgery	exceeding daily recommended doses of pain medication
incidence of side effects and adverse events - Nausea/V omitting	7 days after surgery	Nausea/Vomiting
incidence of side effects and adverse events - Dizziness/balance problems	7 days after surgery	Dizziness/balance problems
incidence of side effects and adverse events - other	7 days after surgery	other
incidence of side effects and adverse events - anaphylaxis	7 days after surgery	anaphylaxis
daily pain level	7 days after surgery	0-10 rating scale
incidence of high risk activities - NSAID polytherapy	7 days after surgery	combining prn NSAIDs with regularly dosed prescription NSAIDs
incidence of side effects and adverse events - diarrhea	7 days after surgery	diarrhea
incidence of side effects and adverse events - heart palpitations/arrythmia/heart racing	7 days after surgery	heart palpitations/arrythmia/heart racing
incidence of side effects and adverse events - ringing in ears	7 days after surgery	ringing in ears
demonstrated patient knowledge	7 days after surgery	as measured by score on the follow-up quiz
prevalence of chronic opioid use	1 year after surgery	patient reported

Trial Locations

Locations (1)

Institute for Orthopedics and Neurosciences; 🇺🇸 Roanoke, Virginia, United States