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

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.

Study Overview

• Status: Unknown
• Conditions: Orthopedic Surgery; Analgesics, Opioid; Ambulatory Surgery; Injuries and Wounds; Education, Patient
• Intervention / Treatment: Behavioral: Wound Care Patient Education Video; Behavioral: Pain Management Patient Education Video

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 Type: Interventional
• Enrollment (Actual): 221
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Institute for Orthopedics and Neurosciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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-beingHave 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

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Investigators: Principal Investigator: Cassandra Mierisch, MD, Carilion Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): November 29, 2018
• Study Completion (Anticipated): June 12, 2020

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: opioid; analgesic; surgery; patient education; video; ambulatory; orthopedic; medication diary
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No