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

Primary Purpose

Analgesics, Opioid, Orthopedic Surgery, Ambulatory Surgery

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain Management Patient Education Video
Wound Care Patient Education Video
Sponsored by
Carilion Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Analgesics, Opioid focused on measuring opioid, analgesic, ambulatory, orthopedic, surgery, patient education, video, medication diary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Institute for Orthopedics and Neurosciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Wound Care Video

Pain Management Video Group

Arm Description

Wound Care Patient Education Video

Pain Management Patient Education Video

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
number of narcotic pills used
number of narcotic pills used
daily pain level
0-10 rating scale
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
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
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
number of pain-related calls/visits to a healthcare provider
patient-reported
use of non-narcotic adjunct pain relief medication and modalities
incidence of high risk activities - sedating medication polytherapy
combining narcotics with muscle relaxants/sedatives/alcohol, other sedating medications
incidence of high risk activities - NSAID polytherapy
combining prn NSAIDs with regularly dosed prescription NSAIDs
incidence of high risk activities - overdosing
exceeding daily recommended doses of pain medication
incidence of side effects and adverse events - Nausea/V omitting
Nausea/Vomiting
incidence of side effects and adverse events - Dizziness/balance problems
Dizziness/balance problems
incidence of side effects and adverse events - fatigue or sedation
fatigue or sedation
incidence of side effects and adverse events - headache
headache
incidence of side effects and adverse events - visual changes
visual changes
incidence of side effects and adverse events - stomach pain
stomach pain
incidence of side effects and adverse events - constipation
constipation
incidence of side effects and adverse events - diarrhea
diarrhea
incidence of side effects and adverse events - fever
fever
incidence of side effects and adverse events - rash
rash
incidence of side effects and adverse events - hives
hives
incidence of side effects and adverse events - swelling
swelling
incidence of side effects and adverse events - difficulty breathing/shortness of breath
difficulty breathing/shortness of breath
incidence of side effects and adverse events - heart palpitations/arrythmia/heart racing
heart palpitations/arrythmia/heart racing
incidence of side effects and adverse events - anaphylaxis
anaphylaxis
incidence of side effects and adverse events - ringing in ears
ringing in ears
incidence of side effects and adverse events - other
other
demonstrated patient knowledge
as measured by score on the follow-up quiz
prevalence of chronic opioid use
patient reported

Full Information

First Posted
November 29, 2017
Last Updated
September 20, 2019
Sponsor
Carilion Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03366805
Brief Title
A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery
Official Title
A Standardized Patient Education Video Program for Improvement of Post-Operative Recovery After Outpatient Upper Extremity Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
November 29, 2018 (Actual)
Study Completion Date
June 12, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carilion Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesics, Opioid, Orthopedic Surgery, Ambulatory Surgery, Education, Patient, Injuries and Wounds
Keywords
opioid, analgesic, ambulatory, orthopedic, surgery, patient education, video, medication diary

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized clinical trial
Masking
Care Provider
Masking Description
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.
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wound Care Video
Arm Type
Active Comparator
Arm Description
Wound Care Patient Education Video
Arm Title
Pain Management Video Group
Arm Type
Experimental
Arm Description
Pain Management Patient Education Video
Intervention Type
Behavioral
Intervention Name(s)
Pain Management Patient Education Video
Intervention Description
Patient education video that were created in-house specifically for this project.
Intervention Type
Behavioral
Intervention Name(s)
Wound Care Patient Education Video
Intervention Description
Patient education video that were created in-house specifically for this project.
Primary Outcome Measure Information:
Title
Quality of Recovery 15 Score
Description
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
Time Frame
2 days after surgery
Secondary Outcome Measure Information:
Title
PROMIS
Description
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)
Time Frame
3 days after surgery
Title
number of narcotic pills used
Description
number of narcotic pills used
Time Frame
7 days after surgery
Title
daily pain level
Description
0-10 rating scale
Time Frame
7 days after surgery
Title
patient-reported satisfaction and feeling of control - pain management
Description
Today, I feel in control of my pain management. Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree
Time Frame
7 days after surgery
Title
patient-reported satisfaction and feeling of control- wound care
Description
Today, I feel in confident about how I am caring for my wound. Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree
Time Frame
7 days after surgery
Title
patient-reported satisfaction and feeling of control - pain management satisfaction
Description
Today, I would rate my satisfaction with my pain control as (circle) Very satisfied Somewhat satisfied Neutral Somewhat dissatisfied Very dissatisfied
Time Frame
7 days after surgery
Title
number of pain-related calls/visits to a healthcare provider
Description
patient-reported
Time Frame
7 days after surgery
Title
use of non-narcotic adjunct pain relief medication and modalities
Time Frame
7 days after surgery
Title
incidence of high risk activities - sedating medication polytherapy
Description
combining narcotics with muscle relaxants/sedatives/alcohol, other sedating medications
Time Frame
7 days after surgery
Title
incidence of high risk activities - NSAID polytherapy
Description
combining prn NSAIDs with regularly dosed prescription NSAIDs
Time Frame
7 days after surgery
Title
incidence of high risk activities - overdosing
Description
exceeding daily recommended doses of pain medication
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - Nausea/V omitting
Description
Nausea/Vomiting
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - Dizziness/balance problems
Description
Dizziness/balance problems
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - fatigue or sedation
Description
fatigue or sedation
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - headache
Description
headache
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - visual changes
Description
visual changes
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - stomach pain
Description
stomach pain
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - constipation
Description
constipation
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - diarrhea
Description
diarrhea
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - fever
Description
fever
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - rash
Description
rash
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - hives
Description
hives
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - swelling
Description
swelling
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - difficulty breathing/shortness of breath
Description
difficulty breathing/shortness of breath
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - heart palpitations/arrythmia/heart racing
Description
heart palpitations/arrythmia/heart racing
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - anaphylaxis
Description
anaphylaxis
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - ringing in ears
Description
ringing in ears
Time Frame
7 days after surgery
Title
incidence of side effects and adverse events - other
Description
other
Time Frame
7 days after surgery
Title
demonstrated patient knowledge
Description
as measured by score on the follow-up quiz
Time Frame
7 days after surgery
Title
prevalence of chronic opioid use
Description
patient reported
Time Frame
1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassandra Mierisch, MD
Organizational Affiliation
Carilion Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Orthopedics and Neurosciences
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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