Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03366805
Recruitment Status : Unknown
Verified September 2019 by Cassandra Mierisch, Carilion Clinic.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2017
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Cassandra Mierisch, Carilion Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Analgesics, Opioid Orthopedic Surgery Ambulatory Surgery Education, Patient Injuries and Wounds Behavioral: Pain Management Patient Education Video Behavioral: Wound Care Patient Education Video Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, randomized clinical trial
Masking: Single (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.
Primary Purpose: Supportive Care
Official Title: A Standardized Patient Education Video Program for Improvement of Post-Operative Recovery After Outpatient Upper Extremity Surgery
Actual Study Start Date : November 30, 2017
Actual Primary Completion Date : November 29, 2018
Estimated Study Completion Date : June 12, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Quality of Recovery 15 Score [ Time Frame: 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 :
  1. PROMIS [ Time Frame: 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)

  2. number of narcotic pills used [ Time Frame: 7 days after surgery ]
    number of narcotic pills used

  3. daily pain level [ Time Frame: 7 days after surgery ]
    0-10 rating scale

  4. patient-reported satisfaction and feeling of control - pain management [ Time Frame: 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

  5. patient-reported satisfaction and feeling of control- wound care [ Time Frame: 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

  6. patient-reported satisfaction and feeling of control - pain management satisfaction [ Time Frame: 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

  7. number of pain-related calls/visits to a healthcare provider [ Time Frame: 7 days after surgery ]
    patient-reported

  8. use of non-narcotic adjunct pain relief medication and modalities [ Time Frame: 7 days after surgery ]
  9. incidence of high risk activities - sedating medication polytherapy [ Time Frame: 7 days after surgery ]
    combining narcotics with muscle relaxants/sedatives/alcohol, other sedating medications

  10. incidence of high risk activities - NSAID polytherapy [ Time Frame: 7 days after surgery ]
    combining prn NSAIDs with regularly dosed prescription NSAIDs

  11. incidence of high risk activities - overdosing [ Time Frame: 7 days after surgery ]
    exceeding daily recommended doses of pain medication

  12. incidence of side effects and adverse events - Nausea/V omitting [ Time Frame: 7 days after surgery ]
    Nausea/Vomiting

  13. incidence of side effects and adverse events - Dizziness/balance problems [ Time Frame: 7 days after surgery ]
    Dizziness/balance problems

  14. incidence of side effects and adverse events - fatigue or sedation [ Time Frame: 7 days after surgery ]
    fatigue or sedation

  15. incidence of side effects and adverse events - headache [ Time Frame: 7 days after surgery ]
    headache

  16. incidence of side effects and adverse events - visual changes [ Time Frame: 7 days after surgery ]
    visual changes

  17. incidence of side effects and adverse events - stomach pain [ Time Frame: 7 days after surgery ]
    stomach pain

  18. incidence of side effects and adverse events - constipation [ Time Frame: 7 days after surgery ]
    constipation

  19. incidence of side effects and adverse events - diarrhea [ Time Frame: 7 days after surgery ]
    diarrhea

  20. incidence of side effects and adverse events - fever [ Time Frame: 7 days after surgery ]
    fever

  21. incidence of side effects and adverse events - rash [ Time Frame: 7 days after surgery ]
    rash

  22. incidence of side effects and adverse events - hives [ Time Frame: 7 days after surgery ]
    hives

  23. incidence of side effects and adverse events - swelling [ Time Frame: 7 days after surgery ]
    swelling

  24. incidence of side effects and adverse events - difficulty breathing/shortness of breath [ Time Frame: 7 days after surgery ]
    difficulty breathing/shortness of breath

  25. incidence of side effects and adverse events - heart palpitations/arrythmia/heart racing [ Time Frame: 7 days after surgery ]
    heart palpitations/arrythmia/heart racing

  26. incidence of side effects and adverse events - anaphylaxis [ Time Frame: 7 days after surgery ]
    anaphylaxis

  27. incidence of side effects and adverse events - ringing in ears [ Time Frame: 7 days after surgery ]
    ringing in ears

  28. incidence of side effects and adverse events - other [ Time Frame: 7 days after surgery ]
    other

  29. demonstrated patient knowledge [ Time Frame: 7 days after surgery ]
    as measured by score on the follow-up quiz

  30. prevalence of chronic opioid use [ Time Frame: 1 year after surgery ]
    patient reported


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03366805


Locations
Layout table for location information
United States, Virginia
Institute for Orthopedics and Neurosciences
Roanoke, Virginia, United States, 24014
Sponsors and Collaborators
Carilion Clinic
Investigators
Layout table for investigator information
Principal Investigator: Cassandra Mierisch, MD Carilion Clinic
  Study Documents (Full-Text)

Documents provided by Cassandra Mierisch, Carilion Clinic:
Study Protocol  [PDF] November 24, 2017
Informed Consent Form  [PDF] November 29, 2017

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Cassandra Mierisch, Orthopedic Surgeon, Carilion Clinic
ClinicalTrials.gov Identifier: NCT03366805    
Other Study ID Numbers: 2266
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cassandra Mierisch, Carilion Clinic:
opioid
analgesic
ambulatory
orthopedic
 surgery
patient education
video
medication diary
Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries