NCT03366805

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
221

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 30, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2020

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

November 29, 2017

Last Update Submit

September 20, 2019

Conditions

Analgesics, OpioidOrthopedic SurgeryAmbulatory SurgeryEducation, PatientInjuries and Wounds

Keywords

opioidanalgesicambulatoryorthopedicsurgerypatient educationvideomedication diary

Outcome Measures

Primary Outcomes (1)

  • 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 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

    2 days after surgery

Secondary Outcomes (30)

  • PROMIS

    3 days after surgery

  • number of narcotic pills used

    7 days after surgery

  • daily pain level

    7 days after surgery

  • patient-reported satisfaction and feeling of control - pain management

    7 days after surgery

  • patient-reported satisfaction and feeling of control- wound care

    7 days after surgery

  • +25 more secondary outcomes

Study Arms (2)

Wound Care Video

ACTIVE COMPARATOR

Wound Care Patient Education Video

Behavioral: Wound Care Patient Education Video

Pain Management Video Group

EXPERIMENTAL

Pain Management Patient Education Video

Behavioral: Pain Management Patient Education Video

Interventions

Pain Management Patient Education VideoBEHAVIORAL

Patient education video that were created in-house specifically for this project.

Pain Management Video Group
Wound Care Patient Education VideoBEHAVIORAL

Patient education video that were created in-house specifically for this project.

Wound Care Video

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Orthopedics and Neurosciences

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Cassandra Mierisch, MD

    Carilion Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: prospective, randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Surgeon

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 8, 2017

Study Start

November 30, 2017

Primary Completion

November 29, 2018

Study Completion

June 12, 2020

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)