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Shared Decision-Making Tool for Opioid Prescribing After Ambulatory Hand Surgery in Veterans

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT04625231
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
42.6
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if an educational patient-centered presentation reduced the amount of opioid pills requested and utilized by patients compared to standard of care group.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Educational Shared-Decision Making Tool
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Both patients and investigators were blinded to group assignment until an envelope was opened after the patient consented.
Primary Purpose:
Treatment
Official Title:
Shared Decision-Making Tool for Opioid Prescribing After Ambulatory Orthopedic Surgery in Veterans - A Randomized Controlled Clinical Trial
Actual Study Start Date :
Nov 9, 2018
Actual Primary Completion Date :
May 1, 2022
Actual Study Completion Date :
May 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Shared-Decision Making Tool Group

Behavioral: Educational Shared-Decision Making Tool
Patients received a short video presentation on pain management, use of over the counter medication, side effects of opioids and over-the-counter medications and ability to choose the amount of opioid pills up to the standard care amount.
No Intervention: Standard of Care Group

Outcome Measures

Primary Outcome Measures

  1. Number of Opioid Pills Dispensed [1 day (Once after surgery)]

  2. Number of Opioid Pills Consumed [4 weeks]

Secondary Outcome Measures

  1. Patient-Reported Outcomes Measurement Information System Pain Interference Score [Once a week for 4 weeks after surgery]

    Lower scores are better

  2. Patient-Reported Outcomes Measurement Information System Pain Intensity Score [Once a week for 4 weeks after surgery]

    Lower scores are better

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
    1. Inclusion Criteria:
    1. 18-89 years of age
    1. Patient at the Orthopedic Department at the Veterans Health Administration
    1. Indicated for upper extremity surgeries: E.g., Carpal Tunnel Release, Trigger Finger Release, Cubital Tunnel Release, Ganglion Cyst Excision
    1. Exclusion Criteria:
    1. History of opioid use disorder
    1. Had any recent surgery within four weeks of upper extremity procedure
    1. Taking opioids prior to surgery
    1. Returning to an institutionalized setting
    1. Pregnancy
    1. Unable to communicate in the English language
    1. Allergy to any medication recommended for post-operative analgesia

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rocky Mountain Regional VA Medical Center Aurora Colorado United States 80045

Sponsors and Collaborators

  • University of Colorado, Denver

Investigators

  • Principal Investigator: Rajshri Bolson, MD, Rocky Mountain Regional VA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT04625231
Other Study ID Numbers:
  • 18-0160
First Posted:
Nov 12, 2020
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Colorado, Denver
orthopedics
hand surgery
opioid use
counseling
education

Study Results

No Results Posted as of Aug 12, 2022