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

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: NCT04625231
Recruitment Status : Terminated (Due to decreased case volume due to COVID-19 enrollment has stopped.)
First Posted : November 12, 2020
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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
Opioid Use Surgery Behavioral: Educational Shared-Decision Making Tool Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 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 : November 9, 2018
Actual Primary Completion Date : September 17, 2020
Actual Study Completion Date : October 1, 2020
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Number of Opioid Pills Dispensed [ Time Frame: 1 day (Once after surgery) ]
  2. Number of Opioid Pills Consumed [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Patient-Reported Outcomes Measurement Information System Pain Interference Score [ Time Frame: Once a week for 4 weeks after surgery ]
    Lower scores are better

  2. Patient-Reported Outcomes Measurement Information System Pain Intensity Score [ Time Frame: Once a week for 4 weeks after surgery ]
    Lower scores are better


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 1. Inclusion Criteria:
  • a. 18-89 years of age
  • b. Patient at the Orthopedic Department at the Veterans Health Administration
  • c. Indicated for upper extremity surgeries: E.g., Carpal Tunnel Release, Trigger Finger Release, Cubital Tunnel Release, Ganglion Cyst Excision
  • 2. Exclusion Criteria:
  • a. History of opioid use disorder
  • b. Had any recent surgery within four weeks of upper extremity procedure
  • c. Taking opioids prior to surgery
  • d. Returning to an institutionalized setting
  • e. Pregnancy
  • f. Unable to communicate in the English language
  • g. Allergy to any medication recommended for post-operative analgesia
Contacts and Locations
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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): NCT04625231


Locations
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United States, Colorado
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Rajshri Bolson, MD Rocky Mountain Regional VA Medical Center
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04625231    
Other Study ID Numbers: 18-0160
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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