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

Surgery Clinical Trial

Official title:

Shared Decision-Making Tool for Opioid Prescribing After Ambulatory Orthopedic Surgery in Veterans - A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04625231
• Other study ID #: 18-0160
• Status: Completed
• Phase: N/A
• Start date: November 9, 2018
• Est. completion date: May 30, 2022

Study information

• Verified date: August 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 30, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Opioid Use
• Surgery

Intervention

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.

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VA Medical Center	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Opioid Pills Dispensed		1 day (Once after surgery)
Primary	Number of Opioid Pills Consumed		4 weeks
Secondary	Patient-Reported Outcomes Measurement Information System Pain Interference Score	Lower scores are better	Once a week for 4 weeks after surgery
Secondary	Patient-Reported Outcomes Measurement Information System Pain Intensity Score	Lower scores are better	Once a week for 4 weeks after surgery