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OpenTrials
Completed

NCT Number: NCT04625231

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

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.

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Key information

Conditions

Opioid Use Surgery

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Educational Shared-Decision Making Tool

Behavioral

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.

Primary outcomes

  1. Number of Opioid Pills Dispensed

    Time frame: 1 day (Once after surgery)

  2. Number of Opioid Pills Consumed

    Time frame: 4 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 12, 2020
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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