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

August 11, 2022 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Rocky Mountain Regional VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Opioid Pills Dispensed
Time Frame: 1 day (Once after surgery)
1 day (Once after surgery)
Number of Opioid Pills Consumed
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes Measurement Information System Pain Interference Score
Time Frame: Once a week for 4 weeks after surgery
Lower scores are better
Once a week for 4 weeks after surgery
Patient-Reported Outcomes Measurement Information System Pain Intensity Score
Time Frame: Once a week for 4 weeks after surgery
Lower scores are better
Once a week for 4 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2018

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 30, 2022

Study Registration Dates

First Submitted

November 6, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 11, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18-0160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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