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Clinical Trials/NCT04625231
NCT04625231CompletedNot Applicable

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

University of Colorado, Denver1 site in 1 country60 target enrollmentStarted: November 9, 2018Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Number of Opioid Pills Dispensed
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
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.

Eligibility Criteria

Ages
18 Years to 89 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

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

Arms & Interventions

Shared-Decision Making Tool Group

Experimental

Intervention: Educational Shared-Decision Making Tool (Behavioral)

Standard of Care Group

No Intervention

Outcomes

Primary Outcomes

Number of Opioid Pills Dispensed

Time Frame: 1 day (Once after surgery)

Number of Opioid Pills Consumed

Time Frame: 4 weeks

Secondary Outcomes

  • Patient-Reported Outcomes Measurement Information System Pain Interference Score(Once a week for 4 weeks after surgery)
  • Patient-Reported Outcomes Measurement Information System Pain Intensity Score(Once a week for 4 weeks after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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