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

NCT ID: NCT04625231

Last Updated: 2022-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-09

Study Completion Date

2022-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Use Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Both patients and investigators were blinded to group assignment until an envelope was opened after the patient consented.

Study Groups

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Shared-Decision Making Tool Group

Group Type EXPERIMENTAL

Educational Shared-Decision Making Tool

Intervention Type 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.

Standard of Care Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rajshri Bolson, MD

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain Regional VA Medical Center

Locations

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Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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18-0160

Identifier Type: -

Identifier Source: org_study_id

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