NCT02997644

Brief Summary

The purpose of this study is to evaluate the use of post-operative opioid use after two different educational interventions. The investigators will compare changes in pain, disability and sleep between groups 6 months after elective lower extremity surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2.9 years

First QC Date

December 6, 2016

Last Update Submit

January 16, 2020

Conditions

Knee Injuries and DisordersHip Injuries and DisordersOpiate Addiction

Keywords

patient educationorthopaedic surgerypost-surgical painchronic opioid use

Outcome Measures

Primary Outcomes (1)

  • Opiate Prescriptions

    Total opiate prescriptions

    6 months

Secondary Outcomes (2)

  • Numeric Pain Rating Scale

    baseline, 1 month, 6 months

  • PROMIS-29

    baseline, 1 month, 6 months

Study Arms (2)

Video Education

EXPERIMENTAL

Video education delivered on a tablet computer

Behavioral: Video Education

Usual Care Group

PLACEBO COMPARATOR

Regular information about opioid usage they typically receive from their surgeon.

Behavioral: Usual Care Group

Interventions

Video EducationBEHAVIORAL

The content of the education focuses on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer non-acute pain. It also discusses some of the dangers of long-term opioid usage. The consent, enrollment, and video education will take about 20-30 minutes for patients in this group, and occur at the end of their preoperative visit. The patient will watch the video on a portable Tablet computer.

Video Education
Usual Care GroupBEHAVIORAL

Patients that are randomized to usual care will only receive the regular instructions about opioid usage they typically receive from their surgeon.

Usual Care Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any Tricare-eligible patient scheduled for a pre-operative surgery appointment for an elective orthopaedic surgery of the hip, knee, or foot/ankle at SAMMC.
  • The surgery is taking place for a condition that has been ongoing for 6 months or longer (chronic)
  • Between the age of 18 - 65 years
  • Read and speak English well enough to understand the education, provide informed consent and follow study instructions (the surgeon, investigators, or research assistants will make this determination. Any patient that needs an interpreter will not be allowed to enroll).

You may not qualify if:

  • Known aversion or allergy that would prevent the patient from taking any opioid-based pain medication (any contraindications to using opioids)
  • History of prior surgery to the same location.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Related Publications (7)

  • French MT, McGeary KA, Chitwood DD, McCoy CB. Chronic illicit drug use, health services utilization and the cost of medical care. Soc Sci Med. 2000 Jun;50(12):1703-13. doi: 10.1016/s0277-9536(99)00411-6.

    PMID: 10798326BACKGROUND

  • Songer TJ, LaPorte RE. Disabilities due to injury in the military. Am J Prev Med. 2000 Apr;18(3 Suppl):33-40. doi: 10.1016/s0749-3797(00)00107-0.

    PMID: 10736539BACKGROUND

  • Vanderlip ER, Sullivan MD, Edlund MJ, Martin BC, Fortney J, Austen M, Williams JS, Hudson T. National study of discontinuation of long-term opioid therapy among veterans. Pain. 2014 Dec;155(12):2673-2679. doi: 10.1016/j.pain.2014.09.034. Epub 2014 Sep 30.

    PMID: 25277462BACKGROUND

  • Toblin RL, Quartana PJ, Riviere LA, Walper KC, Hoge CW. Chronic pain and opioid use in US soldiers after combat deployment. JAMA Intern Med. 2014 Aug;174(8):1400-1. doi: 10.1001/jamainternmed.2014.2726. No abstract available.

    PMID: 24978399BACKGROUND

  • Rozet I, Nishio I, Robbertze R, Rotter D, Chansky H, Hernandez AV. Prolonged opioid use after knee arthroscopy in military veterans. Anesth Analg. 2014 Aug;119(2):454-459. doi: 10.1213/ANE.0000000000000292.

    PMID: 24977636BACKGROUND

  • Dobscha SK, Morasco BJ, Duckart JP, Macey T, Deyo RA. Correlates of prescription opioid initiation and long-term opioid use in veterans with persistent pain. Clin J Pain. 2013 Feb;29(2):102-8. doi: 10.1097/AJP.0b013e3182490bdb.

    PMID: 23269280BACKGROUND

  • Rhon DI, Greenlee TA, Mayhew R, Boyer C, Laugesen M, Roth J, Dowd TC, Gill NW. Engaging Education About Risks of Opioid Use With Patients Before Elective Surgery of the Lower Extremity Did Not Reduce Postoperative Opioid Utilization: A Randomized Controlled Trial. J Am Acad Orthop Surg. 2022 Apr 1;30(7):e649-e657. doi: 10.5435/JAAOS-D-21-00603.

    PMID: 35130200DERIVED

MeSH Terms

Conditions

Knee InjuriesDiseaseHip InjuriesOpioid-Related DisordersPain, Postoperative

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPostoperative ComplicationsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Daniel Rhon, DSc

    Brooke Army Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist, Center for the Intrepid

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 20, 2016

Study Start

June 1, 2016

Primary Completion

April 30, 2019

Study Completion

September 1, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

Data sharing must go through a Data Sharing Agreement via the Defense Health Agency

Time Frame
Usually 1 year, but agreement is contract-specific with the Defense Health Agency
Access Criteria
Submit a Data Sharing Agreement Application through the DHA
More information

Locations

US(1)