Impact of Different Educational Approaches on Post-operative Opiate Utilization After Elective Lower Extremity Surgery (OpiateLEO)

January 16, 2020 updated by: Dan Rhon, Brooke Army Medical Center

The Effect of an Educational Pain Approach Before Elective Lower-extremity Surgery on 6-month Post-operative Use of Opioid Medication: A Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypothesis: The primary hypothesis is that the educational intervention provided prior to the surgery and prior to the prescription, will result in a greater understanding and awareness of the deleterious effects of long-term use of opioid based medications, and in turn reduce utilization post-operatively in the long-term (6 months).

Specific Aim 1: Evaluate prescription opioid medication use for the 6-month period after surgery in subjects that received the education compared to those that received usual care education.

Specific Aim 2: Compare the changes in self-reported outcome measures (pain, disability, and sleep) between groups over the 6-month period after surgery.

Specific Aim 3: Describe the sociodemographic factors and healthcare utilization in enrolled subjects for the 12 months leading up to a surgical procedure. Identify factors that could account for differences in opioid medication utilization, and any potential interaction effect between intervention, opioid use, and clinical outcomes following surgery.

Study Procedures/Research Interventions:

Subjects will be randomized to either receive usual care only or usual care plus the education video. Usual care is defined as typical information the surgeon would otherwise provide the patient before surgery. All patients will receive the usual care education from their surgeon.

Randomization:

Subjects will then be randomized into one of two arms (Group I = Educational Video, Group II= Usual Care Only). The method of group assignment will be sequentially numbered opaque sealed envelopes (SNOSE). To minimize the risk of predicting the treatment assignment of the next eligible patient, randomization will be performed in permuted blocks of two or four with random variation of the blocking number.

All Subjects:

All subjects will receive the usual care education that is typically given by their surgeon. That will be left up to the discretion of each surgeon. The screening and enrollment should take no more than 5-10 minutes, and then the filling out of self-report questionnaires should take approximately 5-7 minutes. Subjects in the group that is randomized to the education will take an additional 11 minutes to view the educational content.

All patients will proceed with the surgical procedure as planned. Each week during the 1-month period after the surgery, patients will be contacted (phone call, email, and text message - depending on what they consented to).

At the 1-month and 6-month time points they will be asked to fill out the additional clinical outcomes measures detailed below. These can be done in person with a visit to the clinic or over the telephone.

Sample Size Estimation. Collection of healthcare utilization will occur in 100% of the subjects as no follow-up is required, and therefore no opportunities to collect data from a follow-up visit will be lost. A sample of 120 subjects should allow us to determine significant differences between groups, based on a moderate effect size of 0.6.

Study Type

Interventional

Enrollment (Actual)

120

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
    • Texas
      • San Antonio, Texas, United States, 78234
        • Brooke Army 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. The surgery is taking place for a condition that has been ongoing for 6 months or longer (chronic)
  3. Between the age of 18 - 65 years
  4. 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).

Exclusion Criteria:

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

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
Experimental: Video Education
Video education delivered on a tablet computer
Behavioral: Video Education

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.
Placebo Comparator: Usual Care Group
Regular information about opioid usage they typically receive from their surgeon.
Behavioral: Usual Care Group
Patients that are randomized to usual care will only receive the regular instructions about opioid usage they typically receive from their surgeon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opiate Prescriptions
Time Frame: 6 months
Total opiate prescriptions
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale
Time Frame: baseline, 1 month, 6 months
A 0-10 numeric pain rating scale ('0' indicating no pain, and '10' worst imaginable pain) will be used to assess LBP intensity. Numeric pain scales are known to have excellent test-retest reliability.
baseline, 1 month, 6 months
PROMIS-29
Time Frame: baseline, 1 month, 6 months
The Patient Reported Outcomes Measurement Information Systems (PROMIS) 29-item short form (version 2) to assess disability. The PROMIS 29-item short form efficiently assesses several outcomes important to patients with a neuromusculoskeletal injury, including pain intensity and interference, sleep disturbance, anxiety, depression, fatigue, and social role participation using items developed with rigorous methodology and patient input. The PROMIS-29 scores have been found valid for patients with orthopedic injuries, with minimum clinically important change thresholds of 2-4 points for most scales. It has also been used to successfully measure psychosocial resiliency in patients with disability.
baseline, 1 month, 6 months

Collaborators and Investigators

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

Sponsor

Brooke Army Medical Center

Investigators

  • Principal Investigator: Daniel Rhon, DSc, Brooke Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2016

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (Estimate)

December 20, 2016

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.2016.142d

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Usually 1 year, but agreement is contract-specific with the Defense Health Agency

IPD Sharing Access Criteria

Submit a Data Sharing Agreement Application through the DHA

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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