Clinical trial NCT02997644: Impact of Different Educational Approaches on Post-operative Opiate Utilization After Elective Lower Extremity Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries and Disorders
Hip Injuries and Disorders
Opiate Addiction
Keywords: patient education
orthopaedic surgery
post-surgical pain
chronic opioid use
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2016-12-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Opiate Prescriptions
timeFrame: 6 months
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: baseline, 1 month, 6 months
measure: PROMIS-29
timeFrame: baseline, 1 month, 6 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Daniel Rhon, DSc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.