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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02997644
Study type Interventional
Source Brooke Army Medical Center
Contact
Status Completed
Phase N/A
Start date June 2016
Completion date September 1, 2019

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