The Effect of a Brief Pre-operative Pain Medication Educational Video on Post-operative Prescription Opioid Medication Use in Patients Undergoing Spine Surgery. A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brooke Army Medical Center
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Number of Opioid Medication Prescriptions
Study Overview
Brief Summary
The purpose of this project is to assess the impact of an educational video on the use of prescription opioid medication during a 6-month period following spine surgery. Subjects will be recruited from the pool of patients coming in for the pre-operative appointment prior to spine surgery. Patients that consent and enroll will be randomized to receive either a brief educational video at this appointment or usual care. Patients will be followed after surgery weekly for the first month, and then again at 6 months to determine their prescription opioid medication utilization patterns. Prescription data will also be pulled from electronic medical records.
Detailed Description
After consenting, meeting inclusion criteria, and enrollment, all participants will complete several standard self-report questionnaires related to medical history, social demographic, and psychosocial variables that are related to low back pain, and often used in clinics that manage patients with low back pain. They will then be randomized to either receive the education, or only usual care (which is the typical information the surgeon provides the patient verbally during the pre-operative appointment). All patients will receive the usual care education from their surgeon.
Education Group:
The educational video is a white board style patient-centric video. The content of the education focus 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 on-acute pain. It also discusses some of the dangers of long-term opioid usage.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Currently scheduled for a pre-operative appointment with an orthopaedic spine surgeon or neurosurgeon specifically for a lumbar surgery.
- •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
Exclusion Criteria
- •a. Known aversion or allergy that would prevent the patient from taking any opioid based pain medication
Arms & Interventions
Educational Video
Evidence-based video: Best Advice for People Taking Opioid Medication
Intervention: Educational Video (Behavioral)
Usual Care
Usual care education provided at time of pre-operative appointment.
Outcomes
Primary Outcomes
Number of Opioid Medication Prescriptions
Time Frame: 12 months
Number of prescriptions within 12 months after surgery
Secondary Outcomes
- Numeric Pain Rating Scale (NPRS)(6 months)
- Modified Oswestry Disability Index (ODI) or Neck Disability Index (NDI)(6 months)
Investigators
Dan Rhon
Director of Physical Therapy, Center for the Intrepid
Brooke Army Medical Center