Impact of Different Educational Approaches on Post-operative Opiate Utilization After Elective Lower Extremity Surgery
Condition: Knee Injuries and Disorders; Hip Injuries and Disorders; Opiate Addiction
MeSH terms: Opioid-Related Disorders; Wounds and Injuries; Knee Injuries; Hip Injuries
Study type: Interventional

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.
    

Intervention name(s): Video Education; Usual Care Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; Patients that are randomized to usual care will only receive the regular instructions about opioid usage they typically receive from their surgeon.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: patient education; orthopaedic surgery; post-surgical pain; chronic opioid use