Background: Surgery can precipitate the development of both chronic pain and long-term opioid use. Preoperative psychological distress is a risk factor for poor post-surgical outcomes. Strategies are needed to augment perioperative pharmacotherapeutic management of pain with non-pharmacologic strategies to optimize post-operative outcomes. Psychological interventions such as cognitive behavioral therapy (CBT) can effectively reduce distress and improve functioning among patients with chronic pain. While CBT has been used extensively in patients with established chronic pain, it has not been used as a preventive intervention targeting the transition from acute to chronic postsurgical pain. Significance/Impact: This proposal addresses the priority areas of chronic pain and opioid use. This study enhances biopsychosocial pain care during the perioperative period and offers a model to prevent the development of chronic pain and prolonged opioid use following surgery. Innovation: The proposed innovative approach to preventing, rather than managing, chronic postsurgical pain among Veterans could incite a clinical paradigm shift from pain treatment to prevention. Specific Aims: Aim 1: Use a Hybrid Type 1 Randomized Controlled Trial design to examine the efficacy of the Perioperative Pain Self-management (PePS) program versus Standard Care (SC) for preventing chronic postoperative pain and prolonged opioid use. Exploratory analyses will examine whether substance use disorders moderate treatment effects and whether changes in pain catastrophizing and self-efficacy relate to postoperative pain at 6-months post-surgery. Aim 2: Determine the impact of the PePS program on secondary outcomes: mood, functioning, and non-opioid analgesic prescriptions. Aim 3: Evaluate the context of implementation by examining acceptability, feasibility, and appropriateness among Veterans and care team members, and quantifying intervention-specific personnel-related costs. Based on the Implementation Outcomes framework, the current study will use primarily qualitative methodology for aim 3. Methodology: The current study is a hybrid efficacy-implementation design to facilitate a more rapid move toward broad-based dissemination and uptake of the PePS program. For Aim 1 and 2 we will utilize a single- blind, two-arm, parallel, randomized control trial. Participants will include 400 Veterans scheduled at the Iowa City or Minneapolis VAs for unilateral primary total joint arthroplasty. Participants will be randomized to PePS or SC. The PePS program includes 4 telephone sessions: Session one will be preoperative and include an introduction to relaxation and the importance of interpretation in the pain experience. Session two (two weeks postoperative) will include: review of relaxation and the connection between thoughts/interpretation and pain, and introduction to thought records. Session three will include review of thought records and relaxation and introduction to goal-setting and cognitive restructuring. Session four will include: review and creating a plan for continued use of skills. Primary and secondary outcomes will be measured for 6 weeks post-surgery (medications only), and at 3 months, and 6 months post-surgery (all other outcomes). Six-months will be the primary endpoint for pain, mood, and functioning. Multivariate logistic regression will be employed to determine the relationship between treatment arm and the dichotomous outcome: moderate to severe pain at 6-months post-surgery. Survival analyses will be used to determine time to opioid (and other analgesic) cessation. Aim 3 will assess acceptability, appropriateness, feasibility, and estimate costs associated with subsequent implementation. This will include qualitative interviews with both Veteran surgical patients and surgery clinic staff (surgeons, nurses, and clerks) at both sites. We will use micro-costing to quantify work time. Implementation/Next Steps: These findings will be used to inform subsequent implementation work of the PePS program within the VA healthcare system.
External Links for this Project
Grant Number: I01HX003225-01A1
None at this time.
Other Conditions, Acute and Combat-Related Injury
Treatment - Efficacy/Effectiveness Clinical Trial, TRL - Applied/Translational
Best Practices, Pain, Symptom Management
None at this time.