Nearly 900,000 Veterans were dispensed opioid medication at the prescribing peak in 2012, with rates of opioid prescribing in VA subsequently declining year-over-year to fewer than 700,000 Veterans dispensed opioid medication in 2016. These downward trends are likely to continue with more widespread implementation of the VA Opioid Safety Initiative, additional efforts at local VA hospitals to enhance opioid risk mitigation and safe opioid prescribing practices, and recently released CDC and VA/DoD opioid prescribing guidelines that discourage long-term opioid therapy for chronic non-cancer pain. Despite steady rates of opioid discontinuation in VA, little is known about consequences?both positive and negative?of opioid discontinuation. The objectives of this study are to characterize patients? experiences with the opioid discontinuation process, identify ways patients subsequently manage their pain through the use of VA and non-VA resources, and examine patient-centered outcomes such as quality of life, pain, substance use, and mental health symptom severity following opioid discontinuation. This prospective cohort study will enroll 1,144 VA patients randomly selected from the population of VA patients prescribed long-term opioid therapy. All patients will complete 5 mailed or online survey assessments at baseline, 6-, 12-, 18-, and 24-month follow-up that assess quality of life, pain, substance use, and mental health symptoms. Additional clinical and pharmacy data will be extracted from patients? VA electronic health record. We will monitor patients in the cohort for reductions in opioid dose and complete opioid discontinuation. Patients who discontinue opioid therapy will complete an additional survey to assess acute patient outcomes following opioid discontinuation. A subset of 40 patients who discontinue opioid therapy will participate in semi-structured interviews over the telephone immediately following discontinuation, as well as 6- and 12 months post-discontinuation. Interviews will ascertain patients? experiences with the opioid discontinuation process, pain treatment approaches utilized within and external to VA, and patient outcomes following discontinuation. This study has three specific aims: (1) compare acute (immediate), intermediate (6-month), and long-term (12-month) quality of life and pain outcomes between patients who discontinue versus those who remain on long-term opioid therapy (LTOT), (2) test the moderating effect of gender and race/ethnicity on changes in quality of life and pain outcomes between patients who discontinue versus those who remain on LTOT, and (3) use qualitative methods to augment quantitative findings on patient quality of life and pain outcomes, identify patient experiences with the opioid discontinuation process, and characterize the impact of discontinuation on patient-clinician relationships. The integration of results from quantitative and qualitative data analyses will characterize patient experiences with, and outcomes following, opioid discontinuation. This study is both timely and highly relevant to current national VA priority goals of (1) Pain and Use of Opioids and (2) Care in Community Networks. Specifically, this study will provide VA operations administrators, hospital executives, and clinicians with information that characterizes opioid discontinuation from patients? perspectives. These perspectives can inform best practices for discontinuing opioid therapy, when clinically indicated, while simultaneously mitigating negative consequences of discontinuation and engaging and empowering patients to manage chronic pain with evidence-based non- opioid treatment modalities available within VA and in the community.
This prospective cohort study aims to characterize Veterans? experiences with, and outcomes following, discontinuation of long-term opioid therapy. Results from this study will provide VA operations administrators, hospital executives, and clinicians with information that characterizes opioid discontinuation from patients? perspectives. These perspectives can inform best practices for discontinuing opioid therapy, when clinically indicated, while simultaneously mitigating negative consequences of discontinuation and engaging and empowering patients to manage chronic pain with evidence-based non-opioid treatment modalities available within VA and in the community. Such approaches are highly consistent with patient-centered care paradigms.
