BACKGROUND/RATIONALE:
Chronic pain is an important public health problem and among the most prevalent and disabling of chronic diseases. Opioid analgesics became the most commonly prescribed medications for chronic pain over two decades; however, recognition of an epidemic of opioid-related addiction and overdose death has triggered a new era in opioid attitudes and policies, in which opioid prescribing trends are being actively reversed.

The Veterans Health Administration (VHA) has been a national leader in pain management -- including early initiatives to promote greater awareness of pain, efforts to expand access to a stepped care model of pain treatment, and responses to the present epidemic of serious opioid-related harms. Recent VHA opioid policies include system-wide opioid safety goals to increase use of opioid risk management tools and decrease high-risk prescribing such as high-dose opioid therapy. If successful, VHA initiatives will reduce potentially hazardous and excessive prescribing of opioids, and improve pain and quality of life (QOL) outcomes among Veterans with chronic pain.

OBJECTIVE(S):
The main objective is to understand patient-reported outcomes of opioid prescribing changes in a prospective cohort of VA patients treated with long-term opioids for chronic pain. Specific aims are to examine, among patients receiving long-term opioid therapy, 1) the relationship between changes in prescribed opioids and changes in patient-reported pain and QOL outcomes; and 2) associations of patient, provider, and facility factors with changes in patient-reported pain and QOL, primarily through their influence on opioid prescribing and use of non-pharmacological pain therapies.

METHODS:
Existing VHA datasets were used to identify VA patients prescribed at least 6 months of opioid analgesic medications for chronic pain. From this population, a national sample of VA primary care patients receiving long-term opioid therapy was identified using a multi-stage random sampling strategy. Patients included in the sample were invited to participate in a longitudinal cohort study and complete brief questionnaires at three time points (baseline, 12 months, and 24 months). Following established methods for maximizing response to mailed surveys, eligible patients were contacted multiple times by mail for each data collection time point, with a final telephone follow-up for non-responders. Questionnaires assess pain-related function and health-related QOL as the primary outcomes and pain characteristics, patient perception of treatment, and aspects of the patient-provider relationship as covariates. VHA administrative data will be used to assess patient use of non-pharmacological pain therapies and patient, provider, and facility covariates. Analyses will used merged patient-reported and administrative datasets.

FINDINGS/RESULTS:
The cohort includes 9,245 patients (65.9% of 14,029 contacted) who completed a baseline questionnaire or interview. Of those contacted, 1697 (12.1%) refused and 3087 (22.0%) didn't respond. At baseline, participants were 7. 6% female with a mean age of 63.5 years (SD 10. 6).

IMPACT:
The VA Opioid Safety Initiative (OSI) aims to reduce risk of harms from inappropriate or excessive prescribing of opioid analgesics for chronic pain. By examining patient-reported pain and quality of life outcomes, the research will allow for a fuller understanding of the impact of VHA opioid and pain management policies on Veterans receiving opioid therapy for chronic pain. Study findings will contribute to identifying successful approaches and targeting potential gaps in VA efforts to achieve patient-centered pain management and opioid safety goals.

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External Links for this Project

NIH Reporter

Grant Number: I01HX001752-01A1
Link: https://reporter.nih.gov/project-details/8979914

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PUBLICATIONS:

Journal Articles

1. Frank JW, Carey E, Nolan C, Hale A, Nugent S, Krebs EE. Association Between Opioid Dose Reduction Against Patients' Wishes and Change in Pain Severity. Journal of general internal medicine. 2020 Dec 1; 35(Suppl 3):910-917. [view]
2. Goldsmith ES, MacLehose RF, Jensen AC, Clothier B, Noorbaloochi S, Martinson BC, Donaldson MT, Krebs EE. Complementary, Integrative, and Nondrug Therapy Use for Pain Among US Military Veterans on Long-term Opioids. Medical care. 2020 Sep 1; 58 Suppl 2 9S:S116-S124. [view]
3. Krebs EE, Clothier B, Nugent S, Jensen AC, Martinson BC, Goldsmith ES, Donaldson MT, Frank JW, Rutks I, Noorbaloochi S. The evaluating prescription opioid changes in veterans (EPOCH) study: Design, survey response, and baseline characteristics. PLoS ONE. 2020 Apr 22; 15(4):e0230751. [view]

Journal Other

1. Martinson BC. Give researchers a lifetime word limit. Nature. 2017 Oct 17; 550(7676):303. [view]

DRA: Other Conditions, Substance Use Disorders, Musculoskeletal Disorders
DRE: Treatment - Observational
Keywords: Pain, Patient Preferences, Pharmacology, Substance Use and Abuse
MeSH Terms: none