Opioid medications have been increasingly prescribed for pain in the U.S. generally and in VHA specifically. Parallel to opioid prescribing increasing in the U.S., the rate of prescription opioid-specific overdoses increased 293% between 1999 and 2009. In 2010, prescription opioids were involved in 57.6% of all overdose deaths in which the drug(s) responsible was recorded. Studies by our study team indicate that: 1) VHA patients have approximately twice the risk of overdose compared to the general population after accounting for age and sex; 2) VHA patients prescribed higher doses of opioids have a markedly elevated risk for overdose; and 3) 76.4% of VHA patients who die of an opioid medication overdose were seen in primary care in the year prior to death. While efforts are underway to address prescriber behavior related to opioids (i.e., the VHA Opioid Safety Initiative), concurrent strategies that address patient behavior are needed.
The proposed study will be a randomized controlled trial (RCT) of a brief, tailored motivational enhancement (ME) intervention to reduce overdose risk behavior for patients in the VA primary care/PC-MHI setting. While ME has demonstrated efficacy in numerous RCTs across a range of behaviors, to date, ME has not been applied to overdose risk behaviors in any VA setting. Our proposed intervention will incorporate ME, as well as cognitive-behavioral strategies, to provide tailored feedback regarding risks associated with opioid use, elicit commitment talk to reduce patients' overdose risk behavior and over-reliance on opioids for pain management, and impart specific cognitive and behavioral "tools" related to pain management and safe use of opioids. The objectives are to examine if patients randomly assigned to a ME brief intervention for overdose prevention report reduced overdose risk behavior over one year of follow-up compared to an enhanced usual care condition (EUC); and to examine if patients randomly assigned to a ME brief intervention report reduced prescription opioid use over one year of follow-up compared to a usual care condition.
To achieve these objectives, the proposed study will recruit patients from primary care clinics at the VA Ann Arbor Healthcare System in Michigan. Patients who have risk factors indicating elevated risk for prescription opioid overdose will be screened and recruited. Participants who meet eligibility criteria and complete the primary survey will be randomized to either the intervention or EUC condition. Those patients randomized to the intervention will receive an intervention session with a trained therapist. Participants will then be re-interviewed over one year of follow-up. Outcomes will include overdose risk behavior, opioid use and misuse, and adverse effects of opioid use. Objective data on opioid medication fills will also be obtained using pharmacy records and opioid therapy risk reports.
Recruitment and data collection are being conducted. Therefore, analyses have not yet begun. We hypothesize that participants randomized to the intervention condition will report fewer overdose risk behaviors than EUC participants at follow-up. We hypothesize that participants randomized to the intervention will have lower average prescription opioid misuse levels than EUC participants over follow-up. Finally, it will be examined if participants randomized to the intervention will report lower levels of aberrant opioid use than EUC participants over follow-up.
The study will increase understanding of strategies to reduce adverse outcomes related to opioid medication use and misuse, namely, risk of overdose, among VHA primary care patients. Knowledge generated in the proposed study is likely to have broad implications for improving the safety of opioid use, and consequently the quality of pain care, for current and future VHA patients.
None at this time.
Substance Abuse and Addiction, Other Conditions
Treatment - Efficacy/Effectiveness Clinical Trial, Treatment - Implementation