Primary Care Intervention to Reduce Prescription Opioid Overdoses

Adverse outcomes, including overdose, related to opioid use have increased and represent a
significant threat to the safety and quality of VHA pain care as well as a national public
health concern. Efforts are underway to change opioid prescribing behavior, but concurrent
strategies are needed to address patient behaviors that decrease opioid safety and thus
increase opioid overdose risk. Overdoses result from a range of behaviors, including taking
more than prescribed, using multiple substances with synergistic effects, and
injecting/snorting crushed pills to get high. Factors such as having a mental health
condition have been found to increase risk of overdose among Veterans receiving opioids for
pain. Given the range of risk behaviors and relevant patient factors, tailored opioid risk
reduction strategies are urgently needed. Motivational enhancement (ME) is an evidence-based
strategy that uses tailoring to enact behavior change through improving self-efficacy and
motivation. Recent VHA initiatives to increase behavioral health providers in primary care,
such as Primary Care-Mental Health Integration (PC-MHI), provide a clear opportunity to
deliver ME interventions to the many patients treated for long-term pain in primary care.
Although the impact of ME on overdose risk behavior is unknown, the use of an ME approach to
improve opioid safety and reduce risk behaviors is potentially well-suited to the context of
long-term opioid pain care, when total and immediate discontinuation of opioid use is often
unfeasible.

The proposed Prescription Opioid Safety Trial (POST) study will be a randomized controlled
trial of a brief, tailored ME conversation that incorporates cognitive behavioral strategies
to increase pain coping and is aimed at improving patients' opioid safety. The study will
recruit 450 patients from primary care clinics at the VA Ann Arbor Healthcare System.
Patients with long-term opioid use, defined as treatment for at least 84 days covered within
the last 90 days, who are prescribed opioid doses of 20 morphine-equivalent mg/day or greater
(an indicator of overdose risk) will be screened and recruited into the study. Participants
will then be randomized to either the intervention (n = 225) or an enhanced usual care (EUC)
condition (n = 225). Pharmacy records and patient self-report will be assessed at baseline
and 3-, 6-, and 12-month follow-ups to measure key outcomes.

The specific aims are:

Aim 1) to examine if patients randomly assigned to a brief opioid safety intervention report
reduced overdose risk behaviors (e.g., higher dose, concurrent alcohol use, concurrent other
drug/medication use, returning to normal dose after breaks in use) over one year of follow-up
compared to patients assigned to equal attention EUC.

Aim 2) to examine if patients randomly assigned to a brief opioid safety intervention have
lower total quantities of opioids prescribed (from pharmacy fill records) and aberrant opioid
use (e.g., using for reasons other than pain, obtaining opioids from someone other than
primary provider) over one year of follow-up compared to patients assigned to equal attention
EUC.

The study has two secondary aims: 1) to examine if patients randomly assigned to the brief
intervention have fewer non-fatal overdoses and other medication-related adverse events
(emergency department visits, over-sedation, injuries), better functioning, and more often
store and dispose of opioids safely compared to patients assigned to EUC; and 2) to examine
mediators (motivation and self-efficacy) and moderators (OIF/OEF/OND status, baseline mental
health) of intervention effects.

Inclusion Criteria:

- Patient at the Ann Arbor VA Medical Center receiving treatment in a primary care
clinic

- Currently prescribed 20 morphine-equivalent mg (MEM) per day or more of an opioid

- Received opioid therapy for at least 90 days

- 18 years of age or older

Exclusion Criteria:

- Plans to stop opioids or reduce dose to below 20 MEM/day in the next 6 months

- Use of fentanyl, due to the difficulty in determining morphine equivalency

- A terminal cancer diagnosis

- Acute suicidality requiring immediate treatment

- Moderately severe cognitive impairment

- Inability to give informed consent