Enhancing an Intervention for Smokers with Chronic Pain using IVR: A Randomized Clinical Trial of Smoking Cessation Counseling for Veterans

Background: Approximately 20% of Veterans smoke. Like smoking, pain is frequently reported by Veterans and smoking is associated with concurrent pain intensity. A reciprocal biopsychosocial model of pain and smoking is hypothesized whereby pain and smoking mutually maintain each other resulting in a cycle marked

by elevations in both. More than 50% of patients with chronic pain smoke and standard smoking cessation interventions are largely ineffective for them – in part because pain is a trigger to smoke. Significance: In a recently completed comparative effectiveness trial (IIR15-092), a standard smoking

cessation protocol (including pharmacotherapy) was compared to an integrated evidence-based pain and smoking cessation intervention (PASS) among Veterans with chronic pain. At 6-month follow-up, 12% of the patients in the PASS condition reported a 30-day point prevalence abstinence from smoking compared to 6%

in the standard protocol. The PASS condition also demonstrated a 6-month improvement in pain interference (34% reported a 30% reduction in pain interference) compared to 19% in the standard protocol. Depressive symptoms were found to have a significant moderating effect such that those with clinically meaningful

depression achieved a lower cessation rate relative to non-depressed (8% vs 17%). Though PASS was significant (and promising), the intervention arm did not surpass the superiority threshold (15%) and it did not achieve the expected 20% cessation rate. Accordingly, a more intense intervention is needed to optimize

smoking cessation among non-depressed Veterans with pain. Future efforts will then need to augment the intervention for those who are depressed. Innovation & Impact: This proposal augments the PASS intervention with Interactive Voice Response (IVR) to optimize the effectiveness of the intervention. IVR allows patients to interact with a computer-operated phone

system and receive personalized asynchronous feedback to reinforce PASS skill acquisition, and utilization. Specific Aims: AIM 1: Determine whether the existing integrated pain and smoking cessation (PASS intervention) augmented with IVR (PASS-IVR) is superior to treatment as usual (e.g., referral to standard VA

smoking cessation clinic) enhanced with pharmacotherapy tele-consult (E-TAU) at 6 (primary endpoint) and 12 months on cigarette abstinence rates among non-depressed Veterans with chronic pain. Hypotheses 1.1: Prolonged abstinence rates and point prevalence abstinence rates will be significantly higher

among non-depressed Veterans with chronic pain who receive PASS-IVR compared with those in E-TAU. AIM 2: Determine whether PASS-IVR is superior to E-TAU at 6 (primary endpoint) and 12 months on pain interference. Hypothesis 2.1: Non-depressed Veterans in PASS-IVR will report significantly lower pain interference relative

to E-TAU. AIM 3: Examine key components of the intervention process to inform future program implementation using the RE-AIM framework which considers intervention strengths and weaknesses with respect to Reach, Effectiveness, Adoption, Implementation, and Maintenance. Methodology: A Hybrid Type 1 randomized comparative effectiveness trial with a two-group design is

proposed. Non-depressed Veterans (N=220) who smoke and have chronic pain will be randomized to either: 1) PASS-IVR, a telemedicine intervention that augments the existing integrated evidence-based PASS intervention with IVR, or 2) E-TAU. Both arms receive pharmacotherapy via telemedicine clinics. Next Steps/Implementation: We will work with our partners in the pain management and opioid prescribing

program office, primary care, mental health, and tobacco to leverage our findings and implement strategies to optimize smoking cessation for veterans with chronic pain.