Pain and Smoking Study - Interactive Voice Response (PASS-IVR)

VA Office of Research and Development

Status: Begins enrollment in 1 month

Conditions: Pain; Smoking; Smoking Cessation

Treatments: Other: Treatment as Usual; Behavioral: PASS-IVR

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06442514

IIR 22-070 (Registry Identifier)

Details and patient eligibility

About

PASS2 aims to expand upon the recently completed study (PASS intervention), which tested the telephone delivery of a cognitive behavioral intervention (CBI). This study will use Interactive Voice Response (IVR) to optimize the intervention's effectiveness for smoking cessation among Veteran smokers with chronic pain.

Full description

Veterans with chronic pain represent an important population in which to focus smoking cessation efforts. Smoking cessation among patients with chronic medical illnesses substantially decreases morbidity and mortality; yet, many patients (>50%) with chronic pain continue to smoke.

This study aims to:

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.
2. Determine whether PASS-IVR is superior to E-TAU at 6 (primary endpoint) and 12 months on pain interference.
3. Examine critical components of the intervention process to inform future program implementation.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• being an enrolled Veteran at VACHS;
• current tobacco use;
• willingness to make a quit attempt;
• significant chronic pain defined as >/=4 on the pain intensity portion of the Brief Pain Inventory (BPI) for more than 90 days.

Exclusion criteria

• active diagnosis of dementia or psychosis in medical record;
• severely impaired hearing or speech;
• lack of telephone access;
• enrollment in concurrent research study that might affect main outcomes of this study;
• terminal illness;
• non-English speaking;
• pregnancy;
• provider advising against exercise;
• planned surgeries; and
• clinically significant depressive symptoms (>10 PHQ-9).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

220 participants in 2 patient groups

PASS-IVR

Experimental group

Description:

An intervention that includes a proactive telehealth intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain, and nightly Interactive Voice Response (IVR) calls. Veterans in PASS-IVR will also be offered 12-weeks of pharmacotherapy (e.g., NRT patches and one of two rescue methods such as nicotine lozenge or gum or varenicline) via telemedicine consult. The NRT dose and delivery route will be tailored to the number of cigarettes smoked per day (using an established protocol).

Treatment:

Behavioral: PASS-IVR

Treatment as Usual

Other group

Description:

Treatment as usual includes referral to the local smoking cessation clinic where Veterans may select a virtual individual or group based cognitive behavioral smoking cessation program with a trained psychology intern, postdoctoral fellow or staff psychologist. In conjunction, Veterans are encouraged but not required, by clinic staff, to connect with the VA Quitline and the VA's Annie text-messaging service to support their quit. Veterans are strongly encouraged to consider pharmacotherapy (e.g., NRT patches and one of two rescue methods such as nicotine lozenge or gum or varenicline). The NRT dose and delivery route will be tailored to the number of cigarettes smoked per day (using an established protocol - interested Veterans will be offered a telemedicine consult for this service

Treatment:

Other: Treatment as Usual