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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PASS-IVR | Experimental | 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). |
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| Treatment as Usual | Other | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PASS-IVR | Behavioral | 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 to report smoking status, pain, and pedometer-measured step counts, which the clinician will use to provide individualized feedback. |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarette Smoking Abstinence Rates | In keeping with the SNRT recommendations for measuring abstinence, we will use prolonged abstinence as our main outcome and allow for a grace period around quit date. During the 6- and 12-month follow-ups, patients will be asked about prolonged abstinence, "Since [end of the grace period] have you ever smoked at least a part of a cigarette on each of 7 consecutive days?" and "After [end of the grace period] have you smoked any in each of 2 consecutive weeks". | 6-month and 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Point prevalent abstinence | Patients will be asked whether they have smoked a cigarette, even a puff, in the past 7 days and, if no, will be asked whether they have smoked a cigarette, even a puff, in the past 30 days. | 6-month and 12-month follow-up |
| Pain intensity and pain-related functional interference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lori A Bastian, MD MPH | Contact | (203) 932-5711 | 3830 | Lori.Bastian@va.gov |
| Mary Driscoll, PhD | Contact | (203) 932-5744 | 3631 | Mary.Driscoll3@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Lori Anne Bastian, MD MPH | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516-2770 | United States |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D010146 | Pain |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as Usual | Other | Referral to the local smoking cessation VA clinic. |
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Pain intensity and interference will be assessed using the 11-item BPI. The BPI also assesses chronicity of pain and areas of the body with pain. The interference subscale has demonstrated adequate internal consistency and robust concurrent validity and responsivity among patients with chronic non-cancer pain. We have also added the PROMIS 8-item pain interference measure and the PROMIS 3-item pain intensity measure which has comparable responsiveness to BPI and excellent internal consistency (.96). |
| baseline, 6-months follow-up, and 12-months follow-up |
| D015438 | Health Behavior |