Pain and Smoking Study - Interactive Voice Response

Pain Clinical Trial

— PASS-IVR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06442514
• Other study ID #: IIR 22-070
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: May 31, 2028

Study information

• Verified date: June 2024
• Source: VA Office of Research and Development
• Contact: Lori A Bastian, MD MPH
• Phone: (203) 932-5711
• Email: Lori.Bastian[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: May 31, 2028
• Est. primary completion date: May 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Pain
• Smoking
• Smoking Cessation

Intervention

Behavioral:
• PASS-IVR
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.

Other:
• Treatment as Usual
Referral to the local smoking cessation VA clinic.

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Pain intensity and pain-related functional interference	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