Dataset Information

Pain and smoking study (PASS): A comparative effectiveness trial of smoking cessation counseling for veterans with chronic pain.

ABSTRACT:

Introduction

Smoking is associated with greater pain intensity and pain-related functional interference in people with chronic pain. Interventions that teach smokers with chronic pain how to apply adaptive coping strategies to promote both smoking cessation and pain self-management may be effective.

Methods

The Pain and Smoking Study (PASS) is a randomized clinical trial of a telephone-delivered, cognitive behavioral intervention among Veterans with chronic pain who smoke cigarettes. PASS participants are randomized to a standard telephone counseling intervention that includes five sessions focusing on motivational interviewing, craving and relapse management, rewards, and nicotine replacement therapy versus the same components with the addition of a cognitive behavioral intervention for pain management. Participants are assessed at baseline, 6, and 12 months. The primary outcome is smoking cessation.

Results

The 371 participants are 88% male, a median age of 60 years old (range 24-82), and smoke a median of 15 cigarettes per day. Participants are mainly white (61%), unemployed (70%), 33% had a high school degree or less, and report their overall health as "Fair" (40%) to "Poor" (11%). Overall, pain was moderately high (mean pain intensity in past week = 5.2 (Standard Deviation (SD) = 1.6) and mean pain interference = 5.5 (SD = 2.2)). Pain-related anxiety was high (mean = 47.0 (SD = 22.2)) and self-efficacy was low (mean = 3.8 (SD = 1.6)).

Conclusions

PASS utilizes an innovative smoking and pain intervention to promote smoking cessation among Veterans with chronic pain. Baseline characteristics reflect a socioeconomically vulnerable population with a high burden of mental health comorbidities.

SUBMITTER: Bastian LA

PROVIDER: S-EPMC8391053 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundIn rural America, cigarette smoking is prevalent and health care providers lack the time and resources to help smokers quit. Telephone quitlines are important avenues for cessation services in rural areas, but they are poorly integrated with local health care resources.ObjectiveThe intent of the study was to assess the comparative effectiveness and cost effectiveness of two models for delivering expert tobacco treatment at a distance: telemedicine counseling that was integrated into smokers' primary care clinics (Integrated Telemedicine-ITM) versus telephone counseling, similar to telephone quitline counseling, delivered to smokers in their homes (Phone).MethodsSmokers (n=566) were recruited offline from 20 primary care and safety net clinics across Kansas. They were randomly assigned to receive 4 sessions of ITM or 4 sessions of Phone counseling. Patients in ITM received real-time video counseling, similar to Skype, delivered by computer/webcams in clinic exam rooms. Three full-time equivalent trained counselors delivered the counseling. The counseling duration and content was the same in both groups and was available in Spanish or English. Both groups also received identical materials and assistance in selecting and obtaining cessation medications. The primary outcome was verified 7-day point prevalence smoking abstinence at month 12, using an intent-to-treat analysis.ResultsThere were no significant baseline differences between groups, and the trial achieved 88% follow-up at 12 months. Verified abstinence at 12 months did not significantly differ between ITM or Phone (9.8%, 27/280 vs 12%, 34/286; P=.406). Phone participants completed somewhat more counseling sessions than ITM (mean 2.6, SD 1.5 vs mean 2.4, SD 1.5; P=.0837); however, participants in ITM were significantly more likely to use cessation medications than participants in Phone (55.9%, 128/280 vs 46.1%, 107/286; P=.03). Compared to Phone participants, ITM participants were significantly more likely to recommend the program to a family member or friend (P=.0075). From the combined provider plus participant (societal) perspective, Phone was significantly less costly than ITM. Participants in ITM had to incur time and mileage costs to travel to clinics for ITM sessions. From the provider perspective, counseling costs were similar between ITM (US $45.46, SD 31.50) and Phone (US $49.58, SD 33.35); however, total provider costs varied widely depending on how the clinic space for delivering ITM was valued.ConclusionsFindings did not support the superiority of ITM over telephone counseling for helping rural patients quit smoking. ITM increased utilization of cessation pharmacotherapy and produced higher participant satisfaction, but Phone counseling was significantly less expensive. Future interventions could combine elements of both approaches to optimize pharmacotherapy utilization, counseling adherence, and satisfaction. Such an approach could commence with a telemedicine-delivered clinic office visit for pharmacotherapy guidance, and continue with telephone or real-time video counseling delivered via mobile phones to flexibly deliver behavioral support to patients where they most need it-in their homes and communities.Trial registrationClinicaltrials.gov NCT00843505; http://clinicaltrials.gov/ct2/show/NCT00843505 (Archived by WebCite at http://www.webcitation.org/6YKSinVZ9).

Project description:IntroductionHospitalization is a unique opportunity for smoking cessation, but prior interventions have measured efficacy with narrowly defined populations. The objective of this study was to enroll smokers admitted to two "safety net" hospitals and compare the effectiveness of two post-discharge cessation interventions.DesignA randomized comparative effectiveness trial was conducted.Setting/participantsAt two New York City public hospitals, every hospitalized patient identified as a smoker (based on admission records) was approached. Inclusion criteria were: smoked cigarettes in the past 30 days; spoke English, Spanish, or Mandarin; had a U.S. phone number; not discharged to an institution where follow-up or smoking was limited; and not pregnant/breastfeeding. Of 18,797 patients identified as current smokers between July 2011 and April 2014, a total of 3,047 (16%) were discharged before being approached, 3,273 (17%) were not current smokers, 4,026 (21%) had no U.S. phone number, 2,831 (15%) were ineligible for other reasons, and 3,983 (21%) refused participation. In total, 1,618 (9%) participants enrolled in the study. During follow-up, 69% of participants were reached at 2 months and 68% at 6 months.InterventionAt discharge, participants were randomized to multisession telephone counseling from study staff (n=804) or referral to the state quitline for proactive outreach and counseling (n=814).Main outcome measuresSelf-reported abstinence at 6 months was measured. Analyses were conducted in late 2015.ResultsOne quarter of participants were homeless or in unstable housing, 60% had a history of substance abuse, 43% reported current hazardous drinking, and half had a psychiatric diagnosis other than substance abuse. At follow-up, the rate of abstinence (30-day point prevalence) was higher in the intensive counseling arm than the quitline arm at 2 months (29.0% vs 20.7%; relative risk=1.40; 95% CI=1.13, 1.73) and 6 months (37.4% vs 31.5%; relative risk=1.19; 95% CI=1.01, 1.40).ConclusionsIntensive counseling was more effective than referral to the state quitline. Long-term abstinence was excellent in both groups. Many patients were not eligible for enrollment despite minimal exclusion criteria.Trial registrationThis study is registered at www.clinicaltrials.gov NCT01363245.

Project description:The focus on acute care, time pressure, and lack of resources hamper the delivery of smoking cessation interventions in the emergency department (ED). The aim of this study was to 1) determine the effect of an emergency nurse-initiated intervention on delivery of smoking cessation counseling based on the 5As framework (ask-advise-assess-assist-arrange) and 2) assess ED nurses' and physicians' perceptions of smoking cessation counseling.The authors conducted a pre-post trial in 789 adult smokers (five or more cigarettes/day) who presented to two EDs. The intervention focused on improving delivery of the 5As by ED nurses and physicians and included face-to-face training and an online tutorial, use of a charting/reminder tool, fax referral of motivated smokers to the state tobacco quitline for proactive telephone counseling, and group feedback to ED staff. To assess ED performance of cessation counseling, a telephone interview of subjects was conducted shortly after the ED visit. Nurses' and physicians' self-efficacy, role satisfaction, and attitudes toward smoking cessation counseling were assessed by survey. Multivariable logistic regression was used to assess the effect of the intervention on performance of the 5As, while adjusting for key covariates.Of 650 smokers who completed the post-ED interview, a greater proportion had been asked about smoking by an ED nurse (68% vs. 53%, adjusted odds ratio [OR] = 2.0, 95% confidence interval [CI] = 1.3 to 2.9), assessed for willingness to quit (31% vs. 9%, adjusted OR= 4.9, 95% CI = 2.9 to 7.9), and assisted in quitting (23% vs. 6%, adjusted OR = 5.1, 95% CI = 2.7 to 9.5) and had arrangements for follow-up cessation counseling (7% vs. 1%, adjusted OR = 7.1, 95% CI = 2.3 to 21) during the intervention compared to the baseline period. A similar increase was observed for emergency physicians (EPs). ED nurses' self-efficacy and role satisfaction in cessation counseling significantly improved following the intervention; however, there was no change in "pros" and "cons" attitudes toward smoking cessation in either ED nurses or physicians.Emergency department nurses and physicians can effectively deliver smoking cessation counseling to smokers in a time-efficient manner. This trial also provides empirical support for expert recommendations that call for nursing staff to play a larger role in delivering public health interventions in the ED.

Project description:ImportanceElectronic cigarettes (e-cigarettes) for smoking cessation remain controversial.ObjectiveTo evaluate e-cigarettes with individual counseling for smoking cessation.Design, setting, and participantsA randomized clinical trial enrolled adults motivated to quit smoking from November 2016 to September 2019 at 17 Canadian sites (801 individuals screened; 274 ineligible and 151 declined). Manufacturing delays resulted in early termination (376/486 participants, 77% of target). Outcomes through 24 weeks (March 2020) are reported.InterventionsRandomization to nicotine e-cigarettes (n = 128), nonnicotine e-cigarettes (n = 127), or no e-cigarettes (n = 121) for 12 weeks. All groups received individual counseling.Main outcomes and measuresThe primary end point was point prevalence abstinence (7-day recall, biochemically validated using expired carbon monoxide) at 12 weeks, changed from 52 weeks following early termination. Participants missing data were assumed to be smoking. The 7 secondary end points, examined at multiple follow-ups, were point prevalence abstinence at other follow-ups, continuous abstinence, daily cigarette consumption change, serious adverse events, adverse events, dropouts due to adverse effects, and treatment adherence.ResultsAmong 376 randomized participants (mean age, 52 years; 178 women [47%]), 299 (80%) and 278 (74%) self-reported smoking status at 12 and 24 weeks, respectively. Point prevalence abstinence was significantly greater for nicotine e-cigarettes plus counseling vs counseling alone at 12 weeks (21.9% vs 9.1%; risk difference [RD], 12.8 [95% CI, 4.0 to 21.6]) but not 24 weeks (17.2% vs 9.9%; RD, 7.3 [95% CI, -1.2 to 15.7]). Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%; RD, 8.2 [95% CI, -0.1 to 16.6]), but was significantly greater at 24 weeks (20.5% vs 9.9%; RD, 10.6 [95% CI, 1.8 to 19.4]). Adverse events were common (nicotine e-cigarette with counseling: 120 [94%]; nonnicotine e-cigarette with counseling: 118 [93%]; counseling only: 88 [73%]), with the most common being cough (64%) and dry mouth (53%).Conclusions and relevanceAmong adults motivated to quit smoking, nicotine e-cigarettes plus counseling vs counseling alone significantly increased point prevalence abstinence at 12 weeks. However, the difference was no longer significant at 24 weeks, and trial interpretation is limited by early termination and inconsistent findings for nicotine and nonnicotine e-cigarettes, suggesting further research is needed.Trial registrationClinicalTrials.gov Identifier: NCT02417467.

Project description:Relative effectiveness of smoking cessation medications-varenicline, bupropion and nicotine replacement therapy (NRT)-remains unclear among smokers in real-world settings. Evidence in females and smokers with light/moderate nicotine dependence is particularly insufficient. This study compared the effectiveness of varenicline, bupropion or NRT gum relative to NRT patch, in achieving abstinence among recent quitters.In a national smoking cessation program in Taiwan (2012-2015), a cohort of 11,968 participants received varenicline (n = 5,052), bupropion (n = 823), NRT gum (n = 1944) or NRT patch (n = 4,149). The 7-day, 1-month or 6-month point-prevalence was calculated based on self-reported last smoking event via telephone interview after 6 months. Logistic regression modellings estimated odds ratios (OR) and 95% confidence intervals (CI) for achieving abstinence using different modalities (NRT patch as referent). Models included age, sex, education, marital status, geographic region, smoke-years, nicotine-dependence level, medical institution, number of clinic visits and medication use duration. Analyses were further stratified by sex and dependence severity.Participants were predominantly male (83%) with a mean age of 43.7±12.6 years. Varenicline users were more likely than NRT patch users to achieve abstinence, based on 7-day point-prevalence (OR = 1.30, CI: 1.19-1.44), 1-month point-prevalence (OR = 1.36, CI: 1.24-1.50) or 6-month point-prevalence (OR = 1.30, CI: 1.14-1.47). Compared with NRT patch, varenicline was associated with greater odds of being abstinent in women (OR = 1.29, CI: 1.01-1.65), men (OR = 1.31, CI: 1.18-1.46), those with light/moderate dependence (OR = 1.42, CI: 1.24-1.63) or smokers with severe dependence (OR = 1.19, CI: 1.04-1.37), based on 7-day point-prevalence. Differences in effectiveness were not observed between users of bupropion, NRT gum and NRT patch.In smoking cessation clinics in Taiwan, varenicline users reported higher abstinence rates than NRT patch users after 6 months. Women and smokers with light/moderate nicotine dependence may also benefit from varenicline in actual clinical practice.

Project description:BackgroundRandomized efficacy clinical trials conducted in research settings may not accurately reflect the benefits of tobacco dependence treatments when used in real-world clinical settings. Effectiveness trials (eg, in primary care settings) are needed to estimate the benefits of cessation treatments in real-world use.MethodsA total of 1346 primary care patients attending routine appointments were recruited by medical assistants in 12 primary care clinics. Patients were randomly assigned to 5 active pharmacotherapies: 3 monotherapies (nicotine patch, nicotine lozenge, and bupropion hydrochloride sustained release [SR]) and 2 combination therapies (patch + lozenge and bupropion SR + lozenge). Patients were referred to a telephone quit line for cessation counseling. Primary outcomes included 7-day point prevalence abstinence at 1 week, 8 weeks, and 6 months after quitting and number of days to relapse.ResultsAmong 7128 eligible smokers (> or =10 cigarettes per day) attending routine primary care appointments, 1346 (18.9%) were enrolled in the study. Six-month abstinence rates for the 5 active pharmacotherapies were the following: bupropion SR, 16.8%; lozenge, 19.9%; patch, 17.7%; patch + lozenge, 26.9%; and bupropion SR + lozenge, 29.9%. Bupropion SR + lozenge was superior to all of the monotherapies (odds ratio, 0.46-0.56); patch + lozenge was superior to patch and bupropion monotherapies (odds ratio, 0.56 and 0.54, respectively).ConclusionsOne in 5 smokers attending a routine primary care appointment was willing to make a serious quit attempt that included evidence-based counseling and medication. In this comparative effectiveness study of 5 tobacco dependence treatments, combination pharmacotherapy significantly increased abstinence compared with monotherapies. Provision of free cessation medications plus quit line counseling arranged in the primary care setting holds promise for assisting large numbers of smokers to quit. Trial Registration clinicaltrials.gov Identifier: NCT00296647.