Tobacco dependence treatment in the emergency department: A randomized trial using the Multiphase Optimization Strategy.
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ABSTRACT: Background
Tobacco dependence remains the leading preventable cause of death in the developed world. Smokers are disproportionately from lower socioeconomic groups, and may use the hospital emergency department (ED) as an important source of care. A recent clinical trial demonstrated the efficacy of a multicomponent intervention to help smokers quit, but the independent contributions of those components is unknown.Methods
This is a full-factorial (16-arm) randomized trial in a busy hospital ED of 4 tobacco dependence interventions: brief motivational interviewing, nicotine replacement therapy, referral to a telephone quitline, and a texting program. The trial utilizes the Multiphase Optimization Strategy (MOST) and a novel mixed methods analytic design to assess clinical efficacy, cost effectiveness, and qualitative participant feedback. The primary endpoint is tobacco abstinence at 3months, verified by participants' exhaled carbon monoxide.Results
Study enrollment began in February 2017. As of April 2017, 52 of 1056 planned participants (4.9%) were enrolled. Telephone-based semi-structured participant interviews and in-person biochemical verification of smoking abstinence are completed at the 3-month follow-up. Efficacy and cost effectiveness analyses will be conducted after follow-up is completed.Discussion
The goal of this study is to identify a clinically efficacious, cost-effective intervention package for the initial treatment of tobacco dependence in ED patients. The efficacy of this combination can then be tested in a subsequent confirmatory trial. Our approach incorporates qualitative feedback from study participants in evaluating which intervention components will be tested in the future trial.Trial registration
Trial (NCT02896400) registered in ClinicalTrials.gov on September 6, 2016.
SUBMITTER: Bernstein SL
PROVIDER: S-EPMC5851600 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Study objectiveTobacco dependence treatment initiated in the hospital emergency department (ED) is effective. However, trials typically use multicomponent interventions, making it difficult to distinguish specific components that are effective. In addition, interactions between components cannot be assessed. The Multiphase Optimization Strategy allows investigators to identify these effects.MethodsWe conducted a full-factorial, 24 or 16-condition optimization trial in a busy hospital ED to examine the performance of 4 tobacco dependence interventions: a brief negotiation interview; 6 weeks of nicotine replacement therapy with the first dose delivered in the ED; active referral to a telephone quitline; and enrollment in SmokefreeTXT, a free short-messaging service program. Study data were analyzed with a novel mixed methods approach to assess clinical efficacy, cost-effectiveness, and qualitative participant feedback. The primary endpoint was tobacco abstinence at 3 months, verified by exhaled carbon monoxide using a Bedfont Micro+ Smokerlyzer.ResultsBetween February 2017 and May 2019, we enrolled 1,056 adult smokers visiting the ED. Odd ratios (95% confidence intervals) from the primary analysis of biochemically confirmed abstinence rates at 3 months for each intervention, versus control, were: brief negotiation interview, 1.8 (1.1, 2.8); nicotine replacement therapy, 2.1 (1.3, 3.2); quitline, 1.4 (0.9, 2.2); SmokefreeTXT, 1.1 (0.7, 1.7). There were no statistically significant interactions among components. Economic and qualitative analyses are in progress.ConclusionThe brief negotiation interview and nicotine replacement therapy were efficacious. This study is the first to identify components of ED-initiated tobacco dependence treatment that are individually effective. Future work will address the scalability of the brief negotiation interview and nicotine replacement therapy by offering provider-delivered brief negotiation interviews and nicotine replacement therapy prescriptions.
| S-EPMC9868063 | biostudies-literature
Project description:Tobacco use is common among emergency department (ED) patients, many of whom have low income. Our objective is to study the efficacy of an intervention incorporating motivational interviewing, nicotine replacement, and quitline referral for adult smokers in an ED.This was a 2-arm randomized clinical trial conducted from October 2010 to December 2012 in a northeastern urban US ED with 90,000 visits per year. Eligible subjects were aged 18 years or older, smoked, and were self-pay or had Medicaid insurance. Intervention subjects received a motivational interview by a trained research assistant, 6 weeks' worth of nicotine patches and gum initiated in the ED, a faxed referral to the state smokers' quitline, a booster call, and a brochure. Control subjects received the brochure, which provided quitline information. The primary outcome was biochemically confirmed tobacco abstinence at 3 months. Secondary endpoints included quitline use.Of 778 enrolled subjects, 774 (99.5%) were alive at 3 months. The prevalence of biochemically confirmed abstinence was 12.2% (47/386) in the intervention arm versus 4.9% (19/388) in the control arm, for a difference in quit rates of 7.3% (95% confidence interval 3.2% to 11.5%). In multivariable logistic modeling controlling for age, sex, and race or ethnicity, study subjects remained more likely to be abstinent than controls (odds ratio 2.72; 95% confidence interval 1.55 to 4.75).An intensive intervention improved tobacco abstinence rates in low-income ED smokers. Because approximately 20 million smokers, many of whom have low income, visit US EDs annually, these results suggest that ED-initiated treatment may be an effective technique to treat this group of smokers.
| S-EPMC4819432 | biostudies-literature
Project description:IMPORTANCE:Opioid-dependent patients often use the emergency department (ED) for medical care. OBJECTIVE:To test the efficacy of 3 interventions for opioid dependence: (1) screening and referral to treatment (referral); (2) screening, brief intervention, and facilitated referral to community-based treatment services (brief intervention); and (3) screening, brief intervention, ED-initiated treatment with buprenorphine/naloxone, and referral to primary care for 10-week follow-up (buprenorphine). DESIGN, SETTING, AND PARTICIPANTS:A randomized clinical trial involving 329 opioid-dependent patients who were treated at an urban teaching hospital ED from April 7, 2009, through June 25, 2013. INTERVENTIONS:After screening, 104 patients were randomized to the referral group, 111 to the brief intervention group, and 114 to the buprenorphine treatment group. MAIN OUTCOMES AND MEASURES:Enrollment in and receiving addiction treatment 30 days after randomization was the primary outcome. Self-reported days of illicit opioid use, urine testing for illicit opioids, human immunodeficiency virus (HIV) risk, and use of addiction treatment services were the secondary outcomes. RESULTS:Seventy-eight percent of patients in the buprenorphine group (89 of 114 [95% CI, 70%-85%]) vs 37% in the referral group (38 of 102 [95% CI, 28%-47%]) and 45% in the brief intervention group (50 of 111 [95% CI, 36%-54%]) were engaged in addiction treatment on the 30th day after randomization (P?<?.001). The buprenorphine group reduced the number of days of illicit opioid use per week from 5.4 days (95% CI, 5.1-5.7) to 0.9 days (95% CI, 0.5-1.3) vs a reduction from 5.4 days (95% CI, 5.1-5.7) to 2.3 days (95% CI, 1.7-3.0) in the referral group and from 5.6 days (95% CI, 5.3-5.9) to 2.4 days (95% CI, 1.8-3.0) in the brief intervention group (P?<?.001 for both time and intervention effects; P?=?.02 for the interaction effect). The rates of urine samples that tested negative for opioids did not differ statistically across groups, with 53.8% (95% CI, 42%-65%) in the referral group, 42.9% (95% CI, 31%-55%) in the brief intervention group, and 57.6% (95% CI, 47%-68%) in the buprenorphine group (P?=?.17). There were no statistically significant differences in HIV risk across groups (P?=?.66). Eleven percent of patients in the buprenorphine group (95% CI, 6%-19%) used inpatient addiction treatment services, whereas 37% in the referral group (95% CI, 27%-48%) and 35% in the brief intervention group (95% CI, 25%-37%) used inpatient addiction treatment services (P?<?.001). CONCLUSIONS AND RELEVANCE:Among opioid-dependent patients, ED-initiated buprenorphine treatment vs brief intervention and referral significantly increased engagement in addiction treatment, reduced self-reported illicit opioid use, and decreased use of inpatient addiction treatment services but did not significantly decrease the rates of urine samples that tested positive for opioids or of HIV risk. These findings require replication in other centers before widespread adoption. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00913770.
| S-EPMC4527523 | biostudies-literature
Project description:BackgroundEffective weight loss interventions exist, yet few can be scaled up for wide dissemination. Further, none has been fully delivered via text message. We used the multiphase optimization strategy (MOST) to develop multicomponent interventions that consist only of active components, those that have been experimentally determined to impact the chosen outcome.ObjectiveThe goal of this study is to optimize a standalone text messaging obesity intervention, Charge, using the MOST framework to experimentally determine which text messaging components produce a meaningful contribution to weight change at 6 months.MethodsWe designed a 6-month, weight loss texting intervention based on our interactive obesity treatment approach (iOTA). Participants are randomized to one of 32 experimental conditions to test which standalone text messaging intervention components produce a meaningful contribution to weight change at 6 months.ResultsThe project was funded in February 2017; enrollment began in January 2018 and data collection was completed in June 2019. Data analysis is in progress and first results are expected to be submitted for publication in 2021.ConclusionsFull factorial trials are particularly efficient in terms of cost and logistics when leveraged for standalone digital treatments. Accordingly, MOST has the potential to promote the rapid advancement of digital health treatments. Subject to positive findings, the intervention will be low cost, immediately scalable, and ready for dissemination. This will be of great potential use to the millions of Americans with obesity and the providers who treat them.Trial registrationClinicalTrials.gov NCT03254940; https://clinicaltrials.gov/ct2/show/NCT03254940.International registered report identifier (irrid)RR1-10.2196/19506.
| S-EPMC7850907 | biostudies-literature
Project description:ObjectivesThe objective was to determine the efficacy of an emergency department (ED)-based smoking cessation intervention.MethodsThis study was a randomized trial conducted from January 2006 to September 2007 at an urban ED that treats 90,000 adults per year. Discharged adults who smoked at least 10 cigarettes per day were randomized to 1) usual care, receiving a smoking cessation brochure; or 2) enhanced care, receiving the brochure, a motivational interview (MI), nicotine patches, and a phone call at 3 days. Interventions were performed by a peer educator trained in tobacco treatment. Blinded follow-up was performed at 3 months.ResultsA total of 338 subjects were enrolled, mean (±SD) age was 40.2 (±12.0) years, 51.8% were female, and 56.5% were either self-pay or Medicaid. Demographic and clinical variables were comparable between groups. Enhanced and usual care arms showed similar cessation rates at 3 months (14.7% vs. 13.2%, respectively). The proportion of subjects making a quit attempt (69.2% vs. 66.5%) and decrease in daily cigarette use (five vs. one; all p > 0.05) were also similar. In logistic modeling, factors associated with quitting included any tobacco-related International Classification of Diseases, ninth revision (ICD-9), code for the ED visit (odds ratio [OR]= 3.42, 95% confidence interval [CI] = 1.61 to 7.26) or subject belief that the ED visit was tobacco-related (OR = 2.47, 95% CI = 1.17 to 5.21). Conversely, subjects who reported having a preexisting tobacco-related illness were less likely to quit (OR = 0.22, 95% CI = 0.10 to 0.50).ConclusionsThe primary endpoint was negative, reflecting a higher-than-expected quit rate in the control group. Subjects whose ED visit was tobacco-related, based either on physician diagnosis or subject perception, were more than twice as likely to quit. These data suggest that even low-intensity screening and referral may prompt substantial numbers of ED smokers to quit or attempt to quit.
| S-EPMC3117220 | biostudies-literature
Project description:Background and aimsIn a recent randomized trial, patients with opioid dependence receiving brief intervention, emergency department (ED)-initiated buprenorphine and ongoing follow-up in primary care with buprenorphine (buprenorphine) were twice as likely to be engaged in addiction treatment compared with referral to community-based treatment (referral) or brief intervention and referral (brief intervention). Our aim was to evaluate the relative cost-effectiveness of these three methods of intervening on opioid dependence in the ED.DesignMeasured health-care use was converted to dollar values. We considered a health-care system perspective and constructed cost-effectiveness acceptability curves that indicate the probability each treatment is cost-effective under different thresholds of willingness-to-pay for outcomes studied.SettingAn urban ED in the United States.ParticipantsOpioid-dependent patients aged 18 years or older.MeasurementsSelf-reported 30-day assessment data were used to construct cost-effectiveness acceptability curves for patient engagement in formal addiction treatment at 30 days and the number of days illicit opioid-free in the past week.FindingsConsidering only health-care system costs, cost-effectiveness acceptability curves indicate that at all positive willingness-to-pay values, ED-initiated buprenorphine treatment was more cost-effective than brief intervention or referral. For example, at a willingness-to-pay threshold of $1000 for 30-day treatment engagement, we are 79% certain ED-initiated buprenorphine is most cost-effective compared with other studied treatments. Similar results were found for days illicit opioid-free in the past week. Results were robust to secondary analyses that included patients with missing cost data, included crime and patient time costs in the numerator, and to changes in unit price estimates.ConclusionIn the United States, emergency department-initiated buprenorphine intervention for patients with opioid dependence provides high value compared with referral to community-based treatment or combined brief intervention and referral.
| S-EPMC5657503 | biostudies-literature
Project description:BackgroundTobacco use is prevalent among persons with alcohol abuse and dependence. Varenicline has been shown to be the most effective pharmacotherapy for smoking cessation and may decrease alcohol consumption. The purpose of this study was to evaluate the efficacy of 12 weeks of varenicline for increasing smoking abstinence rates in smokers with alcohol abuse or dependence.MethodsParticipants were eligible for enrollment if they were 18 years or older, smoked 10 or more cigarettes per day for at least 6 months, had current alcohol abuse or dependence, and were interested in quitting smoking. Participants were randomly assigned to receive 12 weeks of varenicline 1 mg twice daily or matching placebo. The primary end point was 7-day point prevalence smoking abstinence at week 12.ResultsThe 7-day point prevalence smoking abstinence rate at 12 weeks was significantly higher with varenicline (n = 16) than placebo (n = 17) (43.8% vs 5.9%; P = .01). At 24 weeks, the 7-day point prevalence smoking abstinence rate was still significantly higher with varenicline than placebo (31.3% vs 0%; P = .02). At 12 weeks, mean (SD) drinks per drinking day was significantly lower with varenicline than placebo (5.7 [3.9] vs 9.0 [5.3] drinks; treatment effect estimate, -2.8 [90% CI, -6.6 to -1.0]). Adverse events were minor and comparable to varenicline clinical trials.ConclusionsVarenicline is safe and efficacious for increasing smoking abstinence rates in smokers with alcohol abuse or dependence. Varenicline may decrease alcohol consumption in this population of smokers.
| S-EPMC5818285 | biostudies-literature
Project description:Obesity-attributable medical expenditures remain high, and interventions that are both effective and cost-effective have not been adequately developed. The Opt-IN study is a theory-guided trial using the Multiphase Optimization Strategy (MOST) to develop an optimized, scalable version of a technology-supported weight loss intervention.Opt-IN aims to identify which of 5 treatment components or component levels contribute most meaningfully and cost-efficiently to the improvement of weight loss over a 6 month period.Five hundred and sixty obese adults (BMI 30-40 kg/m(2)) between 18 and 60 years old will be randomized to one of 16 conditions in a fractional factorial design involving five intervention components: treatment intensity (12 vs. 24 coaching calls), reports sent to primary care physician (No vs. Yes), text messaging (No vs. Yes), meal replacement recommendations (No vs. Yes), and training of a participant's self-selected support buddy (No vs. Yes). During the 6-month intervention, participants will monitor weight, diet, and physical activity on the Opt-IN smartphone application downloaded to their personal phone. Weight will be assessed at baseline, 3, and 6 months.The Opt-IN trial is the first study to use the MOST framework to develop a weight loss treatment that will be optimized to yield the best weight loss outcome attainable for $500 or less.
| S-EPMC4104542 | biostudies-other
Project description:Spinal manipulative therapy (SMT) is a common nonpharmacological treatment for low back pain (LBP). Although generally supported by systematic reviews and practice guidelines, clinical trials evaluating SMT have been characterized by small effect sizes. This study adopts a Multiphase Optimization Strategy framework to examine individual components of an SMT delivery protocol using a single-blind trial with the goal of identifying and optimizing a multicomponent SMT protocol. We enrolled 241 participants with LBP. All participants received 2 SMT treatment sessions in the first week then were randomly assigned additional treatment based on a fully factorial design. The 3 randomized treatment components provided in twice weekly sessions over 3 weeks were multifidus activating exercise, spinal mobilizing exercise, and additional SMT dose. Primary outcomes included clinical (Oswestry Disability Index, numeric pain intensity rating) and mechanistic (spinal stiffness, multifidus muscle activation) measures assessed at baseline, 1, 4, and 12 weeks. Significant differences were found for the Oswestry index after 12 weeks for participants receiving multifidus activating exercise (mean difference = -3.62, 97.5% CI: -6.89, -0.35; P= .01). There were no additional significant main or interaction effects for other treatment components or different outcome measures. The optimized SMT protocol identified in this study included SMT sessions followed by multifidus activating exercises. PERSPECTIVE: Optimizing the effects of nonpharmacological treatments such as SMT for LBP is challenging due to uncertainty regarding mechanisms and the complexity of multicomponent protocols. This factorial randomized trial examined SMT protocols provided with differing co-interventions with mechanistic and patient-centered outcomes. Patient-centered outcomes were optimized by inclusion of lumbar multifidus strengthening exercises.
| S-EPMC8190177 | biostudies-literature
Project description:BackgroundThere is widespread agreement that the integration of cessation services in lung cancer screening (LCS) is essential for achieving the full benefits of LCS with low-dose computed tomography (LDCT). There is a formidable knowledge gap about how to best design feasible, effective, and scalable cessation services in LCS facilities. A collective of NCI-funded clinical trials addressing this gap is the Smoking Cessation at Lung Examination (SCALE) Collaboration.MethodsThe Cessation and Screening to Save Lives (CASTL) trial seeks to advance knowledge about the reach, effectiveness, and implementation of tobacco treatment in lung cancer screening. We describe the rationale, design, evaluation plan, and interventions tested in this multiphase optimization strategy trial (MOST). A total of 1152 screening-eligible current smokers are being recruited from 18 LCS sites (n = 64/site) in both academic and community settings across the USA. Participants receive enhanced standard care (cessation advice and referral to the national Quitline) and are randomized to receive additional tobacco treatment components (motivational counseling, nicotine replacement patches/lozenges, message framing). The primary outcome is biochemically validated, abstinence at 6 months follow-up. Secondary outcomes are self-reported smoking abstinence, quit attempts, and smoking reduction at 3 and 6 months. Guided by the Implementation Outcomes Framework (IOF), our evaluation includes measurement of implementation processes (reach, fidelity, acceptability, appropriateness, sustainability, and cost).ConclusionWe will identify effective treatment components for delivery by LCS sites. The findings will guide the assembly of an optimized smoking cessation package that achieves superior cessation outcomes. Future trials can examine the strategies for wider implementation of tobacco treatment in LDCT-LCS sites.Trial registrationClinicalTrials.gov NCT03315910.
| S-EPMC9383667 | biostudies-literature