Dataset Information

Proactive outreach for smokers using VHA mental health clinics: protocol for a patient-randomized clinical trial.

ABSTRACT: Persons with a mental health diagnosis have high rates of tobacco use and face numerous barriers to cessation including high levels of nicotine dependence, low rates of tobacco treatment referrals from mental health providers, and limited availability of tobacco treatment targeted to their needs. This manuscript describes the rationale and methods of a clinical trial with the following aims: 1) Compare the reach and efficacy of a proactive telephone-based tobacco cessation program for Veterans Health Administration (VHA) mental health clinic patients to VHA usual care and 2) Model longitudinal associations between baseline patient characteristics and long-term abstinence.We will use the electronic medical record to identify patients across four VHA healthcare facilities who have a clinical reminder code indicating current tobacco use in the past six months and who have had a mental health clinic visit in the past 12 months. We will send each patient an introductory letter and baseline survey. Survey respondents (N = 3840) will be randomized in a 1:1 fashion to intervention or control. Control participants will receive VHA usual care. Intervention participants will receive proactive motivational telephone outreach to offer tobacco treatment. Intervention participants interested in treatment will receive eight weeks of nicotine replacement therapy plus eight sessions of specialized telephone counseling over two months, followed by monthly maintenance counseling for four months. We will conduct telephone surveys with participants at six and 12 months to assess study outcomes. We will collect a mailed saliva sample from patients reporting 7-day abstinence on the telephone surveys. The primary outcome will be cotinine-validated abstinence at 12-month follow-up.Mental health patients are a high-risk smoking population with significant barriers to cessation. This study will evaluate the efficacy of a program that proactively reaches out to smokers with a mental health treatment history to engage them into telephone cessation counseling targeted to the needs of mental health patients.Clinicaltrials.gov: NCT01737281 (registered November 5, 2012).

SUBMITTER: Rogers ES

PROVIDER: S-EPMC4301886 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Proactive outreach for smokers using VHA mental health clinics: protocol for a patient-randomized clinical trial.

Rogers Erin S ES Fu Steven S SS Krebs Paul P Noorbaloochi Siamak S Nugent Sean M SM Rao Radha R Schlede Carolyn C Sherman Scott E SE

BMC public health 20141217

<h4>Background</h4>Persons with a mental health diagnosis have high rates of tobacco use and face numerous barriers to cessation including high levels of nicotine dependence, low rates of tobacco treatment referrals from mental health providers, and limited availability of tobacco treatment targeted to their needs. This manuscript describes the rationale and methods of a clinical trial with the following aims: 1) Compare the reach and efficacy of a proactive telephone-based tobacco cessation pro ...[more]

PMID: 25518878

Similar Datasets

Project description:Current guidelines advise providers to assess smokers' readiness to quit, then offer cessation therapies to smokers planning to quit and motivational interventions to smokers not planning to quit.We examined the relationship between baseline stage of change (SOC), treatment utilization, and smoking cessation to determine whether the effect of a proactive smoking cessation intervention was dependent on smokers' level of motivation to quit.Secondary analysis of a multicenter randomized controlled trial.A total of 3006 current smokers, aged 18-80 years, at four Veterans Affairs (VA) medical centers.Proactive care included proactive outreach (mailed invitation followed by telephone outreach), offer of smoking cessation services (telephone or face-to-face), and access to pharmacotherapy. Usual care participants had access to VA smoking cessation services and state telephone quitlines.Baseline SOC measured with Readiness to Quit Ladder, and 6-month prolonged abstinence self-reported at 1 year.At baseline, 35.8 % of smokers were in preparation, 38.2 % in contemplation, and 26.0 % in precontemplation. The overall interaction between SOC and treatment arm was not statistically significant (p?=?0.30). Among smokers in preparation, 21.1 % of proactive care participants achieved 6-month prolonged abstinence, compared to 13.1 % of usual care participants (OR, 1.8 [95 % CI, 1.2-2.6]). Similarly, proactive care increased abstinence among smokers in contemplation (11.0 % vs. 6.5 %; OR, 1.8 [95 % CI, 1.1-2.8]). Smokers in precontemplation quit smoking at similar rates (5.3 % vs. 5.6 %; OR, 0.9 [95 % CI, 0.5-1.9]). Within each stage, uptake of smoking cessation treatments increased with higher SOC and with proactive care as compared with usual care.Mostly male participants limits generalizability. Randomization was not stratified by SOC.Proactive care increased treatment uptake compared to usual care across all SOC. Proactive care increased smoking cessation among smokers in preparation and contemplation but not in precontemplation. Proactively offering cessation therapies to smokers at all SOC will increase treatment utilization and population-level smoking cessation.

Project description:Widening socioeconomic disparities in mortality in the United States are largely explained by slower declines in tobacco use among smokers of low socioeconomic status (SES) than among those of higher SES, which points to the need for targeted tobacco cessation interventions. Documentation of smoking status in electronic health records (EHRs) provides the tools for health systems to proactively offer tobacco treatment to socioeconomically disadvantaged smokers.To evaluate a proactive tobacco cessation strategy that addresses sociocontextual mediators of tobacco use for low-SES smokers.This prospective, randomized clinical trial included low-SES adult smokers who described their race and/or ethnicity as black, Hispanic, or white and received primary care at 1 of 13 practices in the greater Boston area (intervention group, n?=?399; control group, n?=?308).We analyzed EHRs to identify potentially eligible participants and then used interactive voice response (IVR) techniques to reach out to them. Consenting patients were randomized to either receive usual care from their own health care team or enter an intervention program that included (1) telephone-based motivational counseling, (2) free nicotine replacement therapy (NRT) for 6 weeks, (3) access to community-based referrals to address sociocontextual mediators of tobacco use, and (4) integration of all these components into their normal health care through the EHR system.Self-reported past-7-day tobacco abstinence 9 months after randomization ("quitting"), assessed by automated caller or blinded study staff.The intervention group had a higher quit rate than the usual care group (17.8% vs 8.1%; odds ratio, 2.5; 95% CI, 1.5-4.0; number needed to treat, 10). We examined whether use of intervention components was associated with quitting among individuals in the intervention group: individuals who participated in the telephone counseling were more likely to quit than those who did not (21.2% vs 10.4%; P?<?.001). There was no difference in quitting by use of NRT. Quitting did not differ by a request for a community referral, but individuals who used their referral were more likely to quit than those who did not (43.6% vs 15.3%; P?<?.001).Proactive, IVR-facilitated outreach enables engagement with low-SES smokers. Providing counseling, NRT, and access to community-based resources to address sociocontextual mediators among smokers reached in this setting is effective.clinicaltrials.gov Identifier: NCT01156610.

Project description:This paper describes an innovative protocol for a type-II hybrid effectiveness-implementation trial that is evaluating a smoking cessation telephone care coordination program for Veterans Health Administration (VA) mental-health clinic patients. As a hybrid trial, the protocol combines implementation science and clinical trial methods and outcomes that can inform future cessation studies and the implementation of tobacco cessation programs into routine care. The primary objectives of the trial are (1) to evaluate the process of adapting, implementing, and sustaining a smoking cessation telephone care coordination program in VA mental health clinics, (2) to determine the effectiveness of the program in promoting long-term abstinence from smoking among mental health patients, and (3) to compare the effectiveness of telephone counseling delivered by VA staff with that delivered by state quitlines.The care coordination program is being implemented at six VA facilities. VA mental health providers refer patients to the program via an electronic medical record consult. Program staff call referred patients to offer enrollment. All patients who enroll receive a self-help booklet, mailed smoking cessation medications, and proactive multi-call telephone counseling. Participants are randomized to receive this counseling from VA staff or their state's quitline. Four primary implementation strategies are being used to optimize program implementation and sustainability: blended facilitation, provider training, informatics support, and provider feedback. A three-phase formative evaluation is being conducted to identify barriers to, and facilitators for, program implementation and sustainability. A mixed-methods approach is being used to collect quantitative clinical effectiveness data (e.g., self-reported abstinence at six months) and both quantitative and qualitative implementation data (e.g., provider referral rates, coded interviews with providers). Summative data will be analyzed using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.This paper describes the rationale and methods of a trial designed to simultaneously study the clinical effectiveness and implementation of a telephone smoking cessation program for smokers using VA mental health clinics. Such hybrid designs are an important methodological design that can shorten the time between the development of an intervention and its translation into routine clinical care.

Project description:AimsTo estimate the cost-effectiveness at population-level of the OPT-IN proactive tobacco cessation outreach program for adult smokers enrolled in publicly funded health insurance plans for low-income persons (e.g. Medicaid).DesignCost-effectiveness analysis using a state transition model based on data from the Offering Proactive Treatment Intervention (OPT-IN) randomized control trial.SettingThe trial was conducted in Minnesota, USA, and the economic analysis was conducted from the Medicaid program perspective.ParticipantsData were used from 2406 smokers who were randomized into the intervention or comparator groups.Intervention and comparatorThe intervention was comprised of proactive outreach (mailed invitation and telephone calls) and free cessation treatment (nicotine replacement therapy and intensive telephone counseling). The comparator was usual care, which comprised access to a primary care physician, insurance coverage of Food and Drug Administration (FDA)-approved smoking cessation medications and the state's telephone quitline.MeasurementsSmoking status, quality of life and health-care use at varying times, including at baseline and 1 year.FindingsThe OPT-IN program cost an average of $84 per participant greater than the comparator. One year after randomization, the population-level, 6-month prolonged smoking abstinence rate was 16.5% in the proactive outreach intervention group and 12.1% in the usual care group (P < 0.05). The model projected that the proactive outreach intervention added $78 in life-time cost and generated 0.005 additional quality-adjusted life-years (QALYs), with an expected incremental cost-effectiveness ratio of $4231 per QALY. Probabilistic sensitivity analysis found that the proactive outreach intervention would be cost-effective against a willingness-to-pay threshold of $50 000/QALY approximately 68% of the time.ConclusionsPopulation-level proactive tobacco treatment with personal telephone outreach was effective in achieving higher population-level quit rates and was cost-effective at various willingness-to-pay thresholds, compared with usual care (i.e. reactive treatment). Taken together with prior research, population-level proactive tobacco cessation outreach programs are judged to be highly cost-effective over the long term.

Project description:IntroductionProactive outreach offering tobacco treatment is a promising strategy outside of clinical settings, but little is known about factors for engagement. The study objective is to examine the impact of caller area code in a proactive, phone-based outreach strategy on consenting low-income smokers to a quitline e-referral.Aims and methodsThis pragmatic randomized trial included unassisted adult smokers (n = 685), whose preferred language was English or Spanish, in a Los Angeles safety-net health system. Patients were randomized to receive a call from a local or generic toll-free area code. Log-binomial regression was used to examine the association between area code and consent to a quitline e-referral, adjusted for age, gender, language, and year.ResultsOverall, 52.1% of the patients were contacted and, among those contacted, 30% consented to a referral. The contact rate was higher for the local versus generic area code, although not statistically significant (55.6% vs. 48.7%, p = .07). The consent rate was higher in the local versus generic area code group (adjusted prevalence ratio 1.29, 95% CI 1.01-1.65) and also higher for patients under 61 years old than over (adjusted prevalence ratio 1.47, 95% CI 1.07-2.01), and Spanish-speaking than English-speaking patients (adjusted prevalence ratio 1.40, 95% CI 1.05-1.86).ConclusionsProactive phone-based outreach to unassisted smokers in a safety net health system increased consent to a quitline referral when local (vs. generic) area codes were used to contact patients. While contact rate did not differ by area code, proactive phone-based outreach was effective for engaging younger and Spanish-speaking smokers.ImplicationsPopulation-based proactive phone-based outreach from a caller with a local area code to unassisted smokers in a safety net health system increases consent to an e-referral for quitline services. Findings suggest that a proactive phone-based outreach, a population-based strategy, is an effective strategy to build on the visit-based model and offer services to tobacco users, regardless of the motivational levels to quit.

Project description:There is a high prevalence of smoking and high burden of tobacco-related diseases among low-income populations. Effective, evidenced-based smoking cessation treatments are available, but low-income smokers are less likely than higher-income smokers to use these treatments, especially the most comprehensive forms that include a combination of pharmacotherapy and intensive behavioral counseling.The primary objectives of this randomized controlled trial are to compare the effects of a proactive tobacco treatment intervention compared to usual care on population-level smoking abstinence rates and tobacco treatment utilization rates among a diverse population of low-income smokers, and to determine the cost-effectiveness of proactive tobacco treatment intervention. The proactive care intervention systematically offers low-income smokers free and easy access to evidence-based treatments and has two primary components: (1) proactive outreach to current smokers in the form of mailed invitation materials and telephone calls containing targeted health messages, and (2) facilitated access to free, comprehensive, evidence-based tobacco cessation treatments in the form of NRT and intensive, telephone-based behavioral counseling. The study aims to include a population-based sample (N?=?2500) of adult smokers enrolled in the Minnesota Health Care Programs (MHCP), a state-funded health insurance plan for low-income persons. Baseline data is obtained from MHCP administrative databases and a participant survey that is conducted prior to randomization. Outcome data is collected from a follow-up survey conducted 12 months after randomization and MHCP administrative data. The primary outcome is six-month prolonged smoking abstinence at one year and is assessed at the population level. All randomized individuals are asked to complete the follow-up survey, regardless of whether they participated in tobacco treatment. Data analysis of the primary aims will follow intent-to-treat methodology.There is a critical need to increase access to effective tobacco dependence treatments. This randomized trial evaluates the effects of proactive outreach coupled with free NRT and telephone counseling on the population impact of tobacco dependence treatment. If proven to be effective and cost-effective, national dissemination of proactive treatment approaches would reduce tobacco-related morbidity, mortality, and health care costs for low income Americans.ClinicalTrials.gov: NCT01123967.

Project description:BackgroundUniversity students are reporting concerning levels of mental health distress and challenges. University mental health service provider initiatives have been shown to be effective in supporting students' mental health, but these services are often resource-intensive. Consequently, new approaches to service delivery, such as web-based and peer support initiatives, have emerged as cost-effective and efficient approaches to support university students. However, these approaches have not been sufficiently evaluated for effectiveness or acceptability in university student populations.ObjectiveThus, the overarching goal of this study was to evaluate a mental health service provider-presented versus peer-presented web-based mental health resilience-building video outreach program against a wait-list comparison group.MethodsParticipants were 217 undergraduate students (mean age 20.44, SD 1.98 years; 171/217, 78.8% women) who were randomly assigned to one of the intervention groups (mental health service provider-presented: 69/217, 31.8%; peer-presented: 73/217, 33.6%) or the wait-list comparison group (75/217, 34.6%). Participants in the intervention groups were asked to watch 3 brief skill-building videos addressing strategies for building mental health resilience, whereas the comparison group was wait-listed. The mental health service provider-presented and peer-presented video series were identical in content, with presenters using a script to ensure consistency across delivery methods, but the videos differed in that they were either presented by mental health service providers or university students (peers). All participants were asked to complete web-based self-report measures of stress, coping self-efficacy, social support, social connectedness, mindfulness, and quality of life at baseline (time 1), 6 weeks later (time 2, after the intervention), and 1-month follow-up (time 3).ResultsResults from a series of 2-way ANOVAs found no significant differences in outcomes among any of the 3 groups. Surprisingly, a main effect of time revealed that all students improved on several well-being outcomes. In addition, results for program satisfaction revealed that both the mental health service provider-presented and peer-presented programs were rated very highly and at comparable levels.ConclusionsThus, findings suggest that a web-based mental health resilience-building video outreach program may be acceptable for university students regardless of it being mental health service provider-presented or peer-presented. Furthermore, the overall increases in well-being across groups, which coincided with the onset and early weeks of the COVID-19 pandemic, suggest an unexpected pattern of response among university students to the early period of the pandemic. Limitations and barriers as well as research implications are discussed.Trial registrationClinicalTrials.gov NCT05454592; https://clinicaltrials.gov/ct2/show/NCT05454592.

Project description:Introduction: Although smokers with severe mental illnesses (SSMI) make quit attempts at comparable levels to other smokers, fewer are successful in achieving smoking cessation. Specialized smoking cessation treatments targeting their needs can be effective but have not been widely disseminated. Telephone delivered interventions, including by quitlines, show promise. However, few SSMI contact quitlines and few are referred to them by health professionals. Mental health peer workers can potentially play an important role in supporting smoking cessation. This study will apply a pragmatic model using peer workers to engage SSMI with a customized quitline service, forming the "Quitlink" intervention. Methods: A multi-center prospective, cluster-randomized, open, blinded endpoint (PROBE) trial. Over 3 years, 382 smokers will be recruited from mental health services in Victoria, Australia. Following completion of baseline assessment, a brief intervention will be delivered by a peer worker. Participants will then be randomly allocated either to no further intervention, or to be referred and contacted by the Victorian Quitline and offered a targeted 8-week cognitive behavioral intervention along with nicotine replacement therapy (NRT). Follow-up measures will be administered at 2-, 5-, and 8-months post-baseline. The primary outcome is 6 months continuous abstinence from end of treatment with biochemical verification. Secondary outcomes include 7-day point prevalence abstinence from smoking, increased quit attempts, and reductions in cigarettes per day, cravings and withdrawal, mental health symptoms, and other substance use, and improvements in quality of life. We will use a generalized linear mixed model (linear regression for continuous outcomes and logistic regression for dichotomous outcomes) to handle clustering and the repeated measures at baseline, 2-, 5-, and 8-months; individuals will be modeled as random effects, cluster as a random effect, and group assignment as a fixed effect. Discussion: This is the first rigorously designed RCT to evaluate a specialized quitline intervention accompanied by NRT among SSMI. The study will apply a pragmatic model to link SSMI to the Quitline, using peer workers, with the potential for wide dissemination. Clinical Trial Registration: Trial Registry: The trial is registered with ANZCTR (www.anzctr.org.au): ACTRN12619000244101 prior to the accrual of the first participant and updated regularly as per registry guidelines. Trial Sponsor: University of Newcastle, NSW, Australia.

Project description:ImportanceApproximately 24 million US individuals receive care at federally qualified health centers, which historically have low rates of colorectal cancer screening. The US Preventive Services Task Force recommends routine colorectal cancer screening for individuals aged 50 to 75 years.ObjectiveTo determine the effectiveness of an electronic health record (EHR)-embedded mailed fecal immunochemical test (FIT) outreach program implemented in health centers as part of standard care.Design, setting, and participantsThis cluster randomized pragmatic clinical trial was conducted in 26 federally qualified health center clinics, representing 8 health centers in Oregon and California, randomized to intervention (n = 13) or usual care (n = 13). All participants were overdue for colorectal cancer screening during the accrual interval (February 4, 2014 to February 3, 2015).InterventionsElectronic health record-embedded tools to identify eligible adults and to facilitate implementation of a stepwise mailed intervention involving (1) an introductory letter, (2) a mailed FIT, and (3) a reminder letter; training, collaborative learning, and facilitation through a practice improvement process.Main outcomes and measuresEffectiveness was measured as clinic-level proportions of adults who completed a FIT, and secondarily, any colorectal cancer screening within 12 months of accrual or by August 3, 2015. Implementation was measured as clinic-level proportions of adults who were mailed an introductory letter and ordered a FIT.ResultsTwenty-six clinics with 41 193 adults (mean [SD] age, 58.5 [6.3] years; 22 994 women) were randomized to receive the direct mail colorectal screening intervention (13 clinics; 21 134 patients) or usual care (13 clinics; 20 059 patients). Compared with usual care clinics, intervention clinics had significantly higher adjusted clinic-level proportion of participants who completed a FIT (13.9% vs 10.4%; difference, 3.4 percentage points; 95% CI, 0.1%-6.8%) and any colorectal cancer screening (18.3% vs 14.5%; difference, 3.8 percentage points; 95% CI, 0.6%-7.0%). We observed large variation across health centers in effectiveness (FIT completion differences range, -7.4 percentage points to 17.6 percentage points) and implementation (proportion who were mailed a FIT range, 6.5% to 68.2%). The number needed to mail to achieve a completed FIT was 4.8 overall, and 4.0 in clinics that mailed a FIT reminder.Conclusions and relevanceAn EHR-embedded mailed FIT outreach intervention significantly improved rates of FIT completion and rates of any colorectal cancer screening. Higher rates of colorectal cancer screening occurred in clinics that successfully implemented the mailed outreach program.Trial registrationClinicalTrials.gov identifier: NCT01742065.

Dataset Information

Proactive outreach for smokers using VHA mental health clinics: protocol for a patient-randomized clinical trial.

Publications

Proactive outreach for smokers using VHA mental health clinics: protocol for a patient-randomized clinical trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets