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Design and initial enrollment in the Vascular Physicians Offer and Report (VAPOR) trial.

ABSTRACT: Although patient smoking cessation is a key priority for vascular surgeons, significant variation exists in the manner in which vascular surgeons address this key process of care. We describe a multicenter, cluster-randomized trial that compares a standardized, brief smoking cessation intervention to usual care for patients facing vascular surgery or endovascular interventions. Eight centers were randomized to provide usual care for smoking cessation or a standardized protocol consisting of (1) physician "very brief advice" to stop smoking, (2) offering nicotine replacement therapy, and (3) referral to a phone-based counseling service. Trial enrollment began on September 1, 2014. At present, 142 patients had been enrolled in the trial across eight sites. Compared with patients in the usual care arm, patients enrolled in the smoking cessation intervention arm were more likely to receive physician advice (98% vs 77%), a prescription for nicotine replacement therapy (77% vs 13%), and quitline referral (93% vs 33%; all P < .001). Although final results of the intervention on smoking cessation rates are still forthcoming, surgeon delivery of a brief, evidence-based smoking cessation intervention appears feasible for patients facing invasive vascular care.

SUBMITTER: Spangler EL

PROVIDER: S-EPMC5292248 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Design and initial enrollment in the Vascular Physicians Offer and Report (VAPOR) trial.

Spangler Emily L EL Brooke Benjamin S BS Beck Adam W AW Hoel Andrew A Farber Alik A Goodney Philip P PP

Journal of vascular surgery 20160401 4

Although patient smoking cessation is a key priority for vascular surgeons, significant variation exists in the manner in which vascular surgeons address this key process of care. We describe a multicenter, cluster-randomized trial that compares a standardized, brief smoking cessation intervention to usual care for patients facing vascular surgery or endovascular interventions. Eight centers were randomized to provide usual care for smoking cessation or a standardized protocol consisting of (1) ...[more]

PMID: 27016862

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Project description:Although smoking cessation is a key priority emphasized by professional societies and multidisciplinary consensus guidelines, significant variation exists in the methods and efficacy of smoking cessation treatment practiced by vascular surgeons. We conducted a series of patient, surgeon, and nonpatient stakeholder focus groups to identify important domains for establishment of a successful smoking cessation program.As part of a planning effort for a randomized clinical trial on usual care vs a standardized, evidence-based smoking cessation intervention, our group performed a series of interviews and focus groups. These were four 1-hour interviews, conducted with stakeholders such as tobacco cessation counselors (n = 2), a Quit Line representative (n = 1), and a Vascular Quality Initiative leader (n = 1), as well as two 90-minute, formal, professionally moderated focus groups, one with vascular surgeons (n = 7), and another with patients (n = 4). Transcripts and audio recordings were qualitatively reviewed for themes to establish the most important domains perceived to be associated with a successful smoking cessation program.Patients emphasized four domains critical for a successful smoking cessation program: the motivation to quit, an individualized approach, the timing of an intervention, and the tone of the physician who offers counseling. Although surgeons and nonpatient stakeholders also emphasized the importance of a compassionate physician tone, surgeons and nonpatient stakeholders differed from patients in their remaining domains. They emphasized the feasibility of a brief intervention in a busy clinical practice, implementation of the effort, and necessary infrastructure for smoking cessation programs. All focus group participants described a brief, evidence-based smoking cessation intervention as feasible in routine vascular practice.Differences in motivation and significance exist for patients, surgeons, and stakeholders when they considered the specific domains most important in building a successful smoking cessation program. Despite these differences, all parties involved agreed that a brief, standardized intervention can be successful delivered in a busy vascular clinic setting.

Project description:Although epidemiological research demonstrates that there is an association between lifestyle factors and risk of breast cancer recurrence, progression of disease, and mortality, no comprehensive lifestyle change clinical trials have been conducted to determine if changing multiple risk factors leads to changes in biobehavioral processes and clinical outcomes in women with breast cancer. This article describes the design, feasibility, adherence to the intervention and data collection, and patient experience of a comprehensive lifestyle change clinical trial (CompLife).CompLife is a randomized, controlled trial of a multiple-behavior intervention focusing on diet, exercise, and mind-body practice along with behavioral counseling to support change. The initial exposure to the intervention takes place during the 4 to 6 weeks of radiotherapy (XRT) for women with stage III breast cancer and then across the subsequent 12 months. The intervention group will have 42 hours of in-person lifestyle counseling during XRT (7-10 hours a week) followed by up to 30 hours of counseling via video connection for the subsequent 12 months (weekly sessions for 6 months and then monthly for 6 months). The primary outcome is disease-free survival. Multiple secondary outcomes are being evaluated, including: (1) biological pathways; (2) overall survival; (3) patient-reported outcomes; (4) dietary patterns/fitness levels, anthropometrics, and body composition; and (5) economic outcomes. Qualitative data of the patient experience in the trial is collected from exit interviews, concluding remarks, direct email correspondences, and web postings from patients.Fifty-five patients have been recruited and randomized to the trial to date. Accrual of eligible patients is high (72%) and dropout rates extremely low (5%). Attendance to the in-person sessions is high (95% attending greater than 80% of sessions) as well as to the 30 hours of video counseling (88% attending more than 70% of sessions). Adherence to components of the behavior change intervention is high and compliance with the intensive amount of data collection is exceptional. Qualitative data collected from the participants reveals testimonials supporting the importance of the comprehensive nature of intervention, especially the mind-body/mindfulness component and social support, and meaningful lifestyle transformations.Conducting a comprehensive, multicomponent, lifestyle change clinical trial for women with breast was feasible and collection of biobehavioral outcomes successful. Adherence to behavior change was high and patient experience was overwhelmingly positive.

Dataset Information

Design and initial enrollment in the Vascular Physicians Offer and Report (VAPOR) trial.

Publications

Design and initial enrollment in the Vascular Physicians Offer and Report (VAPOR) trial.

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