Evaluation of two multi-component interventions for integrating smoking cessation treatments into routine primary care practice: a cluster randomized trial
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Background and Rationale: There is a well-documented practice gap in the rates at which evidence-based smoking cessation treatments are delivered to patients in primary care settings. Multi-component intervention that combine practice, provider, and patient-level supports have been shown to increase the rates at which primary care providers deliver smoking cessation treatments to patients and increase rates of smoking abstinence amongst patients. The incremental value of adjunct telephone-based smoking cessation counselling when delivered as part of a multi-component intervention has not been examined. Aim: The primary objective of this study was to determine whether adjunct telephone-based smoking cessation follow-up counselling (FC), when delivered as part of a multi-component intervention program within primary care clinics is associated with increases in (a) the delivery of evidence-based smoking cessation treatments, (b) patient quit attempts, and (c) patient smoking abstinence when compared to the provision of practice and provider supports (PS) alone. The secondary objective of this study was to determine whether the introduction of a multi-component smoking cessation program is associated with increased delivery of evidence-based smoking cessation treatments by primary care providers and patient smoking outcomes, compared to pre-intervention rates. The study also sought to examine the association between patient, provider, clinic and implementation factors, and study outcomes. Methods: A two-group, pre-post cluster randomized controlled trial was conducted. Eligible clinics were randomly assigned to the PS group or FC group. Both groups were supported with implementing a multi-component intervention program that involved outreach facilitation visits, provider training, real time provider prompts and patient tools, and performance feedback. Clinics assigned to the FC group were also able to refer patients who smoke to a telephone-based follow-up support program for supplemental counselling support. An exit survey was completed with a cross-sectional sample of patients who smoked daily at each study clinic before and after the introduction of the intervention program, and all patients were contacted 4 months later to complete a brief telephone-based interview. Outcome measures included the rate at which evidence-based smoking cessation treatments (5As: ask, advise, assess, assist, arrange) were delivered to patients, the number of patients who made a quit attempt, and patient smoking abstinence at the 4-month follow-up. All data was analyzed using multi-level hierarchical modelling. Results: Seven family medicine clinics and 115 providers were enrolled in the study. A total of 12,585 patients were screened, and 835 eligible patients (mean age 45.8 SD± 14.6, 41% male) who smoke participated in the study. Contrary to the study hypothesis, a higher and statistically significant 7-day point prevalence abstinence (OR 6.8, 95% CI 2.1-21.7; p=<0.01) and continuous abstinence (OR 13.7, 95% CI 2.1-128.3; p=<0.05) rate was observed in the PS group compared to the FC group at the post-assessment after controlling for differences in smoking cessation rates between intervention groups during the baseline period. The introduction of the multi-component intervention program was associated with higher rates of provider 5As delivery and patient quit attempts compared to baseline, with no differences between groups documented. The odds ratios (OR) and 95% confidence intervals (CI) for 5As delivery between the pre- and post-intervention assessments for both intervention groups combined were: “ask” (OR 1.5; 95% CI 1.1, 2.0); “advise” (OR 2.0; 95% CI 1.5, 2.7); “assess” (OR 2.1; 95% CI 1.6, 2.9); “assist” with cessation (OR 2.30; 95% CI 1.70, 3.12); “arrange” (OR 1.9; 95% CI 1.2, 3.0); and “patient quit attempts” (OR 1.4; 95% CI 1.04, 1.94). Differences in 7-day point prevalence abstinence were not statistically significant between the pre- and post-intervention assessments (OR 1.5; 95% CI 0.94, 2.5). The study documented intra-provider variability in the rates at which evidence-based smoking cessation treatments are delivered to patients. Patient characteristics (readiness to quit, time to first cigarette, previous quit attempt in the last year), and the purpose of the clinic visit being for an annual health exam were associated with higher rates of 5As delivery. Conclusion: This is the first study to evaluate a multi-component smoking cessation intervention within the primary health care setting in Canada. The study findings demonstrate that the introduction of a multi-component intervention program in primary care settings was associated with significant improvements in the rates at which providers deliver evidence-based smoking cessation treatments, and increase patient quit attempts. The added value of adjunct telephone counselling was not evident at the 4-month follow-up. The conclusions that can be drawn from the present study are limited by the study design and sample size. A larger trial is required to conclusively determine the impact of the program on long-term smoking abstinence and examine the importance of clinic-level variables in explaining observed differences between study clinics.