Swartz 2006.
| Study characteristics | ||
| Methods | Design: Cluster‐randomized controlled trial Setting: 50 primary care practices, USA Recruitment: Practices were recruited by telephone invitations |
|
| Participants | 1892 adults who smoked (807 eligible for abstinence analysis: av.age 42, 25% M, 15 cpd) | |
| Interventions | Common components in both groups: detailing sheet summarizing effective treatment, profiling data feedback (by mail in the control group) and a Treating Tobacco Together pen Intervention: • Providers received the same intervention as the control arm, plus: A 20 ‐ 30 minute educational session on evidence‐based tobacco treatment in their practice and a second educational session 5 ‐ 6 months later. Providers were encouraged to use the ICD‐9 diagnosis code 205.1 and given information about the Maine Tobacco HelpLine which offers counseling Control: providers received the detailing sheet and all profiling data feedback graphs with a summary of findings and a Treating Tobacco Together pen by mail |
|
| Outcomes | 7‐day PPA at 15 ‐ 18 m Validation: None Measures of provider implementation: Advise, Assess, Assist‐Self‐help, Assist‐Meds, Arrange Quit attempts |
|
| Funding Source | Agency of Research and Healthcare Quality | |
| Author's declarations of interest | QUOTE: "Dr Swartz has received honoraria and research support from Pfizer. At the time of the study, Dr Goldstein was employee of Bayer Pharmaceutical Corporation. After the study was conducted, Mr Cowan became an employee of Health Dialog Analytic Solutions. No conflicts: Mooney‐Murray, Haskins, DePue, Thompson, Leighton, Salem‐Schatz" | |
| Notes | Strategy: Outreach facilitation, Audit & feedback, Provider training Level: Provider + Practice Comparison type: Active vs. active (isolates provider training) |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Sequence Generation | Unclear risk | No details reported |
| Allocation concealment | Unclear risk | No details reported |
| Blinding of outcome assessors All outcomes | Low risk | Smoking status self‐report. However, contact with participants did not differ |
| Incomplete outcome data All outcomes | Unclear risk | QUOTE: "Of 1,892 patients who smoked at baseline, 1,238 were contacted at follow‐up (65.4% response)". No further details by group were reported |
| Recruitment bias (cluster RCTs only) | Low risk | Participants were affiliated with the practices before randomization |
| Balanced baseline characteristics? (cluster RCTs only) | Low risk | No significant differences between the clusters, except for more participants in the control group practices were Medicaid enrollees |
| Adjustment for clustering in analysis? (cluster RCTs only) | Low risk | QUOTE: "Models were adjusted for the clustering effect of patients within practices using the survey logistic procedure" |