Sherman 2007.
| Study characteristics | ||
| Methods | Design: Cluster‐randomized controlled trial Setting: 2 primary care teams at the Sepulveda VA Ambulatory Care Center, USA Recruitment: All patients with at least 3 primary care visits in the past year were invited to participate through a computer‐assisted telephone interview |
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| Participants | 482 adults who smoked within the Sepulveda Ambulatory Care Centre, av. age not reported, av. cpd not reported | |
| Interventions | Intervention: • Providers had access to an on‐call counselor who could be paged to provide 10 ‐ 15 minutes of counseling and make a referral to a smoking cessation program or a quitline as required. The counselors provided case management for all participants for 2 months, making follow‐up calls to them each lasting 5 ‐ 15 minutes Each provider received monthly educational outreach visits from the counselors or the opinion leader for the first 3 months. In addition, providers were posted profiling data. The provider who referred the most patients was presented with financial incentives (USD 25 gift certificate) at the end of each month. Participants received case management by the counselor and also medications. Control: usual care. No further details reported |
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| Outcomes | 30‐day PPA at 6m Validation: None Quit attempts Measures of provider implementation: Ask, Assist‐Prescribe (NRT), Assist‐Prescribe Bupropion, Arrange‐Quitline referral, Arrange‐Cessation program |
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| Funding Source | This work was funded by a grant from the California Tobacco‐Related Disease Research Program (#10RT‐0023) | |
| Author's declarations of interest | Authors declared that they had no conflict of interest | |
| Notes | Strategy: Adjunctive counseling & cost‐free medications + academic detailing + financial incentives + audit & feedback Level: Patient, Provider, Practice Comparison type: Multicomponent vs standard care |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Sequence Generation | Low risk | 1 primary care team was randomly assigned by coin flip |
| Allocation concealment | Unclear risk | Coin flip to assign 1 team to the intervention and the other team to usual care |
| Blinding of outcome assessors All outcomes | High risk | Self‐report. Different contact between groups |
| Incomplete outcome data All outcomes | High risk | At participant level, the overall loss to follow‐up was 47.9% (n = 231/482); 50.9% (n = 108/212) in the intervention group and 45.6% (n = 123/270) in the usual care group at post‐intervention follow‐up |
| Recruitment bias (cluster RCTs only) | Low risk | Participants were affiliated with the primary care clinic before randomization |
| Balanced baseline characteristics? (cluster RCTs only) | High risk | Participants on the intervention team were more likely to have ever tried to quit smoking (OR (95% CI): 2.4 (1.4 ‐ 4.2)) and to have quit for at least 1 day in the last year (OR (95% CI): 1.5 (1.1 ‐ 2.2)). They were less likely than participants on the control team to have chronic obstructive pulmonary disease |
| Adjustment for clustering in analysis? (cluster RCTs only) | High risk | QUOTE: "Multilevel modeling could not be used to account for clustering at the team level, as there were only 2 teams" |