Katz 2004.
| Study characteristics | ||
| Methods | Design: Cluster‐randomized controlled trial Setting: Community‐based primary care clinics in southern Wisconsin, USA Recruitment: Patients willing to complete exit interviews |
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| Participants | Pre‐intervention: 1022 adults who smoked (> 10 cpd) (509 control, 513 intervention) av.age 42, 46% M, 17 cpd Post‐intervention: 1141 adults who smoked (> 10 cpd) (499 control, 642 intervention) av.age 40, 45% M, 17 cpd |
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| Interventions | Intervention: • Clinicians received training tutorial on smoking cessation, and group and confidential individual feedback on whether they had assessed smoking status and whether they had provided cessation counseling • A modified vital signs stamp was imprinted on each patient's encounter form for the clinical visit • Participants were offered free NRT patches and/or proactive telephone counseling Control: usual care • Physicians were provided with general information about the Agency for Healthcare Research Quality guideline evaluation trial • Participants who smoked were identified and counseled at the discretion of the clinical staff; neither intake clinicians nor primary care clinicians were instructed to provide (or to not provide) smoking cessation counseling |
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| Outcomes | Repeated PPA at 2m and 6m Validation: None (salivary cotinine validation was attempted but abandoned due to distribution and response issues) Quit attempts Measures of provider implementation: Ask, Advise, Assess, Assist‐Self‐help, Assist‐Quit date, Assist‐Meds |
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| Funding Source | Funded by a Preventive Oncology Academic Award (K07‐CA78540) from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, with supplemental support from the University of Wisconsin Comprehensive Cancer Center and the University of Wisconsin Medical School. GlaxoSmithKline donated transdermal nicotine patches for use in this trial | |
| Author's declarations of interest | QUOTE: "M.C.Fiore has served as a consultant for, has given lectures sponsored by, or has conducted research sponsored by GlaxoSmithKline (Research Triangle Park, NC) and was appointed by the University of Wisconsin to a named Chair made possible by an unrestricted gift to the university from GlaxoSmithKline" | |
| Notes | Strategy: Provider training + Vital signs stamp + Cost‐free medications + Adjunctive counseling + 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 | QUOTE: "...the project statistician used a random number generator to randomly assign each clinic to receive either the intervention or usual care" |
| Allocation concealment | Unclear risk | QUOTE: "...we enrolled 2163 consecutive adult patients who smoked...". No further details reported. |
| Blinding of outcome assessors All outcomes | High risk | Smoking abstinence rates were not biochemically validated and contact with patients varied between arms |
| Incomplete outcome data All outcomes | Low risk | Attrition rates were under 50% and similar across the groups. The overall loss to follow‐up was 9.6% (n = 208/2163); 10.2% (n = 118/1155) in the intervention group and 8.9% (n = 90/1008) in the control group were lost to follow‐up at 6 months. |
| Recruitment bias (cluster RCTs only) | Low risk | Participants were affiliated with the practice before randomization |
| Balanced baseline characteristics? (cluster RCTs only) | Low risk | QUOTE: "No statistically significant differences in sociodemographic characteristics (except educational level), self‐rated health status, and cigarette or alcohol use" |
| Adjustment for clustering in analysis? (cluster RCTs only) | Low risk | Constructed 3‐level hierarchical logistic regression models of performance and cessation outcomes across the test and control sites combined |