Joseph 2004.
Study characteristics | ||
Methods | Design: Cluster‐randomized controlled trial Setting: 20 Veterans Affairs Medical Centers, USA Recruitment: Calls to patients who visited primary care provider in the past 6 weeks |
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Participants | Pre‐intervention 4254 adults who smoked who had visited their primary care provider in the past 6 weeks. av.age 64, 95% M, av. cpd not reported Post‐intervention 1424 adults who smoked who had visited their primary care provider in the past 6 weeks. av.age 64, 97% M, av. cpd not reported 575 (280 in the intervention group and 295 in the control) participants made up the cohort of people who smoked and who were contacted both pre‐and post‐intervention |
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Interventions | Intervention: • Providers (the site‐based principal investigator and 1 other key advocate from each site) received a 2‐day training meeting ‐ Emphasis on options for increasing identification of people who smoked in the computerized patient record system ‐ Promotion of treatment in the primary care setting rather than use of referral‐based care ‐ Encouragement of removal of formulary restrictions to prescription of smoking‐cessation aids and provision of materials to address Pharmacy and Therapeutics Committees • Sites were visited by the interventionist for 2 or 3 days to provide academic detailing of the implementation strategies that was sensitive to local hurdles Control: no information provided on the care this group received or did not receive |
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Outcomes | PPA at 12m Validation: None Quit attempts Measures of provider implementation: Ask, Advise, Assist and Assist‐Meds |
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Funding Source | Grant from the Veterans Administration Health Services Research and Development Service: CPG 97‐039 | |
Author's declarations of interest | Not reported. | |
Notes | Strategy: Provider training + EMR prompts + outreach facilitation Level: Provider + Practice Comparison type: Multicomponent vs. standard care |
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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 | Unclear risk | Smoking status was self‐reported and the number of contacts in the control group is not reported |
Incomplete outcome data All outcomes | Low risk | At site level, there was no loss to follow‐up (n = 0/20) at 1 year. At patient level, it was not the intention of this study to follow up the same participants from the outset. Patients were randomly selected at baseline and at 1 year and surveyed. |
Recruitment bias (cluster RCTs only) | Unclear risk | Participants were affiliated with the practice before randomization. QUOTE: "...among a sample randomly selected from patients who had seen their primary care provider within 6 weeks..." |
Balanced baseline characteristics? (cluster RCTs only) | Low risk | QUOTE: "There were no significant differences between subject characteristics in the 2 treatment groups" |
Adjustment for clustering in analysis? (cluster RCTs only) | High risk | No adjustment for cluster nature of data reported |