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. 2021 Sep 6;2021(9):CD011556. doi: 10.1002/14651858.CD011556.pub2

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
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
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
Outcomes PPA at 12m
Validation: None
Quit attempts
Measures of provider implementation: Ask, Advise, Assist and Assist‐Meds
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
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