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

Papadakis 2018.

Study characteristics
Methods Design: Cluster‐randomized controlled trial
Setting: Family medicine practices in Ontario, Canada
Recruitment: Invitation letters sent to practices. Participants recruited in the waiting room of the clinics
Participants 15 practices
867 adults who smoked completed post‐intervention exit survey, av. age not reported, av. cpd not reported
Interventions Intervention 1: all teams received the Ottawa Model for Smoking Cessation program which included outreach facilitation, provider training, real‐time prompts, and an automated follow‐up program
Intervention 2: all teams received the Ottawa Model for Smoking Cessation program (as described above). In addition, general practitioners and nurse practitioners received a supplemental 1½‐hour coaching session for providers 4 weeks following the program launch at their clinic Providers were given a report of their performance in delivering tobacco use treatment interventions
Outcomes 12w prolonged abstinence at 6m
Validation: None
Measures of provider implementation: Ask, Advise, Assist‐Meds, Assist‐Quit date, Assist‐Self‐help, Arrange
Secondary outcome: Quit attempts
Funding Source This study was funded through a Grant‐in‐aid from the Heart and Stroke Foundation of Canada (Grant # NA7193)
Author's declarations of interest QUOTE: "R.D.R. has received speaker and consulting fees from Pfizer and Johnson & Johnson, K‐A.M. has received speaker fees from Pfizer, A.L.P. has received speaker and consulting fees from Pfizer and Johnson & Johnson that are not related to this study." All others report none
Notes Strategy: Adjunctive counseling, Provider training, Audit & feedback, Vital Sign Stamp, Consult Form, EMR prompts, Outreach facilitation, Performance coaching
Level: Patient, Provider, Practice
Comparison type: Active vs. active (isolates performance coaching)
Risk of bias
Bias Authors' judgement Support for judgement
Sequence Generation Unclear risk QUOTE: "A simple blocked randomization scheme was used in which blocks of four clinics were randomized". No further detail given
Allocation concealment Unclear risk QUOTE: "The Methods Centre provided the principal investigator with the list of practice assignments". No further detail given
Blinding of outcome assessors
All outcomes Low risk Smoking status was self‐report; but contact with participants was balanced between arms
Incomplete outcome data
All outcomes Low risk At participant level, 21.3% (n = 85/399) in the OMSC group and 18.1% (n = 86/475) in OMSC+ group were lost to follow‐up at 6 months post‐intervention
Recruitment bias (cluster RCTs only) Low risk Participants were affiliated with the practice before randomization
Balanced baseline characteristics? (cluster RCTs only) Low risk QUOTE: "There were no differences in practice and clinician characteristics between intervention groups"
Adjustment for clustering in analysis? (cluster RCTs only) Low risk QUOTE: "Multilevel models account for the clustered design. A 3‐level generalised linear mixed model estimated the effect of the intervention for each outcome measure..."