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 |
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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 |
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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 |
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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) |
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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..." |