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

Kalkhoran 2018.

Study characteristics
Methods Design: Randomized controlled trial
Setting: Primary care network, USA
Recruitment: interactive voice response technology was used for participant recruitment; contact information was identified from electronic health record
Participants 233 people who smoked, av. age 53, av. cpd 15
Interventions Intervention 1: participants received brief counseling provided by a health center‐based Tobacco Care Coordinator, coordinated medications with primary care physicians, and a referral to additional care (in‐person, phone call or text)
Intervention 2: participants were transferred directly to a community‐based Quitline for counseling and a free sample of nicotine replacement therapy
Control: participants were given the state quitline number and advised to contact their primary care physician for assistance to quit smoking. Each practice had a certified tobacco treatment specialist available 1 day per week to provide free in‐person individual cessation support. Primary care physicians could also fax a referral to the quitline
Outcomes 30‐day PPA at 6m
Validation: None
Measures of provider implementation: Assist‐counselling, Assist‐medications
Funding Source Pfizer Independent Grants for Learning and Change
Author's declarations of interest QUOTE: "Drs. Rigotti and Kalkhoran receive royalties from UpToDate, Inc. Dr. Rigotti has been an unpaid consultant to Pfizer, Inc. and a paid consultant to Achieve Life Sciences. No other authors have any conflicts of interest to disclose"
Notes Strategy: Adjunctive counseling, cost‐free medications
Level: Patient
Comparison types: Multicomponent vs. standard care; single component (adjunctive counseling) vs. standard care
Risk of bias
Bias Authors' judgement Support for judgement
Sequence Generation Low risk Random‐number generator
Allocation concealment Low risk Implemented by interactive voice response
Blinding of outcome assessors
All outcomes High risk Smoking status was self‐report, and contact was differential between arms
Incomplete outcome data
All outcomes Low risk The overall loss to follow‐up was 45.4% (n = 106/233); 48.1% (n = 38/79) in the internal care coordination group, 47.4% (n = 37/78) in the external community referral group and 40.8% (n = 31/76) in the usual care group were lost to follow‐up at 6 months