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. 2021 Mar 9;2021(3):CD013522. doi: 10.1002/14651858.CD013522.pub2

Hammett 2019.

Study characteristics
Methods Study design: secondary analysis of RCT
Country: USA
Data collection period: not stated ‐ secondary analysis of data from the 'Proactive Smoking Cessation Treatment for Minnesota Priority Populations' (OPTIN) study
Registry ID: ClinicalTrials.gov: NCT01123967
Participants Number of participants: N = 2321; Number included in meta‐analysis: ranges from N = 527 – N = 879 dependent on SMI category and outcome
Sample characteristics (at baseline):
Age (mean): mean not reported, 18 – 24 years (SMI 15.2%, non‐SMI 22.3%), 25 – 34 years (SMI 32.7%, non‐SMI, 35.9%), 35 – 64 years (SMI 52.1%, non‐SMI 41.8%); Sex (% male): SMI 26.6% (250/939), non‐SMI 41.6% (436/1382)
Population category: general population and psychiatric population; Specific population: people who smoked, enrolled in Minnesota Health Care Programs (MHCP), people with serious mental illness (SMI, n = 939; categorised using ICD 9 codes) and remaining people who smoked categorised as non‐SMI (n = 1382)
Nicotine dependence: minutes until fist cigarette ≤ 5 (SMI 32.2%, non‐SMI 22.%); Baseline cigarettes per day: SMI: 14.7 (SD 9.6), non‐SMI: 13.0 (SD 8.8); Motivation to quit: selected by motivation to quit
Interventions Behavioural support for smoking cessation: the proactive care intervention systematically offers low‐income people who smoke free and easy access to evidence‐based treatments and has 2 primary components: (1) proactive outreach to people who currently smoke in the form of mailed invitation materials and telephone calls containing targeted health messages, and (2) facilitated access to free, comprehensive, evidence‐based tobacco cessation treatments in the form of NRT and intensive, telephone‐based behavioural counselling. The proactive tobacco treatment intervention is based on social cognitive theory, the stages of change model and the biopsychosocial model of perceived discrimination. Comparison group received usual care which included similar smoking cessation treatment components (including pharmacotherapy and telephone counselling) ‐ participants must self‐initiate access to treatment
Pharmacological support for smoking cessation: NRT available for both the intervention and usual‐care group in the original trial
Psychotherapeutic or psychoactive support for mental health or mood: did not receive mood management
Outcomes Definition of cessation used: a self‐report measure was used to assess 6‐month prolonged smoking abstinence at 12‐month follow‐up
Cessation definition used for outcome(s) in this analysis: prolonged abstinence
Measure of biovalidation: not bioverified
Definition of people who continued to smoke used: participants were asked whether they had smoked 1) at least once on 7 consecutive days, or 2) at least once on 2 consecutive weekends in the 6‐month period prior to the follow‐up survey – those who responded yes to either question were considered to be people continuing to smoke
Time‐point(s) at which follow‐up was conducted: 12 months
Outcome category: Anxiety, Depression
Outcome measure(s): Patient‐Reported Outcomes Measurement Information System (PROMIS); Patient Health Questionnaire 2‐item (PHQ‐2)
Funding source Primary funding provided by NCI Grant R01CA141527‐01. Additional support provided by NCI Grant 2T32CA163184 and the Center for Chronic Disease Outcomes Research, VA, Minneapolis, MN
Author conflicts of interest No conflict declared
Notes Outcome data source: Published and unpublished data