title: Telephone care coordination for smokers in VA mental health clinics: protocol for a hybrid type-2 effectiveness-implementation trial.
abstract: BACKGROUND
  This paper describes an innovative protocol for a type-II hybrid effectiveness-implementation trial that is evaluating a smoking cessation telephone care coordination program for Veterans Health Administration (VA) mental-health clinic patients. As a hybrid trial, the protocol combines implementation science and clinical trial methods and outcomes that can inform future cessation studies and the implementation of tobacco cessation programs into routine care. The primary objectives of the trial are (1) to evaluate the process of adapting, implementing, and sustaining a smoking cessation telephone care coordination program in VA mental health clinics, (2) to determine the effectiveness of the program in promoting long-term abstinence from smoking among mental health patients, and (3) to compare the effectiveness of telephone counseling delivered by VA staff with that delivered by state quitlines.
  
  
  METHODS
  The care coordination program is being implemented at six VA facilities. VA mental health providers refer patients to the program via an electronic medical record consult. Program staff call referred patients to offer enrollment. All patients who enroll receive a self-help booklet, mailed smoking cessation medications, and proactive multi-call telephone counseling. Participants are randomized to receive this counseling from VA staff or their state's quitline. Four primary implementation strategies are being used to optimize program implementation and sustainability: blended facilitation, provider training, informatics support, and provider feedback. A three-phase formative evaluation is being conducted to identify barriers to, and facilitators for, program implementation and sustainability. A mixed-methods approach is being used to collect quantitative clinical effectiveness data (e.g., self-reported abstinence at six months) and both quantitative and qualitative implementation data (e.g., provider referral rates, coded interviews with providers). Summative data will be analyzed using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.
  
  
  CONCLUSIONS
  This paper describes the rationale and methods of a trial designed to simultaneously study the clinical effectiveness and implementation of a telephone smoking cessation program for smokers using VA mental health clinics. Such hybrid designs are an important methodological design that can shorten the time between the development of an intervention and its translation into routine clinical care.
authors.affiliation: VA New York Harbor Healthcare System, 423 East 23rd Street - 15N, New York, NY 10010, USA. erin.rogers2@va.gov
authors.forename: Erin
authors.initials: E
authors.lastname: Rogers
authors.forename: Senaida
authors.initials: S
authors.lastname: Fernandez
authors.forename: Colleen
authors.initials: C
authors.lastname: Gillespie
authors.forename: David
authors.initials: D
authors.lastname: Smelson
authors.forename: Hildi J
authors.initials: HJ
authors.lastname: Hagedorn
authors.forename: Brian
authors.initials: B
authors.lastname: Elbel
authors.forename: David
authors.initials: D
authors.lastname: Kalman
authors.forename: Alfredo
authors.initials: A
authors.lastname: Axtmayer
authors.forename: Karishma
authors.initials: K
authors.lastname: Kurowski
authors.forename: Scott E
authors.initials: SE
authors.lastname: Sherman
mesh_terms: D000328:Adult; D003376:Counseling / Q000379:methods*; D005260:Female; D006284:Health Plan Implementation; D006801:Humans; D008297:Male; D008605:Mental Health Services / Q000706:statistics & numerical data; D008875:Middle Aged; D010348:Patient Care Team / Q000458:organization & administration; D010349:Patient Compliance / Q000706:statistics & numerical data; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D011795:Surveys and Questionnaires; D013689:Telephone / Q000706:statistics & numerical data*; D014029:Tobacco Use Disorder / Q000534:rehabilitation*; D016896:Treatment Outcome; D014481:United States; D014493:United States Department of Veterans Affairs / Q000458:organization & administration*; D014728:Veterans / Q000523:psychology / Q000706:statistics & numerical data*; D055815:Young Adult