A cluster randomized controlled trial conducted in 20 pediatric practices in 16 states across the United States, assessed the percentage of parents who received tobacco control assistance from their child's pediatric care provider that participated in either CEASE or usual care. The 20 participating practices were part of Pediatric Research in Office Settings (PROS), a research network of the American Academy of Pediatrics that includes over 700 practices. All PROS practices that met the following criteria were invited to participate: (1) had a minimum of 3 practitioners, (2) were not part of a medical school or parent university, (3) saw at least a minimum of 50 patients per day, and (4) saw at least 10 patients per day with one or more parent smokers. Practices were randomized to receive the CEASE intervention (n=10) or usual care (n=10). Usual care practices received no training, but practice staff in this group were aware that they were participating in the comparison arm in the study. Baseline data over a 3-day period were collected to determine the smoking prevalence of parents at each practice. These data, along with data on the number of providers in each practice, were used to assign practices to the CEASE intervention or usual care through stratified random sampling. All study procedures were approved by the institutional review boards of the American Academy of Pediatrics and Massachusetts General Hospital and by individual practice institutional review boards, if required.
Each study site aimed to recruit a sample of 100 parents exiting their child's pediatrics office to result in a total of 2,000 study participants. Parents aged 18 years and older who smoked within the past 7 days and who had a child under age 18 were eligible to participate. A 14-item screening questionnaire was given to parents to collect data on demographics, reason for the visit, parent smoking rules in the home and car, and parent smoking behavior. Parents were also asked about the tobacco control assistance they received during the visit. Follow-up data were collected from the parents through a telephone survey 12 months after their exit interview. During the call, parents were asked about their current tobacco use behavior, smoking rules in the home and car, and any visits to their child's pediatrics office in the past 12 months. Parents who reported that they had at least one office visit in the past 12 months were asked about the tobacco control assistance they received during the visit. A saliva sample was requested from parents who reported cessation of tobacco use.
A total of 1,980 parents participated in the study (999 parents in the CEASE group and 981 parents in the usual care group). The average age of parents was 30 years, and 78% of parents in the study were mothers. In the CEASE group, the participants were 73% White, 11% African American, 8% Hispanic, 4% Native Hawaiian or other, 3% more than one race, and <1% Asian. In the usual care group, the participants were 62% White, 20% African American, 14% Hispanic, 3% more than one race, 1% Native Hawaiian or other, and <1% Asian. Among the 1,355 parents who completed the 12-month telephone survey, the average age was 31 years, and 81% were mothers.
The outcome assessed was the percentage of parents who received tobacco control assistance, first at the initial visit and second during the following 12-month period. Parents were considered to have received tobacco control assistance if they said "yes" to any of the following questions: Did your provider "discuss medicine to help you quit smoking (e.g., nicotine replacement gum, patch, lozenge, or other medicine)," "discuss methods and strategies (other than medicine) to help you quit smoking" or "suggest you use a telephone quitline or other program to help you quit smoking"?