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DOI: 10.1542/peds.2012-3901 ; originally published online June 24, 2013; 2013;132;109 Pediatrics Nancy A. Rigotti Dempsey, Jeremy Drehmer, Bethany Hipple, Victoria Weiley, Sybil Murphy and Regan, Richard Wasserman, Deborah Ossip, Heide Woo, Jonathan Klein, Janelle Jonathan P. Winickoff, Emara Nabi-Burza, Yuchiao Chang, Stacia Finch, Susan Implementation of a Parental Tobacco Control Intervention in Pediatric Practice http://pediatrics.aappublications.org/content/132/1/109.full.html located on the World Wide Web at: The online version of this article, along with updated information and services, is of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275. Boulevard, Elk Grove Village, Illinois, 60007. Copyright © 2013 by the American Academy published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point publication, it has been published continuously since 1948. PEDIATRICS is owned, PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly at Amer Acad of Pediatrics on September 12, 2013 pediatrics.aappublications.org Downloaded from

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DOI: 10.1542/peds.2012-3901; originally published online June 24, 2013; 2013;132;109PediatricsNancy A. Rigotti

Dempsey, Jeremy Drehmer, Bethany Hipple, Victoria Weiley, Sybil Murphy andRegan, Richard Wasserman, Deborah Ossip, Heide Woo, Jonathan Klein, Janelle Jonathan P. Winickoff, Emara Nabi-Burza, Yuchiao Chang, Stacia Finch, Susan

Implementation of a Parental Tobacco Control Intervention in Pediatric Practice  

  http://pediatrics.aappublications.org/content/132/1/109.full.html

located on the World Wide Web at: The online version of this article, along with updated information and services, is

 

of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.Boulevard, Elk Grove Village, Illinois, 60007. Copyright © 2013 by the American Academy published, and trademarked by the American Academy of Pediatrics, 141 Northwest Pointpublication, it has been published continuously since 1948. PEDIATRICS is owned, PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly

at Amer Acad of Pediatrics on September 12, 2013pediatrics.aappublications.orgDownloaded from

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Implementation of a Parental Tobacco ControlIntervention in Pediatric Practice

WHAT’S KNOWN ON THIS SUBJECT: Young adult smokersfrequently encounter the health care system as parents coming infor their child’s medical visit. Child health care clinicians,however, do not typically provide smoking cessation assistance toparents.

WHAT THIS STUDY ADDS: This national cluster-randomized trialdemonstrates that a tobacco dependence intervention for parentscan be effectively implemented in routine pediatric outpatientpractice.

abstractOBJECTIVE: To test whether routine pediatric outpatient practice canbe transformed to assist parents in quitting smoking.

METHODS: Cluster RCT of 20 pediatric practices in 16 states that re-ceived either CEASE intervention or usual care. The intervention gavepractices training and materials to change their care delivery systemsto provide evidence-based assistance to parents who smoke. Thisassistance included motivational messaging; proactive referral toquitlines; and pharmacologic treatment of tobacco dependence. Theprimary outcome, assessed at an exit interview after an office visit,was provision of meaningful tobacco control assistance, defined ascounseling beyond simple advice (discussing various strategies toquit smoking), prescription of medication, or referral to the statequitline, at that office visit.

RESULTS: Among 18 607 parents screened after their child’s office visitbetween June 2009 and March 2011, 3228 were eligible smokers and1980 enrolled (999 in 10 intervention practices and 981 in 10 controlpractices). Practices’ mean rate of delivering meaningful assistance forparental cigarette smoking was 42.5% (range 34%–66%) in the interven-tion group and 3.5% (range 0%–8%) in the control group (P , .0001).Rates of enrollment in the quitline (10% vs 0%); provision of smokingcessation medication (12% vs 0%); and counseling for smoking cessation(24% vs 2%) were all higher in the intervention group compared with thecontrol group (P , .0001 for each).

CONCLUSIONS: A system-level intervention implemented in 20 outpatientpediatric practices led to 12-fold higher rates of delivering tobaccocontrol assistance to parents in the context of the pediatric officevisit. Pediatrics 2013;132:109–117

AUTHORS: Jonathan P. Winickoff, MD, MPH,a,b,c Emara Nabi-Burza, MBBS, MS,a,c Yuchiao Chang, PhD,c,d Stacia Finch,MA,e Susan Regan, PhD,c,d Richard Wasserman, MD,e,f

Deborah Ossip, PhD,g Heide Woo, MD,e,h Jonathan Klein,MD, MPH,b Janelle Dempsey, BA,a,c Jeremy Drehmer, MPH,e

Bethany Hipple, MPH,a,c Victoria Weiley, MIS,e Sybil Murphy,BSW,a,c and Nancy A. Rigotti, MDc,d

aCenter for Child and Adolescent Health Research and Policy,cTobacco Research and Treatment Center, and dGeneral MedicineDivision, Massachusetts General Hospital, Boston, Massachusetts;bAAP Richmond Center of Excellence, and ePediatric Research inOffice Settings, American Academy of Pediatrics, Elk Grove Village,Illinois; fDepartment of Pediatrics, University of Vermont,Burlington, Vermont; gDepartment of Public Health Sciences,University of Rochester Medical Center, Rochester, New York;and hDepartment of Pediatrics, University of California LosAngeles, Los Angeles, California

KEY WORDSSmoking cessation, tobacco smoke exposure, parental smoking,pediatrics, secondhand smoke

ABBREVIATIONSAAP—American Academy of PediatricsCEASE—Clinical Effort Against Secondhand Smoke ExposureCI—confidence intervalMGH—Massachusetts General HospitalNRT—nicotine replacement therapyOR—odds ratioPROS—Pediatric Research in Office SettingsRA—research assistantRCT—randomized controlled trialTSE—tobacco smoke exposure

Dr Winickoff conceived of and conducted the trial as principalinvestigator. He conceived of and designed this article, draftedthe manuscript and revised it, and takes full responsibility forthe final submission. Drs Nabi-Burza, Wasserman, and Ossipmade substantial intellectual contributions to the design,analysis, and interpretation of data; edited the manuscript; andrevised and approved the final submitted manuscript. Dr Changadvised on and conducted data analyses, participated in theinterpretation of results, and approved the final manuscript assubmitted. Ms Finch, Drs Woo and Klein, Ms Dempsey, MrDrehmer, Mrs Hipple, Ms Weiley, and Mrs Murphy madesubstantial intellectual contributions to the conception anddesign, editing the manuscript, and approved the finalmanuscript as submitted. Dr Regan supervised the designing ofthe data collection instruments data, data collection, managedthe database, made significant contribution to the design,critically reviewed the manuscript, and approved the finalmanuscript as submitted. Dr Rigotti made substantialintellectual contributions to the conception and design of thestudy, analysis and interpretation of data, editing themanuscript, and approved the final manuscript as submitted.

This trial has been registered at www.clinicaltrials.gov(identifier NCT00664261).

(Continued on last page)

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Quitting smoking adds an average of 7years to a parent’s life,1 eliminates mostof their children’s tobacco smoke expo-sure (TSE),2–4 eliminates smoking-relatedpoor pregnancy outcomes for all futurepregnancies,5 addresses the primarycause of house fire mortality,6,7 decrea-ses the accessibility of cigarettes andodds that teens becomesmokers,8–10 andimproves the financial resources of dis-advantaged families.11 Therefore, helpingparents quit smoking is a critically im-portant national priority. The child healthcare setting may provide the most fre-quent and sometimes only access to thehealth care system for parents whosmoke. Parents who smoke are often un-derserved medically, but see their child’sdoctor an average of 4 times each year,12

significantly more than they themselvessee a clinician.13–16 Evenmodest cessationrates can have a significant impact on thehealth of families when applied consis-tently over time and when the diseaseburden is high.11 One of 2 smokerswill dieof an illness attributable to their smok-ing.17,18 Missing this opportunity to helpparents quit smoking may mean greatercancer and cardiovascular disease risk inthis population of young adults.

The effectiveness of smoking cessationstrategies iswell established. Accordingto meta-analyses from the 2008 updateof the US Public Health Service Guidelinefor the Treatment of Tobacco Use andDependence,19 counseling, quitline, andnicotine replacement therapy (NRT) areeach more effective than placebo orusual care. Combining these therapieshas been demonstrated to be moreeffective than individual componentsalone.19 Furthermore, a meta-analysisrecently demonstrated the effectivenessof parental smoking cessation initiatedin the pediatric context.20 Effectivestrategies to help parents quit smokingare currently not implemented in thepediatric outpatient setting, despite thisstrong evidence that a child’s visit to thedoctor provides a teachable moment for

parental smoking cessation.21–23 Ourteam has shown that parents acceptsmoking cessation medications andquitline enrollment in this clinical con-text.24,25 The extent to which theseevidence-based tobacco control strate-gies could be routinely implemented inthe pediatric outpatient setting is notknown. This cluster randomized con-trolled trial is the first to test whethera tobacco dependence intervention forparents can be effectively implementedin routine pediatric outpatient practice.

METHODS

Sample

This cluster randomized controlled trialwas conducted in partnership with thePediatric Research in Office Settings(PROS), the practice-based researchnetwork of the American Academy ofPediatrics (AAP). PROS includes morethan 700 practice sites throughout theUnited States.26 Compared with AAPgeneral practitioners, PROS practi-tioners are more likely to practice inrural and urban inner-city areas andless likely to practice in suburbanareas. As of 2009, PROS involved morethan 4% of the nation’s 42 000 practic-ing generalist pediatricians.27 Visits toPROS practices are comparable to na-tional office visit data from the NationalAmbulatory Medical Care Survey.26,28

For this study, we invited the participa-tionofallPROSpracticesthat(1) includedat least 3 practitioners, (2) were nothousedwithinamedicalschoolorparentuniversity, (3)sawat least50patientsperday, and (4) saw at least 10 patients perday with 1 or more parent smokers. Thefirst 22 practices that responded wereenrolled and randomly assigned to in-terventionorcontrolgroups.Samplesizecalculations were based on having atleast 20 practices per arm completingthe full study protocol, including accrualof the necessary parent subjects. Thesample size calculations assume a =0.05, 1-b (power) = 0.80, 2-tailed test of

significance, and 20 total practices (10intervention and 10 control). Each grouphad only 1 dropout, because of slowsubject enrollment defined as ,1 sub-ject per day. The 20 practices in whichdata were collected were located in 16states Alaska, Virginia, Connecticut, NewMexico, Pennsylvania, Missouri, SouthCarolina, Tennessee, Massachusetts,Oregon, Ohio, Oklahoma, Illinois, WestVirginia, Maryland, and South Dakota.Institutional review board approval wasobtained from the Massachusetts Gen-eral Hospital (MGH), the AAP, and localpractice institutional review boardswhen required by the practices.

Randomization

Figure 1 displays the study design. Par-ticipating practices randomly assigned tointervention or usual care control groupswere stratified by the prevalence ofsmoking among parents in the practice(categorized as $30%, 20%–29%, and,20%) and by practice size (di-chotomized as more than 4 individualclinicians versus 2–4 clinicians). A ran-dom generator (from MS Excel; MicrosoftCorporation, Redmond, WA) was used togenerate a sequence of group assign-ments within each of the 6 blocks createdby combining the 2 strata. To assignpractices to the appropriate stratum ofparental smoking prevalence, each par-ticipating practice distributed the PracticePopulation Survey to all parents ofpatients seen at that site on 3 consecutivedays and returned all completed surveysto MGH staff, who entered and analyzedresults. MGH staff forwarded baselinesmoking rate to PROS staff, who enteredeach practice identification in the nextavailable slot in the appropriate blockin the random allocation sequence. Thisprotocol determined assignment to eitherthe control or intervention group. Thepracticeswere awareof theirassignment.

Data Collection

Research assistants (RAs) attempted torecruit a consecutive sample of 100

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parents as they exited the pediatricoffice after their child’s visit betweenJune 1, 2009, and March 7, 2011. Alladults with children up to the age of 18years, presenting for any type of visit,were asked to complete a screeningsurvey consisting of 14 questions re-garding demographics, reason for visit,whether the parent was asked aboutsmoking rules in the car and/or home,and smoking behaviors. Parents wereeligible for the full study if they were theparent or legal guardian of the childseen that day (hereafter referred to asparents), indicated that they hadsmoked a cigarette, even a puff, in thepast 7 days, were at least 18 years old,and had not already enrolled in thestudy during a prior visit (whether forthat child or a different one). The RAinvited parents who met all eligibilitycriteria to participate in the Clinical andCommunity Effort Against SecondhandSmoke Exposure (CEASE) study, ob-tained written informed consent, andadministered an additional 14-item en-rollment survey that included questions

regarding the tobacco control servicesthey received during that day’s visit.Participating parents were given $5 atthe conclusion of enrollment. RAs en-rolled approximately 100 parents at eachpractice. If both parents were presentand both smoked cigarettes, both wereeligible for enrollment.

Intervention

The intervention was based on 10years of work on CEASE, an evidence-based system for implementing to-bacco dependence treatment of parentsin the pediatric setting.11,16,21,22,29–32 Theintervention includes (1) routine screen-ing for parental tobacco use using aCEASE Action Sheet, which helped theoffice staff identify each smoking familymember and document smoking statusin the child’s medical record; (2) moti-vational messaging that is based on theparents’ own concerns as well as po-tential teachable moments that may becued by the child’s illness; and (3) rec-ommendation and possible provision ofnicotine patch and gum by the clinician,

and enrollment in the free state quitline.The intervention is designed to functionwithin existing systems of care; re-search staff deliver none of the clinicaltobacco dependence treatment. Beforethe RAs begin parent screening andenrollment, practices completed a chartreview of at least 10 charts. Once thepractice reached $60% of the chartsincluding a completed CEASE ActionSheet, the study team scheduled a startdate for the RA to start data collection(usually within 7 days of the practiceimplementing the intervention).

Practices were first trained to use theCEASE intervention as follows. Theprincipal investigatorconductedaninitial1-hour individual training session withthe pediatric practice leader to identifynecessary office systems changes, fol-lowed1 to2weeks laterbya1-hourgroupsession with all available clinical andoffice staff to discuss how to deliver the 3critical implementation steps (1. Ask, 2.Assist, 3. Refer) in the context of theclinical office care that they currentlydelivered. Lunch was offered as an

FIGURE 1Randomization design.

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incentive to improve attendance at themeeting. Brief clinical counseling videos,created for CEASE, covered the likelyscenarios that clinicians would encoun-ter with parents who smoke and pro-vided an overview of strategies forintegrating tobacco cessation screening,assistance, and referral into visits withparents in the pediatric setting. Thesevideos demonstrate how clinicians whohave limited time to see a patient canaddress tobacco use in the pediatrichealth care setting, covering strategies,such as eliciting information about in-terest and readiness to quit smoking,respectfully setting an agenda to discusssmoking, helping the smoker set an ac-tion plan for cessation, working withparents to establisha completely smoke-free home and car, and using brief mo-tivationalmessaging todiscuss theeffectof tobacco smoke exposure on the child’shealth. Clinicians were encouraged towatch the videos after the 1-hour groupmeeting. Continuing medical educationcredits were offered for attendance attraining sessions. Sixty-two child healthcare providers, including pediatricians,registered nurses, and medical assis-tants, were trained to deliver the in-tervention during the course of thestudy. The approximate training time perclinician is between 2 and 3 hours, whichincludes attending the training phonecall and watching the videos.

Practices were sent office materials, in-cluding a smoking cessation pharmaco-therapy poster that featured direct toconsumer marketing and had a dosingguide for quick reference for those clini-cians who wished to prescribe pharma-cotherapy, practice-initiated materialslike “quit cards” (business cards withquitline information), and a menu ofother customizable available materialsfor display or distribution that could becustomized based on the state-specificinformation, such as the quitline number.

Innovative aspects of the intervention in-cluded the 3-step Ask, Assist, Refer ap-

proach (as opposed to the moretraditional 5 A’s approach); pediatriciansprescribing NRT to parents of theirpatients; and a 1-page implementationguide to help the practice implement theintervention. Other important aspectswere an optional local press release an-nouncing the availability of the in-tervention for parents, and the previouslymentioned customizable office materials.

Measures

The primary aim of the study was to testthe implementation of the CEASE in-tervention as measured by the tobaccocontrol services actually delivered toparents who smoke. Parents were con-sidered to have received any tobaccocessation assistance (the primary out-come) if they answered yes to any one ofthe following questions administeredduring theexit interview:Duringyourvisittoday, did a doctor, nurse or other healthcare provider (1) discuss medicine tohelp you quit smoking (for example,nicotine replacement gum, patch, loz-enge, or other medicine), (2) discussmethods and strategies (other thanmedicine) tohelpyouquit smoking, or (3)suggest you use a telephone quitline orother program to help you quit smoking?Questions used in this study to assesstobacco control service delivery wereused previously in our other inpatient oroutpatient studies.16,22 Covariates col-lected included gender, age, race, edu-cation, smoking history, smokingbehavior inside the home and car, andattitudes about the dangers of child’s TSE.

Data Analysis

SAS version 9.3 (SAS Institute, Cary, NC)was used for all analyses. All analyseswere intention-to-treat regardless of theamount of interventiondelivered in eachpractice. The primary outcome was theproportion of parents who receivedassistance with quitting smoking be-yond simple advice. In the bivariateanalysis, we used both x2 tests and lo-

gistic regression models with general-ized estimating equations to adjust forphysician clustering to compare theproportion of parents receiving assis-tance between intervention and controlgroups. The analyses were conductedfor overall and subgroups stratified bydemographic, smoking behavior, andpractice level variables. We also per-formed a multivariable logistic regres-sionmodel to determine the interventioneffect adjusting for factors that were un-balanced between intervention and con-trol groups. To determine whether anypatient or practice characteristics wereassociated with delivering assistance toparents who smoked, we conducteda separate analysis limited to the in-tervention practices only. All predictors ofclinician behavior that were significant atthe P, .1 level in the bivariate analyseswere considered as potential covariatesin the multivariable model. The general-ized estimating equation approach wasused in all logistic regression models toaccount for physician clustering.

RESULTS

Thirty-two RAs screened 8598 parentsexiting the interventionpractices and10009 parents exiting the control practi-ces. Self-reported smoking rates were20% in the intervention and 17% in thecontrol condition, respectively. Of the1630 eligible smokers in the interven-tion group, 999 (61%) enrolled, com-pared with 981(61%) of 1598 eligiblesmokers in control practices (Fig 1).

Table 1 presents characteristics of theenrolled parents. The average age was30 years and 22% of the parents in thestudy were fathers. The 2 groups wereslightly imbalanced, possibly owing topractice-level randomization. The inter-vention group had more white parents,fewer black non-Hispanic parents, fewerHispanic parents, fewer college gradu-ates, more cigarettes smoked per day,and lower rates of private insurancecoverage for children. Intervention

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practices tended tobe slightly larger, havehigher smoking rates, and were morelikely to use an electronic health record.

The intervention group, compared withcontrol group, had a higher rate ofproviding counseling beyond simpleadvice by discussing various methodsand strategies to quit smoking (24% vs2%, P # .001), prescribing nicotine re-placement medication (12% vs 0%, P#.001), and enrolling parents in the quit-line (10% vs 0%, P # .001). Of all pa-rental smokers in the study, 42.5% in theintervention condition and 3.5% in thecontrol condition received any tobaccocontrol assistance (P , .001) (Fig 2).

The overall effect of the intervention onreceipt of cessation assistance wasobserved within strata of participantsdefined by a broad range of demo-graphic, behavioral, and practice varia-bles (Table 2). At the individual clinicianlevel, the majority (77%) in interventionpractices delivered assistance to pa-rents who smoke, whereas 6 of 7 incontrol practices did not (Fig 3).

In a multivariable logistic regressionmodel that adjusted for demographics(parent’s race/ethnicity, education level,child’s age category, and insurance cov-erage), behavioral factors (daily versusnondaily smoker, number of cigarettesper day), and practice factors (practicesize and baseline smoking rate), de-livering assistance was strongly associ-ated with the intervention (odds ratio[OR] 29.3, 95% confidence interval [CI]12.8–44.7). Other factors entered intothe model did not alter these resultsappreciably. In a multivariable logisticmodel examining only the interventiongroup, factors associated with providinghigher rates of assistance includedroutine well-child visits (OR 1.6, 95% CI1.2–2.2), and minority race (OR 1.4, 95%CI 1.01–2.0).

DISCUSSION

This cluster randomized controlled ef-fectiveness trial demonstrated that the

CEASE intervention program could besuccessfully implemented in the childhealth care setting. Practices in theintervention group had a 12-fold higherrate of delivering tobacco control as-sistance to parents compared withpractices in the control group, without

the use of research staff to deliver theclinical intervention. Furthermore, thisoutcome is attributable to most physi-cians in the intervention practices de-livering assistance to parents whosmoke, supporting the conclusion thatthe changewas truly at the system level

TABLE 1 Characteristics of Enrolled Parents (Total n = 1980)

Characteristic Control % Intervention % P Value

n = 981 n = 999

Age: mean (range) 30.6 (18–65) 30.0 (18–78) .69a

18–24 25.8 27.125–44 67.7 66.5.45 6.4 6.4

Gender .93a

Male 22.0 21.3Female 77.9 78.6

Race and ethnicity ,.0001a

Hispanic 13.7 8.2Non-Hispanic .1 race 2.5 3.0Non-Hispanic black or African American 19.8 11.3Non-Hispanic Asian 0.5 0.4Non-Hispanic Native Hawaiian or other 1.2 3.5Non-Hispanic white 61.5 72.9

Education ,.0001a

,High school 14.5 16.4High school graduate 45.0 47.5Some college 26.8 29.0College graduate 13.5 6.6

Other smokers in home .67a

1 41.1 40.1.1 58.9 59.9

Child’s age: mean, mo 17.5 11.5 .022a

,1 y 29.1 23.81–4 y 34.4 39.05–9 y 18.8 20.010–14 y 12.6 11.2.14 y 3.9 5.2

Home and car smoking policyStrictly enforced smoke-free home, % 52.7 52.6 .53Strictly enforced smoke-free car, % 19.1 20.6 .44No. cigarettes/d: mean 10.3 11.7 .0007a

1–9 47.1 38.9.10 52.8 61.0

% Daily smoker 82.3 87.3 .005Child’s insurance coverage ,.0001a

Medicaid 64.5 69.8Private insurance/HMO 27.1 20.2Other/self-pay 7.1 9.9

Type of visit .093a

Well child 43.5 41.9Sick visit/Others 56.5 58.1

Practice size ,.0001a

#4 clinicians 20.0 40.0.4 clinicians 80.0 60.0

Overall smoking rate in the practice ,.0001a

,15% 40.0 10.015%–20% 20.0 30.0.20% 40.0 60.0

Electronic Health Record 30.4 50.2 ,.0001a P-value for the whole category.

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and not simply a few physicians in eachpractice accounting for the demon-strated change. Put another way, in thecontrol condition, most did nothingto help parents quit smoking but inthe intervention condition, most as-sisted at least some parents in quittingsmoking.

Development of the intervention wasinformedbymore thanadecadeofwork.The CEASE intervention is adaptable tothe particular practice’s staffing, re-sources, and physical configuration,29

and practices choose materials rele-vant to their own particular systems ofcare. Prior research describes theseconceptually grounded and focus groupstested strategies for parental tobaccocontrol now available for implementa-tion in the pediatric outpatient setting,including the Ask, Assist, Refer clinicalaction framework.30,31

This is the first national study in whichpediatricians provided NRT prescriptionsdirectly to parents in the context of thechild’s clinic visit. Pediatricians weregiven a number to call if there were anyproblems or issues with the study andthere were no reported adverse eventsrelated to prescribing NRT. We receivedno complaints from parents’ primarycare providers about distribution ofprescriptions for this over-the-countermedication to their patients. The posterwith the dosing guide for pharmaco-therapy provided a quick reference forthose clinicians who wish to prescribe

pharmacotherapy so that they save timerequired to look up the requested med-ication to treat the parent’s tobaccodependence. The American Medical As-sociation policy amended its tobaccocontrol policy and now recommendsthat clinicians treat people who smokewith the available tobacco dependencetreatments regardless of the clinicalcontext inwhich they are encountered.33

This policy was specifically written tosupport pediatricians who want togive NRT prescriptions for parents whosmoke.

Our work with clinicians in this studyidentified noncoverage of NRT as thebiggest concern. Where NRT is not cov-ered, physicians told us that they stop-ped offering prescriptions for parents.Overall enthusiasm for the interventionis greatly diminished when these clini-cians cannot get NRT, the most effectivesingle component of the intervention,34

into the hands of parents who smoke.However, all NRT will be covered bypublic insurance by 2014.35 This trialmay also help motivate and justifyprivate insurers to move to coveringNRT at least in the context in whicha covered patient has children. Futurework will be needed to study the sus-tainability of the intervention whenNRT is more uniformly covered, inanticipation of the changes in Centersfor Medicare and Medicaid Servicesregulation. Critical next steps includestudying implementation in a nation-

ally generalizable context of pediatricpractices, measurement of institutionalsustainability,36 and cost-effectiveness37;key parameters that will influence na-tional adoption.

The study has a number of limitations.First, 1 practice in the intervention groupand 1 practice in the control groupdropped out of the study because of slowenrollment, leaving us with our targetnumberof 10practices ineachcondition.Although differential drop out might re-flect inability toperformthe intervention,the fact that we had 1 in each conditionwas reassuring. Second, PROS practicesare not completely representative ofnational pediatric practices; however,based on estimates of 1545 patients perPROS practitioner, PROS practitionerscare for an estimated 2.7 million of thenation’s children.26 Third, providingcustomized state-specific materials andtelephone support during office trainingmeetings may be an important part ofoptimizing the implementation strategy.This extra support may be a criticalfeature in the success of the trial, andtherefore, the availability of an onlineCEASE module that guides implementa-tion for the Ask, Assist, Refer strategymay be necessary but not sufficient topromote effective implementation na-tionally. Last, implementation does notequal sustained intervention. Withoutattention to the problem of how to sus-tain this intervention, it will likelyweaken and dissipate over time.36,38,39

Incorporating the intervention into thestandard electronic health record mayhelp universal integration into pediatricwork flow in the future.

The 2006 and 2010 Surgeon Generalreports conclude that there is no safelevel of tobacco smoke exposure.40,41

Protection of children from the dangersof household TSE includes helping pa-rents quit smoking.30 The generalizableintervention model used in this study,meeting the new quality improvementrecertification requirement, was recently

FIGURE 2Rates of tobacco control assistance for parental smokers in 10 control vs 10 intervention practices.

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recognized as an “innovation in med-icine” by the Agency for HealthcareResearch and Quality42 and couldspread rapidly across child healthcare settings to help families elimi-nate tobacco use. Essential nationalenvironmental factors external to pe-diatric practices are now in place tomaximize the potential for practicechange with this intervention. Thesefeatures are (1) an available quitlinein every state43, (2) publically coveredcessation medication44, (3) a requiredcontinuing medical education projectaddressing quality improvement toobtain pediatric recertification45 (anonline, tailored, self-pacedmodulewhereclinicians work on a full practice imple-mentation over the course of severalmonths of self-study and hands-onimprovement cycles; this module sat-isfies the new American Board of Pe-diatrics Maintenance of CertificationPerformance in Practice requirement,creating a natural “pull” for the train-ing45), and (4) a social climate in whichit is acceptable and even expected thatparents receive cessation support fromany health care clinician.24,25

CONCLUSIONS

This study demonstrates that an in-tervention, including routine screen-ing for parents who smoke, NRTmedication prescription for parents,and enrollment in free state tobaccoquitlines, can be implemented as partof routine child health care outpatientpractice nationally. The high diseaseburden of parental tobacco use andlow current levels of intervention inthis population highlight the need forexploring all promising options toreach these young adult parentalsmokers. Future studies are needed todetermine how all effective compo-nents of the intervention can be sus-tained and optimized to promoteparental smoking cessation over timein this clinical context.

TABLE 2 Enrolled Parents Who Received Any Tobacco Cessation Assistance (Total n = 1980)

Characteristic Control % Intervention % P Value(Unadjusted)

P Value(Adjusted for

Physician Clustering)n = 981 n = 999

Overall 3.5 42.5 ,.0001 ,.0001Age: mean, range18–24 3.2 41.0 ,.0001 ,.000125–44 3.6 43.4 ,.0001 ,.0001.45 3.2 40.6 ,.0001 .001

GenderMale 2.8 40.8 ,.0001 ,.0001Female 3.5 43.1 ,.0001 ,.0001

Race and ethnicityHispanic 3.0 46.3 ,.0001 .0005Non-Hispanic .1 race 4.0 56.7 ,.0001 .007Non-Hispanic black or

African American5.7 40.7 ,.0001 .002

Non-Hispanic Asian 20.0 25.0 .90 .76Non-Hispanic Native

Hawaiian or other8.3 45.7 .025 .063

Non-Hispanic white 2.5 41.3 ,.0001 ,.0001Education,High school 2.1 43.9 ,.0001 .0007High school graduate 3.4 41.9 ,.0001 ,.0001Some college 3.4 43.1 ,.0001 ,.0001College graduate 5.3 39.4 ,.0001 .0002

Other smokers in home1 2.5 41.4 ,.0001 ,.0001.1 4.2 43.3 ,.0001 ,.0001

Child’s age: mean, mo,1 y 2.8 44.5 ,.0001 ,.00011–4 y 4.7 42.1 ,.0001 ,.00015–9 y 4.9 46.5 ,.0001 .000110–14 y 0.8 35.7 ,.0001 .0001.14 y 0 36.5 ,.0001 .0001

Strictly enforcedsmoke-free home, %Yes 5.0 40.8 ,.0001 ,.0001No 1.8 44.3 ,.0001 ,.0001

Strictly enforcedsmoke-free car (%)Yes 3.2 45.6 ,.0001 .0002No 3.5 41.7 ,.0001 ,.0001

No. cigarettes/day:1–9 3.2 36.8 ,.0001 ,.0001.10 3.7 46.3 ,.0001 ,.0001

Daily smoker 3.6 44.0 ,.0001 ,.0001Child’s insurance coverageMedicaid 3.6 41.9 ,.0001 ,.0001Private insurance/HMO 3.0 40.1 ,.0001 ,.0001

Other/self-pay 2.9 35.3 .003 .013Type of visitWell child 3.3 43.5 ,.0001 ,.0001Sick visit/Others 4.6 38.5 ,.0001 .0003

Practice type,4 clinicians 6.1 43.8 ,.0001 .063.4 clinicians 2.8 41.7 ,.0001 .0007

Overall smoking ratein the practice,15% 4.4 46.9 ,.0001 .2215%–20% 1.5 36.8 ,.0001 .039.20% 3.5 44.6 ,.0001 .006

Electronic Health Record 1.3 36.5 ,.0001 .012

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ACKNOWLEDGMENTS

We especially appreciate the efforts ofthe PROS practices and practitioners.The pediatric practices or individualpractitioners who enrolled participantsin the larger study are listed here by AAPChapter: Alaska: Anchorage Pediatric

Group, LLC (Anchorage); Connecticut: Hos-pital of Saint Raphaels (New Haven); Illi-nois: Community Health ImprovementCenter (Decatur);Maryland: CambridgePediatrics LLC (Waldorf);Massachusetts:QuabbinsPediatrics(Ware),RiverBendMedi-calGroup-SpringfieldOffice (Springfield);

Missouri: Priority Care Pediatrics LLC(Kansas City); New Mexico: Las VegasClinic for Children and Youth, PA (LasVegas); Ohio: Bryan Medical Group(Bryan), The Cleveland Clinic Wooster(Wooster); Oklahoma:ShawneeMedicalCenter Clinic (Shawnee); Oregon: Sis-kiyou Pediatric Clinic LLP (Grants Pass);Pennsylvania: Pennridge Pediatric Asso-ciates (Sellersville); South Carolina: InletPediatrics(Murrells Inlet); SouthDakota:Avera McGreevy Clinic (Sioux Falls); Ten-nessee: Raleigh Group PC (Memphis);Virginia: Pediatrics of Kempsville PC (Vir-ginia Beach), Riverside Pediatric Center(Newport News), The Clinic (Richlands);West Virginia: Shenandoah CommunityHealth Center (Martinsburg).

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(Continued from first page)

www.pediatrics.org/cgi/doi/10.1542/peds.2012-3901

doi:10.1542/peds.2012-3901

Accepted for publication Mar 28, 2013

Address correspondence to Jonathan P. Winickoff, MD, MPH, Center for Child and Adolescent Health Research and Policy, Massachusetts General Hospital forChildren, 15th floor, Suite 1542A, 100 Cambridge St, Boston, MA 02114. E-mail: [email protected]

PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).

Copyright © 2013 by the American Academy of Pediatrics

FINANCIAL DISCLOSURE: Dr Rigotti served as a consultant for Alere Wellbeing Inc; the other authors have indicated that they have no financial relationshipsrelevant to this article to disclose.

FUNDING: Supported by the National Institutes of Health National Cancer Institute grant R01-CA127127 (to Dr Winickoff), the National Institute on Drug Abuse, andthe Agency for Healthcare Research and Quality. This study was also partially supported by a grant from the Flight Attendant Medical Research Institute to theAmerican Academy of Pediatrics Julius B. Richmond Center, and the Pediatric Research in Office Settings Network, which receives core funding from the HealthResources and Services Administration Maternal and Child Health Bureau (HRSA 5-UA6-10-001) and the American Academy of Pediatrics. The funders had no role inthe design or conduct of the study; collection, management, analysis and interpretation of the data; or preparation, review, and approval of the manuscript. Fundedby the National Institutes of Health (NIH).

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DOI: 10.1542/peds.2012-3901; originally published online June 24, 2013; 2013;132;109PediatricsNancy A. Rigotti

Dempsey, Jeremy Drehmer, Bethany Hipple, Victoria Weiley, Sybil Murphy andRegan, Richard Wasserman, Deborah Ossip, Heide Woo, Jonathan Klein, Janelle Jonathan P. Winickoff, Emara Nabi-Burza, Yuchiao Chang, Stacia Finch, Susan

Implementation of a Parental Tobacco Control Intervention in Pediatric Practice  

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