Brief FASD prevention intervention: physicians' skills demonstrated in a clinical trial in Russia.

0.6 MB·English

by  Balachova, Tatiana

Balachovaetal.AddictionScience&ClinicalPractice2013,8:1
http://www.ascpjournal.org/content/8/1/1
RESEARCH Open Access
’
Brief FASD prevention intervention: physicians
skills demonstrated in a clinical trial in Russia
Tatiana Balachova1*, Barbara L Bonner1, Mark Chaffin1, Galina Isurina2, Vladimir Shapkaitz3, Larissa Tsvetkova2,
Elena Volkova4, Irina Grandilevskaya2, Larissa Skitnevskaya4 and Nicholas Knowlton5
Abstract
Background: Alcohol consumption during pregnancy can result ina range ofadversepregnancy outcomes
including Fetal Alcohol Spectrum Disorders (FASD). Risky drinking amongRussian women constitutesa significant
risk for alcohol-exposed pregnancies (AEP). Russian women report thatobstetrics and gynecology (OB/GYN)
physicians are themost importantsource of information about alcohol consumption during pregnancy and
developing effective prevention interventions by OB/GYNs is indicated. This is the first study focused on
implementation ofan AEP preventioninterventionat women’sclinics inRussia.
Method: The paper describes the intervention protocol and addresses questions about thefeasibility of a brief
FASDprevention interventiondelivered by OB/GYNs at women’s clinics inRussia. Briefphysician intervention
guidelines and two evidence-based FASD prevention interventions were utilized to design a brief dual-focused
physician intervention(DFBPI) appropriate to Russian OB/GYN care. The questions answered were whether trained
OB/GYN physicians could deliver DFBPI during women’sroutine clinic visits, whether they maintained skills over
time inclinical settings, and which specific intervention components were better maintained. Data were collected
as part of a larger study aimed atevaluatingeffectiveness ofDFBPI inreducing AEP risk in non-pregnant women.
Methods of monitoring theinterventiondelivery included fidelity check lists (FCL) with thekey components of the
intervention completed by physicians and patients and live and audio taped observationsof interventionsessions.
Physicians (N = 23) and women (N = 372) independently completed FCL, and 78 audiotapes were coded.
Results: The differences between women’s and physicians’reports on individual items were not significant.
Although themajorityof physician and patient reportswere consistent (N = 305), a discrepancy existed between
thereportsin57 cases. Women reported more interventioncomponents missing comparedto physicians
(p< 0.001). Discussing barriers was themost difficult component for physicians to implement, and OB/GYN
demonstrated difficulties indiscussing contraception methods.
Conclusions: TheresultssupportedthefeasibilityoftheDFBPIinRussia.OB/GYNphysicianstrainedintheDFBPI,
monitored,andsupportedwereabletoimplementandmaintainskillsduringthestudy.Inadditiontothealcoholfocus,
DFBPItrainingneedstohaveasufficientcomponenttoimprovephysicians’skillsindiscussingcontraceptionuse.
Background 1,000 in the US, and FASD prevalence is estimated to be
Alcohol use during pregnancy is the leading preventable 2%-5% among elementary school children in the US and
causeofmentalretardationandcanresultinFetalAlcohol some Western European countries [6]. The rates are likely
Syndrome (FAS) and a wide range of Fetal Alcohol to be higher in countries with greater alcohol use and
Spectrum Disorders (FASD) [1-4]. The worldwide rate of limitededucationabouttheeffectsofalcoholconsumption
FAS has been estimated to be 1.9 per 1,000 live births [5]. during pregnancy. Although the FAS rates in Russian
Recent studies indicate a higher FAS rate of 2 to 7 per general populations have not been established, studies
report high FAS and FASD rates in Russian orphanages
*Correspondence:[email protected] [7-9]andinchildrenadoptedfromRussia[10].
1TheUniversityofOklahomaHealthSciencesCenter,940N.E.13thStreet, FAS and FASD are completely preventable by avoiding
NicholsonTowerSuite4900,OklahomaCity,OK73104,USA
alcohol use during pregnancy [11,12]. Approximately 12%
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©2013Balachovaetal.;licenseeBioMedCentralLtd.ThisisanOpenAccessarticledistributedunderthetermsoftheCreative
CommonsAttributionLicense(http://creativecommons.org/licenses/by/2.0),whichpermitsunrestricteduse,distribution,and
reproductioninanymedium,providedtheoriginalworkisproperlycited.
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ofwomenintheUS[13]andover20%worldwideconsume erability. In other words, the intervention must be amen-
alcohol during pregnancy [14]. Most women eliminate or able to implementation, at scale, within authentic service
reducealcoholconsumptiononlearningthattheyarepreg- systems, with reasonable fidelity and quality, and in sub-
nant. However, approximately half of all pregnancies are stantial quantity. Feasibility of AEP prevention utilizing
unplanned,andmanywomenarenotawaretheyarepreg- BPIintheRussianculturalcontextandhealthcaresystem
nant until four to six weeks into pregnancy and continue hasnotbeenstudied.
using alcohol at pre-pregnancy levels [15]. As a result, a Our initial studiesofAEPriskinRussiausedsurveyand
significant proportion of women consume alcohol during interview methods with women and physicians in order to
theearlystagesofpregnancypriortopregnancyidentifica- inform development of an AEP prevention strategy. Key
tion [14,16]. Studies indicate that alcohol exposure early in findings included that a) the periconceptual period
pregnancymayaffectfetaldevelopmenteveniffollowedby appeared to be a critical risk window; b) Russian women
later gestational abstinence [17]. A combination of at-risk viewed their OB/GYN physicians as having perhaps the
drinking with the possibility of becoming pregnant consti- single strongest influence on their health beliefs and beha-
tutes a significant risk for alcohol-exposed pregnancies viors; c) most women already modify their drinking after
(AEP), and a pre-conceptional approach to preventing pregnancy recognition, largely due to an interest in their
FASDhasbeenrecommended[18]. baby’shealth;andd)mostwomenareunawareofAEPrisk
In Russia, nearly all women report drinking in the year prior to pregnancy identification. Based on these key
before pregnancy, and depending on the study, 20%-60% findings,weadaptedaBPImodel(tobedescribedindetail
drink to some extent after pregnancy recognition, and later) and began implementing it at OB/GYN clinics in
3%-7.4%reportbingedrinkingduringpregnancy[19,20].In Russia. The parent study was a two-arm, 20-site, site-
a longitudinal outcome study of 413 pregnant women in randomizedtrialaimedatevaluatingtheeffectivenessofan
Moscow,20.2%reportedbingedrinkingaroundthetimeof intervention to reduce the risk for AEP in non-pregnant
conception, and 4.8% reported binge drinking in the most women. OB/GYNs (“women’s clinics”) were randomly
recentmonthofpregnancy[21].Inasampleof648women assignedtointerventionorcontrol(nointervention)condi-
recruited from women’s clinics in two regions of Russia, tion,andstudyparticipantswererecruitedfrombothinter-
between32%and54%ofnon-pregnantwomenwereatrisk vention (10 clinics) and control sites (10 clinics). The aim
forAEPa[19]incontrastto2%ofnon-pregnantwomenin ofthecurrentpaperistodescribetheBPImodelthatwas
a US national sample [22]. Applying comparable risk developed and deployed at the intervention clinics, and
criteria, the general population at-risk rate in Russia present information drawn from implementation of qual-
(32%-54%) washigher then that ofthe highest risk women ity control efforts about its feasibility and deliverability in
in the US, i.e., US women at drug and alcohol treatment the Russian context. This is the first study focused on
centers US (24%) [22]. Many Russian women eliminate or implementation of an AEP prevention intervention at
significantly curtail alcohol consumption after pregnancy women’sclinicsinRussia.Subsequentpaperswillexamine
recognition, but minimal reduction in use occurs during intervention impact on downstream client level AEP risk
the pre-conception period, even among women who are outcomes.
actively attempting to become pregnant [19]. Among
women who were trying to conceive, 67% reported binge Methods
drinking in the prior three months [14]. The prevalence of The study was reviewed and approved by Institutional
binge drinking among Russian women who might become Review Boards at St. Petersburg State University (SPSU)
or are trying to become pregnant constitutes a significant and the University of Oklahoma Health Sciences Center
publichealthproblem. (OUHSC) and was conducted with approvals from the
Briefphysicianintervention(BPI)hasbeenrecognizedas participatingclinics.
an effective approach to reducing alcohol use and related
health problems in patients at risk in primary care [23,24]. Settingandparticipants
Although research provides some evidence that BPI The study was conducted at public women’s clinics in two
reduces women’s AEP risk [25-32], studies are needed to locationsinRussiarepresentedbythemajorurbanpopula-
ascertain the efficacy of brief interventions (BI) for women tion of St. Petersburg (SPB) and more rural population of
andtodeterminethetypeofAEPpreventioninterventions theNizhnyNovgorodRegion(NNR).Atotaloftenclinics,
that could be the most effectively implemented in primary five at each location (SPB and NNR), were assigned to the
health care [33-35]. BPI can be effective in reducing AEP intervention. The clinics varied from a small rural clinic
risk if it is feasible, deliverable, and correctly implemented; withoneOB/GYNintheNNRtoalargeurbanclinicwith
however, feasibility has sometimes proven challenging over 20 OB/GYNs in SPB. Commitments from the SPB
[36-39].Inordertohaveasignificantpublichealthimpact, and NNR Health Administrations were received to ensure
intervention models must have both efficacy and deliv- cooperation from the participating clinic directors.
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Organizational support wasobtained from the clinicdirec- pregnancy, e.g., non-pregnant women of childbearing age,
tors to participate in the study and to allow participating and addressing both behaviors that place women at AEP
physicians at intervention clinics to incorporate the study risk, e.g. at-risk drinking and inconsistent family planning/
interventionintoroutineclinicvisitswiththestudypartici- contraception. Women from our prior studies indicated
pants.Participatingphysiciansmetthefollowingcriteria:1) that advice by OB/GYN physicians or nurses would be the
certified in obstetrics and gynecology, 2) employed at least most trusted source of information about health behaviors
50% timeat aclinicassigned to theintervention,3) agreed andalcoholconsumptionduringpregnancy[42].Thereisa
to serve in the study, 4) participated in the intervention well-established Russian OB/GYN health care system with
training,and5)demonstratedskillsincompletingtheinter- services such as prenatal care and family planning/contra-
vention protocol. A total of 26 OB/GYN physicians were ception services provided at district women’s clinics freeof
trainedintheprotocol. Two didnot commit to participate charge.Basedonourpriorsurveysofphysiciansandinter-
in the study, and one did not meet the post-training skills views with Russian experts, it was decided that the
criteriaandwasremoved.Atotalof23OB/GYNphysicians intervention protocol should be brief, incorporated in a
(8inNNRand15inSPB)participatedinthestudyasinter- routine clinic visit, and should require one to two sessions
ventionists.Thephysicianswerefemalewithameanageof maximumasitisunlikelythat somenon-pregnantwomen
38 years and average of 13 years in practice. Physicians wouldreturnformorethanonefollow-upvisit.Thisisthe
werereimbursedapproximately$20perintervention. first intervention protocol for AEP prevention in Russia
Patient participants were recruited for the study as con- and the first protocol for a dual-focused AEP prevention
secutively enrolled non-pregnant women who were at risk intervention designed to be deliverable by OB/GYN physi-
for AEP between July, 2009-July, 2011. Patient inclusion ciansduringroutinewomen’sclinicvisits.
criteriawere:a)childbearingagewomen(ages18–44years); First, we reviewed BI guidelines to make certain that the
b) fertile; c) not currently pregnant (by self-report or a test major components of effective interventions (e.g., advice,
result); d) engaging in AEP risk behaviors, i.e., specifically feedback,goalsetting,additionalcontactsforfurtherassist-
reporting having unprotected intercourse at least once in ance, and support [24,43]) were included in the interven-
the last six months and drinking eight or more drinks per tion protocol. Second, we reviewed FASD prevention
week on average or four or more drinks on one occasion studies and extracted elements from two evidence-based
withinthepastthreemonths;e)livingintheareaservedby FASD prevention interventions with sound evidence for
one of the study clinics; f) available for follow-up for reducingAEPriskinnon-pregnantwomen:HealthyMoms
12months;andg)providingvoluntaryinformedconsent.A [30] and Project CHOICES [41]. Project CHOICES is a
plan was made to over-recruit women with higher alcohol dual-focused intervention drawn from the Motivational
consumptionto haveat least20%ofthesamplescore8or Interviewing(MI)[44]frameworkanddesignedtodecrease
higher on the Alcohol Use Disorders Identification Test the AEP risk in non-pregnant childbearing age women by
(AUDIT) [40]. A review of women’s AUDIT scores either reducing drinking or improving contraception or
conducted after enrolling 80% of the targeted sample at both. However, CHOICES itself could not be directly used
eachstudylocationindicatedasignificantnumberofstudy within our intended parameters because it requires four
participants with high AUDIT scores at the majority of 45 to 60 min counseling sessions with a mental health
clinics (N=8). At the remaining two clinics, AUDIT was professional/counselor and one contraception session with
administered upon screening to recruit few heavier a family planning clinician. A key reason for selecting
drinkers. A total of 374 women were recruited at the 10 CHOICESas one source for adaptionto the Russian con-
intervention clinics in SPB (n=197) and the NNR (n=177); text was its flexibility in targeting both prevalent among
29%ofthestudyparticipantsscored8orhigheronAUDIT. Russian women problematic behaviors (risky drinking
Participants received a gift at completion of the baseline and lack of contraception) in one intervention. Also, OB/
assessmentandthefirstinterventionsession(anequivalent GYNphysiciansassessandassistwomenincontraception
of$25). useandareinauniquepositiontodeliverthisfacetofthe
CHOICES approach. This is the first feasibility study
Interventionprotocol testing delivery a dual-focused AEP prevention interven-
The intervention was adapted from two evidence-based tionbyOB/GYNphysicians.
FASD prevention interventions, Healthy Moms [30] and We adapted the structural elements from the Healthy
Project CHOICES [41]. Results from our previous studies Moms [30] protocol to make our intervention deliverable
in Russia guided selection and adaptation of this interven- during routine clinic visits. The Healthy Moms protocol
tion protocol. The high prevalence of AEP risk among was designed for women in the postpartum period to be
non-pregnantwomeninRussiawhocombineat-riskdrink- deliverable in two 15-min clinic visits followed by two
ing with a possibility of becoming pregnant [19] dictated a phone calls by OB/GYNs, outpatient nurses, or research
need in intervention that would target women prior to staff. Similarly to CHOICES, Healthy Moms utilizes MI
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and includes a patient workbook that contains results of sheets for self-evaluation of importance, confidence, and
screeningandpersonalizedfeedbackaboutAEPrisk,work- readiness to use alcohol safely; 7) plans for pregnancy or
sheets on drinking (and contraception in CHOICES), and contraception, 8) decisional balance regarding alcohol and
drinkingdiarycards. contraceptionuse;9)goalsetting,and10)adiarytorecord
The adapted protocol, which was termed the Dual- intercourse, contraception use, and alcohol use during the
Focused Brief Physician Intervention protocol (DFBPI), subsequent four weeks. The participant was asked to read
implements MI principles, focuses on both contraception information in the workbook and educational brochures
andalcoholuse,andisdesignedtobedeliverableroutinely aboutFASDandcontraception,completeexercisesandthe
by OB/GYN physicians at women’s clinics. The interven- diary between visits, and bring the book to the next clinic
tiontargetschildbearingagenon-pregnantwomenwhoare visit to discuss with the OB/GYN. The second session
atriskforAEP,i.e.,riskydrinkerswhoareusingcontracep- protocol is tailored to the woman’s choice of pregnancy
tioninconsistently.TheDFBPIprotocolandmaterialswere planning or contraception. (The key structural elements of
prepared in consultation with Russian project consultants, the second intervention session are included in Figure 3).
obstetricians and behavioral health experts, including The two DFBPI sessions were incorporated into routine
Russian women. The CHOICES and Healthy Moms inter- OB/GYN clinic visits and could include taking a medical
vention materials (e.g. workbooks) were translated and history, conducting a physical exam, and providing
modified in accordance with DFBPI. Materials were trans- prescriptions or contraceptives if indicated. The estimated
lated and back translated by bi-lingual behavioral health totaltimerequiredforphysicianstodelivertheDFBPIwas
expertsinordertoensurethatthematerialswereculturally 5–10minpersession.
congruent,accurate,andwouldbecorrectlycomprehended
by Russian women. A physician training protocol was
developed and pre-tested by the study research group in a Trainingandmonitoringofphysicians
small randomized educational trial using a two-arm, pre/ Physicians were trained in the intervention by the study
posttest design [45]. The results of this study showed that supervisorswho werePhD levelpsychologistsand a senior
Russian OB/GYN physicians randomized to the training MD/PhD OB/GYN physician. The training included a
condition demonstrated significantly improved skills after three-hour FASD education module on the effects of
thetraining. alcohol consumption during pregnancy, FASD, prevention,
The DFBPI, with the translated title, Baby’s Health is and screening and brief interventions followed by a four-
YourChoice, consisting oftwo face-to-facestructured brief hour instructional and practice workshop. The physicians
5–10 min intervention sessions was incorporated in OB/ learnedtheDFBPIprotocol,applicationof basicMIprinci-
GYN clinic visits scheduled approximately one month ples, and practiced conducting the intervention in a
apart. Because of the lack of informational materials about nonjudgmental and empathic manner. The intervention
contraceptioninRussia,aneducationalbrochure[46]about protocol was presented in a step-by-step format with
contraception methods was also developed for the study. instructions,andskilltrainingtechniquessuchasscenarios,
The DFBPI physician algorithm or steps to be taken by video demonstration, and role plays, which were employed
physiciansareincludedinFigure1. totrainphysicianstothebehavioralcompetencycriteriaby
In the intervention condition during the first visit, a demonstrating their delivery of all components of the
woman’s contraception practices and alcohol use were 5–10minDFBPIprotocol.Feasibilityanddeliverabilitydata
assessed and feedback about AEP risk was provided. The for the DFBPI protocol were drawn from project quality
woman received informational materials about the effects control efforts. Physicians delivering DFBPI were moni-
of alcohol on a fetus and FASD, risky levels of alcohol use, tored in four ways. Monitoring included reviews of the
and contraception methods; was provided an opportunity intervention fidelity check lists (see Measures section)
todiscussheroptionsandpossiblebarriers;wasassistedin completed by physicians and by patients after each inter-
settingupherAEPreductiongoal(ifshechoseAEPreduc- ventionsession, direct observations ofphysician’s interven-
tion); received a workbook with exercises; and was sched- tion interactions with patients conducted by the study
uled for a follow-up visit. (Key structural elements of the supervisors (at least one session was observed for each
firstinterventionsessionprotocolareincludedinFigure2). physician at the beginning of the study), and reviews of
Theworkbookconsistedofcondensedinterventionmes- audiorecordingsofclinicinterventionvisits.TheOB/GYN
sages that included 1) self-determination/feedback about intervention fidelity plan required completing 80% of the
the woman’s risk for AEP; 2) defining safe alcohol use components of the protocol with 90% of patient contacts.
during pregnancy, if attempting to become pregnant or if The project supervising faculty, which included PhD
at-riskofunintendedpregnancy;3)recommendeddrinking psychologists, an OB/GYN, and a substance abuse phys-
limitsifusingcontraception;4)familyplanning/appropriate ician, were available to provide feedback, consult about
contraception use; 5) how to reduce AEP risk; 6) work- cases,problem-solve,andprovidecoachingasnecessary.
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Step 1: Ask
Assess contraception/pregnancy planning and alcohol consumption:
Ask “How often have you had four or more drinks? ”or use T-ACE, TWEAK, or AUDIT
Step 2: Feedback
Provide feedback and information/facts about the effects of alcohol
Step 3: Advise and help to set up an AEP prevention goal: alcohol free pregnancy or contraception
Give Advice
If there is no risk, support the woman’s behavior
If there is arisk for the woman or fetus, discuss the behavior change: reducing/abstaining from alcohol and/or contraception
Assess readiness to change
Help to set upan AEP prevention goal if the woman chooses AEP reduction
If the woman is not ready for change, do not insist on setting up a goal (Ask “How would you feel if you had a child with FASD as a
result of your drinking?”)
Support any steps in right direction,repeat the advice, reaffirm your willingness to help when she is ready/don’t move to 4
Step 4: Assist
Ask about the possible barriers and discuss how to overcome or reach the goal reaffirm your willingness to help (refer if needed)
Assist with contraception if needed
Step 5: Follow-up
Figure1Dual-FocusedBPIprotocol.
Measures prior to implementation. Women’s FCL were administered
The intervention fidelity check lists (FCL) were developed inpersontopatientsbythestudyresearchassistantsimme-
forthisstudyandincludedthekeystructuralaspectsofthe diately after the session. Examples of women’s and physi-
interventionprotocol.FCLwere completedbywomenand cians’ FCL are included in Figure 2 (women’s FCL for the
physiciansindependentlyaftereachclinicinterventionvisit. first session) and Figure 3 (physicians’ FCL for the second
Patientexitinterviewsregardingclinicvisitshavebeenused session). Asspecified bythe intervention protocol, thefirst
inresearchtomonitorinterventiondeliveryanddetermine visit intervention componentswereuniform for all women
feasibility of interventions [47-49]. FCL were reviewed by while the second intervention visit components varied
Russian project faculty and consultants and pilot tested depending on the goals selected by the woman. The first
Question Yes No
The doctor asked me if I planned a pregnancy or used contraception.
The doctor asked me about my alcohol consumption.
The doctor told me about the incompatibility of pregnancy and alcohol use.
The doctor provided information about negative effects of alcohol on the fetus and child’s health.
The doctor advised me to make a choice: either stop/reduce drinking or use effective contraception.
The doctor asked me what I would choose.
The doctor helped me to make my choice (stop/reduce drinking or use effective contraception).
The doctor talked to me how to achieve the goal.
The doctor discussed with me barriers I might face.
The doctor made a follow-up appointment
I felt the doctor’s support and willingness to help me.
Figure2FidelityCheckList-1stclinicvisit(Women’sForm).
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Question Yes No
Figure3FidelityCheckList-2ndclinicvisit(Physicians’Form).
session FCL completed by physicians and women were helpedtomakeachoice)and96.5%(discussedbarriers)by
utilizedinthisimplementationstudy. physicians’ reports and between 100% (informed about
As an additional measure to ensure that physicians incompatibility of pregnancy and alcohol use) and 93.8%
maintain intervention skills over the time, audio recording (discussed barriers) by women’s reports (Figure 4). The
of first intervention sessions was implemented in year 2 of differences between women’s and physicians’ reports on
the study. The audiotapes were coded using the FCL by individual items were not significant. Physician and patient
two research investigators independently (85% agreement FCL reports were consistent in the majority of cases
between coders). The physician’s intervention style/imple- (N=307); however, some discrepancy existed between the
mentationofMIskills,includinghownon-confrontational/ reportsin57cases(Table1).Womenreportedmoreinter-
non-judgmental the physicians’ style of interaction was, vention components missing compared to physicians’
howgreatanopportunitythepatienthadtosetupherown self-reports(p<0.0001).
goal, and how much the physician supported the patient’s Similarresultswerereceivedforasubsetofinterventions
self-confidencewerecodedonascale1to5. (N=78) by 12 physicians that were audio recoded. Out of
90 first intervention sessions completed from October 5,
Dataanalysis 2010toJuly7,2011,81wereaudiorecorded(5patientsdid
Categoricalvariablesweresummarizedasproportions.Cat- not consent to audio recording and 4 sessions were not
egorical contingency tables were analyzed with McNemar’s recorded because of technical problems). It was not
testifthedatawerepairedandthroughachi-squaretestif possible to code three tapes because of sound quality,
theywerenot.Continuousvariablesweresummarizedwith resulting in a sample of 78 coded audiotapes (87% of all
means, standard deviations, and ranges. An alpha of 0.05 sessions). In 62 cases, there was an agreement between
wasconsideredstatisticallysignificant. physicians’andwomen’sFCLreportsonwhetherinterven-
tion components were completed; however, in 13 cases a
Results and discussion discrepancy existed between physicians’ and women’s FCL
FCL were completed for all first clinic intervention visits reports, which indicated a significant difference between
(N=374) conducted by 23 physicians. Two patient FCLs physician and women’s self-reports about completed inter-
were incomplete, which resulted in a total of 372 patient vention components (p < 0.001). Audiotape coding indi-
FCL (196 in SPB and 176 in NNR) and 23 physician FCLs cated that physicians implemented basic MI skills, which
utilizedintheanalysis. included nonconfrontational/nonjudgmental style of inter-
The proportions of completion of the intervention com- action (94.7% out of an ideal 100% score), provided the
ponentsbyphysicians’andwomen’sreportsareincludedin patientwithanopportunitytosetupherowngoals(90.7%
Figure4. out of 100%), and supported the patient’s self-confidence
Completion of the intervention components varied (88% out of 100%). Reviews of audiotapes of the interven-
between100%(askedaboutalcoholconsumption,informed tionwithpatientsrevealedthatdiscussinghowtoachievea
about incompatibility of pregnancy and alcohol use, and goal selected by a woman and discussing barriers were
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more likely to be omitted when the woman’s goal was components of the intervention with 90% of patient
contraception. If a woman chose reducing alcohol con- contacts.SimilarlytoBaboretal.[49],bothphysicians’and
sumption and planned pregnancy, physicians were more women’s reports indicated high performance in delivery of
likelytodiscusswaystoreduce/avoiddrinkingandpossible the intervention components. However, a discrepancy
barriers. When the goal was delaying pregnancy, discus- between women’s and physicians’ reports was significant
sionsofchoicesofcontraceptionandbarrierstoconsistent with women more likely reporting omission of specific
contraceptionusewerelimitedoromitted. intervention components compared to physicians’ self-
reports.Althoughtheremaybeseveralexplanationsforthe
Discussion discrepancy,areviewofaudiotapesindicatedthatproviders
The overall pattern of results supports the feasibility and may have thought that a patient had already understood a
deliverability of a brief dual-focus AEP prevention model point so they did not need to cover it much when in fact
byOB/GYNphysiciansinRussia.Theresultsareconsistent the patient did not. That was observed particularly when
with results of prior studies of alcohol reduction BPI and physicians discussed with patients contraception options
MI outside of Russia, namely that physicians will counsel and possible barriers to reducing alcohol use or utilizing
their patients if they are provided skill training and quality contraceptionconsistently.
control support [49,50]. Recruitment and participation Discussingdifficulties/barriersthatmaypreventawoman
agreement rates were high, and the majority of physicians fromachievingherAEPpreventiongoalappearedtobethe
who attended the training met skill criteria. Physicians most difficult component for physicians to implement (or
trained in DFBPI and provided with support, individual for women to grasp) and was more likely to be omitted
feedback about their performance, coaching, and consult- than other components of DFBPI. In Russia, family plan-
ation during the clinical trial demonstrated high rates of ning and contraception counseling are conducted by
deliveryofallDFBPIcomponents.Theywereabletoimple- OB/GYN physicians as a part of routine women’s health
menttheinterventionandintegrateitintoroutinewomen’s care. Therefore, the DFBPI training was focused more on
clinicvisits.Basedonreportsfromphysicians,patients,and intervention components related to alcohol consumption,
audiotapes,physiciansoutperformedthestudyintervention which is not typically a part of OB/GYN services. The as-
fidelityplanrequirementthatwassetinitiallyat80%ofthe sumptionwasthatifawomanselecteddelayingpregnancy/
Woman’s report P hysician’s
The doctor… (N=372) report1 (N=23)
Figure4Proportionofcompletedinterventioncomponents.1Thedifferencesbetweenwomen’sandphysicians’reportsonindividualitems
werenotsignificant.
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Table1Summaryofphysicianandpatientreport and therefore, the study sample represents the major
discrepancies1 OB/GYNservicedeliverysysteminRussia.
Physician(N=23)
NO YES Conclusions
Patient(N=372) NO 12 47 ThisstudysupportedthefeasibilityofincorporatingDFBPI
in routine women’s clinics visits in Russia. Physicians
YES 10 295
trainedinDFBPIwereabletoimplementandmaintainthe
1Discrepanciesbetweenphysicianandwomenresponsesweresummed
acrossallFCLquestions.Forexample,ifapatientreportedYesforeveryFCL intervention skills. Despite some discrepancies between
questionandaphysicianreportedYesforeveryquestion,therewas women and physicians’ reports regarding completed inter-
agreement,whichwascodedasYes/Yes(295cases).IfapatientreportedYes
vention components, there were far more congruencies,
foreveryquestionbutherphysicianreportedNoforoneormorequestions,
thatwasYes/No(10cases).Discrepenciesbetweenphysiciansandpatients and OB/GYN physicians trained in the DFBPI, monitored,
reportsweresignificant(p<0.0001). andsupportedduringthestudydemonstratedperformance
thatmetorexceededbenchmarks.Broaderimplementation
contraception as her AEP reduction goal, the OB/GYN ofthesetypesofclinic-based,motivationaldual-focusmod-
would be equipped with skills to address her goal of els outside of a research context may benefit from add-
improving contraception use. Unexpectedly, physicians itionalresearchthatwoulddeterminetheamountandtype
were more likely to omit discussing methods of achieving of quality control effort needed to obtain the highest cost-
goals and possible barriers when a woman chose delaying benefit.Thisstudydemonstratesthatmultisiteimplementa-
pregnancy. The physicians trained in DFBPI and MI basic tionisfeasible,butitdoesnotestablishanimplementation
principles to address alcohol consumption appeared to be strategy that is necessarily the most efficient. Research is
comfortabledeliveringalcoholreductioninterventioncom- neededtoidentifyefficientwaystosupportimplementation
ponents of the intervention; however, they demonstrated ofAEPpreventioninterventionsinclinicalsettings.
difficulty in implementing basic MI principles to address
inconsistent contraception, e.g., providing information Endnotes
about contraception methods and discussing options and aRisk for AEP among non-pregnant women was defined
possible barriers to improve consistent contraception use. asat-riskalcoholconsumption(fourormoredrinksonone
OB/GYN physicians may benefit from expanding the occasionoreightormoredrinksperweek)plusthechance
contraception component of the training and developing orintenttobecomepregnant[38].
skills to better address their patients’ contraception
practices. Abbreviations
AEP:Alcohol-exposedpregnancy(pregnancies);BI:Briefintervention;
Strengths of this study include a relatively large sample
BPI:Briefphysicianintervention;DFBPI:Dual-focusedbriefphysician
sizeof374womenandacombinationofdifferentmethods intervention;FAS:FetalAlcoholSyndrome;FASD:FetalAlcoholSpectrum
thatincludedphysicianandwomen’sself-reportscompleted Disorders;FLC:Fidelitychecklist;MI:Motivationalinterviewing;NNR:The
NizhnyNovgorodRegion,Russia;OB/GYN:Obstetricsandgynecology
shortly after sessions and live or audiotaped intervention
(obstetricsandgenecologyphysicians);SPB:St.Petersburg,Russia.
observations were important for cross-validation of the
results. Monitoring was conducted systematically and Competinginterests
patientandproviderFCLwereobtainedforallintervention ThestudywassupportedbyGrantNumberR01AA016234fromtheNational
InstitutesofHealth/NationalInstituteonAlcoholAbuseandAlcoholismand
sessions. Although audio recording was completed for a
FogartyInternationalCenteranditscontentsaresolelytheresponsibilityof
subset of interventions only, results indicated agreement theauthorsanddonotnecessarilyrepresenttheofficialviewsoftheNIH.
between the audiotape and FCL data about completion of Theauthorshavenocompetinginterests.
specific intervention components. Study limitations also
Authors’contributions
shouldbeconsidered.Theinterventionwasapartofaclin- Allauthorshavemadesubstantialcontributionstoconception,design,
ical trial, and physicians and patientswere provided with a gatheringdata,analysis,and/orinterpretationofdataandhavecontributed
totheintellectualcontentandwritingofthearticle.Specifically,TB:isPIon
level of quality control support that may be higher than
thestudyandleddevelopmentofthestudydesign,theintervention
what is found in routine clinical practice, which may limit protocolandmaterials,measures,conductedsupervision,coding,
generalization. The study was limited to physicians in participatedindataanalysis,anddraftedthemanuscript;BB:have
significantlycontributedtothestudyconceptionandcoordination,design,
public OB/GYN clinics and to the patients attending these
andanalyzingdata;MC:providedsignificantcontributiontothestudy
clinics,sogeneralizationtootherservicesystemsshouldbe designandconceptualization,participatedinthemanuscriptwriting;GI:
made cautiously.Itis possible that somewomen withhigh conductedresearchsupervision,contributedsignificantlytodevelopingthe
studymaterials;VS:coordinatedstudyandcollaboratedwithclinics,
AEP risk, such as alcohol-dependent women, do not seek
supervisedandconsultedphysicians,conductedtrainingofphysicians;LT:
OB/GYNorprenatal care, and it isnot clear howwellthis contributedtothestudyconceptualizationandcoordination;EV:conducted
AEPpreventionmodelwouldservethesewomen.However, researchsupervision,contributestodevelopingthestudymaterials,provided
significantcontributiontothestudycoordination;IG:coordinatedclinicsand
Russiangovernmentstatisticsindicatethat96.4%ofwomen
conductinginterventions,conductedtrainingofphysiciansandsupervision;
receive prenatal services from public women’s clinics [51], LS:coordinateddatacollectionandconductinginterventions,participatedin
Balachovaetal.AddictionScience&ClinicalPractice2013,8:1 Page9of10
http://www.ascpjournal.org/content/8/1/1
physicianssupervision,prepareddataforanalysis;NK:participatedin 15. FloydRL,DecoufleP,HungerfordDW:Alcoholusepriortopregnancy
designingthestudy,performingstatisticalanalysis,andpreparingthe recognition.AmJPrevMed1999,17:101–107.
manuscript.Allauthorsreadandapprovedthefinalmanuscript. 16. EthenMK,RamadhaniTA,SchehereleAE,CanfieldMA,WyszynsjiDF,
DruschelCM,RomittiPA:Nationalbirthdefectspreventionstudy.Matern
Acknowledgments ChildHealthJ2007,13:274–285.
AuthorswishtothankconsultantsLindaSobell,PhD,ofNovaSoutheastern 17. ClarrenSK,AstleySJ,GundersonVM,SpellmanD:Cognitiveandbehavioral
UniversityandMichaelFleming,MD/MPH,oftheUniversityofWisconsin- deficitsinnonhumanprimatesassociatedwithveryearlyembryonic
Madison(currentlyatNorthwesternUniversity)fortheirinvaluableadviseto bingeexposurestoethanol.JPediatr1992,121(5Pt1):789–796.
thestudyandKarenBeckman,MD,oftheUniversityofOklahomaHealth 18. FloydRL,EbrahimSH,BoyleCA,ObservationsfromtheCDC:Preventing
ScienceCenter,thestudyadvisoronprotectionofhumansubjectsin alcohol-exposedpregnanciesamongwomenofchildbearingage:the
research,acknowledgecontributionofdatacollectors-graduatestudents necessityofapreconceptionalapproach.JWomensHealthGendBased
fromSt.PetersburgStateUniversityandNizhnyNovgorodStatePedagogical Med1999,8:733–736.
UniversityandphysicianinterventionistsfromOB/GYNclinics,andtothank 19. BalachovaT,BonnerB,ChaffinM,BardD,IsurinaG,TsvetkovaL,VolkovaE:
thestudyparticipants. Women’salcoholconsumptionandriskforalcohol-exposedpregnancies
ThestudywassupportedbyGrantNumberR01AA016234fromtheNational inRussia.Addiction2012,107(1):109–117.
InstitutesofHealth/NationalInstituteonAlcoholAbuseandAlcoholismand 20. KristjansonAF,WilsnackSC,ZvartauE,TsoyM,NovikovB:Alcoholuseinpregnant
FogartyInternationalCenteranditscontentsaresolelytheresponsibilityof andnon-pregnantRussianwomen.AlcoholClinExpRes2007,31:299–307.
theauthorsanddonotnecessarilyrepresenttheofficialviewsoftheNIH. 21. ChambersCD,KavteladzeL,JoutchenkoL,BakhirevaLN,JonesKL:Alcohol
consumptionpatternsamongpregnantwomenintheMoscowregion
Authordetails oftheRussianFederation.Alcohol2006,38:133–137.
1TheUniversityofOklahomaHealthSciencesCenter,940N.E.13thStreet, 22. TheProjectCHOICESInterventionResearchGroup:Reducingtheriskof
NicholsonTowerSuite4900,OklahomaCity,OK73104,USA.2St.Petersburg alcohol-exposedpregnancies:astudyofamotivationalinterventionin
StateUniversity,6Makarovanab,St.Petersburg199053,Russia.3St. communitysettings.Pediatrics2003,111(5):1131–1135.
PetersburgStatePediatricAcademy,54,MalayaBalkanskayaStr.,St. 23. BaborTF,McReeBG,KassebaumPA,GrimaldiPL,AhmedK,BrayJ:Screening,
Petersburg192283,Russia.4NizhnyNovgorodStatePedagogicalUniversity, briefintervention,andreferraltotreatment(SBIRT):towardapublichealth
12UlyanovaStr.,NizhniyNovgorod603950,Russia.5NSKStatisticalSolutions approachtothemanagementofsubstanceabuse.SubstAbus2007,8(3):7–30.
LLC,Choctaw,OK73020,USA. 24. WhitlockEP,PolenMR,GreenCA,OrleansT,KleinJ:Behavioralcounseling
interventionsinprimarycaretoreducerisky/harmfulalcoholuseby
Received:13March2012Accepted:14December2012 adults:asummaryoftheevidencefortheU.S.preventiveservicestask
Published:8January2013 force.AnnInternMed2004,140(7):557–568.
25. ChangG,McnamaraTK,OravEJ:Briefinterventionforprenatalalcohol
use:arandomizedtrial.ObstetGynecol2005,105(5):991–998.
References
26. HankinJ,McCaulME,HeussnerJ:Pregnant,alcohol-abusingwomen.
1. AmericanAcademyofPediatrics,CommitteeonSubstanceAbuseand
AlcoholClinExpRes2000,24:1276–1286.
CommitteeonChildrenWithDisabilities:Fetalalcoholsyndromeand
alcohol-relatedneurodevelopmentaldisorders.Pediatrics2000,106:358–361. 27. ChangG,GoetzMA,Wilkins-HaugL,BermanS,HankinJ,McCaulME,
2. BertrandJ,FloydRL,WeberMK,O’ConnorM,RileyEP,JohnsonKA,CohenDE: HeussnerJ:Abriefinterventionforprenatalalcoholuse:anin-depth
NationalTaskForceonFAS/FAE.FetalAlcoholSyndrome:GuidelinesforReferral look.JSubstAbuseTreat2000,18(4):365–369.
andDiagnosis.Atlanta:CentersforDiseaseControlandPrevention;2004. 28. ManwellLG,FlemingMF,MundtMP,StauffacherEA,BarryKL:Treatmentof
3. StreissguthAP,O’MalleyK:Neuropsychiatricimplicationsandlong-term problemalcoholuseinwomenofchildbearingage:resultsofabrief
consequencesoffetalalcoholspectrumdisorders.SeminClin interventiontrial.AlcoholClinExpRes2000,24:1517–1524.
Neuropsychiatry2000,5(3):177–190. 29. O’ConnorMJ,WhaleySE:Alcoholuseinpregnantlow-incomewomen.
4. WarrenKR,HewittBG,ThomasJD:Fetalalcoholspectrumdisorders:research JStudAlcohol2003,64(6):773–783.
challengesandopportunities.AlcoholResHealth2011,34(1):4–14. 30. FlemingMF,LundMR,WiltonG,LandryM,ScheetsD:TheHealthyMoms
5. AbelEL,SokolRJ:Incidenceoffetalalcoholsyndromeandeconomic study:theefficacyofbriefalcoholinterventioninpostpartumwomen.
impactofFAS-relatedanomalies.DrugAlcoholDepend1987,19:51–70. AlcoholClinExpRes2008,32(9):1600–1606.
6. MayPA,GossageJP,KalbergWO,RobinsonLK,BuckleyD,ManningM, 31. NilsenP:Briefalcoholinterventiontopreventdrinkingduring
HoymeHE:PrevalenceandepidemiologiccharacteristicsofFASDfrom pregnancy:anoverviewofresearchfindings.CurrOpinObstetGynecol
variousresearchmethodswithanemphasisonrecentin-schoolstudies. 2009,21(6):496–500.
DevDisabilResRev2009,15(3):176–192. 32. ChangG:Screeningandpreventioninprenatalcaresettings.AlcoholRes
7. MillerLC,ChanW,LitvinovaA,RubinA,ComfortK,TirellaL,CermakS,MorseB, Health2004,28(2):80–84.
KovalevI:FetalalcoholspectrumdisordersinchildrenresidinginRussian 33. CommitteeopinionNo.496.AmericanCollegeofObstetriciansand
orphanages:aphenotypicsurvey.AlcoholClinExpRes2006,30:531–538. Gynecologists:At-riskdrinkingandalcoholdependence:obstetricand
8. RileyEP,GuerriC,CalhounF,CharnessME,ForoudTM,LiTK,MattsonSN,May gynecologicimplications.ObstetGynecol2011,118:383–388.
PA,WarrenKR:Prenatalalcoholexposure:advancingknowledgethrough 34. StadeBC,Dzendoletas,SgroM,DowswellT,BennettD:Psychologicaland/
internationalcollaborations.AlcoholClinExpRes2003,27:118–135. oreducationalinterventionsforreducingalcoholconsumptionin
9. PalchikA,LegonkovaS,SofronovaG:Этническиеособенности pregnantwomenandwomenplanningpregnancy(Review).Cochrane
проявленияалкогольногосиндромаплода[Ethnicfeaturesoffetal DatabaseSystRev2009,27.
alcoholsyndromemanifestation].YakutMedJ2011,34:22–25.(InRussian). 35. MillerWR,SorensenJL,SelzerJA,BrighamGS:Disseminatingevidence-
http://ymj.ykt.ru/images/stories/2-2011.pdf. basedpracticesinsubstanceabusetreatment:areviewwith
10. LandgrenM,SvenssonL,StrömlandK,AnderssonGrönlundM:Prenatal suggestions.JSubstAbuseTreat2006,31(1):25–39.
alcoholexposureandneurodevelopmentaldisordersinchildren 36. ChangG:FASD:Preventionandnutrition:CommentaryonFloyd,Denny
adoptedfromEasternEurope.Pediatrics2010,125:e1178–e1185. andWeber,andNguyenandThomas.InEncyclopediaonEarlyChildhood
11. FloydRL,O’ConnorMJ,SokolRJ,BertrandJ,CorderoJF:Recognitionand Development[online].EditedbyTremblayRE,BoivinM,DeV,PetersR.
preventionoffetalalcoholsyndrome.ObstetGynecol2005,106:1059–1064. Montreal:CentreofExcellenceforEarlyChildhoodDevelopmentand
12. WarrenKR,FoudinLL:Alcohol-relatedbirthdefects-thepast,present,and StrategicKnowledgeClusteronEarlyChildDevelopment;2011:1–5.
future.AlcoholResHealth2001,25(3):153–158. 37. AndréassonS,HjalmarssonK,RehnmanC:Implementationand
13. CentersforDiseasesControlandPrevention:Alcoholuseamongpregnant disseminationofmethodsforpreventionofalcoholproblemsinprimary
andnonpregnantwomenofchildbearingage:UnitedStates,1991–2005. healthcare:afeasibilitystudy.AlcoholAlcohol2000,35(5):525–530.
MMWRMorbMortalWklyRep2009,58(19):529–532. 38. BaborTE,Higgins-BiddleJ,DauserD,HigginsP,BurlesonJA:Alcohol
14. SkagerstromJ,ChangG,NilsenP:Predictorsofdrinkingduring screeningandbriefinterventioninprimarycaresettings:
pregnancy:asystematicreview.JWomensHealth2011,20:901–913. implementationmodelsandpredictors.JStudAlcohol2005,66(3):361.
Balachovaetal.AddictionScience&ClinicalPractice2013,8:1 Page10of10
http://www.ascpjournal.org/content/8/1/1
39. MengelMB,SearightHR,CookK:Preventingalcohol-exposed
pregnancies.JAmBoardFamMed2006,19:494–505.
40. BaborTF,Higgins-BiddleJC,SaundersJB,MonteiroM:AUDIT–theAlcohol
UseDisorderIdentificationTest:GuidelinesforuseinPrimaryHealthCare.2nd
edition.Geneva,Switzerland:WorldHealthOrganization,Departmentof
MentalHealthandSubstanceAbuse;2001.WHO/MSD/MSB/01.6a.
41. FloydRL,SobellM,VelasquezMM,IngersollK,NettlemanM,SobellL,
MullenPD,CeperichS,VonSternbergK,BoltonB,SkarpnessB,NagarajaJ:
Preventingalcohol-exposedpregnancies:arandomizedcontrolledtrial.
AmJPrevMed2007,32:1–10.
42. BalachovaTN,BonnerBL,IsurinaGL,TsvetkovaLA:Useoffocusgroupsin
developingFAS/FASDpreventioninRussia.SubstUseMisuse2007,
42:881–894.
43. BaborTF,Higgins-BiddleJC:BriefInterventionforHazardousandHarmful
Drinking:AManualforUseinPrimaryCare.Geneva:WHO;2001.
44. MillerW,RollnickS:MotivationalInterviewing:PreparingPeopleforChange.
2ndedition.NewYork:GuilfordPress;2002.
45. BalachovaT,BonnerB,IsurinaG,PalchikA,ShapkaitzV,TsvetkovaL:
Changingphysicians’knowledge,skillsandattitudestopreventFASDin
Russia.Proceedingsofthe33rdAnnualScientificMeetingoftheResearch
SocietyonAlcoholism,Alcoholism:Clinical&ExperimentalResearch2010,
34(Suppl6):210A.
46. ShapkaitzV,BalachovaTN,RegentovaA:Каквыбратьконтрацептив
[Howtochooseacontraceptionmethod].St.Petersburg:SPSU-OUHSC-
NNSPU;2009(inRussian).
47. PbertL,FletcherK,FlintA,YoungM,DrukerS,DiFranzaJ:Smoking
preventionandcessationinterventiondeliverybypediatricproviders,as
assessedwithpatientexitinterviews.Pediatrics2006,118:e810–e824.
48. FrancoLM,FrancoC,KumwendaN,NkhomaW:Methodsforassessing
qualityofproviderperformanceindevelopingcountries.IntJQual
HealthCare2002,14(Suppl1):17–24.
49. BaborTF,Higgins-BiddleJC,HigginsPS,GassmanRA,GouldBE:Training
medicalproviderstoconductalcoholscreeningandbriefinterventions.
SubstAbus2004,25(1):17–26.
50. D’OnofrioG,NadelES,DegutisLC,SullivanLM,CasperK,BernsteinE,Samet
JH:Improvingemergencymedicineresidents’approachtopatientswith
alcoholproblems:acontrollededucationaltrial.AnnEmergMed2002,
40(1):50–62.
51. SukhanovaLP:Статистикародовспоможениякакфакторобеспечения
качестваакушерскойиперинатальнойпомощивРоссии.[Statisticsof
obstetricaidasafactorofprovidingqualityofobstetricandperinatal
careinRussia].InfAnalRepSocAspectsPublicHealth2008,(inRussian)
http://vestnik.mednet.ru/content/view/47/30/.
doi:10.1186/1940-0640-8-1
Citethisarticleas:Balachovaetal.:BriefFASDpreventionintervention:
physicians’skillsdemonstratedinaclinicaltrialinRussia.Addiction
Science&ClinicalPractice20138:1.
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