STUDY PROTOCOL Open Access
Complex mul iple isk in e en ion o
p omo e heal hy beha iou s in people
be ween 45 o 75 yea s a ended in
p ima y heal h ca e (EIRA s udy): s udy
p o ocol o a hyb id ial
Edu ne Zabale a-del-Olmo
1,2,3,4*
, Haizea Pombo
5
, Ma iona Pons-Vigués
1,3,4
, Ma c Casajuana-Closas
1,3
,
En ique a Pujol-Ribe a
1,2,3,4
, Tomás López-Jiménez
1,3
, Ca men Cabezas-Peña
6
, Ca me Ma ín-Bo às
7,8
,
An oni Se ano-Blanco
9,10
, Ma ia Rubio-Vale a
9,10
,JoanLlobe a
11
, Al onso Lei a
11
, Ca e ina Vicens
11
,Cla aVidal
11
,
Manuel Campiñez
12
,RemediosMa ín-Ál a ez
12
, José-Ángel Made uelo
13
,José-IgnacioRecio
13,14
,LuisGa cía-O iz
13,15
,
Emma Mo ico
16
, Juan-Ángel Bellón
17,18,19,20
, Pa icia Mo eno-Pe al
17,18
, Ca los Ma ín-Can e a
1,3
, Ana Cla e ía
21
,
Susana Aldecoa-Landesa
21,22
,RosaMagallón-Bo aya
23
and Bona en u a Bolíba
1,3
Abs ac
Backg ound: Heal h p omo ion is a key p ocess o cu en heal h sys ems. P ima y Heal h Ca e (PHC) is he ideal
se ing o heal h p omo ion bu mul i ace ed ba ie s make i s in eg a ion di icul in he usual ca e. The majo i y o
he adul popula ion engages wo o mo e isk beha iou s, ha is why a mul iple in e en ion migh be mo e
e ec i e and e icien . The p ima y objec i es a e o e alua e he e ec i eness, he cos -e ec i eness and
an implemen a ion s a egy o a complex mul iple isk in e en ion o p omo e heal hy beha iou s in people
be ween 45 o 75 yea s a ended in PHC.
Me hods: This s udy is a clus e andomised con olled hyb id ype 2 ial wi h wo pa allel g oups compa ing a
complex mul iple isk beha iou in e en ion wi h usual ca e. I will be ca ied ou in 26 PHC cen es in Spain. The
s udy ocuses on people be ween 45 and 75 yea s who ca y ou wo o mo e o he ollowing unheal hy
beha iou s: obacco use, low adhe ence o he Medi e anean die a y pa e n o insu icien physical ac i i y le el.
The in e en ion is based on he T ans heo e ical Model and i will be made by physicians and nu ses in he
ou ine ca e o PHC p ac ices acco ding o he concep ual amewo k o he “5A’s”. I will ha e a maximum du a ion
o 12 mon hs and i will be ca ied ou o h ee di e en le els (indi idual, g oup and communi y). Inc emen al cos
pe quali y-adjus ed li e yea gained measu ed by he a i s o he Eu oQol-5D ques ionnai e will be es ima ed. The
implemen a ion s a egy is based on he “Consolida ed F amewo k o Implemen a ion Resea ch”, a se o disc e e
implemen a ion s a egies and an e alua ion amewo k.
(Con inued on nex page)
* Co espondence: [email p o ec ed]
1
Ins i u Uni e si a id’In es igació en A encióP imà ia Jo di Gol (IDIAP Jo di
Gol), G an Via Co s Ca alanes 587 à ic, 08007 Ba celona, Spain
2
Ge ència Te i o ial de Ba celona, Ins i u Ca alà de la Salu , c/Balmes 22,
08007 Ba celona, Spain
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Zabale a-del-Olmo e al. BMC Public Heal h (2018) 18:874
h ps://doi.o g/10.1186/s12889-018-5805-y
(Con inued om p e ious page)
Discussion: EIRA s udy will de e mine he e ec i eness and cos -e ec i eness o a complex mul iple isk
in e en ion and will p o ide a be e unde s anding o implemen a ion p ocesses o heal h p omo ion
in e en ions in PHC se ing. I may con ibu e o inc ease knowledge abou he indi idual and s uc u al ba ie s
ha a ec implemen a ion o hese in e en ions and o quan i y he con ex ual ac o s ha mode a e he
e ec i eness o implemen a ion.
T ial egis a ion: ClinicalT ials.go ,NCT03136211.Re ospec i ely egis e ed on May 2, 2017.
Keywo ds: Complex in e en ions, Cos -e ec i eness analysis, Heal h beha iou , Heal h p omo ion, Hyb id ial,
Implemen a ion esea ch, Medi e anean die , Physical ac i i y, P ima y heal h ca e, Smoking
Backg ound
Ch onic diseases ep esen a huge pe sonal, social and
economic bu den and one o he g ea es challenges o
heal h sys ems. They a e he leading cause o 68% o he
dea hs a he global le el and app oxima ely 42% o
hese dea hs co espond o people younge han 70 yea s
old. I is es ima ed ha a ound 80% o ca dio ascula
diseases and 30% o all cance s could be p e en ed wi h
he adop ion o heal hy beha iou s: a majo po ion o
hese diseases is closely ela ed o smoking, unheal hy
die , seden a y li es yle, and excessi e use o alcohol [1].
Likewise, e idence sugges s ha die and physical
ac i i y le el a e impo an modi iable isk ac o s o
dep essi e and anxie y diso de s [2]. Al hough social de-
e minan s o heal h play a key ole, and he e is an im-
po an social g adien in he p e alence o isk ac o s,
i is an essen ial issue o de elop e ec i e s a egies o
cope wi h hem especially in people o low socioeco-
nomic s a us. Thus, heal h p omo ion and p e en ion is
a key p ocess o cu en heal h sys ems wi h he goals o
educing he isk o disease and disabili y, con ibu ing
o an ac i e and heal hy ageing and educing he need
o mo e expensi e heal h ca e.
P ima y Heal h Ca e (PHC) is he mos accessible and
mos commonly used heal h se ice which p o ides an
in eg al and con inuous ca e besides, PHC p o essionals
a e he majo heal h-ca e p o ide s o people wi h mul-
iple mo bidi ies [3]. Tha is why PHC is he ideal se ing
o heal h p omo ion and p e en ion in e en ions [4,5].
Fu he mo e, PHC plays a key pa in add essing he so-
cial de e minan s o heal h, mainly h ough i s ole in he
communi y, and con ibu ing, in collabo a ion wi h o he
sec o s, o he educ ion o social inequali ies in heal h
[6]. Mo eo e , as Ba ba a S a ield poin s ou , o achie e
“mo e e ec i e, mo e e icien , sa e and mo e equi able”
PHC se ices, he emphasis should shi om ea ing
diseases o ca ing o indi iduals and popula ions [7].
Howe e , he implemen a ion o heal h p omo ion and
p e en ion in e en ions emains subop imal mainly as a
esul o wo k o e load and lack o ime o aining
[8–10]. In addi ion o all hese ba ie s, he mos sui able
model o app oach beha iou change emains unclea , and
he e is a lack o heo e ical basis o in e en ions, skills in
helping people changing beha iou and knowledge o he
local con ex in which hese in e en ions a e unde aken
[11–13]. Likewise, he e a e in ape sonal (belie s, a i-
udes, knowledge, skills, sel -concep , mo i a ion and e-
sou ces) and in e pe sonal (heal h p o essionals, amily
and iends) ac o s which a ec PHC use s’ ecep i eness
o heal h p omo ion and p e en ion in e en ions [9].
One aspec o keep in mind is ha a high pe cen age o
people who isi hei PHC p o essionals end o ha e
con idence wi h hem and hei sugges ions ha e a high
impac in PHC use s’e e yday li e [14].
On he o he hand, al hough he majo i y o he adul
popula ion engages wo o mo e isk beha iou s, mos
o he ime he app oach is ca ied ou sepa a ely when
mul iple in e en ions migh be mo e e ec i e and e i-
cien . Ne e heless, mos o he s udies ha e only o-
cused on a single beha iou so he knowledge abou he
e ec i eness o a mul iple app oach is s ill limi ed.
Howe e , he e has been a sus ained ise in s udies
e alua ing mul iple beha iou in e en ions since 2002
[15,16]. These s udies show ha mul iple in e en ions
app oach comp ising educa ion and skills aining a e
associa ed wi h small educ ions in isk beha iou s [15].
Heal h p omo ion and p e en ion in e en ions a e
complex and need an in-dep h unde s anding o he
con ex which con ibu es o i s e ec i eness. Rega ding
his, he me hodology p oposed by he Medical Resea ch
Council o e s a unique oppo uni y [17]. This me hod-
ology p oposes a de elopmen in i e sequen ial phases
in which bo h quan i a i e and quali a i e me hods a e
used, which include: a) de ini ion o he heo e ical basis
(p eclinical phase), b) modelling (phase I), c) explo a o y
ial (phase II), d) de ini i e andomised con olled ial
(phase III) and e) long- e m implemen a ion (phase IV).
This me hodology p omo es he pa icipa ion o ci izens
and p o essionals in esea ch and inc eases he accep -
abili y and he easibili y o in e en ion. I is also an
ideal ool o achie e he sus ainabili y o in e en ions
and he ans e o esea ch o p ac ice. Resea ch on
complex in e en ions ma ks a u ning poin in he con-
en ional way o conduc ing expe imen al s udies in
Zabale a-del-Olmo e al. BMC Public Heal h (2018) 18:874 Page 2 o 15
which he mos impo an hing is inding alue and un-
de s anding he con ex o p ac ice a he han ying o
con ol i s in luence. Hyb id ials ep esen he ideal de-
sign because hey allow a join assessmen o clinical e -
ec i eness and implemen a ion, hanks o hei dual
app oach [18]. These ials use heo e ical amewo ks
which ensu e a sys ema ic and comp ehensi e way o
unde s and he de e minan s o implemen a ion as well
as i s success and impac [19–21].
In his connec ion, Spanish p ima y ca e p e en ion
and heal h p omo ion esea ch ne wo k ( edIAPP) [22]
s a ed in 2012 he EIRA s udy and ca ied ou he i s
h ee phases (p eclinical phase, phase I and phase II)
[8,9,23–25]. Cu en ly, he esea ch eam is pu suing
he phase III h ough a hyb id ial which aims o
e alua e he e ec i eness, he cos -e ec i eness and
he implemen a ion o a complex mul iple isk beha -
iou in e en ion o p omo e heal hy beha iou s in
people be ween 45 o 75 yea s a ended in PHC. This
a icle desc ibes he p o ocol o his ial.
S udy objec i es and hypo heses
This hyb id ial has he ollowing p ima y objec i es:
1. To e alua e he e ec i eness and cos -e ec i eness
o a complex mul iple isk in e en ion on educing
obacco use, enhancing adhe ence o Medi e anean
die a y pa e n and inc easing physical ac i i yle el
in 12 mon hs o baseline compa ed wi h usual ca e.
2. To assess he e ec i eness o an implemen a ion
s a egy in e ms o accep abili y, adop ion,
app op ia eness, easibili y, ideli y, implemen a ion
cos and pene a ion.
Fu he mo e, o he seconda y objec i es ela ed o he
e ec i eness o he in e en ion will also be e alua ed:
i s impac on educing ca dio ascula and dep ession
isksas well as dep essi e and anxie y symp oms and in-
cidence o majo dep ession.
We hypo hesise ha he p opo ion o people who
show a posi i e beha iou change wi h ega d o any
baseline beha iou s will be highe among people who e-
cei e he in e en ion han people who ecei e usual
ca e. We also hypo hesise ha he in e en ion will e-
duce ca dio ascula isk, incidence o majo dep ession,
dep ession isk and dep essi e and anxie y symp oms.
Me hods
Design
This s udy is a andomised con olled hyb id ype 2 ial
wi h wo pa allel g oups which aims o es a complex
mul iple isk beha iou in e en ion o a maximum du -
a ion o 12 mon hs and an implemen a ion s a egy sim-
ul aneously [18]. The p o ocol o hyb id ial has been
w i en acco ding o he S anda ds P o ocol I ems:
Recommenda ions o In e en ional T ials (SPIRIT) [26]
and he S anda ds o Repo ing Implemen a ion s udies
(S aRI) [27]. Cos -e ec i eness analysis will be conduc ed
ollowing in e na ional ecommenda ions [28].
S udy se ing
The s udy will be ca ied ou in PHC cen es o se en o
he 17 Spanish Au onomous Communi ies: Andalusia,
A agon, he Balea ic Islands, Basque Coun y, Cas ile
and León, Ca alonia and Galicia. Spanish heal h sys em
which is based on uni e sal co e age wi h ee access o
all ci izens, is unded by public sou ces and depends p e-
dominan ly on he public sec o . PHC is p o ided by
mul idisciplina y eams (physicians and nu ses, paedia-
icians, social wo ke s and den is s) who pe o m ac i -
i ies o heal h ca e, heal h educa ion and p e en ion.
Heal h p omo ion and communi y ca e a e included in
he basic PHC se ices; howe e , he e a e mul iple ba -
ie s, like wo k o e load and lack o ime o aining,
ha hinde hei implemen a ion [8,9,29–31].
Pa icipan s
EIRA s udy has wo a ge s
PHC cen es The s udy comp ises 26 PHC cen es. The
c i e ia o selec ing hem a e: 1) o ha e in e ne ac-
cess; 2) ha e he possibili y o ca ying ou communi y
ac i i ies; 3) o be no loca ed in a eas wi h a huge cul-
u al and linguis ic di e si y o in ou is a eas and 4) o
ha e a highly commi ed and ac i e managemen eam.
All p o essionals, heal hca e p o essionals and adminis-
a i e s a , om PHC cen es, will be in i ed o pa ici-
pa e olun a ily. In ol ed p o essionals mus sign a
collabo a ion commi men o he s udy.
PHC use s The s udy ocuses on people be ween 45 and
75 yea s who ca y ou wo o mo e o he ollowing un-
heal hy beha iou s: obacco use, low adhe ence o he
Medi e anean die a y pa e n o insu icien physical ac-
i i y le el. Pa icipan s mus p o ide in o med consen
be o e any s udy p ocedu es occu . In addi ion, hey
mus be egis e ed wi h a heal h p o essional o he PHC
cen e. They will be excluded i hey ha e ad anced se -
ious illnesses, cogni i e impai men , dependence in basic
e e yday ac i i ies, se e e men al illness, hey a e in-
cluded in a long- e m home heal h ca e p og am, hey
a e in ea men o cance o in end-o -li e ca e, o hey
do no plan o eside in he a ea du ing he ime ha
he in e en ion las s.
In e en ion
The in e en ion is based on he T ans heo e ical Model
(TTM) [32,33] and will be made by physicians and
Zabale a-del-Olmo e al. BMC Public Heal h (2018) 18:874 Page 3 o 15
nu ses in he ou ine ca e o PHC p ac ices acco ding o
he concep ual amewo k o he “5A’s”: Assess, Ad ise,
Ag ee, Assis , and A ange- ollow up [34]. I will consis
o a i s isi o sc eening in which PHC p o essional
will assess pe son le el o beha iou and s age o
change (“Assess”). Beha iou s will be assessed by one
ques ion o know obacco use du ing he las mon h, wo
alida e ques ions abou he daily consump ion o ui s
and ege ables [35] and he B ie Physical Ac i i y Assess-
men Tool [36,37]. S ages o change will be assessed on
he basis o co e cons uc s o he TTM o each o he
a ge beha iou s (see Table 1)[32]. Subsequen ly, he
PHC p o essional will ad ise he pe son (“Ad ise”), will
ag ee wi h him/he on a ealis ic se o goals (“Ag ee”),
will assis o an icipa e ba ie s and will de elop a speci ic
ac ion plan (“Assis ”), and will a ange ollow-up suppo
(“A ange”).
In e en ion is based on he esul s o p e ious phases
(p eclinical, phase I and phase II) [23–25,38–42]. I will
ha e a maximum du a ion o 12 mon hs and i will be
ca ied ou o h ee di e en le els (indi idual, g oup
and communi y) acco ding o s ages o change and un-
heal hy beha iou (see Table 2). I will ocus on all
h ee a ge beha iou s and PHC p o essional oge he
wi h he pa icipan will de elop p io i y ac ions on one
o mo e o hese beha iou s.
In e en ion a he indi idual le el has an a e age in-
ensi y be ween 2 and 3 isi s; i necessa y, p o essionals
ha e he eedom o make a g ea e numbe o isi s.
Depending on he s ages o change i includes: a) a “ e y
b ie in e en ion” o inc ease awa eness o he need o
beha iou change o o suppo he change and help wi h
elapse p e en ion; b) a “b ie in e en ion” o make an
ag eed plan o beha iou change. Heal h p o essionals
will apply hei mo i a ional in e iewing skills a e
ollowing a 20-h online aining, an in-pe son g oup
eedback session and a coded ac ing pa ien session
[11,13,43]. The in e en ion plan includes he pa icipa-
ion in a heal h educa ion wo kshop and social p esc ib-
ing. In addi ion, he in e en ion has he suppo o
in o ma ion and communica ion echnologies, such as a
web page add essed o he pa icipan (h p://p oyec oei a.
ediapp.es), he sending o pe sonalised ex messages, he
use o a mobile app [44] o he ecommenda ion o o he
gadge s (pedome e s, sma wa ches, e c).
G oup in e en ion is ca ied ou h ough wo heal h
educa ion wo kshops ocused on heal hy die and phys-
ical ac i i y. These wo kshops a e planned o be de el-
oped some weeks a e ini ia ing he indi idual
in e en ion and will be conduc ed by PHC p o essionals
a he heal h cen e. They will ake 90–120 min and
hei pu pose is o ein o ce he ecommenda ions p o-
ided in he indi idual in e en ion and o p o ide
people wi h guidelines ha acili a e he p ac ice o
physical ac i i y and he adop ion o a heal hy die , o
example h ough physical exe cise sessions, cooking
wo kshops o p epa ing seasonal menus.
Communi y in e en ion ocuses mainly on he social
p esc ibing [45] o esou ces and ac i i ies ha a e ca -
ied ou in he communi y whe e he pa icipan pe son
esides. P e iously e e y PHC eam will iden i y he
communi y heal h asse s [46] and will choose he mos
app op ia e acco ding o unheal hy beha iou s de ec ed,
accessibili y and he possibili y o e e al o pa icipan s.
These in e en ions will include, o ins ance, cooking
cou ses, heal hy ea ing wo kshops, heal hy walks, local
walking e en s, line dances, g een physical ac i i y
p og ams, e c).
Usual ca e
PHC p o essionals o he con ol g oup (usual ca e) in e-
g a e in o hei p ac ice he ecommenda ions o he
P og am o P e en i e Ac i i ies and Heal h P omo ion
[47]. This p og am inco po a es p e en i e p o ocols
ha include li es yle ecommenda ions and a se o p e-
en i e ac i i ies o a speci ic age, sex and isk pa ien
g oups. P e en i e ac i i ies a e based on sys ema ic
sc eening and b ie ad ice o he p e en ion o ca dio-
ascula and men al diseases and cance as well as ac-
cine ecommenda ions.
Implemen a ion s a egy
The implemen a ion s a egy is based on:
a) The “Consolida ed F amewo k o Implemen a ion
Resea ch”(CFIR) [19] which iden i ies i e cons uc s:
1) in e en ion cha ac e is ics (in e en ion sou ce,
e idence s eng h and quali y, ela i e ad an age,
adap abili y, ialabili y, complexi y, design quali y and
packaging; and cos ); 2) ou e se ing (pa ien needs
and esou ces, cosmopoli anism, pee p essu e, and
ex e nal policy and incen i es); 3) inne se ing
(s uc u al cha ac e is ics, ne wo ks and
communica ions, cul u e, implemen a ion clima e
and eadiness o implemen a ion); 4) cha ac e is ics
Table 1 Co e cons uc s o he T ans heo e ical Model
(P ochaska e al. 2008) [32]
S ages o Change Desc ip ion
P econ empla ion No in en ion o ake ac ion wi hin he nex
6 mon hs
Con empla ion In ends o ake ac ion wi hin he nex 6 mon hs
P epa a ion In ends o ake ac ion wi hin he nex 30 days and
has aken some beha iou al s eps in his di ec ion
Ac ion Changed o e beha iou o less han 6 mon hs
Main enance Changed o e beha iou o mo e han 6 mon hs
Te mina ion No emp a ion o elapse and 100% con idence
Zabale a-del-Olmo e al. BMC Public Heal h (2018) 18:874 Page 4 o 15
Table 2 Desc ip ion o in e en ion
Unheal hy beha iou s
Tobacco use Insu icien physical ac i i y Non-adhe ence o Medi e anean die a y pa e n
Le el o in e en ion Indi idual G oup Communi y Indi idual G oup Communi y Indi idual G oup Communi y
S ages o change
P econ empla ion Ve y b ie
in e en ion + SMS
Ve y b ie
in e en ion + SMS
Ve y b ie
in e en ion + SMS
Con empla ion B ie In e en ion
+ App + SMS
Heal h educa ion
wo kshops
Social
p esc ibing
P epa a ion B ie In e en ion
+ SMS
Social
p esc ibing
B ie In e en ion
+ App + SMS
Heal h educa ion
wo kshops
Social p esc ibing
Ac ion Ve y b ie
in e en ion + SMS
Main enance Ve y b ie
in e en ion + SMS
Ve y b ie
in e en ion + SMS
Te mina ion
SMS Sho Message Se ice
Zabale a-del-Olmo e al. BMC Public Heal h (2018) 18:874 Page 5 o 15

o indi iduals (knowledge and belie s abou he
in e en ion, sel -e icacy, indi idual s a e o change,
indi idual iden i ica ion wi h he o ganisa ion, and
o he pe sonal a ibu es); and 5) he implemen a ion
p ocess i sel .
b) A se o disc e e implemen a ion s a egies [20,
48] which includes: plan s a egies (ga he
in o ma ion, adap and pilo ma e ial and p ocesses,
build buy-in, ini ia e leade ship and de elop
ela ionships); educa e s a egies (de elop ma e ials,
educa e, educa e h ough pee s, in o m and in luence
s akeholde s); inance s a egies (modi y incen i es
and acili a e inancial suppo ); es uc u e
s a egies ( e ise p o essional oles and c ea e
communi y and g oup in e en ions commi ees)
and quali y managemen s a egies (de elop and
o ganise implemen a ion moni o ing sys ems, con-
duc con inuous assessmen and eedback, es ablish a
sys em o eminde s, ob ain and use pa ien opinion,
cen alise echnical assis ance ocused on implemen a-
ion issues).
c) An e alua ion amewo k [21] o de e mine
he e ec i eness o implemen a ion h ough
se en implemen a ion ou comes: accep abili y,
adop ion, app op ia eness, easibili y,
ideli y, implemen a ion cos and
pene a ion.
This implemen a ion s a egy will be ca ied ou in
h ee s ages, p e-implemen a ion, implemen a ion and
pos -implemen a ion, u he desc ibed in Table 3.
Ou comes
This s udy dis inguishes be ween h ee di e en bu in-
e ela ed ypes o ou comes: i) e ec i eness, ii) cos -e -
ec i eness and iii) implemen a ion ou comes.
i) E ec i eness ou comes
The e ec i eness o he complex mul iple isk beha iou
in e en ion in compa ison wi h he usual ca e a max-
imum 12 mon hs pos -in e en ion will be measu ed by:
a) P ima y ou come measu es
–Posi i e change in baseline ea ing beha iou :
adhe ence o he Medi e anean die a y pa e n
in low adhe ence people. Fo he e alua ion, he
14-i em Ques ionnai e o Medi e anean die
adhe ence (PREDIMED s udy) will be used [49].
The posi i e change has been de ined as ob aining
eigh o ewe poin s a he s udy en y and nine
o mo e a he end o he s udy in his
ques ionnai e.
–Posi i e change in baseline physical ac i i y
beha iou : su icien physical ac i i y le el in
Table 3 Desc ip ion o implemen a ion s a egies
S age Key elemen Desc ip ion
P e-implemen a ion Ba ie s and acili a o s Du ing his s age, he scien i ic li e a u e will be e iewed. Likewise, he
esea che s will assess local needs, esou ces, ba ie s and acili a o s o
de elop speci ic implemen a ion s a egies. Pe spec i es o clinicians on he
in e nal esou ces will be measu ed by he “Su ey o O ganiza ional A ibu es
o P ima y Ca e”.
Suppo ma e ials All he suppo ma e ial o he in e en ion will be d awn up.
Managemen and quali y con ol sys ems Mechanisms o he e ec i e communica ion and he case epo o m will
be de ined and pilo ed. A checklis (on-line da abase) will be de eloped and
pilo ed o moni o he p og ess o implemen a ion in each PHC cen e.
Facili a ion and leade ship The acili a o (membe o he esea ch eam) and he leade (membe o he
p ima y ca e eam) o he implemen a ion will be designa ed.
Commi men o he s akeholde s Fo mal comp omises will be made wi h he manage s (a he mac o, meso
and mic o le els) and wi h he p o essionals o he cen es in ol ed and
communi y pa ne s.
T aining T aining ac i i ies will be ca ied ou in which aining in mo i a ional in e iew
will ha e a cen al ole
Collabo a i e modelling Local sessions o adap and ailo he in e en ion o he speci ic con ex
ough sha es decisions making.
Implemen a ion Collabo a i e lea ning The acili a o and he leade o implemen a ion will moni o he implemen a ion
p ocesses, iden i y oppo uni ies o imp o emen and op imise implemen a ion.
Commi men o main s akeholde s Audi and eedback echniques will be used owa ds he main s akeholde s
in o de o keep he ag eed comp omise and he mo i a ion.
T aining Heal h p o essionals will ecei e con inuous aining in mo i a ional in e iew.
Pos -implemen a ion Managemen and quali y con ol sys ems The e alua ion o implemen a ion will be ca ied ou h ough quali a i e and
quan i a i e me hodologies
Zabale a-del-Olmo e al. BMC Public Heal h (2018) 18:874 Page 6 o 15
insu icien ly ac i e people. Fo he e alua ion,
he In e na ional Physical Ac i i y Ques ionnai e
will be used [50]. The posi i e change has been
de ined as ha ing a low physical ac i i y le el a
he s udy en y and a mode a e o high physical
ac i i y le ela he end o he s udy.
–Posi i e change in baseline smoking beha iou :
sel - epo ed con inuous abs inence [51]. Fo he
e alua ion, he in e iew will be used and op ionally
he cooxime y. The posi i e change has been
de ined as smoking a he s udy en y and no
smoking a he end o he s udy. We will measu e
he punc ual and con inuous abs inence a hese
wo imes.
b) Seconda y ou come measu es
–Beginning o making a beha iou change. The
p opo ion o people who a e in he s ages o
ac ion, main enance o e mina ion acco ding o
he TTM a he s udy en y and a 12 mon hs.
–Change om baseline on seden a y beha iou . I
will be measu ed by he si ing i ems om he
In e na ional Physical Ac i i y Ques ionnai e.
–Change om baseline on die quali y. Die
Quali y Index-In e na ional will be used o
de e mine die quali y [52].
–Change om baseline on heal h- ela ed quali y
o li e. I will be measu ed by he Eu oQol-5D
ques ionnai e [53].
–Reduc ion o he ca dio ascula isk. The
p opo ion o people wi h low/mode a e and
high/ e y high baseline ca dio ascula isk who
ha e educed i . Ca dio ascula isk will be
calcula ed using REGICOR [54,55] and SCORE
[56] unc ioncha s.
–Change om baseline on body mass index. Body
mass index is de ined as he body weigh di ided
by he squa e o he body heigh and is exp essed
in uni s o kg/m
2
.
–Change om baseline on wais ci cum e ence.
The wais ci cum e ence will be measu ed a a
le el midway be ween he lowes ib and he iliac
c es . I will be exp essed in uni s o cm.
–Change om baseline on blood p essu e. I will
be measu ed in he ou ine clinical p ac ice by
alida ed elec onic moni o s and i will be
exp essed in uni s o mmHg.
–Change om baseline on lipid p o ile. The lipid
p o ile will include: low-densi y lipop o ein,
high-densi y lipop o ein, iglyce ides and o al
choles e ol. They will be exp essed in uni s o
mg/dl.
–Change om baseline on a e ial s i ness. A e ial
s i ness will be assessed by he “Ca dio-Ankle
Vascula Index”. I will be measu ed by he
Vascula Sc eening Sys em VaSe a VS-1500 N
o VaSe a VS-2000.
–Change om baseline on heankle-b achial
index. I will be measu ed by he Vascula
Sc eening Sys em VaSe a VS-1500 N o VaSe a
VS-2000.
–Change om baseline on he “REgico and
A pe Sco e O aNkle b achial index
(REASON)”[57].
–Change om baseline on he pe cei ed unc ional
social suppo . The ques ionnai e Duke-UNC-11
will be used o de e mine he pe cei ed unc ional
social suppo [58–60].
–Reduc ion o he incidence o majo dep ession
will be e alua ed by CIDI in e iew [61].
–Reduc ion o he isk o dep ession in pa icipan
non-dep essed a baseline. Risk o dep ession will
be calcula ed using he algo i hm P edic D [62].
–Reduc ion o dep ession symp oms. The Pa ien
Heal h Ques ionnai e-9 will be used o de e mine
he p e alence and he se e i y o dep ession
symp oms [63].
–Reduc ion o anxie y symp oms. The Gene al
Anxie y Diso de -7 ques ionnai e will be used o
de e mine he p e alence and he se e i y o
anxie y symp oms [64].
–Change om baseline on unheal hy beha iou s
o p o essionals o he PHC in e en ion cen es.
ii) Cos -e ec i eness ou comes
An economic e alua ion will be conduc ed om he pe -
spec i e o he socie y and he Heal h Se ice compa ing
he EIRA in e en ion s. he usual ca e g oup a
12-mon hs pos -in e en ion.
a) Ou come measu e
–Inc emen al cos pe quali y-adjus ed li e yea s
(QALYs) gained will be calcula ed. QALYs will
be measu ed using he Spanish a i s o he
Eu oQol-5D ques ionnai e [53]. The ollowing
cos s will be aken in o accoun : hospi al ca e
(eme gency isi s and s ays), seconda y ca e
( isi s o specialis s), p ima y ca e ( isi s o
physician and nu se), social ca e se ices
( isi s o social wo ke ), ou pa ien diagnos ic
es s, medica ion use, g oup sessions a ended,
communi y esou ces used and loss o p oduc i i y
(days o wo k). This in o ma ion will e e o he
las 12 mon hs p io o s udy en y and o he
subsequen 12 mon hs. Use o heal hca e esou ces
and los p oduc i i y will be assessed h ough he
pa ien s’clinical his o y and also he Clien Se ice
Receip In en o y [65].In o ma ionon heuseo
medicines (ac i e subs ance, dose, and uni s
Zabale a-del-Olmo e al. BMC Public Heal h (2018) 18:874 Page 7 o 15
supplied) will also be collec ed. The uni cos s
o public heal hca e se ices will be ob ained
om he O icial Bulle in o he Go e nmen .
Cos s o p i a ely unded se ices will be ob ained
om published a i s. The mean p ice pe
millig am o ac i e subs ance will be calcula ed
using he p ices o he gene ic e sions o all
he p esen a ions as epo ed in he Spanish
Vademecum. P oduc i i y losses will be calcula ed
based using in o ma ion on he minimum and
a e age daily wage in Spain [66].
iii) Implemen a ion ou comes
–Ea ly app op ia eness and accep abili y. I will be
e alua ed in p o essionals and pa icipan s by means
o a su ey p io o he s a o he in e en ion.
–Final app op ia eness and accep abili y. I will be
e alua ed in p o essionals and pa icipan s by means
o a su ey. Wha is mo e, discussion g oups will be
held a he end o he in e en ion wi h he
p o essionals and pa icipan s.
–Adop ion. The p opo ion o p o essionals who
exp ess hei willingness o pa icipa e in he s udy
be ween o o al o po en ial p o essionals p io o
he s a o he in e en ion.
–Feasibili y. On he basis o he calcula ion o
pa icipa ion, ec ui men and e en ion a e a
12 mon hs pos -in e en ion.
–Fideli y o he mo i a ional in e iew model. The
quali y o he mo i a ional in e iew deli e ed will
be assessed by coding ideo eco dings o an ac ing
pa ien session wi h he “mo i a ional in e iewing
assessmen scale”[67] be o e and a e he aining
cou se p o ided.
–Fideli y o he planned in e en ion. The deg ee o
compliance o he ac i i ies eco ded in he case epo
o m (CRF) will be analysed.
–Fideli y o he implemen a ion. The deg ee o
compliance o he implemen a ion s a egies.
–Cos o ime in es ed in aining and o ganisa ional
mee ings o ca y ou he in e en ion.
–Pene a ion. The p opo ion o p o essionals who
ha e in eg a ed he in e en ion in o hei usual
clinical p ac ice a e comple ing hein e en ion.
Sample size
The sample size was calcula ed on he basis o da a om
he li e a u e and some esul s o phase II. We expec a
di e ence in he pe cen age o people who show a posi-
i e change in one o mo e o he h ee beha iou s be-
ween he wo g oups o a leas 8%. Assuming 30%
pa ien loss o ollow-up, alpha isk o 5%, be a isk o
20%, and an in aclus e co ela ion o 0.01 [68], we
conside ha i is necessa y o s udy a minimum o 140
pa icipan s o each PHC cen e, a o al o 3640 people
(1820 o each o he wo g oups, 13 PHC cen e pe
g oup). PASS so wa e was used o compu e he sample
size [PASS 14 Powe Analysis and Sample Size So wa e
(2016). NCSS, LLC. Kays ille, U ah, USA, ncss.com/so
wa e/pass]. Sampling was done in o de o ul il an
es ablished sex and age quo a which is p opo ional o
he las gene al popula ion census.
Rec ui men
Se e al in e ac i e and passi e ec ui men s a egies will
be conside ed o inc ease he easibili y o achie ing he
a ge sample size [69]. Pa icipan s will be ec ui ed o
hyb id ial a PHC cen es h ough i e me hods: 1) a
he ime o isi as pa o usual ca e; 2) sel -adminis-
e ed ques ionnai es deli e ed in he wai ing oom o in
he admission desk; 3) a pa - ime aining ec ui e ; 4)
ad e ising by pos e s in he PHC cen es and 5) phone
calls o selec ed pa ien s om e iew o elec onic heal h
eco ds. Me hod o ec ui men should be egis e ed o
each pa icipan en olled. Rec ui men will ca y ou
du ing six mon hs. The acili a o and he leade o he
s udy (see Table 3) will ha e a c ucial ole o moni o e-
c ui men . PHC p o essionals and pa icipan s will no
ecei e any inancial incen i es o en olmen ; howe e ,
he e will be he possibili y o se manage ial goals e-
la ed o ec ui men .
Assignmen o in e en ion
The alloca ion schedule o andom assignmen o in e -
en ion o PHC cen es will be compu e gene a ed a a
cen al loca ion (IDIAP Jo di Gol, Ba celona, Spain). Fo
each o he se en Spanish Au onomous Communi ies,
we will andomly alloca e hal o he PHC cen es o he
in e en ion g oup and he o he hal o he con ol
g oup. In o al, 13 PHC cen es will be alloca ed
o he in e en ion g oup and 13 o he o he con ol
g oup. The alloca ion will no be concealed a PHC cen-
es and no blinding will be done.
Da a collec ion and managemen
Da a will be collec ed a PHC cen e, p o essional and
pa icipan le els. Da a collec ion me hods and p oce-
du es a e summa ised in Table 4.
A PHC cen e le el, we will collec in o ma ion e-
la ed o: assigned popula ion ( o al numbe ; a e age age;
dis ibu ion by age g oup and sex; pe cen age o immi-
g an s; dep i a ion index; p e alence o obacco use;
le el o physical ac i i y and numbe o people alloca ed
o home ca e), o ganisa ional s uc u e (popula ion
co e age; a e age a endance; numbe o physicians,
nu ses and social wo ke s; acc edi a ion as aining
heal h cen e; pa icipa ion in unde g adua e and
Zabale a-del-Olmo e al. BMC Public Heal h (2018) 18:874 Page 8 o 15
Table 4 Schedule o Da a Collec ion Me hods and P ocedu es
P e-implemen a ion/
P e-s udy consen /
sc eening
Du ing implemen a ion Pos -
implemen a ion
Ac i i y/Assessmen Da a collec ion Responsible S udy baseline In e en ion isi s Follow-up
12-mon hs
PHC cen e le el
Cha ac e is ics o assigned people Fo m epo Resea ch eam each
au onomous communi y
x
O ganisa ional s uc u e Fo m epo Resea ch eam each
au onomous communi y
x
Su ey o O ganiza ional A ibu es
o P ima y Ca e
Sel -adminis e ed ques ionnai e Resea ch eam each
au onomous communi y
xx
P o essional le el
Age, sex, academic educa ion and
expe ience in PHC
Sel -adminis e ed ques ionnai e Resea ch eam each
au onomous communi y
x
Daily consump ion o ui s and
ege ables/Le el o physical
ac i i y/Smoking beha iou
Sel -adminis e ed ques ionnai e Resea ch eam each
au onomous communi y
xx
App op ia eness and accep abili y Sel -adminis e ed ques ionnai e Resea ch eam each
au onomous communi y
xx
De e minan s o implemen a ion
(CFIR cons uc s)
Focus g oup Resea ch eam each
au onomous communi y
x
Pa icipan le el
In o med consen Pape documen PHC p o essionals x
Age and sex CRF PHC p o essionals x
Sc eening unheal hy beha iou s CRF PHC p o essionals x
Inclusion/Exclusion c i e ia CRF PHC p o essionals x
Adhe ence o he Medi e anean
die a y pa e n
CRF (14-i em Ques ionnai e o
Medi e anean die adhe ence
Ex e nal uni o local ained
pe sonnel
xx
Quali y o die CRF (Die Quali y Index-In e na ional) Ex e nal uni o local ained
pe sonnel
xx
Physical ac i i y beha iou CRF (In e na ional Physical
Ques ionnai e)
Ex e nal uni o local ained
pe sonnel
xx
Smoking beha iou CRF (in e iew and op ional
cooxime y)
Ex e nal uni o local ained
pe sonnel
xx
S age o change CRF PHC p o essionals (in e en ion
g oup)
xx
Ex e nal uni o local ained
pe sonnel (con ol g oup)
xx
Heal h- ela ed quali y o li e CRF (Eu oQol-5D ques ionnai e) Ex e nal uni o local ained
pe sonnel
xx
Zabale a-del-Olmo e al. BMC Public Heal h (2018) 18:874 Page 9 o 15