Engaging Disadvantaged Patients in Sharing Patient Generated Health Data and Patient Reported Outcomes Through Health Information Technology
Phase: NA
Conditions: Obesity
Sponsor: Denver Health and Hospital Authority

 
St u d y Titl e :   
E n g a gi n g dis a d v a nt a g e d p ati e nts i n s h ari n g 
p ati e nt g e n er at e d h e alt h d at a a n d p ati e nt 
r e p ort e d o utc o m es t hr o u g h h e alt h i nf or m ati o n 
t ec h n ol o g y 
 
 
N C T # :  
N C T 0 3 3 8 6 7 7 3  
 
 
V ersi o n D at e :  1 0/ 1 2/ 2 0 1 6  
 

S P E CI FI C AI M S  
T his a p plic ati o n  i n r es p o ns e t o S p eci al E m p h asis N oti c e N O T-H S -1 6-01 5  pr o p os es  a pil ot st u d y t o d e m o nstr at e 
t h e f e asi bilit y of usi n g p ati e nt-c e nt er e d c o m m er ci al off -t h e-s h elf ( C O T S) h e alt h i nf or m ati o n t ec h n ol o g y (I T) 
s ol uti o ns t o: 1) c oll ect p ati e nt -g e n er at e d h e alt h d at a ( P G H D) a n d p ati e nt -r e p ort e d o ut c o m es (P R O s) fr o m 
di v ers e, dis a d v a nt a g e d p o p ul ati o ns, a n d 2) r e p ort P G H D a n d P R O s i n a w a y t h at will all o w t h e m t o b e 
i nt e gr at e d i nt o cli ni c al i nf or m ati o n s yst e ms a n d us e d t o i m pr o v e c ar e. T his st u d y a d dr ess es f o ur of t h e fi v e 
r es e ar c h ar e as of i nt er est t o t h e A g e nc y f or H e alt hc ar e R es e ar c h a n d Q u alit y: d esi g n  ( Ai m 1), us e  ( Ai m 2), 
i m p a ct o n o ut c o m es ( Ai m 2), a n d i m pl e m e nt ati o n ( Ai m 3).  
P ati e nt e n g a g e m e nt is p arti c ul arl y criti c al t o ac hi e vi n g g o o d c hr o nic dis e as e s elf-m a n a g e m e nt . T his is 
es p eci all y i m p or t a nt f or dis a d v a nt a g e d p ati e nts, w h o ar e dis pr o p orti o n at el y aff ect e d b y c hr o nic dis e as e. A k e y 
c o m p o n e nt of c hr o ni c dis e as e s elf -m a n a g e m e nt  is t h e a bilit y f or p ati e nts t o r ec or d a n d m o nit or t h eir o n g oi n g 
p e rf or m a nc e o n i n di c at or m e as ur es. W hil e h e alt h I T  s ol utio ns h a v e b e e n s h o w n t o i m pr o v e c hr o nic dis e as e 
s elf-m a n a g e m e nt, a d o pti o n a n d us e of c ostl y, s p eci aliz e d t ec h n ol o gi es a m o n g dis a d v a nt a g e d p ati e nts is l o w er 
t h a n a m o n g hi g h er-i nc o m e p o p ul ati o ns. I n c o ntr ast, C O T S  t ec h n ol o gi es s u c h as m o bil e p h o n es ar e m or e 
a c c essi bl e t o a n d wi d el y a d o pt e d b y dis a d v a nt a g e d p ati e nts , t h us bri d gi n g t h e g a p of t h e di git al di vi d e.  
T h e c e nt r al r e s e a r c h h y p ot h e si s p o sit s t h at 1) l o w-i n c o m e, di s a d v a nt a g e d p ati e nt s b ot h c a n  
a n d will  p r o vi d e  hi g h q u alit y P G H D a n d P R O s t h r o u g h C O T S -b a s e d  h e alt h I T s ol uti o n s , a n d 2 ) 
t h e s e d at a  c a n b e i nt e g r at e d i nt o cli ni c al s y st e m s a n d u s e d t o i m p r o v e h e alt h c a r e q u alit y a n d 
d eli v e r y . P G H D c a n b e c oll ect e d t hr o u g h p ati e nt i nt er acti o n wit h C O T S  h e alt h I T s ol uti o ns s uc h as m o bil e 
h e alt h a p ps a n d  fit n ess tr ac k ers. P R O s c a n b e c oll ect e d vi a p ati e nt r es p o ns e t o q u esti o n n air e -b as e d P R O s 
m e as ur es , or P R O Ms. T h es e d at a c a n b e  tr a ns mitt e d t o cli ni c al i nf or m ati o n s yst e ms, i nt e gr at e d i nt o cli ni c al 
w or kfl o ws a n d us e d  b y pr o vi d ers  t o i m pr o v e  h e alt h c ar e q u alit y a n d d eli v er y. Usi n g a s e q u e nti al i nt e gr at e d 
mi x e d -m et h o ds a p pr o ac h, w e  pr o p os e t o t est t h e c e ntr al h y p ot h esis t hr o u g h t hr e e s p ecifi c ai ms, as f oll o ws: 
Ai m 1 : T o a s s e s s t h e n e e d s a n d p r ef e r e n c e s of di s a d v a nt a g e d p ati e nt s a n d s af et y n et 
h e alt h c a r e p r o vi d e r s r e g a r di n g t h e u s e of h e alt h I T f o r c o m m u ni c ati n g P G H D  a n d P R O s.  
Ai m 1 R es e ar c h Q u esti o n s:  W h at  s p ecific f e at ur es i n C O T S s ol uti o ns  m e et t h e n e e ds a n d pr ef er e nc es of 
dis a d v a nt a g e d p ati e nts f or c o m m u ni c ati n g P G H D  a n d P R O s t o t h eir pr o vi d ers? W h at P G H D a n d P R O s ar e 
d e e m e d  m ost i m p ort a nt  b y pr o vi d ers a n d p ati e nts f or i m pr o vi n g h e alt h c ar e  a n d h e alt h o ut c o m es ?  
A ns w er i n g t h es e q u esti o ns will i nf or m h e alt h I T s ol uti o n s el ecti o n, d esi g n , us a bilit y, a n d utilit y; assist 
wit h pri oritizi n g P G H D  a n d P R O s c oll ecti o n b y d at a el e m e nt a n d m e as ur e t y p e ; a n d i d e ntif y p ot e nti al 
dis cr e p a nci es b et w e e n p ati e nts’ a n d pr o vi d ers’ p er c e pti o ns of P G H D  a n d P R O s i m p ort a nc e.  
Ai m 2 : T o  d e m o n st r at e t h e f e a si bilit y of P G H D  a n d P R O s c oll e cti o n t h r o u g h C O T S h e alt h 
I T s ol uti o n s i n a p ati e nt -c e nt e r e d  pil ot i nt e r v e nti o n f o r w ei g ht m a n a g e m e nt a m o n g 
di s a d v a nt a g e d p ati e nt s . 
Ai m 2 H y p ot h esis : Pr o vi di n g P G H D  a n d P R O s t hr o u g h C O T S  s ol uti o ns will i m pr o v e e n g a g e m e nt  
a m o n g dis a d v a nt a g e d p ati e nts . S ec o n d ar y o ut c o m es i ncl u d e  i m pr o vi n g k e y h e alt h i n di c at ors ( e. g.,  w ei g ht, 
p h ysi c al acti vit y)  a n d P R O Ms  ( e. g., q u alit y of lif e, m e nt al h e alt h s y m pt o ms).  
W e i g ht m a n a g e m e nt is i m p ort a nt i n d el a yi n g , a v erti n g , a n d r e d u ci n g t h e eff ects of m ulti pl e c hr o nic 
dis e as es, i ncl u di n g di a b et es, h y p ert e nsi o n, a n d o b esit y. A w ei g ht m a n a g e m e nt -r el at e d i nt er v e nti o n als o s er v es 
as a n eff ecti v e t est of P G H D a n d P R O M s c oll ecti o n, d u e t o t h e e xist e nc e of n u m er o us C O T S s ol uti o ns w hic h 
us e  diff er e nt m et h o ds f or tr ac ki n g c o m m o n d at a el e m e nts r el at e d t o w ei g ht, p h ysi c al acti vit y, a n d fit n ess.  
Ai m 3 : T o c r e at e a n o nt ol o g y m a p pi n g a n d s et of i nt e r o p e r a bilit y r e s o u r c e s w hi c h c a n b e 
u s e d t o s u p p o rt i nt e g r ati o n of P G H D  a n d P R O  i nt o cli ni c al i nf o r m ati o n s y st e m s . 
Ai m 3 H y p ot h esis : P G H D  a n d P R O s c a n b e  c h ar act eriz e d b y disti nct t y p es, el e m e nts, a n d str uct ur es 
w hic h , o nc e d escri b e d , m a y b e m o d el e d a n d m a p p e d t o e xisti n g v oc a b ul ari es f or h e alt h d at a m a n a g e m e nt.   
I n or d er t o m a k e P G H D a n d P R O s acti o n a bl e, t h es e d at a m ust b e i nt e gr at e d i nt o cli nic al i nf or m ati o n 
s yst e ms s u c h as el ectr o nic h e alt h r ec or ds ( E H Rs) w h er e it c a n b e us e d b y cli ni ci a ns i n t h eir pr acti c e . Cr e ati n g a 
“tr a nsl ati o n” b y m at c hi n g  P G H D a n d P R O s d at a el e m e nts  t o c o m p ar a bl e o n es i n e xisti n g cli ni c al v o c a b ul ari es  
will pr o vi d e a t o ol t o s u p p ort f ut ur e d at a i nt e gr ati o n  i nt o t h e E H R. Cr e ati n g a r es o ur c e s et w hic h c a n b e us e d 
wit h m ulti pl e E H Rs will i m pr o v e t h e g e n er aliz a bilit y a n d br o a d us a bilit y of t h e o nt ol o g y m a p pi n g  t o ol. 
C O MI R B # 1 7- 1 0 8 2
Versi o n 1 0/ 1 2/ 2 0 1 6

R E S E A R C H S T R A T E G Y  
1.
SI G NI FI C A N C E
1. 1.  
 T h e p r o bl e m of c h r o ni c di s e a s e i s b ot h s e v e r e a n d d e a dl y.  I n A pril of 2 011, t h e W orl d H e alt h 
Or g a niz ati o n ( W H O) c o nfir m e d t h at c hr o ni c  dis e as es h a v e b ec o m e t h e l e a di n g c a us e of d e at h w orl d wi d e  (1). 
T h at eff ect  h as c o nti n u e d t o w ors e n, wit h 6 8 % of a n n u al gl o b al m ort alit y ( 3 8  milli o n  d e at hs ) n o w d u e t o 
c hr o ni c dis e as e, t h e m aj orit y of w hi c h ar e  fr o m c ar di o v asc ul ar dis e as e, di a b et es, c a nc er, a n d  c hr o nic l u n g 
dis e as e  (2 ). As t h es e ill n ess es ar e all aff ect e d b y o b esit y, w e h a v e c h os e n t o us e o b esit y as a n e x e m pl ar  f or t his 
st u d y. O b esit y is a c o m pl e x c hr o nic dis e as e a ss o ci at e d wit h i ncr e as e d m ort alit y a n d hi g h er ris k f or m or e t h a n 
2 0 ot h er c hr o ni c dis e as es a n d h e alt h c o n diti o ns, i ncl u di n g h y p ert e nsi o n ( H T N), di a b et es ( D M), 
h y p erc h ol est er ol e mi a, h e art dis e as e, str o k e, a n d c ert ai n c a nc ers (3- 11). F ull y a t hir d of H T N c as es c a n b e 
attri b ut e d t o o b esit y, a n d m or e t h a n 8 0 % of p e o pl e wit h D M ar e o v er w ei g ht or o b es e (1 2). T h e lif eti m e ris k of 
c or o n ar y h e art dis e as e is 7 % h i g h er a m o n g o b es e p e o pl e t h a n t h os e of n or m al-w ei g ht (1 3). A m o n g p ers o ns 
a g e d 2 0 -3 0 y e ars, o b esit y c o ntri b ut es t o l o w er lif e e x p ect a nc y b y 5 -2 0 y e ars (1 3, 1 4). A t ot al of 11 2, 0 0 0 p e o pl e 
di e a n n u all y fr o m o b esit y -r el at e d c a us es (1 0).  P e o pl e w h o w er e o b es e as c hil dr e n ar e t wic e as li k el y t o di e 
b ef or e r e ac hi n g a g e 5 5 as ar e t h os e w h o w er e at a h e alt h y w ei g ht  d uri n g c hil d h o o d  (1 0). I n t h e l ast 3 0 y e ars, 
o b esit y r at es h a v e d o u bl e d i n t h e Unit e d S t at es ( U S) a m o n g a d ults t o 3 5 % f or m e n a n d 4 0 % f or w o m e n, a n d 
tri pl e d t o 1 7 % a m o n g c hil dr e n (1 3, 1 5-1 7).  T his aff ects 8 5 milli o n p e o pl e i n t h e U S a n d 5 0 0 milli o n p e o pl e 
w orl d wi d e (1 3, 1 5-1 7). T h e i m p act o n t h e h e alt h s yst e m ass o ci at e d wit h o b esit y-r el at e d e x p e n dit ur es is li k e wis e 
o v er w h el mi n g. O v er $1 5 0 billi o n is s p e nt a n n u all y o n o b esit y -r el at e d dir ect m e di c al c osts, w hic h e q u als n e arl y 
1 0 % of all m e di c al c osts (7 , 1 8) a n d $1, 4 2 9 m or e s p e nt a n n u all y p er p ati e nt a m o n g o b es e p e o pl e as c o m p ar e d 
t o e x p e n dit ur es f or n or m al-w ei g ht p ati e nts (1 5, 1 9). 
1. 2.  
T h e i m p a ct of c h r o ni c di s e a s e i s m u c h w o r s e f o r di s a d v a nt a g e d p ati e nt s. T h e a p p ell ati o n of 
“ dis a d v a nt a g e d p ati e nts” is h er e s y n o n y m o us wit h t h e “ pri orit y p o p ul ati o ns” of i nt er est t o t h e A g e nc y f or 
H e alt h c ar e R es e arc h a n d Q u alit y  ( A H R Q). T h es e ar e p ati e nts w h o ar e pri m aril y  s er v e d b y t h e h e alt h c ar e 
s af et y n et (2 0 ), w hi c h is c o m pris e d of h e alt h s yst e ms a n d p r ovi d ers w h o c ar e f or p ati e nts r e g ar dl ess of t h eir 
a bilit y t o p a y .  T h es e p ati e nts r e pr es e nt r aci al a n d et h ni c mi n oriti es, l o w-lit er ac y p o p ul ati o ns, p e o pl e wit h 
dis a biliti es, c hil dr e n a n d t h e el d erl y, t h os e li vi n g i n r ur al ar e as, t h e u ni ns ur e d, t h e u n d eri ns ur e d, a n d t h os e 
wit h l o w i nc o m e. O n a gl o b al s c al e, n e arl y 7 5 % of d e at hs fr o m c hr o ni c dis e as e o c c ur i n l o w a n d mi d dl e -i nc o m e 
c o u ntri es, wit h n e arl y h alf ( 4 8 %) oc c urri n g b ef or e a g e 7 0 (2 ). Si mil ar tr e n ds ar e r efl ect e d i n t h e U S , w h er e 
dis a d v a nt a g e d  p ati e nts ar e m or e gr e atl y b ur d e n e d b y c hr o ni c dis e as e (21 -2 3 ) a n d als o e x p eri e nc e dis p ariti es i n 
tr e at m e nt. Si g nific a ntl y hi g h er pr e v al e nc e of c hr o ni c dis e as e h as b e e n o bs er v e d a m o n g bl ac ks, L ati n os, a n d 
Asi a ns t h a n a m o n g w hit es, as w ell as a m o n g t h os e n e ar or b el o w t h e f e d er al p o v ert y l e v el as c o m p ar e d t o t h os e 
2 0 0 % or m or e a b o v e it (2 4 -2 6 ). Bl ac ks a n d L ati n os r ec ei v e w ors e c ar e t h a n w hit es ( 4 0 % a n d 6 0 %, r es p ecti v el y) 
a n d h a v e m or e diffic ult y ac c essi n g c ar e ( 3 3 % a n d 8 3 % of t h e ti m e, r es p ecti v el y), a n d  t h e p o or r ec ei v e w ors e 
c ar e a n d h a v e w ors e acc ess t h a n t h os e wit h hi g h er i nc o m es (2 7 -2 9 ). As wit h ot h er c hr o nic dis e as es, t h e i m p act 
of o b esit y is m uc h w ors e f or dis a d v a nt a g e d p ati e nts (1 2, 1 5-1 7, 3 0 ).  Bl ac k a d ults ar e o n e a n d a h alf ti m es a s 
li k el y as w hit es t o b e o b es e; 3 8. 2 % of bl ac k m e n a n d 5 7. 2 % of bl ac k w o m e n ar e o b es e, c o m p ar e d t o 3 5. 4 % of 
w hit e m e n a n d 3 8. 7 % of w hit e w o m e n (1 6). A m o n g L ati n os, t h e f ast est-i ncr e asi n g p o p ul ati o n i n t h e U S, 4 3 % of 
a d ults ar e o b es e (1 2, 1 5, 1 6). Of t h e 1 0 st at es wit h t h e hi g h est r at es of o b esit y, ( 31. 7 % - 3 5.1 % o b es e), 9 ar e 
a m o n g t h e p o or est i n A m eri c a, wit h 3 0 % or m or e of t h eir p o p ul ati o n li vi n g i n p o v ert y (1 2, 31 ).   
1. 3.  
P ati e nt r e p o rt e d o ut c o m e s ( P R O s ) a n d p ati e nt g e n e r at e d h e alt h d at a ( P G H D) a r e 
c riti c all y i m p o rt a nt f o r  g o o d c h r o ni c di s e a s e m a n a g e m e nt.   I n c o ntr ast t o tr e at m e nt f or s h ort-t er m 
ac ut e c o n diti o ns, c ar e f or c hr o ni c dis e as e d e p e n ds o n e n g a gi n g p ati e nts i n s u c c essf ul s elf -m a n a g e m e nt of t h eir 
c o n diti o ns  o v er ti m e , o utsi d e t h e s etti n g of t h e i nfr e q u e ntl y-o c c urri n g, tr a diti o n al 2 0-mi n ut e pri m ar y c ar e 
cli ni c visit  (2 5 ).  T his is e v e n m or e i m p ort a nt f or dis a d v a nt a g e d p ati e nts, w h o h a v e l ess acc ess t o cli ni c s etti n gs 
a n d m or e s e v er e b ur d e n of c hr o ni c dis e as e  (21 -2 3 , 2 7 -2 9 ). R e g ul ar d ail y a n d w e e kl y l o g gi n g of P G H D s u c h as 
f asti n g gl uc os e l e v els, bl o o d pr ess ur es, mi n ut es of p h ysi c al acti vit y, a n d w ei g ht h as pr o v e n b e n efi ci al i n c hr o ni c 
dis e as e m a n a g e m e nt  (3 2 -3 4 ). S u c h l o gs n ot o nl y gi v e p ati e nts a n o n g oi n g pi ct ur e of t h eir h e alt h a n d s u cc ess at 
s elf-m a n a g e m e nt, b ut als o gi v e pr o vi d ers a v al u a bl e s o ur c e of i nf or m ati o n t h at c a n b e us e d t o m o nit or dis e as e 
tr e n ds a n d p erf or m a nc e o v er ti m e o n k e y i n di c at ors. I n a d ditio n t o t h e v al u e of P G H D l o g gi n g, r e g ul ar 
c oll ecti o n of P R Os m e as ur es, or P R O Ms, t hr o u g h a d mi nistr ati o n of v ali d at e d i nstr u m e nts c a n pr o vi d e criti c al 
o n g oi n g i nf or m ati o n a b o ut a p ati e nt’s o v er all h e alt h st at us, q u alit y of lif e, c o -o cc urri n g c o n diti o ns, “ act i v ati o n” 
or e n g a g e m e nt i n c ar e, acti viti es of d ail y li vi n g, a n d p er c ei v e d s elf -effi c ac y at c hr o ni c dis e as e m a n a g e m e nt  (3 5 -
C O MI R B # 1 7- 1 0 8 2
Versi o n 1 0/ 1 2/ 2 0 1 6

3 9 ). H a vi n g t his i nf or m ati o n r e a dil y a v ail a bl e t o pr o vi d ers t hr o u g h i nt e gr ati o n i nt o cli ni c al w or kfl o ws a n d 
E H Rs m a k es it acti o n a bl e f or us e i n c ar e pl a n ni n g a n d d uri n g cli n ic al visits, t h us i m pr o vi n g t h e q u alit y of c ar e. 
R et ur ni n g t o o b esit y as o ur e x e m pl ar c o n diti o n , e x p erts h a v e c o ncl u d e d t h at o b esit y is a c o m pl e x c hr o ni c 
dis e as e  w hi c h r e q uir es l o n g -t er m b e h a vi or al c h a n g es (4 0 ). E vi d e nc e-b as e d str at e gi es f or w ei g ht l oss s u c c ess, 
ac c or di n g t o r ec e ntl y -u p d at e d cli ni c al g ui d eli n es (4 0 , 41 ), i ncl u d e e n g a gi n g i n c o m pr e h e nsi v e lif est yl e 
i nt er v e nti o ns t h at i ncl u d e r e g ul ar c o nt act wit h a n d s u p p ort fr o m tr ai n e d i nt er v e nti o nists (4 0- 4 2 ). Pr o vi d er 
c o u ns eli n g h as b e e n s h o w n t o h a v e si g nifi c a nt p ositi v e i m p act o n p ati e nt att e m pts t o l os e w ei g ht (4 3 ), b ut t h e 
ti m e c o nstr ai nts of pri m ar y c ar e cli ni c visit s li mit w h at a d vi c e c a n b e gi v e n (3 0 ). M or e o v er, a d e p e n d e nc y o n 
visit -b as e d pri m ar y c ar e f or o b esit y m a n a g e m e nt i n p artic ul ar m a y e v e n c a us e u ni nt e n d e d h ar m. Pr o vi d ers ar e 
oft e n r el u ct a nt t o c o u ns el p ati e nts a b o ut w ei g ht l oss, or d o s o l ess eff ecti v el y d u e t o t h e i nfl u e nc e of w ei g ht 
sti g m a a n d w ei g ht bi as (4 4- 4 7 ). P ati e nts w h o e x p eri e nc e w ei g ht sti g m a h a v e l o w er l e v els of tr ust i n t h eir 
Pr o vi d ers a n d m a y a v oi d or d el a y n e e d e d h e alt h c ar e (6 , 4 8 , 4 9 ); i n a d diti o n, sti g m atiz ati o n its elf is ass oci at e d 
wit h i ncr e as e d p h ysi ol o gi c al a n d ps y c h ol o g ic al diffi c ult y i n l osi n g w ei g ht (5 0 -5 3 ). It is t h er ef ore cl e ar t h at a 
s ol el y visit-b as e d m o d el is i ns uffici e nt f or g o o d c hr o ni c dis e as e c ar e. T h e C hr o ni c C ar e M o d el ( C C M), as 
d e v el o p e d b y W a g n er et al.  (5 4 -5 6 ), d es cri b es a n i nt er acti v e a ppr o ac h t o c hr o ni c dis e as e m a n a g e m e nt t h at is 
b as e d o n a d y n a mi c p art n ers hi p b et w e e n h e alt h s yst e ms, p r ovi d ers a n d p ati e nts . T h e C C M i nc or p or at es t h e 
us e of h e alt h d at a f or d ecisi o n s u p p ort, f or c ar e pl a n ni n g, f or p erf or m a nc e m o nit ori n g, a n d f or s elf -
m a n a g e m e nt s u p p ort i nt e n d e d t o e m p o w er a n d e n g a g e p ati e nts i n t h ei r c ar e (5 7 , 5 8 ). P G H D a n d P R Os  
c oll ecti o n pr o vi d es a str o n g f o u n d ati o n f or  a C C M -b as e d a p pr o ac h .  Fi g ur e 1 d e picts a m o difi c ati o n t o t h e C C M 
t h at ill ustr at es h o w P G H D a n d P R Os  c a n b e i nc or p or at e d t o i nfl u e nc e p ati e nt acti v ati o n a n d h e alt h t e a m 
pr e p ar ati o n b y m a ki n g p ati e nt -pr o vi d er i nt er acti o ns m or e pr o d u cti v e.  
1. 4.  
P ati e nt -c e nt e r e d  c o m m e r ci al off -t h e-
s h elf ( C O T S)  h e alt h  I T s ol uti o n s c a n f a cilit at e 
c oll e cti n g P G H D a n d P R O s  f r o m di s a d v a nt a g e d 
p ati e nt s b et w e e n cli ni c al vi sit s . H e alt h I T is w ell 
s uit e d t o s u p p ort h e alt h s yst e ms a n d c o m m u niti es i n 
t h e f o ur i d e ntifi e d d o m ai ns of t h e C C M (5 4 -5 7 , 5 9 ). 
P ati e nt -e n g a gi n g  h e alt h I T s ol uti o ns h a v e pr o v e n 
eff ecti v e i n c hr o ni c dis e as e m a n a g e m e nt (6 0 ), wit h 
r es ults t h at i ncl u d e i mpr o v e d bl o o d pr ess ur e c o ntr ol i n 
p ati e nts  wit h H T N (61 , 6 2 ), i mpr o v e d gl y c e mic c o ntr ol 
i n p ati e nts wit h D M  (6 3 , 6 4 ), a n d i mpr o v e d m e di c ati o n 
a d h er e nc e i n ast h m ati c p ati e nts (6 5 ). S uc h s ol uti o ns 
h a v e li k e wis e pr o v e n eff ecti v e f or w ei g ht l oss, wit h 
o utc o m es t h at i ncl u d e cli ni c all y si g nifi c a nt d ecr e as es i n 
w ei g ht, b ett er -s ust ai n e d w ei g ht l oss, a n d p ositi v e s o ci al 
s u p p ort (6 6 , 6 7 ). D es pit e a still-p er v asi v e b eli ef t h at 
d is a d v a nt a g e d p ati e nts ar e n ot eff ecti v e u s ers of 
t ec h n ol o g y, dis a d v a nt a g e d p ati e nts h a v e s h o w n cl e ar 
r ec e pti vit y t o a n d i nt er est i n p ati e nt -c e nt er e d h e alt h I T 
s ol uti o ns (6 8 -7 6 ). St u di es a m o n g p ati e nts at D e n v er 
H e alt h ( D H) , a n ur b a n i nt e gr at e d s af et y net h e alt h c ar e s yst e m t h at pr e d o mi n a ntl y c ar es f or a di v ers e 
p o p ul ati o n of l o w -i nc o m e, dis a d v a nt a g e d  p ati e nts , h a v e d e m o nstr at e d p ati e nt e n g a g e m e nt wit h r e p orti n g 
P G H D  t o t h e h e alt h c ar e s yst e m b y t e xt m ess a g e (7 7 -7 9 ), a n d h a v e s h o w n i mpr o v e m e nts i n w ei g ht l oss 
o utc o m es  a m o n g p ati e nts p arti ci p ati n g i n a t e xt -m ess a g e b as e d i nt er v e nti o n ali g n e d wit h t h e C e nt ers f or 
Dis e as e C o ntr ol a n d Pr e v e nti o n’s ( C D C) e vi d e nc e -b as e d Di a b et es Pr e v e nti o n Pr o gr a m  (7 8 , 8 0 ).  A d diti o n al 
fi n di n gs a m o n g D H p ati e nts (81 ) i n di c at e a si g nific a nt, p ositi v e ass o ci a ti o n b et w e e n I T-b as e d h e alt h 
i nf or m ati o n s e e ki n g a n d g e n er al h e alt h st at us (6 6 , 6 7 , 81 ) a n d wi d es pr e a d i nt er est i n usi n g h e alt h I T t o o bt ai n 
i nf or m ati o n a b o ut f o o d, n utriti o n, a n d di et ( 7 9 % of r es p o n d e nts) a n d e x ercis e a n d p h ysi c al acti vit y ( 7 2 % of 
r es p o n d e nts). T h es e r es ults mirr or n ati o n wi d e fi n di n gs (8 2 ). M or e o v er, f or i nf or m ati o n a n d c o m m u ni c ati o n 
t ec h n ol o gi es (I C T) s u c h as c o m p ut ers a n d c ell p h o n es , us e  a m o n g D H p ati e nts w as si mil ar t o us e r e p ort e d b ot h 
n ati o n wi d e a n d i n ot h er dis a d v a nt a g e d p o p ul ati o ns (81 , 8 3 -8 8 ). T his off ers si g nific a nt p ot e nti al f or h e alt h 
i nt er v e nti o ns t h at ar e a g o o d fit wit h p ati e nts’ est a blis h e d h e alt h I T us e p att er ns (81 ) a n d w hi c h utiliz e 
t ec h n ol o gi es t h at h a v e r e ac h e d t h e p oi nt of wi d es pr e a d c o m m erci al a v ail a bilit y. T h es e c o m m erci al off-t h e-s h elf 
C O MI R B # 1 7- 1 0 8 2
Versi o n 1 0/ 1 2/ 2 0 1 6

( C O T S) s ol uti o ns (8 9 )ar e i d e all y s uit e d f or  c oll ect i n g P R Os  a n d P G H D  fr o m p ati e nts d u e t o t h eir hi g h d e gr e e of 
a d o pti o n a n d i nt e gr ati o n i nt o d ail y us e . Th e m ar k et -st a n d ar d l o w er pri c es ass oci at e d wit h wi d es pr e a d 
a d o pti o n als o r e d uc e b arri ers t o ac c ess f or dis a d v a nt a g e d p ati e nts . I n a d diti o n, C O T S t ec h n ol o gi es s u c h as 
s m art p h o n es a n d fit n ess tr ac k ers h a v e t h e p ot e nti al t o s u p p ort t h e c oll ecti o n of p ati e nt c o nt e xt u al d at a t hr o u g h 
c o ns e nt -b as e d p assi v e m et h o ds t h at d o n ot i m p os e an e xc essi v e d at a e ntr y b ur d e n o n p ati e nts.  E x a m pl es of 
s u c h d at a i ncl u d e n ei g h b or h o o d a n d ot h er l o c ati o n-b as e d c h ar act eristics dr a w n fr o m G P S r e a di n gs a n d 
p h ysi c al acti vit y t y p e a n d d ur ati o n i nf or m ati o n b as e d o n ac c el er o m et er r e a di n gs.  
T h e i m p a ct of C O T S t ec h n ol o gi es o n P G H D a n d P R Os c oll ecti o n c a n b e pr e di ct e d b y h e alt h b e h a vi or t h e or y. 
T h e T h e or y of Pl a n n e d B e h a vi or  ( T P B) ( Ajz e n, 1 9 91) d es cri b es h o w a p ers o n’s  b e h a vi or c a n b e pr e di ct e d  b y  t h e 
str e n gt h of t h at p ers o n’s i nt e nti o n t o p erf or m t h e b e h a vi or . I nt e nti o n is i nfl u e nc e d b y t h e p ers o n’s 1) attit u d e  
t o w ar d t h e b e h a vi or, 2) s u bj ecti v e n o r ms , a n d 3) p er c ei v e d b e h a vi or al c o nt r ol  (9 0 ). T h e m or e p ositi v e t h e 
p ers o n’s attit u d e, b eli ef i n n or m ati v e b e h a vi ors, a n d p er c ei v e d b e h a vi or al c o ntr ol, t h e str o n g er t h eir i nt e nti o n, 
a n d t h e m or e li k el y t h e y will ac hi e v e t h e i nt e n d e d b e h a vi or. T h e T ec h n ol o g y A c c e pt a nc e M o d el  ( T A M) ( D a vis, 
1 9 8 9, ori gi n al; V e n k at es h & D a vis, 2 0 0 0, e xt e n d e d) d escri b es h o w T P B c o nstr ucts c a n b e a p pli e d t o pr e di ct I T 
a d o pti o n a n d us e (91 , 9 2 ). T h e  str o n g er t h e i nfl u e nc e of t h e T P B c o nstr u cts, t h e m or e li k el y a p ers o n is t o us e 
a n I T s ol uti o n. C O T S s ol uti o ns ar e m or e li k el y t o b e p er c ei v e d as e as y t o us e a n d ac c e pt e d as e v er y d a y, 
n or m aliz e d t ec h n ol o gi es. T h es e p erc e pti o ns t h e n i nfl u e nc e t h e p ati e nt’s i nt e nti o n t o us e a n d s u bs e q u e ntl y 
i ncr e as e t h e p ati e nt’s li k eli h o o d of p erf or mi n g t h e d esir e d b e h a vi or, i n t his c as e t h e c oll ecti o n a n d r e p orti n g of 
P G H D a n d P R Os. Fi g ur e 2 ill ustr at es t h e a p pli c ati o n of t h e T A M t o t h e pr o visi o n of P G H D a n d P R Os  t hr o u g h 
C O T S h e alt h I T  s ol uti o ns, s h o wi n g t h e t h e oriz e d i m p act. 
1. 5.  
C oll e cti n g P G H D a n d P R O s t h r o u g h pati e nt -c e nt e r e d C O T S h e alt h I T s ol uti o n s al s o 
ali g n s wit h n ati o n al t r e n d s f o r c a r e d eli v e r y a n d l o n g -t e r m g o al s f o r k n o wl e d g e m a n a g e m e nt. 
T h e pl a n pr o p os e d b y t h e Offi c e of t h e N ati o n al C o or di n at or f or H e alt h I T ( ON C ) t o ac hi e v e a n i nt er o p er a bl e 
h e alt h I T i nfr astr u ct ur e (9 3 ) i ncl u d es r ec o m m e n d ati o ns f or e m p o w eri n g p ati e nts  t o i nt e gr at e i nf or m ati o n fr o m 
el ectr o ni c h e alt h r ec or ds ( E H Rs)  i nt o p ers o n al s oft w ar e a p ps a n d di git al h e alt h t o ols, wit h a 1 0-y e ar g o al s et 
f or p ati e nt  m a n a g e m e nt of h e alt h i nf or m ati o n acr oss m ulti pl e pl atf or ms  fr o m t h eir o w n C O T S d e vic es. T h e 
O N C’s pl a n als o c alls  f or bi dir ecti o n al d at a i nt er c h a n g e b et w e e n h e alt h c ar e pr o vi d ers a n d p u blic h e alt h  
s yst e ms, wit h t h e i nt e nti o n of i m pr o vi n g c ar e q u alit y, cli ni c al pr o c ess es, h e alt h o ut c o m es, a n d t h e o v er all 
p u bli c h e alt h  (9 3 ). I nt e gr ati n g P G H D, P R Os, a n d p ati e nt c o nt e xt u al d at a o bt ai n e d fr o m e n g a g e d p ati e nts 
t hr o u g h C O TS h e alt h I T s ol uti o ns i nt o i nt er o p er a bl e s yst e ms w h er e it c a n b e m a d e acti o n a bl e f or us e i n h e alt h 
c ar e dir ectl y s u p p orts t h e O N C’s r ec o m m e n d ati o ns . 
A t pr es e nt, a c hi e vi n g i nt er o p er a bilit y r e m ai ns a c o nsi d er a bl e c h all e n g e. D es pit e eff orts b e g u n u n d er t h e H e alt h 
I nf or m ati o n T ec h n ol o g y f or Ec o n o mi c a n d Cli nic al H e alt h ( HI T E C H) A ct a n d e x p a n d e d u n d er t h e P ati e nt 
Pr o t ecti o n a n d Aff or d a bl e C ar e A ct ( A C A) (6 0 , 9 4 , 9 5 ), h e alt h d at a r e m ai n fr a g m e nt e d acr oss dis p ar at e 
s yst e ms a n d s ol uti o ns.  T h e J A S O N r e p ort  (9 6 , 9 7 ) hi g hli g hts t his l ac k  of i nt e gr ati o n  a n d c alls f or a n 
C O MI R B # 1 7- 1 0 8 2
Versi o n 1 0/ 1 2/ 2 0 1 6

or c h estr at e d arc hit ect ur e b as e d o n o p e n st a n d ar ds as t h e s ol uti o n.  H e alt h L e v el S e v e n I nt er n ati o n al ( H L 7 ) h as 
b e e n ac cr e dit e d b y t h e A m eri c a n N ati o n al St a n d ar ds I nstit ut e ( A N SI) as a n or g a niz ati o n wit h t h e g o al of 
cr e ati n g i nt er o p er a bilit y f or t h e h e alt h c ar e fi el d b y d e v el o pi n g a c o m pr e h e nsi v e fr a m e w or k a n d r el at e d 
st a n d ar ds t o g o v er n t h e e xc h a n g e, i nt e gr ati o n, s h ari n g, a n d r etri e v al of el ectr o nic h e alt h i nf or m ati o n fr o m 
E H Rs a n d ot h er i nf or m ati o n s yst e ms. C urr e ntl y, H L 7 ’s >2, 3 0 0 m e m b ers r e pr es e nt o v er  9 0 % of h e alt h I T 
v e n d ors  (9 8 ). T h e n e w est st a n d ar d fr o m H L 7 is t h e F ast H e alt hc ar e I nt er o p er a bilit y R es o ur c es ( F HI R) 
s p ecifi c ati o n, w hi c h is i nt e n d e d t o p r ovi d e a s et of r es o ur c es t h at will d efi n e  t h e i nf or m ati o n c o nt e nt a n d 
str uct ur e s h ar e d b y t h e m aj orit y of i m pl e m e nt ati o ns  (9 9 ).  F HI R r es o urc es c a n b e r e pr es e nt e d i n t h e wi d el y-
a d o pt e d e Xt e nsi bl e M ar k u p L a n g u a g e ( X M L) a n d J a v a Scri pt O bj ect N ot ati o n ( J S O N) f or m ats, w hic h e ns ur es 
e as e of us e b y h e alt h I T v e n d ors a n d d e v el o p ers. T h e Ar g o n a ut Pr o j ect (1 0 0, 1 01) r e pr es e nts a c o aliti o n of 11 
or g a niz ati o ns, i ncl u di n g E H R v e n d ors ( e. g, E pi c, C er n er ) a n d h e alt h s yst e ms ( e. g., I nt er m o u nt ai n, M a y o 
Cli ni c ) w h o h a v e j oi n e d t o i m pl e m e nt J A S O N-b as e d r ec o m m e n d ati o ns b y ac c el er ati n g t h e a d o pti o n of F HI R as 
a n i nt er o p er a bilit y st a n d ar d.  T h e S u bstit ut a bl e M e di c al A p ps & R e us a bl e T ec h n ol o g y ( S M A R T) Pr o j ect (1 0 2, 
1 0 3) h as a d o pt e d F HI R i n its l at est pl atf or m ar c hit ect ur e r el e as e; S M A R T o n F HI R is a s et of o p e n 
s p ecifi c ati o ns t h at s u p p ort t h e i nt e gr ati o n of m H e alt h s ol uti o ns wit h E H Rs a n d ot h er h e alt h I T s yst e ms (1 0 4).  
It s e e ms cl e ar t hat t h e gr o wi n g a d o pti o n of F HI R as t h e n e xt -g e n er ati o n st a n d ar d will ac c el er at e t h e 
i nt er o p er a bl e e xc h a n g e of d at a b et w e e n C O T S h e alt h I T s ol uti o ns a n d E H Rs. It will b e criti c all y i m p ort a nt t o 
a d dr ess t h e str uct ur e d i ncl usi o n of P G H D, P R Os, a n d p ati e nt c o nt e xt u al d at a i n t h e i nf or m ati o n b ei n g 
e xc h a n g e d.  
M ulti -i nstit uti o n al distri b ut e d d at a r es e ar c h n et w or ks ar e als o  a d dr essi n g t h e c h all e n g es i n h er e nt i n 
est a blis hi n g a n d s ust ai ni n g bi g d at a i nfr astr u ct ur e t o s u p p ort h e alt h r es e ar c h, p u bli c h e alt h s ur v eill a n c e a n d 
h e alt h d at a e xc h a n g e .  B esi d es i nt er o p er a bilit y, t h es e  c h all e n g es i ncl u d e q u esti o ns of g o v e r n a nc e, s ec urit y, 
d at a b as e ar c hit ect ur e, d at a w ar e h o usi n g, a n d m et h o ds f or q u er yi n g  d at a s yst e ms . E x a m pl es of s u c h n et w or ks 
i ncl u d e t h e H e alt h M ai nt e n a nc e Or g a niz ati o n R es e ar c h N et w or k ( H M O R N) (1 0 5); t h e F o o d a n d Dr u g 
A d mi nistr ati o n’s ( F D A) Mi ni -S e nti n el Pr o gr a m  (1 0 6); a n d t h e P ati e nt C e nt er e d O ut c o m es R es e ar c h I nstit ut e’s 
p ati e nt c e nt er e d o utc o m es r es e ar c h cli ni c al r es e ar c h n et w or k ( P C O R n et ), l a u nc h e d i n l at e 2 01 3 wit h t h e 
cr e ati o n of 11 cli nic al d at a r es e ar c h n et w or ks a n d 1 8 p ati e nt -p o w er e d r es e ar c h n et w or ks as c o m p o n e nts of a  
n ati o n al  i nfr astr u ct ur e (1 0 6-1 0 8). P art of P C O R n et’s missi o n is t o i ncl u d e P G H D el e m e nts t o g et h er wit h E H R 
d at a i n t h e n et w or k ar c hit ect ur e.  D oi n g s o est a blis h es a f o u n d ati o n f or i ncl u di n g P R Os a n d p ati e nt c o nt e xt u al  
d at a as ot h er p ati e nt -c e nt er e d  d at a el e m e nts i m p ort a nt t o h e alt h c ar e q u alit y a n d d eli v er y . Cr e ati n g a m o d el 
a n d a s et of r es o urc es  t o s u p p ort t his d at a i nt e gr ati o n will b e of b e n efit t o t his pr o c ess. 
1. 6.  
I n su m m a r y,  t his st u d y will d e m o nstr at e t h e f e asi bilit y of usi n g C O T S h e alt h I T s ol uti o ns t o c oll ect 
P R Os a n d P G H D fr o m l o w -i nc o m e, dis a d v a nt a g e d p ati e nt p o p ul ati o ns t h at ar e of pri orit y i nt er est t o A H R Q.  
T h e P G H D a n d P R Os d at a c oll e ct e d fr o m t h es e p ati e nts will  t h e n b e m a p p e d f or tr a ns missi o n t o cli ni c al 
i nf or m ati o n s yst e ms, i nt e gr ati o n int o cli ni c al w or kfl o ws, a n d us e  b y pr o vi d ers t o i m pr o v e h e alt h c ar e d eli v er y 
a n d q u alit y.  T his w or k c a n h el p circ u m v e nt b arri ers t o h e alt h c ar e ac c ess, i m pr o v e c hr o ni c dis e as e 
m a n a g e m e nt f or dis a d v a nt a g e d p ati e nts, i m pr o v e c o m m u ni c ati o n a n d k n o wl e d g e s h ari n g b et w e e n p ati e nts 
a n d pr o vi d ers, s u p p ort t h e c oll ecti o n a n d i nt e gr ati o n of acti o n a bl e h e alt h d at a  i nt o cli nic al s yst e ms a n d bi g 
d at a i nfr astr u ct ur es , a n d off ers p ot e nti al f or cr e ati n g b ett er h e alt h c ar e i nt er v e nti o ns t h at utiliz e t ec h n ol o g y -
b as e d m e a ns of d eli v er y.  
2.
I N N O V A TI O N
T h e r e s ults of t his st u d y ar e e x p ect e d t o c h all e n g e e xisti n g pr ec o nc e pti o ns a b o ut t h e a bilit y a n d willi n g n ess of 
dis a d v a nt a g e d p ati e nts i n A H R Q’s pri orit y p o p ul ati o ns t o us e t ec h n ol o g y s u c h as s m art p h o n es a n d m o bil e 
d e vi c es t o s h ar e p ati e nt -pr o vi d e d h e alt h  i nf or m ati o n wit h t h eir c ar e pr o vi d ers b et w e e n cli ni c visits.  B y 
d e m o nstr ati n g t h e f e asi bilit y of P G H D a n d P R Os d at a c oll ecti o n t hr o u g h C O T S h e alt h I T s ol uti o ns, t his st u d y 
will s h o w t h e c a p a bilit y of  e n g a g e d p ati e nts fr o m pri orit y p o p ul ati o ns t o acti v el y  p arti ci p at e  i n t h eir o w n 
c hr o ni c dis e as e m a n a g e m e nt.  F urt h er m or e, b y pr o vi di n g a r o a d m a p a n d st a n d ar ds -b as e d s et of r es o ur c es t o 
f acilit at e i nt e gr ati n g P G H D a n d P R Os d at a i nt o a m ultit u d e of cli nic al s yst e ms, t his st u d y will cr e at e a m e a ns t o 
m a k e t h es e  d at a acti o n a bl e f or us e i n i m pr o vi n g h e alt h c ar e q u alit y a n d d eli v er y. If t h e ai ms of t h e st u d y ar e 
ac hi e v e d, t h e r es ults will s u bst a nti all y e x p a n d o pti o ns f or c o n d ucti n g hi g h -q u alit y h e alt h c ar e i nt er v e nti o ns 
wit h  dis a d v a nt a g e d p ati e nts usi n g  h e alt h I T.  
T h e r es e ar c h pr op os e d u n d er t his a w ar d is i n n o v ati v e i n t hr e e w a ys:   
C O MI R B # 1 7- 1 0 8 2
Versi o n 1 0/ 1 2/ 2 0 1 6

2. 1.  
It will i d e ntif y  s p e cifi c n e e d s a n d p r ef e r e n c e s f o r P R O s a n d P G H D d at a c oll e cti o n, al o n g 
wit h f e at u r e s a n d d e si g n el e m e nt s c o m m o n t o C O T S s ol uti o n s  t h at a r e p r ef e r r e d b y 
di s a d v a nt a g e d p ati e nt s a n d t h e p r o vi d e r s w h o c a r e f o r t h e m ( Ai m 1). Asc ert ai ni n g  t h es e f act ors will 
i nf or m h e alt h I T s ol uti o n s el ecti o n, d esi g n, us a bilit y, a n d utilit y f or A H R Q pri orit y p o p ul ati o ns.  T his will 
s u p p ort t h e f ut ur e d e v el o p m e nt of m or e e xt e nsi bl e s ol uti o ns wit h br o a d a p pli c a bilit y ; ai d wit h pri oritizi n g 
P G H D a n d P R O c oll ecti o n b y d at a el e m e nt a n d m e as ur e t y p e; a n d i d e ntif y p ot e nti al c o nfli cts b et w e e n p ati e nts’ 
a n d pr o vi d ers’ i nt er ests a n d r el ati v e p er c e pti o ns of t h e v al u e of P G H D a n d P R Os d at a.  
2. 2.  
It will d e m o n st r at e  t h e f e a si bilit y of c oll e cti n g P G H D a n d P R O s d at a f r o m di s a d v a nt a g e d 
p ati e nt s t h r o u g h C O T S  h e alt h I T s ol uti o n s  ( Ai m 2 ). Usi n g e xt a nt p ati e nt -pr ef err e d C O T S t ec h n ol o gi es 
r at h er t h a n li miti n g p ati e nts t o i nt er acti o n t hr o u g h si n gl e-p ur p os e , hi g h-m ai nt e n a nc e  h e alt h I T s ol uti o ns will 
i ncr e as e e n g a g e m e nt, pr o m ot e a d o pti o n, a n d s u p p ort fl e xi bl e, e x p a n d a bl e o pti o ns f or f ut ur e i nt er v e nti o ns.  
O bt ai ni n g acti o n a bl e P G H D a n d P R Os d at a f or us e b y pr o vi d ers  will i m pr o v e c ar e pl a n ni n g a n d c hr o ni c 
dis e as e m a n a g e m e nt f or a dis a d v a nt a g e d p ati e nt p o p ul ati o n t h at is i n c o nsi d er a bl e n e e d.    
2. 3.  
It will a d d r e s s t h e i nt e g r ati o n of P G H D a n d P R O s d at a  i nt o E H R s  ( Ai m 3). T o m a k e P G H D 
a n d P R O acti o n a bl e f or us e b y pr o vi d ers, t h es e d at a m ust b e m a d e a v ail a bl e wit hi n t h e cli nic al i nf or m ati o n 
s yst e ms t h at pr o vi d ers alr e a d y us e. E xisti n g E H R -b as e d i m p ort m et h o ds f or t h es e d at a h a v e pr o v e n i n eff ecti v e.  
Cr e ati n g a “tr a nsl ati o n” b y m a p pi n g P G H D a n d P R Os d at a el e m e nts t o c o m p ar a bl e o n es i n  e xisti n g cli ni c al 
v o c a b ul ari es will pr o vi d e a t o ol t o s u p p ort d at a i nt e gr ati o n.  Cr e ati n g a F HI R r es o urc e s et w hi c h c a n b e us e d 
f or i m pl e m e nt ati o n wit h m ulti pl e E H Rs a n d cli nic al i nf or m ati o n s yst e ms will i m pr o v e t h e g e n er aliz a bilit y a n d 
us a bilit y of t h e m a p pi n g t o ol.  
3.
A P P R O A C H
T h e o v er all d esi g n p r op os e d f or t his r es e arc h is a s e q u e nti al i nt e gr at e d mi x e d m et h o ds st u d y (1 0 9, 11 0). T h e 
st u d y will c o nsist of t hr e e p h as es, o n e f or e ac h s p ecifi c ai m, e ac h of w hic h i nf or ms a n d s u p p orts t h e n e xt: (1) a 
q u alit ati v e f or m ati v e  p h as e t o r efi n e i nt er v e nti o n d esi g n; ( 2) a r a n d o miz e d c o ntr oll e d tri al t o ass ess t h e 
f e asi bilit y of c oll ecti n g w ei g ht m a n a g e m e nt-r el at e d P G H D a n d P R Os d at a t hr o u g h C O T S h e alt h I T s ol uti o ns ; 
a n d ( 3) t h e cr e ati o n of a d at a m o d el,  o nt ol o g y m a p pi n g t o ol a n d s et of F HI R r es o urc es t o s u p p ort i nt e gr ati o n of 
P G H D a n d P R Os d at a i nt o cli ni c al i nf or m ati o n s yst e ms .  
3. 1.  
S etti n g  
T his st u d y will b e c o n d u ct e d at D e n v er H e alt h ( D H), a n ur b a n i nt e gr at e d s af et y n et h e alt h d eli v er y s yst e m t h at 
s er v es as t h e pri m ar y h e alt h c ar e  s af et y n et f or t h e c it y a n d c o u nt y of D e n v er, C ol or a d o. D H s er v es a n 
esti m at e d o n e i n f o ur D e n v er r esi d e nts, or a p pr o xi m at el y 1 9 0, 0 0 0 i n di vi d u als p er y e ar. Al m ost t w o -t hir ds of 
t h e p ati e nts s e e n ar e m e m b ers of r aci al / et h ni c mi n orit y gr o u ps . T h e m aj orit y o f D H p ati e nts ar e l o w-i nc o m e, 
wit h o v er 7 0 % li vi n g  b e n e at h t h e p o v ert y li n e, a n d o v er 9 5 % li vi n g wit hi n 2 0 0 % of t h e f e d er al p o v ert y l e v el. D H 
i ncl u d es a 5 2 5-b e d ac ut e c ar e h os pit al wit h a n ac a d e mi c L e v el 1 A d ult a n d P e di atri c L e v el II Tr a u m a C e nt er, 
ni n e f e d er all y q u alif i e d c o m m u nit y h e alt h c e nt ers, si xt e e n s c h o ol-b as e d cli ni cs i n t h e D e n v er p u bli c s c h o ol 
s yst e m, a 1 0 0-b e d n o n -m e di c al d et o xific ati o n f acilit y, c orr ecti o n al c ar e s er vi c es f or D e n v er’s j ails, a h e alt h 
m ai nt e n a nc e or g a niz ati o n, t h e 911 m e dic al r es p o ns e s yst e m, a 2 4 -h o ur n urs e li n e, t h e R oc k y M o u nt ai n P ois o n 
a n d Dr u g C e nt er, a n d t h e D e n v er P u bli c H e alt h d e p art m e nt .   
3. 2.  
R e s e a r c h T e a m  
T h e r e s e ar c h t e a m f or t his st u d y is c o m pris e d of a m ulti dis ci pli n ar y gr o u p of i n v esti g at ors wit h e x p ertis e i n 
h e alt h I T, m o bil e a n d di git al h e alt h, h e alt h i nf or m ati cs, distri b ut e d d at a n et w or ks, pri m ar y c ar e, c hr o ni c 
dis e as e m a n a g e m e nt, q u alit ati v e m et h o ds , mi x e d m et h o ds r es e ar c h, h e alt h s er vi c es r es e ar c h, p u bli c h e alt h, 
a n d d eli v er y s yst e m a n d i m pl e m e nt ati o n s ci e nc e. T h e di v ersit y of t his gr o u p r e pr es e nts t h e br o a d 
i nt er disci pli n ar y n at ur e of t e a ms n e e d e d t o a d dr ess tr e at m e nt f or c o m pl e x c hr o ni c c o n diti o ns t hr o u g h h e alt h 
I T s ol uti o ns t h at i n v ol v e h u m a n f act ors a n d i nfr astr u ct ur e c o nsi d er ati o ns f or P G H D a n d P R Os  d at a c o ll ecti o n 
a n d k n o wl e d g e m a n a g e m e nt . T e a m m e m b ers i ncl u d e:  
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Versi o n 1 0/ 1 2/ 2 0 1 6

•
S u s a n L. M o o r e, P h D , M S P H ( P ri n ci p al I n v e sti g at o r).  Dr. M o or e is a h e alt h s er vi c es
r es e ar c h er a n d t h e Assist a nt Dir ect or of t h e C e nt er f or H e alt h S yst e ms R es e ar c h at D H , w h er e s h e h as
b e e n i n v ol v e d  i n r es e arc h pr oj ects c o nc er ni n g t h e us e of h e alt h I T t o i m pr o v e p u bli c h e alt h e m er g e nc y
pr e p ar e d n ess, p ati e nt s af et y, a n d c ar e f or c hr o nic c o n diti o ns.. S h e als o s er v es as t h e m o bil e h e alt h
r es e ar c h c or e l e a d i n t h e A d ult a n d C hil d C o ns orti u m f or O ut c o m es R es e arc h a n d D eli v er y S ci e nc e
( A C C O R D S) at t h e U ni v ersit y of C ol or a d o.  Pri or t o h er r es e ar c h c ar e er, Dr. M o or e w or k e d i n I T f or t e n
y e ars, f oc usi n g pri m aril y o n i m pl e m e nt ati o n a n d s u p p ort f or s oft w ar e s yst e ms a n d t ec h ni c al e d uc ati o n,
tr ai ni n g, a n d e v al u ati o n.  H er o n g oi n g r es e arc h i nt er ests i ncl u d e c o ns u m er h e alt h i nf or m atics, cli nic al
d ecisi o n s u p p ort, t h e a p pli c ati o n of mi x e d m et h o ds t o h e alt h s yst e ms r es e ar c h, a n d t h e us e of m o bil e
h e alt h t ec h n ol o g y t o d eli v er p ati e nt -c e nt er e d c ar e.
•
A rt h u r J . D a vi d s o n, M D, M S P H ( C o-I n v e sti g at o r).   Dr. D a vi ds o n is  t h e Dir ect or of P u bli c
H e alt h I nf or m atics, E pi d e mi ol o g y a n d Pr e p ar e d n ess at D e n v er P u bli c H e alt h, a di visi o n of D H . H e h as
s er v e d o n t w o f e d er al a d vis or y c o m mitt e es, t h e H e alt h I T P olic y C o m mitt e e t o t h e Offic e of t h e N ati o n al
C o or di n at or f or HI T ( O N C) a n d t h e B o ar d of Sci e ntifi c C o u ns el ors f or t h e N ati o n al C e nt er f or P u blic
H e alt h I nf or m atics, a n d as a b o ar d m e m b er f or t h e N ati o n al e H e alt h C oll a b or ati v e. His c urr e nt
r es e ar c h is f o c us e d o n i nt e gr at e d i nf or m ati cs a p pli c ati o ns a n d distri b ut e d d at a n et w or ks t h at s u p p ort
b ot h cli nic al c ar e a n d p u bli c h e alt h i niti ati v es. H e is t h e sit e l e a d o n D H’s c oll a b or ati o n wit h K ais er
P er m a n e nt e of C ol or a d o  t o d e v el o p a cli ni c al d at a r es e ar c h n et w or k f u n d e d b y P C O RI.
•
H e n r y H. Fi s c h e r, M D ( C o -I n v e sti g at o r).  Dr. Fis c h er pr actic es i nt er n al m e di ci n e a n d h as b e e n
t h e Dir ect or of t h e D H Di a b et es C oll a b or ati v e si nc e 2 01 0.  His r es e ar c h i nt er ests i ncl u d e t h e
e x pl or ati o n of  n e w m o d aliti es f or c hr o nic dis e as e m a n a g e m e nt, i ncl u di n g t h e us e of h e alt h I T, t e xt
m ess a gi n g , a n d n urs e-b as e d  al g orit h mi c c ar e. H e c urr e ntl y o v ers e es t h e s yst e m-wi d e o p er ati o n of D H’s
t e xt m ess a gi n g pr o gr a ms f or a p p oi nt m e nt r e mi n d ers, w ei g ht l oss s u p p ort, fl u v ac ci n ati o n, a n d w ell
c hil d visits.
•
A n d r e w  
W. St e el e, M D, M P H, M S c ( C o-I n v e sti g at o r).   Dr. St e el e is  a g e n er al i nt er nist, t h e C hi ef
M e di c al I nf or m ati o n  Offic er at D H , a n d o n e of t h e first b o ar d -c ertifi e d cli nic al i nf or m ati cs
s u bs p eci alists i n t h e n ati o n.  His r es e ar c h i nt er ests i ncl u d e a n e m p h asis o n c ost -eff ecti v e utiliz ati o n of
c o m p ut er t ec h n ol o g y i n t h e cli ni c al ar e n a, t h e us e of p ati e nt -r e p ort e d d at a f or c hr o ni c dis e as e
m a n a g e m e nt, a n d t h e us e of a ut o m at e d cli ni c al d eci si o n s u p p ort t o i m pr o v e p ati e nt s af et y a n d q u alit y
of c ar e.  H e c urr e ntl y o v ers e es t h e E pi c E H R d esi g n a n d i m pl e m e nt ati o n acti viti es f or D H.
F urt h er d et ail o n t h e i n v esti g at ors a n d a d diti o n al r es e ar c h t e a m st aff is i ncl u d e d i n t h e Bi os k etc h es a n d B u d g et 
J ustifi c ati o n s ecti o ns.  
3. 3.  
P r eli mi n a r y St u di e s  
F or t h e l ast si x y e ars, o ur r es e ar c h t e a m h as c oll a b or at e d o n pr oj ects d esi g n e d t o i m pr o v e h e alt h c ar e q u alit y 
a n d d eli v er y f or dis a d v a nt a g e d p o p ul ati o ns t hr o u g h h e alt h I T s ol uti o ns. C o m m o n r es e arc h t h e m es  a m o n g t h e 
pr oj ects d es cri b e d i ncl u d e 1) usi n g q u alit ati v e m et h o ds t o eli cit p ati e nts’ p ers p ecti v es a b o ut e m pl o yi n g s p ecifi c 
f a mili ar t ec h n ol o gi es,  2) cr e ati n g a n d / or e n h a nci n g d at a i nfr astr u ct ur e, a n d 3) p ati e nt -g e n er at e d d at a 
c oll ecti o n t hr o u g h t e xt m essa gi n g .  T h e pr o p os e d w or k will b uil d o n t his f o u n d ati o n b y e n g a gi n g dis a d v a nt a g e d 
p ati e nts i n t h e us e of C O T S h e alt h I T s ol uti o ns t h at ar e m or e a d v a nc e d, f e at ur e-ri c h, a n d s ec ur e t h a n t e xt 
m ess a gi n g  al o n e. It will als o e n h a nc e p ati e nt -r e p ort e d d at a c oll ecti o n b y i ncl u di n g n ot o nl y P G H D b ut als o 
m or e c o m pl e x d at a el e m e nts, s u c h as m ulti -q u esti o n v ali d at e d P R O M i nstr u m e nts  a n d p ati e nt c o nt e xt u al 
d at a, a n d will  d efi n e a r o ut e t o i nt e gr ati n g t h es e dis cr et e d at a el e m e nts i nt o i nt er o p er a bl e E H Rs, cli ni c al 
i nf or mati o n s yst e ms, a n d bi g d at a i nfr astr uct ur es . Bri ef d escri pti o ns of p erti n e nt st u di es ar e i ncl u d e d b el o w.  
3. 3.1.  C h r o nic c a r e a n d p ati e nt r el ati o ns hi p m a n a g e m e nt p r o of of c o n c e pt  (i nt e r n al f u n di n g)(7 7 ). 
T his mi x e d  m et h o ds pr o of of c o nc e pt st u d y i n v ol v e d t h e cr e ati o n of a h e alt h I T s yst e m t o s u p p ort c hr o ni c 
dis e as e  m a n a g e m e nt t hr o u g h bi dir ecti o n al t e xt m ess a gi n g. A d ult p ati e nts wit h di a b et es s elf-r e p ort e d f asti n g 
gl u c os e l e v els  o n a d ai l y b asis i n r es p o ns e t o a t e xt m ess a g e pr o m pt; a n urs e c as e m a n a g er r e ac h e d o ut t o 
f oll o w u p b y p h o n e wit h p ati e nts w h os e gl u c os e l e v els w er e o utsi d e a n ac c e pt e d cli nic al r a n g e. P ati e nts als o 
C O MI R B # 1 7- 1 0 8 2
Versi o n 1 0/ 1 2/ 2 0 1 6

r ec ei v e d t e xt m ess a g e r e mi n d ers of u p c o mi n g a p p oi nt m e nts i n a n u r b a n s af et y n et h e alt h c ar e s yst e m. P ati e nts 
r es p o n d e d t o 6 8 % of pr o m pts a n d r e p ort e d f e eli n g m or e c o n n ect e d t o t h e h e alt h s yst e m.  
3. 3. 2.  E x p a n di n g c o m p a r ati v e eff ecti v e n ess r es e a rc h ( C E R) c a p a bilit y t h r o u g h c o m pl e x p ati e nt r el ati o ns hi p 
m a n a g e m e nt . A H R Q, g r a nt 1 R 2 4 H S 01 9 4 5 3. (7 9 , 111)
T his mi x e d  m et h o ds f e asi bilit y st u d y b uilt o n t h e pr e vi o us pr o of of c o nc e pt t o d e m o nstr at e  t h e us e of a n 
e x p a n d e d h e alt h I T i nfr astr uct ur e f or p ati e nt -r e p ort e d d at a c oll ecti o n a n d s u bs e q u e nt d at a i nt e gr ati o n i nt o a n 
E H R.  A d ult p ati e nts wit h di a b et es us e d a t e xt m ess a g e -b as e d m o bil e h e alt h i nfr astr u ct ur e t o r e p ort f asti n g 
bl o o d gl uc os e l e v els, bl o o d pr ess ur e m e as ur e m e nts, a n d / or st e p c o u nts i n r es p o ns e t o r e g ul arl y -s c h e d ul e d 
pr o m pts.  R e p ort e d v al u es w er e a ut o m ati c all y f or m att e d  i nt o a s elf-r e p ort e d d at a l o g, tr a ns mitt e d t o t h e E H R, 
a n d m a d e a v ail a bl e t o pr o vi d ers t hr o u g h att ac h m e nt  t o t h e p ati e nt’s m e di c al r ec or d as a n i m a g e fil e. 
3. 3. 3.  I nt e g r at e d m o d el of i n di vi d u aliz e d a m b ul at o r y c a r e f o r l o w-i n c o m e c hil d r e n a n d a d ults ( 21st C e nt u r y 
C a r e) . C M MI, H e alt h C a r e I n n o v ati o n A w a r d 1 C1 C M S 3 31 0 6 4 .(11 2, 11 3) 
T his pr o gr a m s o u g ht t o i m pr o v e o utc o m es ass oci at e d wit h t h e Tri pl e Ai m (11 4) t hr o u g h a n i nt e gr at e d a p pr o ac h 
c o m bi ni n g r e vis e d st affi n g m o d els, u p d at e d a p pr o ac h es t o t e a m -b as e d c ar e, a n d t h e us e of h e alt h I T 
i nfr astr u ct ur e t ail or e d t o s u p p ort c ar e m a n a g e m e nt, c o m pl e x d at a r e p orti n g a n d a n al ysis, a n d b et w e e n-visit 
t e xt m ess a g e o utr e ac h i niti ati v es.  As p art of t h e pr oj ect, t h e R E -AI M fr a m e w or k  (11 5) w as us e d t o ass ess ( a) 
pil ot a n d e x p a nsi o n -p h as e pr oc ess a n d h e alt h o ut c o m es f or e ac h of 5 s e p ar at e t e xt m ess a gi n g i n iti ati v es 
t ar g et e d at i m pr o vi n g s er vi c e d eli v er y a n d h e alt h pr o m oti o n, a n d ( b) t h e i m pl e m e nt ati o n a n d a d o pti o n of n e w 
h e alt h I T i nfr astr u ct ur e  t o i m pr o v e c ar e c o or di n ati o n a n d m a n a g e m e nt f or s af et y n et p ati e nts acr oss 8 pri m ar y 
c ar e cli ni c s etti n gs.  
3. 3. 4.  D e v el o pi n g i nf r ast r u ct u r e f o r p ati e nt -c e nt e r e d o ut c o m es r es e a rc h ( P C O R) at D e n v e r H e alt h . A H R Q, 
g r a nt 1 R 2 4 H S 0 2 21 4 3 -01 .(11 6) 
T his pr oj ect cr e at e d m ulti pl e P C O R i nfr astr u ct ur e c o m p o n e nts at D e n v er H e alt h : a r es e ar c h s u p p ort c or e, a 
n e w i n v esti g at or tr ai ni n g pr o gr a m, a c o m m u nit y a d vis or y  p a n e l, a n d t hr e e r es e ar c h pr oj ects.  T h e first r es e ar c h 
pr oj ect  w as a r a n d o miz e d c o ntr oll e d tri al t o e x a mi n e t h e us e of t e xt m ess a gi n g f or w ei g ht l oss  s u p p ort a m o n g 
p ati e nts wit h pr e -di a b et es , w hi c h r es ult e d i n cli ni c all y si g nifi c a nt w ei g ht l oss.  A n ot h er p erti n e nt c o m p o n e nt  of 
t h e o v er all gr a nt-f u n d e d i niti ati v e i n v ol v e d t h e e x p a nsi o n of a n e xisti n g virt u al d at a w ar e h o us e ( V D W) t o 
i nc or p or at e m e nt al h e alt h d at a fr o m t w o p art n eri n g h e alt h f or p u blic h e alt h s ur v eill a nc e a n d P C O R p ur p os es.  
3. 4.  
St u d y  D e si g n a n d M et h o d s 
3. 4.1.  T o ass ess t h e n e e ds a n d p r ef e r e n c es of dis a d v a nt a g e d p ati e nts a n d s af et y n et h e alt h c a r e p r o vi d e rs 
r e g a r di n g t h e us e of h e alt h I T f o r c o m m u nic ati n g P G H D a n d P R O . 
D esi g n.  S e mi -str u ct ur e d i nt er vi e ws wit h p r ovi d ers a n d f o c us gr o u ps wit h p ati e nts will b e c o n d u ct e d  i n 
t h e q u alit ati v e f or m ati v e p h as e of t his p r op os e d st u d y . T h es e s essi o ns will eli cit i n -d e pt h i nf or m ati o n t h at is 
e x p ect e d t o yi el d a ric h c o nt e xt u al u n d erst a n di n g of n e e ds a n d pr ef er e nc es f or C O T S h e alt h I T -b as e d  P G H D 
a n d P R Os r e p orti n g , i ncl u di n g p er c ei v e d s elf-effi c ac y at d oi n g s o a n d a n ass ess m e n t of g a ps i n c urr e nt s yst e ms. 
S etti n gs /  p o p ul ati o ns. Pr o vi d er i nt er vi e w p arti ci p a nts will b e i d e ntifi e d fr o m a m o n g t h e 1, 0 8 7 
cr e d e nti al e d p r ovi d ers e m pl o y e d b y a n d affili at e d wit h D H.  P ati e nt f oc us gr o u p p artici p a nts will b e r ecr uit e d 
fr o m t h e 9 f e d er all y q u alifi e d h e alt h c e nt ers ( F Q H Cs) t h at pr o vi d e pri m ar y c ar e s er vic es t o D H p ati e nts. 
M et h o ds . S e mi -str u ct ur e d p r ot o c ols will b e d e v el o p e d f or us e i n b ot h i nt er vi e ws a n d f oc us gr o u ps. 
Pr o t o c ols will b e t ail or e d t o eli cit f act or d at a t h at c a n b e us e d i n  q u alit ati v e c o m p ar ati v e a n al ysis ( Q C A ). Q C A is 
a c as e -ori e nt e d a p pr o ac h b as e d o n s et t h e or y a n d B o ol e a n al g e br a, a n d us es c o nfi g ur ati o n al m et h o ds t o 
e v al u at e c o m pl e x c a us al r el ati o ns hi ps a n d f act ors d e e m e d n ec ess ar y a n d s uffi ci e nt t o i nfl u e nc e o utc o m es (11 7, 
11 8).  U nli k e r e gr essi o n m o d els, Q C A ass u m es m ulti pl e p at hs l e a d t o i nt e n d e d g o als (“ e q uifi n alit y”), a n d 
e x pli citl y ass ess es  t h e eff ect of c o m bi n ati o ns of f act ors (“ m ulti pl e c o nju nct ur al c a us ati o n”) (11 7-11 9). Q C A h as 
b e e n us e d t o st u d y h e alt h c ar e m o d els a n d pr actic es as w ell as str uct ur es a n d pr o c ess es li n k e d t o w ei g ht l oss 
o utc o m es (11 8-1 2 0).  Q u esti o ns a ntici p at e d t o eli cit Q C A f act or d at a i ncl u d e  i n q uiri es a b o ut us er -pr ef err e d 
C O MI R B # 1 7- 1 0 8 2
Versi o n 1 0/ 1 2/ 2 0 1 6

t ec h n ol o gi es, willi n g n ess a n d a bilit y t o us e t ec h n ol o g y t o s u p p ort w ei g ht l oss, a n d s o ci al a n d b e h a v ori al f act ors 
aff ecti n g b ot h w ei g ht l oss a n d t ec h n ol o g y us e . Pr ot o c ol q u esti o ns will als o b e i nf or m e d b y pr e vi o us fi n di n gs 
fr o m a c o ns u m er h e alt h i nf or m ati cs-f o c us e d s ur v e y of D H p ati e nts (81 ) a n d b y q u alit ati v e e v al u ati o n s 
c o n d uct e d d uri n g t h e pr eli mi n ar y st u di es ( S ecti o n  3. 3 ), a n d will a d dr ess h e alt h I T d esi g n c o nsi d er ati o ns of 
us ef ul n ess, us a bilit y a n d  us er e x p eri e nc e, a n d c ar e pr oc ess i m p act . A dr aft p r ot o c ol is i ncl u d e d as A p p e n di x 1. 
P ur p os ef ul s a m pli n g (1 21) wi ll b e us e d t o e nr oll o v er w ei g ht a n d o b es e a d ult p ati e nts ( B MI 2 5. 0-3 9. 9, 1 8+ 
y e ars ) i n f oc us gr o u ps str atifi e d b y t w o  d o m ai ns: pri m ar y l a n g u a g e ( E n glis h or S p a nis h)  a n d s elf-r e p ort e d 
t ec h n ol o g y us e ( hi g h or l o w). F oc us gr o u ps will b e c o n d u ct e d b y a tr ai n e d f acilit at or i n E n glis h or S p a nis h 
b as e d o n p ati e nts’ pri m ar y l a n g u a g e , wit h t h e assist a nc e of a bili n g u al r es e ar c h assist a nt  tr ai n e d i n q u alit ati v e 
m et h o ds as a n o bs er vi n g n ot e -t a k er. P ati e nts will b e cl assifi e d as t ec h n ol o g y us ers b as e d o n t h eir r es p o ns es at 
e nr oll m e nt t o scr e e ni n g q u esti o ns  a b o ut I T us e t y p e a n d fr e q u e nc y.   I n or d er t o r e ac h s at ur ati o n, d efi n e d as t h e 
p oi nt at w hi c h n o n e w t o pi cs a n d t h e m es e m er g e fr o m disc ussi o n, 2 f o c us gr o u ps will b e c o n d uct e d f or e ac h 
d o m ai n , f or a t ot al of 8 gr o u ps .  Si x t o 8 p ati e nts will b e r ecr uit e d p er  gr o u p, f or a t ot al of 4 8 t o 6 4 p ati e nts.  
Pr o vi d er i nt er vi e w p arti ci p a nts will b e s oli cit e d as  k e y i nf or m a nts  i d e ntifi e d b y t h eir p e ers as t h os e w h o ar e 
li k el y t o b e p artic ul arl y k n o wl e d g e a bl e a b o ut t h e t o pic of i nt er est  (1 21). B ot h p a ti e nt a n d pr o vi d er p arti ci p a nts 
will r ec ei v e a $ 2 5 gift c ar d i nc e nti v e. T w o t o 3  i nt er vi e ws ar e a nti ci p at e d p er F Q H C sit e, f or a t ot al of 1 8 t o 2 7  
i nt er vi e ws.   All f oc us gr o u p a n d i nt er vi e w s essi o ns will b e a u di o r ec or d e d a n d tr a ns cri b e d ; a d diti o n al 
o bs er v ati o ns will b e d oc u m e nt e d t hr o u g h d et ail e d n ot e -t a ki n g. 
D at a A n al ys is.  Tr a ns cri pt a n d n ot e d at a will b e s u bj ect e d t o c o nt e nt a n al ysis.  A list of c o d es will b e 
d e v el o p e d a p ri o ri , wit h a d diti o n al c o d es a d d e d t hr o u g h a h e uristi c a pp r oac h, w hic h s u p p orts t h e 
i nc or p or ati o n of e m er g e nt t o pi cs a n d t h e m es.  D at a will b e i n d e p e n d e ntl y c o d ed i n Atl as.ti b y b ot h t h e f oc us 
gr o u p f acilit at or /i nt er vi e w er a n d t h e o bs er vi n g n ot e -t a k er, wit h i nt err at er r eli a bilit y ass ess e d t hr o u g h t h e 
k a p p a  st atisti c (1 2 2-1 2 4).  Id e ntifi e d p att er ns  will b e i nc or p or at e d i nt o a n o v er all s y nt h esis t h at will b e us e d t o 
i nf or m t h e d e v el o p m e nt of t h e i nt er v e nti o n a n d t o cr e at e s et-t h e or eti c gr o u ps f or Q C A (s e e S p ecifi c Ai m 2) . 
R es ults ar e a nti ci p at e d t o r e v e al c o m m o n aliti es  a b o ut t h e t y p es of t ec h n ol o g y t h at p ati e nts us e; d at a t y p es, 
fr e q u e nci es a n d m et h o ds f or r e p orti n g d at a  as pr ef err e d b y b ot h p ati e nts a n d pr o vi d ers ; a n d c o nt e xt u al f act ors 
t h at aff ect t ec h n ol o g y us e a n d w ei g ht l oss ( ec o n o mi c, e d uc ati o n al, g e o gr a p hic, s o ci al, a n d b e h a vi or al). T h es e 
will b e us e d t o r efi n e t h e list of s p ecifi c P G H D a n d p ati e nt c o nt e xt u al d at a el e m e nts f or p at i e nts t o r e p ort. 
3. 4. 2.  S p ec ific Ai m 2: T o d e m o nst r at e t h e f e asi bilit y of P G H D a n d P R O  c oll ecti o n t h r o u g h C O T S h e alt h I T 
s ol uti o ns t h r o u g h a p ati e nt -c e nt e r e d pil ot i nt e r v e nti o n f o r w ei g ht m a n a g e m e nt a m o n g 
dis a d v a nt a g e d p ati e nts.  
D esi g n.  T his p h as e of t h e st u d y will b e c o n d u ct e d as a r a n d o miz e d c o ntr oll e d tri al ( R C T). 
S etti n gs /  p o p ul ati o ns. I nt er v e nti o n a n d c o ntr ol p ati e nts f or t his tri al will b e r ecr uit e d fr o m a m o n g D H 
o v er w ei g ht a n d o b es e a d ults ( B MI 2 5. 0 -3 9. 9, 1 8 + y e ars) w h o ar e c o nsi d er e d t o b e at m e di u m h e alt h ris k 
ac c or di n g t o a ris k str atifi c ati o n al g orit h m d e v el o p e d b y D H a n d us e d i n its 21st C e nt ur y C ar e m o d el t o t ail or 
c ar e t o p ati e nts acc or di n g t o l e v el of n e e d  (1 2 5, 1 2 6). Ris k s tr atifi c ati o n is b as e d o n a c o m bi n ati o n of cli ni c al 
crit eri a, a p ati e nt’s di a g n ostic s c or e (1 2 7), a n d h e alt h c ar e utiliz ati o n  (1 2 7, 1 2 8).  Pr e vi o us f i n di n gs i n di c at e a n 
ass oci ati o n b et w e e n g o o d g e n er al h e alt h st at us o n t h e C D C’s  H e alt h y D a ys m e as ur e ( H R Q O L - 4) a n d t h e us e of 
h e alt h i nf or m ati o n a m o n g p ati e nts i n t h e m e di u m ris k gr o u p. T his ass o ci ati o n w as a bs e nt a m o n g p ati e nts i n 
t h e l o w er ris k gr o u p a n d t h us m a y i n di c at e a p oi nt i n c hr o ni c dis e as e pr o gr essi o n w h e n h e alt h I T -b as e d 
i nt er v e nti o ns c o ul d p ositi v el y aff ect c hr o nic dis e as e m a n a g e m e nt t hr o u g h p ati e nt e n g a g e m e nt, wit h t h e l o n g-
t er m g o al of d el a y i n g or a v oi d i n g p o or h e alt h o utc o m es  (81 ). 
M et h o ds . R ecr uit e d p artici p a nts will b e r a n d o miz e d t o o n e of t w o ar ms, i nt er v e nti o n or c o ntr ol.  B ot h 
i nt er v e nti o n a n d c o ntr ol gr o u ps will e n g a g e i n a 1 6- w e e k p r ogr a m w h er e t h e y will r ec ei v e  r e g ul ar h e alt h 
pr o m oti o n m ess a gi n g a b o ut ( a) f o o d, n utriti o n, a n d di et; a n d (b ) e x er cis e a n d p h ysi c al acti vit y.  E xisti n g 
c o nt e nt i n t h es e t o pi c ar e as is a v ail a bl e i n a D H t e xt m ess a gi n g li br ar y ali g n e d wit h t h e C e nt ers f or Dis e as e 
C o ntr ol a n d Pr e v e nti o n’s ( C D C) e vi d e nc e -b as e d Di a b et es Pr e v e nti o n Pr o gr a m  (8 0 ), f or w hi c h a pr e vi o us st u d y 
d e m o nstr at e d cli nic al effi c ac y  (11 6). Ad diti o n al m ess a gi n g c o nt e nt  will b e  i nf or m e d b y f oc us gr o u p a n d 
i nt er vi e w fi n di n gs. I nt er v e nti o n p ati e nts will b e as k e d t o tr ac k P G H D el e m e nts r el at e d t o w eig ht m a n a g e m e nt 
t hr o u g h a m o bil e he alt h a p p l o a d e d o n t h eir p h o n es a n d / or t hr o u g h usi n g a fit n ess tr ac k er, d e p e n di n g o n 
p ati e nt pr ef er e nc e, a n d t o s h ar e t h at i nf or m ati o n wit h t h e r es e ar c h t e a m.  If i nt er v e nti o n p ati e nts d o n ot h a v e a 
fit n ess tr ac k er, a l o w-c ost C O T S o pti o n will b e pr o vi d e d f or t h e m. B ot h i O S a n d A n dr oi d p h o n e o pti o ns will b e 
C O MI R B # 1 7- 1 0 8 2
Versi o n 1 0/ 1 2/ 2 0 1 6

s u p p ort e d. T h e a p p will b e s el ec t e d fr o m a li mit e d s et of w ell-est a blis h e d o pti o ns s u c h as L os eIt!, 
M y Fit n ess P al, A p pl e  H e alt h, or G o o gl e Fit. T h e P G H D r e q u est e d  t hr o u g h acti v e tr ac ki n g a n d p ati e nt d at a e ntr y 
will i ncl u d e s elf -m o nit ori n g el e m e nts pr e vi o usl y s h o w n t o b e s u cc essf ul at e nc o ur a gi n g o b esit y -r el at e d 
b e h a vi or al c h a n g e (1 2 9), s u c h as c al ori e i nt a k e, f o o d l o g gi n g, mi n ut es of p h ysi c al acti vit y, a n d w ei g ht. P ati e nt 
c o nt e xt u al d at a r e q u est e d t hr o u g h p assi v e tr ac ki n g m a y i ncl u d e it e ms s u c h as g e o gr a p hic l o c ati o n, sl e e p 
q u alit y, a n d h e art r at e. A n y a d diti o n al  d at a r e q u est e d will b e d et er mi n e d b as e d o n t h e r es ults of Ai m 1 a n d i n 
c o ns ult ati o n wit h t h e r es e ar c h t e a m t o i d e ntif y s oci al, b e h a vi or al, a n d cli nic all y r el e v a nt i nf or m ati o n. B ot h 
i nt er v e nti o n a n d c o ntr ol p ati e nts will b e w ei g h e d o n a cli ni c s c al e a n d as k e d t o c o m pl et e t hr e e P R O Ms pr e - a n d 
p ost -i nt er v e nti o n. T h es e i ncl u d e t h e  s h ort f or m of t h e P ati e nt A cti v ati o n M e as ur e ( P A M -1 3), w hi c h is a 
v ali d at e d P R O M  t h at ass ess es a n i n di vi d u al’s k n o wl e d g e, s kills a n d c o nfi d e nc e i n s elf-m a n a g e m e nt b e h a vi ors 
(3 5 , 3 6 ); t h e H R Q O L -4, w hic h is a v ali d at e d P R O M t h at ass ess es p ati e nts’ o v er all p h ysi c al a n d m e nt al h e alt h 
st at us o v er t h e pri or  3 0 d a ys  (3 7 ); a n d t h e H e alt h y D a ys S y m pt o ms M o d ul e, w hic h is a v ali d at e d P R O M t h at 
ass ess es  p h ysi c al a n d m e nt al h e alt h s y m pt o ms w hi c h m a y h a v e aff ect e d p ati e nts’ li v es o v er t h e pri or 3 0 d a ys  
(3 7 ). I nt er v e nti o n p ati e nts will als o b e as k e d t o c o m pl et e t h e t hr e e P R O Ms o nc e e ac h p er m o nt h o v er t h e 
c o urs e of t h e 1 6 -w e e k i nt er v e nti o n b y e m ail, o nli n e w e b f or m, t e xt m ess a g e , or a p p -b as e d pri v at e m ess a g e . 
O nl y pri v at el y s u b mitt e d P R O M  d at a will b e us e d i n a n al ysis, t o pr ot ect p ati e nt pri v ac y a n d t o a v oi d s o ci al 
d esir a bilit y bi as d u e t o s elf -c ur ati o n b e h a vi ors ass o ci at e d wit h p u bli c r e p orti n g.  O n e P R O M will b e c oll ect e d 
p er w e e k, t o a v oi d o v er b ur d e ni n g p ati e nts w hil e e ns uri n g a m o nt hl y c oll ecti o n of P R O M d at a. T h e f o urt h  w e e k 
will i ncl u d e a si m pl e c h ec k -i n r e q u est, t o m ai nt ai n t h e w e e kl y c o m m u nic ati o n p att er n. P G H D a n d P R O s d at a 
will b e e xtr act e d fr o m s h ar e d s yst e ms, o nli n e f or ms, a n d m ess a g es as a p pr o pri at e a n d pl ac e d i nt o a R E D C a p 
(1 3 0) r es e arc h d at a b as e cr e at e d f or t h e p r oj ect. T h es e d at a will als o b e m a d e a v ail a bl e t o  a n d acti o n a bl e b y  D H 
p r ovi d ers m o nt hl y t hr o u g h m a n u al tr a nsf er t o pr acti c e-st a n d ar d p ati e nt-r e p ort e d d at a  f or ms a n d s u bs e q u e nt 
e ntr y i nt o t h e E H R . As t his is a f e asi bilit y st u d y, a ut o m at e d d at a e xc h a n g e is b e y o n d t h e s c o p e of t his i niti al 
pr oj ect; h o w e v er, t h e pr o d u ct of S p ecifi c Ai m 3 will s u p p ort f ut ur e a ut o m at e d i nt e gr ati o n.  
O ut c o m es a n d m e as ur es . T h e pri m ar y o ut c o m e  of i nt er est  f or t h e R C T is p ati e nt e n g a g e m e nt . T his 
o utc o m e will b e m e as ur e d b y p ati e nt r es p o ns e r at es t o d at a r e q u ests; b y t h e fr e q u e nc y of  u n pr o m pt e d 
m ess a g es s e nt b y p ati e nts t o r es e ar c h p ers o n n el; a n d b y p erf or m a nc e o n t h e P A M -1 3. S ec o n d ar y o ut c o m es 
i ncl u d e w ei g ht l oss a n d p erf or m a nc e o n t h e H R Q O L-4 a n d H e alt h y D a ys S y m pt o ms P R O Ms pr e - a n d p ost -
i nt er v e nti o n. W ei g ht l oss will b e ass ess e d as c h a n g e i n b o d y m ass i n d e x ( B MI) a n d a bs ol ut e p er c e nt w ei g ht . 
D at a A n al ysis .  D es cri pti v e st at isti cs will b e c o m p ut e d f or p arti ci p a nt d e m o gr a p hi c c h ar act eristi cs ( e. g., 
a g e, g e n d er, r ac e / et h nicit y ). Gr o u p diff er e nc es (i nt er v e nti o n vs. c o ntr ol) will b e e v al u at e d t o e ns ur e t h at t h e 
r a n d o m gr o u p assi g n m e nts w er e si mil ar. If st atisti c all y si g nifi c a nt diff er e nc es ( p < 0. 0 5) ar e f o u n d b et w e e n t h e 
gr o u ps f or d e m o gr a p hic or b as eli n e m e as ur es, t h es e will b e c o ntr oll e d f or i n s u bs e q u e nt a n al ys es. L o gisti c  
r e gr essi o n or t h e C hi-s q u ar e t est of p r op orti o ns will b e us e d t o t est diff er e nc es i n r es p o ns e r at es a n d P R O M 
s c or es b et w e e n t h e R C T i nt er v e nti o n a n d c o ntr ol gr o u ps. T h e distri b uti o n of t h e n u m b er of u n pr o m pt e d  
m ess a g es will b e ass ess e d  a n d eit h er a n al yz e d usi n g P oiss o n r e gr essi o n  or  di c h ot o miz e d b as e d o n a cli ni c all y 
r el e v a nt c ut-off a n d a n al yz e d wit h eit h er l o gisti c r e gr essi o n or t h e C hi -s q u ar e t est of Pr o p orti o ns. W ei g ht  l oss 
will b e a n al yz e d usi n g t h e m ost a p p r opri at e a n d p arsi m o ni o us m ulti v ari a bl e r e gr essi o n t ec h ni q u e, b as e d o n t h e 
n at ur e of t h e o ut c o m e v ari a bl e ( e. g., c o nti n u o us, ti m e -v ar yi n g, dic h ot o m o us, et c.). F uzz y -s et Q C A  will b e 
c o n d uct e d t o e x a mi n e t h e i m p act of f act ors i d e ntifi e d t hr o u g h w or k c o n d uct e d u n d er S p ecifi c Ai m 1. 
P o w er .  A t ot al s a m pl e siz e of 2 5 6  p ati e nts is n ec ess ar y t o d et ect a p r op orti o n al diff er e nc e of 2 0 % ( 0. 5 5 
i nt er v e nti o n; 0. 4 0 c o ntr ol) i n t h e pri m ar y o ut c o m e b et w e e n t h e i nt er v e nti o n a n d c o ntr ol gr o u ps wit h 9 0 % 
p o w er ( al p h a = 0. 0 5). A s a m pl e siz e of 1 9 2 p ati e nts w o ul d b e n e e d e d at 8 0 % p o w er.  Gi v e n t h e n at ur e of t his 
f e asi bilit y st u d y, w e will att e m pt t o r ecr uit 3 0 0 p ati e nts f or t h e R C T, b ut will c o nsi d er t h e st u d y a d e q u at el y 
p o w er e d wit h 2 0 0 p ati e nts e nr oll e d (1 0 0 i nter v e nti o n,  1 0 0 c o ntr ol) . T his als o all o ws f or s o m e l oss t o f oll o w -u p .  
3. 4. 3 . S p ecific Ai m 3. T o c r e at e a n o nt ol o g y m a p pi n g a n d s et of i nt e r o p e r a bilit y r es o u rc es w hic h c a n b e us e d 
t o s u p p o rt i nt e g r ati o n of P G H D a n d P R O s i nt o cli nic al i nf o r m ati o n s yst e ms. 
D esi g n.  I n t his p h as e of t h e st u d y, a n e n h a nc e d e ntit y-r el ati o ns hi p ( E E R) d at a m o d el will b e cr e at e d f or 
t h e c o m m o n s et of P G H D  el e m e nts a n d P R O Ms i d e ntifi e d a n d c oll ect e d  i n Ai m 2. K n o wl e d g e r e pr es e nt ati o n 
t ec h ni q u es will b e utiliz e d t o d escri b e t h e m o d el i n o nt ol o gi c al t er ms, a n d c o nc e pts fr o m t h e U M L S 
M et at h es a ur us will b e us e d t o cr e at e a m a p pi n g t o t h e S N O M E D -C T cli nic al v o c a b u l ar y. T h e m o d el will us e d t o 
cr e at e a s et of F HI R r es o ur c es w hic h c a n b e us e d f or f ut ur e i m pl e m e nt ati o n t o f acilit at e i nt er o p er a bl e d at a 
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tr a nsf er b et w e e n F HI R-c o m pli a nt m o bil e h e alt h I T s ol uti o ns,  E H Rs a n d ot h er F HI R -c o m pli a nt cli ni c al 
i nf or m ati o n s yst e ms.  
M et h o d s.  T h e P G H D  el e m e nts a n d P R O Ms  us e d i n Ai m 2 will b e r e vi e w e d f or c o nfir m e d f e asi bilit y a n d 
us e d t o est a blis h a fi n al, f e asi bl e s et list of f e asi bl e d at a el e m e nts t h at ar e p er c ei v e d t o b e v al u a bl e t o p ati e nts 
a n d p r ovi d ers e n g a g e d i n o b esit y -r el at e d c hr o nic dis e as e m a n a g e m e nt.  E ac h d at a el e m e nt will b e d o c u m e nt e d 
as a F HI R r es o ur c e a n d r e pr es e nt e d i n t h e X M L f or m at. A n ass ess m e nt of d at a e xc h a n g e a n d c o m m o n 
t ec h ni c al i nt erf ac e r e q uir e m e nts will b e c o n d u ct e d f or t h e C O T S  s ol uti o ns us e d b y p ati e nts i n Ai m 2  ( e. g., 
M y Fit n ess P al o n i O S a n d  A n dr oi d, i nt e gr at e d wit h a fit n ess tr ac k er a n d / or m o bil e p h o n e as a p assi v e  d at a 
c oll ecti o n s o ur c e). T h e r es ults of t his ass ess m e nt will b e d oc u m e nt e d as a F HI R i nt erf ac e d es cri pti o n a n d 
p r ofil e. R el ati o ns hi ps b et w e e n m o d el el e m e nts will b e p ortr a y e d usi ng c o m m o n k n o wl e d g e r e pr es e nt ati o n 
t ec h ni q u es. A n “i nsi d e-o ut” d esi g n will b e us e d f or t hr e e -p h as e m o d el d e v el o p m e nt, i ncl u di n g cl assifi c ati o n, i n 
w hic h si mil ar d at a el e m e nts ar e gr o u p e d i nt o e ntit y t y p es; i d e ntific ati o n, i n w hi c h t y p es ar e assi g n e d u ni q u e 
i d e ntifi ers; a n d r el ati o ns hi p i d e ntific ati o n. R el ati o ns hi p i d e ntifi c ati o n is a f o ur-p art a p p r oac h t h at i ncl u d es 
s p eci aliz ati o n, i n w hic h t o o -g e n er al t y p es ar e r efi n e d; g e n er aliz ati o n, i n w hi c h t o o -s p ecific t y p es ar e a bstr act e d; 
a g gr e g ati o n, i n w hi c h c o m p os it e o bj ects ar e cr e at e d; a n d ass oci ati o n, i n w hi c h o bj ects fr o m i n d e p e n d e nt t y p es 
ar e li n k e d (1 31, 1 3 2). T h e k n o wl e d g e r e pr es e nt ati o n p r oc ess will i nc or p or at e i nf er e nti al r e as o ni n g a n d t h e 
cr e ati o n of c orr es p o n d e nc e b et w e e n m o d el c o nc e pts ( e ntiti es a n d attri b ut es) a n d t h eir r e al -w orl d a n al o g u es 
(1 3 2, 1 3 3). O nc e t h e m o d el is d e v el o p e d, a f or m al s y nt acti c d es cri pti o n will b e cr e at e d b y m a p pi n g m e a ni n g-
e q ui v al e nt c o nc e pts i n t h e  U M L S M et at h es a ur us t o t h e S N O M E D -C T cli ni c al v o c a b ul ar y (1 3 4-1 3 6).  T his 
d es cri pti o n s er v es as a n o nt ol o g y, utilizi n g G u ari n o’s e x p a nsi o n o n Gr u b er’s d efi niti o n of a n o nt ol o g y as “ a 
s p ecifi c ati o n of a c o nc e pt u aliz ati o n” t o i ncl u d e a l a n g u a g e -d e p e n d e nt s et of r el ati o ns (t h e v oc a b ul a r y-m a p p e d 
m o d el) d efi n e d o n a p arti c ul ar d o m ai n s p ac e (t h e  p ati e nt -r e p ort e d d at a el e m e nts) (1 3 7, 1 3 8). S h o ul d m o d el 
el e m e nts b e d efi n e d t h at h a v e n o dir ect m a p pi n g, t h e cl os est e q ui v al e nt will b e i d e ntifi e d a n d a n u p d at e will b e 
p r op os e d f or t h e n e xt S N O M E D -C T r el e as e.  
R es ul ts.  T h e d et ail e d E E R m o d el s c h e m a, d at a e xc h a n g e a n d i nt erf ac e ass ess m e nt, o nt ol o g y  m a p pi n g , 
a n d c o m pr e h e nsi v e list of U M L S c o nc e pts a n d S N O M E D C T t er ms us e d i n t h e o nt ol o g y m a p pi n g ar e t h e 
e x p ect e d p r od u cts of t his ai m. T h e d at a m o d el  s c h e m a a n d o nt ol o g y m a p pi n g will b e  doc u m e nt e d  as F HI R 
r es o ur c es. T h e t er m “r es o urc e” is us e d t o r ef er t o all e xc h a n g e a bl e c o nt e nt, a n d e ac h F HI R r es o urc e i ncl u d es: 
1) c o m m o n d efi niti o ns a n d r e pr es e nt ati o ns b as e d o n d at a t y p es wit h r e us a bl e p att er ns; 2) a c o m m o n m et a d at a
s et; a n d 3) a h u m a n-re a d a bl e p art t o ai d us er i nt er pr et ati o n. F HI R als o i ncl u d es a n i nt erf ac e d es cri pti o n a n d a 
p r ofil e f or e ac h i m pl e m e nt ati o n. T h e d at a e xc h a n g e a n d i nt erf ac e ass ess m e nt will b e us e d t o cr e at e t h e F HI R 
i nt erf ac e d es cri pti o n a n d pr ofil e. All F HI R r es o urc es cr e at e d will b e  p ac k a g e d as a n e xt e nsi bl e s et w hic h c a n 
s u bs e q u e ntl y b e us e d f or i nt e gr ati o n of P G H D a n d P R Os  i nt o i nt er o p er a bl e E H Rs , cli ni c al i nf or m ati o n 
s yst e ms, a n d bi g d at a i nfr astr u ct ur es.  
3. 5.  
P r oj e ct Ti m eli n e  
T a bl e 1 ill ustr at es t h e pr o p os e d ti m eli n e f or acti viti es u n d er t his a w ar d. 
T a bl e 1 . P r o p o s e d T i m eli n e 
M o nt h  
3  
6  
9  
1 2 
1 5 
1 8 
21  
2 4  
S p e cific  Ai m 1: Q u alit ati v e F or m ati v e  P h as e  
     I R B s u b missi o n a n d a p pr o v al 
     P ati e nt a n d pr o vi d er r e cr uit m e nt a n d e nr oll m e nt  
     F o c us gr o u ps a n d i nt er vi e ws  
     Q u alit ati v e d at a a n al ysis  
S p e cific Ai m 2: R a n d o miz e d C o ntr oll e d Tri al  
     P ati e nt r e cr uit m e nt a n d e nr oll m e nt  
     R C T  c o n d u ct e d , i n c or p or ati n g S A1 r es ults 
     D at a a n al ysis  
S p e cific Ai m 3: D at a M o d el, O nt ol o g y M a p pi n g, F HI R R es o ur c es  
Diss e mi n ati o n: c o nf er e n c es, m a n us cri pt s, r es o ur c e s et s h ari n g 
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3. 6.  
Pl a n  f o r P ri v a c y a n d S e c u rit y P r ot e cti o n s i n t h e D e v el o p m e nt a n d I m pl e m e nt ati o n of 
H e alt h I T S y st e m s  
W hil e  cli ni c al i nf or m ati o n s yst e ms wit hi n h e alt h c ar e or g a niz ati o ns ar e r e q uir e d t o b e HI P A A-c o m pli a nt, t h e 
C O T S h e alt h I T s ol uti o n m ar k et is m or e c o m plic at e d . M a n y s ol uti o ns, es p eci all y o n es t h at f oc us o n w ell n ess 
a n d fit n ess, h a v e n o s p ecifi c r e q uir e m e nt f or d at a e ncr y pti o n, m uc h l ess a d h er e nc e t o HI P A A st a n d ar ds. Gi v e n 
t h e p ot e nti al s e nsiti vit y of c oll ecti n g P G H D a n d P R Os d at a fr o m C O T S h e alt h I T s ol uti o ns to i nf or m f ut ur e 
p ati e nt c ar e p ur p os es , w e i nt e n d t o t h or o u g hl y a d dr ess pri v ac y a n d s ec urit y c o nsi d er ati o ns as p art of t his 
pr oj ect .  W hil e i nstit uti o n al r e vi e w b o ar d pr ot ecti o ns m a y b e s uffi ci e nt t o g o v er n r es e ar c h d at a pr ot ecti o ns, t h e 
i nt e n d e d us e of t h e r es ults of t his pr oj ect t o i nf or m d eli v er y s yst e m i m pl e m e nt ati o n r e q uir es t h at w e a d h er e t o 
st a n d ar ds g o v er ni n g p ati e nt c ar e. T h er ef or e, i n a d diti o n t o t h e r es e arc h t e a m, D H’s l e g al d e p art m e nt, h e alt h 
i nf or m ati o n m a n a g e m e nt t e a m, a n d i nf or m ati o n s ec urit y t e a m will b e e n g a g e d i n t h e pr oc ess. A p p e n di x A 
c o nt ai ns a d et ail e d d escri pti o n of o ur pr o p os e d pl a n.  
3. 7.  
A nti ci p at e d  R e s ult s, Di s s e mi n ati o n, a n d F ut u r e Di r e cti o n s  
W e a n ti ci p at e t h at t h e r es ults of t his w or k will d e m o nstr at e t h e f e asi bilit y of usi n g C O T S h e alt h I T s ol uti o ns t o 
c oll ect P G H D a n d P R Os d at a fr o m dis a d v a nt a g e d p ati e nts.  W e b eli e v e t h at t his h ol ds t h e p ot e nti al t o a d dr ess 
p er c e pti o ns a n d f oll o w -o n h e alt h s yst e m i n e q uiti es c urr e ntl y e xt a nt r e g ar di n g t h e us e of h e alt h I T t o s u p p ort 
dis a d v a nt a g e d p ati e nts o utsi d e pri m ar y c ar e cli nic visits, a n d t h at o ur w or k will f urt h er t h e d e v el o p m e nt a n d 
e xt e nsi o n of b ett er h e alt h I T -b as e d i nt er v e nti o ns a n d c ar e pr o c ess es t o t h es e A H R Q pri orit y p o p ul ati o ns. W e 
als o a nti ci p at e t h at t h e d at a m o d el a n d o nt ol o g y m a p pi n g m a d e a v ail a bl e as a F HI R r es o ur c e s et will h el p 
c o ntri b ut e t o t h e i nt e gr ati o n of P G H D a n d P R Os as acti o n a bl e d at a i n i nt er o p er a bl e E H Rs, cli ni c al i nf or m ati o n 
s yst e ms, a n d bi g d at a i nfr astr u ct ur es.  I n a d diti o n t o pr es e nti n g at h e alt h I T -f o c us e d c o nf ere nc es a n d 
p u blis hi n g m a n uscri pts wit h t h e r es ults of o ur r es e ar c h, a s D H is a p arti ci p a nt i n P C O R n et t hr o u g h t h e 
P O R T A L cli nic al d at a r es e ar c h n et w or k l e d b y K ais er P er m a n e nt e (1 3 9), t his w or k will b e c on d uct e d i n 
ali g n m e nt wit h t h at r es e ar c h e n d e a v or a n d s h ar e d wit h t h at r es e arc h c o ns orti u m t o i nf or m distri b ut e d d at a 
n et w or k  arc hit ect ur e d e v el o p m e nt. T h e  F HI R r es o urc e s et  wil l als o b e m a d e a v ail a bl e t o Pri m e H e alt h , w hi c h is 
a C ol or a d o -b as e d c oll a b or ati v e of 1 2 0 m o bil e a n d di git al h e alt h c o m p a ni es,  a n d t o t h e Hi g h V al u e H e al t h c ar e 
C oll a b or ati v e ( H V H C), w hi c h is a pr o vi d er l e ar ni n g n et w or k of 1 3 h e alt h s yst e ms c o m mitt e d t o i m pr o vi n g 
h e alt h c ar e v al u e t hr o u g h d at a a n d c oll a b or ati o n , of w hi c h D H is a f o u n din g m e m b er  (s e e F aciliti es a n d 
R es o ur c es  f or m or e d et ail o n Pri m e H e alt h a n d t h e H V H C). W e e x p ect t his will h el p pr o m ot e  a d o pti o n a n d 
i nt e gr ati o n i nt o E H Rs a n d h e alt h I T s ol uti o ns b y i n d ustr y p art n ers a n d h e alt h d eli v er y s yst e ms n ati o n wi d e.  
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