BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email
[email protected]
BMJ Open
Nurse-led medicines’ monitoring in care homes study protocol: a process evaluation of the impact and sustainability of the Adverse Drug Reaction (ADRe) Profile for Mental Health Medicines
BMJ Open
Fo
Journal:
Manuscript ID
Protocol
rp
Article Type:
bmjopen-2018-023377
Date Submitted by the Author:
Jordan, Susan; Swansea University, College of Human and Health Sciences Bannner, Timothy; Cardiff University, Welsh School of Pharmacy Gabe-Walters, Marie; Swansea University, College of Human and Health Sciences Mikhail, Jane; Swansea University College of Human and Health Sciences, Round, Jeff; University of Bristol School of Social and Community Medicine Snelgrove, Sherrill; Swansea University, College of Human and Health Sciences Storey, Mel; Swansea University College of Human and Health Sciences Wilson, Douglas; Swansea University Hughes, David; University Wales Swansea, School of Health Science
Keywords:
iew
ev
rr
ee
Complete List of Authors:
04-Apr-2018
Adverse events < THERAPEUTICS, Protocols & guidelines < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, Organisation of health services < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, Quality in health care < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, Adult psychiatry < PSYCHIATRY
ly
on For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
Page 1 of 53
! ! " ( 2
#
$
%
)
*
+& )
%
Fo
, 3 1
4
-#
56
7- 4
:0
%:- #
2
'
-# :
,
4
#
5
'
& )
*
+& )
-4
5
&*
+
'
& )
*
'
'
+:
'
'
!3 (
58 9
& )
' 8
$
*
& )
& )
&6
-;
+- ) +& )
* *
6
-4
+& ) +& )
5
-4
5 5
-4 -4
ly
on
1
-4
-
-4
'
3
+& #
+- )
+& )
'
:
*
*
iew
4- #
+& #
rr
4
& )
*
'
(
- - 0 1 23 " ,"!
& )
#
+ :- #
'
&
'
-#
"
/)
'
'
%!
- - -.
'
ev
:- #
'
ee
4
,
rp
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
5 5
BMJ Open
< < $
9
$
-7
!
+
$
"
9
$
-=
2
$
,
-
3
)
+
$
)
)
9
ee &
9 &
0
9
) 9
$
9
$ 9
9+ 1 9 -
!
)
rr
$
+
$
rp
: 7
(
&
-
(
1
$
Fo
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Page 2 of 53
&$
&) +
0
#
7
-
?:
$
G
BMJ Open
+&
9
) +
9 )
!
4
9
&
>
) 0
)
9
"
)
:
+& )
9 $ $
) *
9+
9
&111
rp
-F!2G
+
8
4
4
9
-F!!G
+
&)
+$
2
G
$
$
+
G)
-4
ly
+$
&
$
9
on
$+
J!
&F
$
)
9
+
)
1
1
+
iew
,
$
ev
>
(
>$ +
0
+ F 3G
;*
ee
# (
"
!
"
4
&111
+
-7
+
2" ,!&
6
$
) 2"A
F!(G
+'
$
$ 4
8
" "&111
1
9
- 6:*'6
,
!
) 6
$ $
$ -F! ! G
1
( 2
&
$
6:*'6 )
"
3
$
Fo
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Page 6 of 53
+
9 &
)
$
+
5) 0
&
( For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
9
Page 7 of 53
# $
&9 $
-4
&
9+
&
$
9 $
2
0 +
-
+
&
&$
$
)
&
"
)
* M ,
9
'
!
(
) )
&
&
0
&
&
&
-F!,G
, 3
!"
1
9
$
F 3G&
>$
&
"
$
&
)
9
-7
$ . 9
5
)
1
&
$ )
1
$
9 &
9+
)9
)
&
$
C
)
1 1
) $ )
1 1 9 )
2
31A $ ) -F"!G 4
,
)
L )
C
$
1
-
-F!3 "1G 7 $
>$
-F
) $
!"
+
$
9
9
"1A $
9
+
$ F" G
1
1 )
) )
)
+ )
9 9+
$
+
&" " G4
+$ )
&
3
-
$ ) 0 @
>
(
-
$
ly
7
"
)
L
!
&
.
on
$
$
0 &
9
iew
ev
&9
)
9
-
2
3
$ 9
+
9
,
+- 4
&
0
9+
0
rr
-:
&
)
+)
!
9+
ee
$
(
6:*'6 )
rp
Fo
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
0
$
2 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
5) -
BMJ Open
=
$ ) 0
-
&F 3& $
( 2
) 0
$
F
-F
C G
0
$
& ! & !,G
) &
,
$
+
3 1
$ )
&
$
+
+
& ! & "" "(G
&
$
)
9+
! "
)
F
+
+G
$
$
F"2G-
0
0$
9
)
#
-F", "3G 4
9
6 @
# &
>
$
ee
$
&
rp
0 $
C
Fo
$$
&
-7
)
!
$
"
)
9
2
+&F"(G
9
F
9
9
-F
$
1
&
K
$ 9 $ 9
)
"
+$
(
$
&$
9
+
&
O
ly
4
!
$
0 +C
O $
)
$ 9
&$
9 9
$
+
on
+$
+
-
-
$
+&
+ 0 +
+ *B&
$
K
$+
$ 0 $
9
0 +
+ 9
+F("G +
&
-@
-@ C
&
9 -F( G
&
1
9
$
0 +
3
&9 &
+$ 9+
&F(!G
$ $
+
-
!
$ &
ly
9
$+
+
+
>
on
& -= +
+
+- @
)
&
9
$
+ $
iew
+
$
) +
9 &
F", "3&( G
,
,
&
$
ev
C
>
&
$-
(
2
9
rr
9
$
+
9
$
9 )
7
)
&) $
ee
$
+ $
3
C
-F & " (G
+)
"
>
rp
$ 9
)
&
$
9
(
)
$
+)
(
"
+)
) 0
"
2
+
-
!
!
5F(1G
Fo
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
9
&F( G
+
+
) + +
$
-F("G ' )
3 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
&
BMJ Open
$
9
0 $
$ 9
-7
&)
C 9
!
@
>
$
+
$
$ &)
)
9
(
9
)
&
"
$ 9
-
)
$
9
+
+$
+
-
2 ,
F"(& (( (,G
3
0
1
-F & "(& ((& 2 G
) 0
Q
D
$
+
$ $ 9
&
+9
0
+$
$ +
0
" (
4 0
2
9
$$
$ 9. +&
$
&$
$
!
C
9
$
&F (G
$ 9
&F2!G
$
4
+
-
F2"G
) +&
-
0 $
1
)
$
F 3G& &
$
9
)
)+ +
-4 $
9 )
9
+
.
$$
&
+
, 3
9
$
ly
L
&
)
>+
) -F 3G 4
$ 9
-F(( (3 21G * C
$
+
-=
on
$ $
)
&
+
$$
+&F2 2 G
$
+ $
&
$
$ +$
3 1
$+
&
9
iew
,
$
ev
0
$
rr
&9
9
+
) $ &F((G
&
(
: '
#
)
)&
2
9:
) F(2 (,G
"
E
E
) 0
(- - , - #
D
ee
$ )
$
$
rp
;
!
) F(3 21G
Fo
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Page 10 of 53
P
$
$ 9 P
1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
Page 11 of 53
$
>
#
$
+9 )
&
) 0 )
9 $
$
$
$ -F2( 22G 4
2
$
-
>$
" (
C $
) 0- 4
>
!
)
9+ $ $
>$
9 &F2,G
+ )
>$
$ @
-
, 3 1
Fo
$
&
&9
(
+ .
2 ,
9
3
$
) +
9
) 0
-F23G 7
) &
&
$
$
-
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
BMJ Open
) 9
,
$
$
) 9 9
! "
$ 9
9
+
&
+
3
+
&)
1
)
$ +
9+
$ -
1
&
$ &
&)
9 9
) 9
9
9
$
"
$
$
- $
,
1
9
$
$
+$
9
&
9+
-7
$
9
-6
&
-
9
9
2
&" G@
$ 9
$
) ) 9
(
$
9
&
-F
&
ly
& !
$
on
+
) 9
&9
iew
$ $
$
9 0) 9
ev
,
, =
&
$
$
)
-7
)
+-F, G
2
(
&
&
$
$ $
(
1
rr
&
"
$
)
ee
) & 9
!
) 0) 9
0 -F, G 7
&
$
9
rp
)
3
$ $
-
$
on
F((& 13
$
1 G 6+
9+ $
$9 )
!
9+
-F 1
$ 9
#&
$
)
&
&
F 1" 1(G
3
9
0
)
+
1- "A-F 11G&
& +
iew
&
$
9
ev
(
,
&F33G 0
F (G- ' )
rr
-F 1 G # )
2
$
+
9
$
$
ee
$
!
$
$
$
&F3,G )
F# -F
,
9
3
>$
&
$ +
G
9
$
-F
$
+
$ +9
!
-F
(
$ + >
2
&>
+
& +$ 9
&
1
9
!
9
9
+
"G $
+&
&9
$
$
> &)
( 2
IH 1
,
9
0
$
-F
-2
1
1 , -F
,G
$
)
$ $
H
$
0
)
2G =
&)
$$
-F 3G :
+
9+
S
9+
ly
>
!
3
(G
> &
-
.
9 -F
$
$ 9
&
9
+& $
#
"
&
on
) 0
-F
& $
3
$
iew
0$
,
&
+
+
&
&
$
)
G
ev
&
"A P+
$
rr
"
1G
&
ee
rp
5F
$
3G
+
$ $
$
1
&F
&
1G :
Fo
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
-4 ) 9+ $
& >
*
T 1-2386
:
" For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
) &
BMJ Open
;& $
9
$
,A
*
9 !
S!!!-3& (! ( " H
3G
$
9
C
0
9+
-
(
0
2 ,
$
-F(1G ' ) $
3
&
$
9
$
&
+
+
Fo
$
$
+
1
$
9
9 -F ,& ! G :
&
$
9
C
+ 4
4
& -4
9
0
)
$
$ $
)
$$ $
&
)
$ 0
+ +
>$
$
>$
$
9
$
+
)
+- = +
) $ .
$$ -F !(G
+&
&
0 +
0 +
+
9
-
) &F 2G
$+
9+
)
*
$
F !"G
3 1
&F ! G
ly
,
)
) 9
+
"
2
&
$
6 9
(
9
on
8 = '
!
+
&
iew
3 1
-' )
ev
,
&
)
&F ! G >$
-F !!G
-7
$
$
&
2
0
9
& &$
(
9
rr
) 0
"
&
+ )
+ 9+ $ 0
$
!
U
ee
9
+
$
rp
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
) 9
&
) )
2 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
+9
BMJ Open
& ) )
$
$
+
-F !2G ' )
$ 9
9
-8
&
&
F G-
4
1
)
$
0
&$
(
-4
2
0
,
+
3
+
$
+
$
$$
+&
) 9
$
"
&
&
-F !,G ' )
&)
$
'
&
1
)
$
;
"
$
+
0
)
$
+
&
0
$
9 $
$
$
9
$ 9
3
2 " "1A
I
F 3G- 4
-
9 *B-F !3G
(
9+
+9
9
+
2
$ 9
$
9 $
$ +
+
&
&
+
)
9
&
ly
!
9 -
$
$
-7
9
iew
$
3
9 $
+
)
&
,
+
&
$
-4
!&" &"(G-
ev
9
$ $
rr
$
&
)
. > $
F 3&
ee
)
2
0
$
9
(
&)
$$ +
$ $
rp
)
!
9
) 9 9 C
9
+ $
$
-=
+
P
L F" "!G&
)
1
,
9
+ L
! "
$
)
Fo
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Page 18 of 53
-
+&
+ 9+ 8 &
-
1
, For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
Page 19 of 53
+ 7
4'=
+#
P:
+ ! "
7
$
4'= 8 9
$$
-F " G 4
$
'&F
1
$
G &F ,G
9
'
'
& $ 9
4
0
&F !G
=
9
$ 9+ $
&$
4'=&F "1G F$ 9
)K
-
111(! F$ 9
%& :
K
1!->
rp
!-
1
K
-1
2
2
-
-
0
1 2-
(
!
-
$ KK)))-)
Fo
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
2 '+ $ KK)))-
K 1 !K 1K >$ -$
1
1 2-
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
1-
BMJ Open
1-
4'= $
$ KK $$ -)
-
K
K9
1 -
! "
9
2
@
1 -
,
1
+ 1 G
)
&'
+-
@
1 !K1"K !G 6
.
58 2
1-
) + :&
Y
#'
-
-
$K
Y
(( F$ 9
&6
$
-
-
- 0K
A 1 A 1 ' A 14 1
) - 1 "-
(
(-
0
&@
2
' $
L
&: #
,
-1
C
=
@
F$ 9
7&
-
=
%& 4
&
+&
#
=
#
-
- 0K$
Y 1, 1 -$
1
2 '/
K
A 1
/
A 1$
+
A
A 1A ,@
7
1
A 1
K (
-:
3 2(1
=
& 1 !$ )
1 (K
-
K? 9
+Y Y?
Y
$
K*$ Y#
K1K
$ ) -'
=
@
# / 1 !K1!K1,G
+ > 1 (514 ! " -
'
K1 G
%(
K Y
Y Y=
3
;
1 (-
9
A 1
$
)
Y Y# Y' Y
$ Y
Y
Y Y#
#
Y'
%
A 1 9
+K=$ )
1
@
Y
1 2-
-# K
-
9
& 7-
-
=
$
F$ 9
@ 4
1
$ KK)))- $
1
?&
""K 1 !K,! (
+& 4
3
$
-2
&6
11 518 ! 2
2
11 51: "" ("- F$ 9
-
YW
,
0- 1
ly
Y Y
1! 21
$
1-
/
-
L
2
#
$
$
on
$
$ KK)))-
1K
+
$
iew
"
)
1!!2 F$ 9
# !
-:
4
=
-1 !1 1
$
ev
"-
-$
$
-1
& : + #& %
1-22!,K - 1 (-
#
-#
1-
+
-
4
2 K.
rr
1 ! ,! (
1
4
4
1 (59
0
& 8 9 :&
%
+
[:
+
#& +0
[
%
*
11 K1"K "G
9
!-
'&
ee
%
1
1-
rp
%
: $$
;
11 K1 K 1G -
?
>
2
3
&4
$
[
(
,
1 "547 1 !1 1 -
+
! "
#
& ' 99
!,- F$ 9 -
&
=$
1 "K 1K (G
#
+
-
:;& 4 0
-:
2
'
- $& ' (
$
,
#
11,-
)
!
"
Fo
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
$
A 1 -$ O
1 ,-
" For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
+
K T 1 (
+
BMJ Open
2-
@
?
-
#
7
+=
$ KK) 9 ! " (
C
+-
/
2 4
1 2-
& :- !
%
3-
7&
9
-
$
; ;#7
$ = K
2
-
,
+
= @
113K
+ %& :
) 0
3
@
$
$
$ ) @
1-
33K9. $13Z!2
1"
-
'
(
$
&
9
%& 8
+
;&
-;
1-
,(K !2
,
?&
-
!-
& $
$
+
=
( F$ 9
B& '
112K
#&
K
$ O
@
+
$
(-
1-
$
K.-
("
9 1
# =
)
G
-
F$ 9
,
+
$
)
$
-4
1 !565 232 ,12-
1 !K1 K 3G
$
2
$
$
K1!K 3G
"
3"
ly
544 (-
@
9 )
+ 1
=
+ >$
$
-7
?& ; 0 :#& 8. 9
- 43 "
1
" F$ 9
1 3-
$$ $
1
.-
on
@
=
1 2-
$
-
1- 11 K $ -!12 F$ 9 -
K
1 1537
%&
) )
1-
K 1G
&
!"3"
9
iew
F$ 9
K
$$ $
- ;
$
-
$
,3 32-
-4 1"
#
1
ev
(
7
$ ;
&
rr
"
7
%
$ 9
3
- 0K
-:
ee
1-
&
1 1 (593
3
!
3
#
-)
rp
-
B& #
=
$ KK)))-
4
$ KK)))-
1 (K1,K 2G
!
K
2 ! ( ,13 (!!" 9! 2 ( ( " ,2(,3 2( " ( 2-$
$
1
! $
9
$
#
&
$
1 !-
- 0K 1 "1!121,!
1
$
!
9
-
) %& 6
2 '
",-
1-
(K9 .-
",
G
2 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
BMJ Open
!
! -
4
+
-1
=
@
!!-
; +*
(
$ KK 1
,
!"-
3
8
%& 6 3
1 (K1 K
G
$ -
K
K 9.
K
>Y
-
1!
K;
/ &
$
& -1
)
%
&' -2
2 ,
" -
:
3
8
9+
%
1
(
1,K%'=: 12 1 ! 1
-$
5 1 "-
!
!
1-
'
Y$
4
/
3
1-
=9.
K
!(-
,
1 (517
#
1
2
L
5 11,-
:
(
-
-
1
"
'&
(
$
"
2
# &
Fo
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Page 28 of 53
$
@ L
11 K1!K 1G W
+
2
1
1- !
*&
(
3
+$
#
Fo
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Page 30 of 53
$ 3
1 (569 321 ,1-
1 (K1"K1"G -
$+
$
*B - 12(
-4 1$ F$ 9
=
@
1
K12K !G
1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
Page 31 of 53
2 -
] $& B- & B
& ;- & #
$ +
!
9& "
"
2!-
9 +
+
( -
1-!
%:& :
9: :
,
8
L
#&
0
- 1 2% 9:
&
,(K
&6
,22 1 2 1! , -
1
F$ 9
1-
]
1
-
@
< 7
B7
=$ 6&
& -!
, -
# 9 %&
& -4
*
$ KK)))-
#
-
$9
- 0K
:B&
8& ; 9
@
1
@
1 2K1 K1(G
9
,'
#
3(2#
&? 1
5( ,1 ,,-
9
$
1 ,-
1 1 1-
-
*
1
3
-#
,(
11,-
-$
5192 "(( -
- 1 "1
=
= 0
&
$
-# +!
#36
:
1- 11 K
!
789>
1
'
(
K 1 (K1(K
- 431 1
1
'
#=
+ '
=
1-
#"
' '
)-
^:
3,"-
-1- 1
2
-:
+ +
9
+
-7 -7
-?
1 "56: (!
3
"
L
1 2K1 K 1G
!
- ^#
1 254: !-
ly
8
,!-
&
% 43 "
@
+ #-
,1-
,
$
,22 1 2 1! ( -
on
8& #
+$
=
1 "K13K !G
B +
, -
&$
$
1 2 1"(1 " F$ 9 ?&
:
2
&
:#" 21 " -
&
[9
]#&
=
23-
, -
0
-;
%;& B
,(K
+
(
,(K
iew
;$
B &%
$$
1-
ev
3
*&
=
'?& C
1 2546 12,-
:#
,
-
(
0
112531 "13 "-
-'
@
("K
-
+
0
+9 )
1-
2
1
9
112K1 K !G
(
1-
$
G
1 1547 !"-
1-
&'
$
"
565 !" ( -
-
rp
1
&
?&
1 "531 !2( ,"-
$
K1"K
$
1 1K12K1,G B%& 4 0
13-
1
- 43 "
$
'
- 113-1(-11
8-
1
@
%7&
@
1,-
7& =
-
$
3
!
#
$ 11111 F$ 9
1- 1 (K.- .
1 1K13K 1G
:&
!
1 1568 33! 11 -
3
Fo
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Page 34 of 53
789:
789B+
# +# - 0K
5 1 2K
K
9
K 1 2121 Y
#Y
Y Y$
Y@
:
-
1-
2 K.
%:& 6
-11(23
0 ?
6&
1
:
546 "2
31! 2",5 %#-
3,
!,-
!
$ 1- 112K 11
2
!3-
,
+ $ %
#
!2K#< - !((
#
:#
$
) $
&
3 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
+
BMJ Open
7
+
9+ )
*
+
!
9+ 9 +-
&
:
$ +
$
) *
+'
+
+
5)
9
"
$
+
(
) 6
$
$ 9
&
-7
)
6
&
$
5
&
&
+)
$ +
+
+
+
-
2
0
,
)
3
:
1
8 )+
-7 :
8
&
7
)
1
@
-?
$
U
\ 4 )
9
U
+
$
$
+
& 7 >
$ .
U
+ % +)
-
* + K$ K ? :
4
;> K $
K
+K
33, * ? 9+ 4-B- B K
: @ +K
U 1 !
$
K
&*
#
-
1 " C
$$
ly
*B& $ ) + $ =7 $ $ 8< $ $ 7 9 $ KK)))- ) >4-B- B @ $ KK)))-)00 $ 7 B @ - 9 $ KK)))-)00 $
&
on
$
! " ( 2
-4
9
:
$
#
% ! " ( 2 , 3 1
&B
iew
-
:
-:
ev
@
&B
rr
3
& ; + N- :
ee
(
-7
0
+
+
"
@
& 6
4
*
!
,
$ %
&\
$
@
- -4
+- 7
=)
2
&
rp
$ 7
=)
Fo
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Page 40 of 53
?
:
8 K 11(K1 K)0 0 6
7
&6 # 0& : K 11(K1 K)0 0
&; -
!1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
& 9
Page 41 of 53
iew
ev
rr
ee
rp
Fo Figure 1. The Medication Chain (Colour) 67x53mm (300 x 300 DPI)
ly
on
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
BMJ Open
iew
ev
rr
ee
rp
Fo Figure 1. The Medication Chain (Mono) 67x53mm (300 x 300 DPI)
ly
on
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Page 42 of 53
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
Page 43 of 53
iew
ev
rr
ee
rp
Fo ly
on
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
Figure 2. Study Flow Diagram (Colour) 75x106mm (300 x 300 DPI)
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
BMJ Open
iew
ev
rr
ee
rp
Fo ly
on
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Page 44 of 53
Figure 2. Study Flow Diagram (Mono) 75x106mm (300 x 300 DPI)
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
Page 45 of 53
iew
ev
rr
ee
rp
Fo ly
on
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
Figure 3. Logic model for ADRe (Colour) 84x114mm (300 x 300 DPI)
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
BMJ Open
iew
ev
rr
ee
rp
Fo ly
on
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Page 46 of 53
Figure 3. Logic model for ADRe (Mono) 84x114mm (300 x 300 DPI)
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
Page 47 of 53
!"# $
%
&'(
)
*
, ./ 0% !"# /
)
*
+
1
+ 3 -
4
1 *
55)))- ) 2-'- ' 6 55)))-)77 / ' 6 2-'- ' 6 5 5
& * 5 5
5 + 3
2 5 *
5 *
4 1
" * 5 99: & 3 4 (; < 7( 4 85 5)717 1
#
0 5 ; - !* 1
85 5)717 1 / $ ( * 55)))-)77 1 1 * 1
1
1
1
( 5
!
* -$
1
iew
ev
rr
ee
rp
Fo ly
on
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
1
BMJ Open
SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents* Section/item
ItemNo Description
Page No
Administrative information Title
1
Descriptive title identifying the study design, 1 population, interventions, and, if applicable, trial acronym
Fo
Trial identifier and registry name. If not yet registered, name of intended registry
2
2b
All items from the World Health Organization Trial Registration Data Set
Trial registration
2a
2
3
Date and version identifier
As registered
Sources and types of financial, material, and other support
39-40
5a
Names, affiliations, and roles of protocol contributors
39
5b
Name and contact information for the trial sponsor
13
5c
Role of study sponsor and funders, if any, in 13; 39 study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication, including whether they will have ultimate authority over any of these activities
5d
Composition, roles, and responsibilities of the coordinating centre, steering committee, endpoint adjudication committee, data management team, and other individuals or groups overseeing the trial, if applicable (see Item 21a for data monitoring committee)
4
Roles and responsibilities
iew
ev
Funding
rr
Protocol version
ee
rp
ly
on
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Page 48 of 53
39-40
Introduction
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
1
Page 49 of 53
6a
Description of research question and justification for undertaking the trial, including summary of relevant studies (published and unpublished) examining benefits and harms for each intervention
4-5
6b
Explanation for choice of comparators
N/A
Objectives
7
Specific objectives or hypotheses
5
Trial design
8
Description of trial design including type of trial (eg, parallel group, crossover, factorial, single group), allocation ratio, and framework (eg, superiority, equivalence, noninferiority, exploratory)
7-11
Background and rationale
Fo
Methods: Participants, interventions, and outcomes
rp
Study setting
9
Description of study settings (eg, community clinic, academic hospital) and list of countries where data will be collected. Reference to where list of study sites can be obtained
6
Eligibility criteria
10
Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centres and individuals who will perform the interventions (eg, surgeons, psychotherapists)
6-7
Interventions
11a
Interventions for each group with sufficient detail 8-9 to allow replication, including how and when they will be administered
11b
Criteria for discontinuing or modifying allocated interventions for a given trial participant (eg, drug dose change in response to harms, participant request, or improving/worsening disease)
11c
Strategies to improve adherence to intervention 10 protocols, and any procedures for monitoring adherence (eg, drug tablet return, laboratory tests)
11d
Relevant concomitant care and interventions that are permitted or prohibited during the trial
iew
ev
rr
ee
N/A
ly
on
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
10-11
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
2
BMJ Open
Outcomes
12
Primary, secondary, and other outcomes, 12 including the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen efficacy and harm outcomes is strongly recommended
Participant timeline
13
Time schedule of enrolment, interventions 8-11 (including any run-ins and washouts), assessments, and visits for participants. A schematic diagram is highly recommended (see Figure)
Sample size
Fo
Recruitment
15
14
Estimated number of participants needed to achieve study objectives and how it was determined, including clinical and statistical assumptions supporting any sample size calculations
7
Strategies for achieving adequate participant enrolment to reach target sample size
7
rr
ee
rp
Methods: Assignment of interventions (for controlled trials) Allocation:
iew
ev
Sequence generation
16a
Method of generating the allocation sequence N/A (eg, computer-generated random numbers), and list of any factors for stratification. To reduce predictability of a random sequence, details of any planned restriction (eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants or assign interventions
Allocation concealment mechanism
16b
Mechanism of implementing the allocation sequence (eg, central telephone; sequentially numbered, opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned
Implementation 16c
ly
on
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Page 50 of 53
N/A
Who will generate the allocation sequence, who N/A will enrol participants, and who will assign participants to interventions
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
3
Page 51 of 53
Blinding (masking)
17a
Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome assessors, data analysts), and how
N/A
17b
If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant’s allocated intervention during the trial
N/A
Methods: Data collection, management, and analysis Data collection methods
18a
Plans for assessment and collection of 10-11 outcome, baseline, and other trial data, including any related processes to promote data quality (eg, duplicate measurements, training of assessors) and a description of study instruments (eg, questionnaires, laboratory tests) along with their reliability and validity, if known. Reference to where data collection forms can be found, if not in the protocol
18b
ee
rp
Fo
Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols
N/A
12-14
ev
rr
Data management
19
Plans for data entry, coding, security, and storage, including any related processes to promote data quality (eg, double data entry; range checks for data values). Reference to where details of data management procedures can be found, if not in the protocol
Statistical methods
20a
Statistical methods for analysing primary and 12 secondary outcomes. Reference to where other details of the statistical analysis plan can be found, if not in the protocol
20b
Methods for any additional analyses (eg, subgroup and adjusted analyses)
20c
Definition of analysis population relating to N/A protocol non-adherence (eg, as randomised analysis), and any statistical methods to handle missing data (eg, multiple imputation)
iew
ly
on
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
N/A
Methods: Monitoring
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
4
BMJ Open
Data monitoring
21a
Composition of data monitoring committee 39-40 (DMC); summary of its role and reporting structure; statement of whether it is independent from the sponsor and competing interests; and reference to where further details about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not needed
21b
Description of any interim analyses and stopping guidelines, including who will have access to these interim results and make the final decision to terminate the trial
N/A
Fo
Harms
22
Plans for collecting, assessing, reporting, and 11 managing solicited and spontaneously reported adverse events and other unintended effects of trial interventions or trial conduct
rp
Auditing
23
Frequency and procedures for auditing trial N/A conduct, if any, and whether the process will be independent from investigators and the sponsor
Ethics and dissemination
rr
ee Research ethics approval
24
Plans for seeking research ethics committee/institutional review board (REC/IRB) approval
Protocol amendments
25
Plans for communicating important protocol modifications (eg, changes to eligibility criteria, outcomes, analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial registries, journals, regulators)
Consent or assent
26a
Who will obtain informed consent or assent from 13 potential trial participants or authorised surrogates, and how (see Item 32)
11-12
26b
Additional consent provisions for collection and N/A use of participant data and biological specimens in ancillary studies, if applicable
Confidentiality
27
How personal information about potential and 13-14 enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial
Declaration of interests
28
Financial and other competing interests for principal investigators for the overall trial and each study site
iew
ev
2, 13
12-13
ly
on
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Page 52 of 53
39-40
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
5
Page 53 of 53
Access to data
29
Statement of who will have access to the final trial dataset, and disclosure of contractual agreements that limit such access for investigators
N/A
Ancillary and post-trial care
30
Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm from trial participation
N/A
Dissemination policy
31a
Plans for investigators and sponsor to N/A communicate trial results to participants, healthcare professionals, the public, and other relevant groups (eg, via publication, reporting in results databases, or other data sharing arrangements), including any publication restrictions
rp
Fo 31b
Authorship eligibility guidelines and any intended use of professional writers
39
31c
Plans, if any, for granting public access to the full protocol, participant-level dataset, and statistical code
N/A
Appendices
ev
rr
ee
Informed consent 32 materials
Model consent form and other related documentation given to participants and authorised surrogates
6, 13
Biological specimens
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in the current trial and for future use in ancillary studies, if applicable
N/A
33
iew
on
*It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013 Explanation & Elaboration for important clarification on the items. Amendments to the protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT Group under the Creative Commons “Attribution-NonCommercial-NoDerivs 3.0 Unported” license.
ly
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
6
BMJ Open
Nurse-led medicines’ monitoring in care homes study protocol: a process evaluation of the impact and sustainability of the Adverse Drug Reaction (ADRe) Profile for Mental Health Medicines
BMJ Open
Fo
Journal:
Manuscript ID
Protocol
rp
Article Type:
bmjopen-2018-023377.R1
Date Submitted by the Author:
Jordan, Susan; Swansea University, College of Human and Health Sciences Bannner, Timothy; Cardiff University, Welsh School of Pharmacy Gabe-Walters, Marie; Swansea University, College of Human and Health Sciences Mikhail, Jane; Swansea University College of Human and Health Sciences, Round, Jeff; University of Bristol School of Social and Community Medicine Snelgrove, Sherrill; Swansea University, College of Human and Health Sciences Storey, Mel; Swansea University College of Human and Health Sciences Wilson, Douglas; Swansea University Hughes, David; University Wales Swansea, School of Health Science
Primary Subject Heading: Secondary Subject Heading:
Pharmacology and therapeutics
Mental health, Nursing, Geriatric medicine, Qualitative research Adverse events < THERAPEUTICS, Protocols & guidelines < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, Organisation of health services < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, Quality in health care < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, Adult psychiatry < PSYCHIATRY
ly
on
Keywords:
iew
ev
rr
ee
Complete List of Authors:
02-Jul-2018
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
Page 1 of 50
1 2 3 4
Nurse-led medicines’ monitoring in care homes study protocol: a process evaluation of the impact and sustainability of the Adverse Drug Reaction (ADRe) Profile for Mental Health Medicines Short title: Nurse-led medicines’ monitoring using the Adverse Drug Reaction (ADRe) Profile
5 6
Corresponding author: Professor Sue Jordan, College of Human and Health Sciences,
7
Swansea University, Swansea SA2 8PP.
[email protected] 01792518541
Fo
8 9
Authors: Jordan S. College of Human and Health Sciences, Swansea University. Swansea.
rp
10
Wales; Banner T. Welsh School of Pharmacy, Cardiff University, Cardiff. Wales; Gabe-
11
Walters M. College of Human and Health Sciences, Swansea University, Swansea. Wales;
12
Mikhail JM. College of Human and Health Sciences, Swansea University, Swansea. Wales;
13
Round J. School of Social and Community Medicine, University of Bristol, Bristol. England;
14
Snelgrove S. College of Human and Health Sciences, Swansea University. Swansea. Wales;
15
Storey M. College of Human and Health Sciences, Swansea University, Swansea. Wales;
16
Wilson DW. College of Human and Health Sciences, Swansea University, Swansea. Wales;
17
Hughes D. College of Human and Health Sciences, Swansea University, Swansea. Wales; for
18
the Medicines’ Management Group
19
Word Count: 5019
21
ly
on
20
iew
ev
rr
ee
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
BMJ Open
1
Abstract
2
Introduction
3
Improved medicines’ management could lead to real and sustainable improvements to the
4
care of older adults. The over-use of mental health medicines has featured in many reports,
5
and insufficient patient monitoring has been identified as an important cause of medicines-
6
related harms. Nurse-led monitoring using the structured Adverse Drug Reaction (ADRe)
7
Profile identifies and addresses the adverse effects of mental health medicines. Our study
8
investigates clinical impact and what is needed to sustain utilisation in routine practice in
9
care homes.
Fo
10
Methods and Analysis
11
This process evaluation will use interviews and observations with the participants of all five
12
homes involved in earlier research, and five newly recruited homes caring for people
13
prescribed mental health medicines. The ADRe Profile is implemented by nurses, within
14
existing resources, to check for signs and symptoms of adverse drug reactions, initiate
15
amelioration, and share findings with pharmacists and prescribers for medication review.
16
Outcome measures are the numbers and nature of problems addressed, and understanding
17
of changes needed to optimise clinical gain and sustain implementation.
18
Data will be collected by 30 observations and 30 semi-structured interviews. Clinical gains
19
will be described and narrated. Interview analysis will be based on the constant comparative
20
method.
21
Ethics and Dissemination
22
Ethical approval was conferred by the NHS Wales Research Ethics Committee (REC). If the
23
ADRe Profile can be sustained in routine practice, it has potential to a) improve the lives of
24
patients e.g. by reducing pain and sedation, and b) assist in early identification of problems
25
caused by ADRs. Therefore, in addition to peer-reviewed publications and conferences, we
26
shall communicate our findings to healthcare professionals, policy makers and sector
27
regulators.
28
Registration: ClinicalTrials.gov NLM Identifier NCT03110471
iew
ev
rr
ee
rp
ly
on
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Page 2 of 50
2 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
Page 3 of 50
1
Key words
2
Adverse drug reactions, patient safety, nursing, long-term care (MeSH checked 14.8.17)
3
Strengths and Limitations of this Study
4 5
•
This intervention is the first simple, low-risk, low-cost, multidisciplinary strategy to check
6
patients comprehensively for potential adverse effects of their medicines and
7
ameliorate any harms identified.
8
•
For the last decade some 5-8% of UK unplanned hospital admissions have been caused by adverse drug reactions (ADRs), most of which were preventable. Our intervention has
9
rp
potential to address this situation, but sustainability needs to be tested.
10 11
Fo
•
The intervention was effective in a pragmatic randomised controlled trial (RCT), but a
ee
12
qualitative exploration of how it embeds into routine care is needed to highlight a) how
13
clinical gains are achieved and b) the barriers to and facilitators of sustained
14
implementation. •
We are working with volunteer care homes in South West Wales and the transferability
ev
15
rr
16
of findings will depend on readers’ interpretations of their practical adequacy, and
17
professionals’ assessment of the importance of using ADRe.
iew
18
ly
on
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
3 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
BMJ Open
1 2 3
Nurse-led medicines’ monitoring in care homes study protocol: a process evaluation of the impact and sustainability of the Adverse Drug Reaction (ADRe) Profile for Mental Health Medicines
4 5
Background
6
The success of the WHO 3rd Global Patient Safety Challenge on Medication Safety will
7
depend on effective strategies to address concerns that “medicines sometimes cause
8
serious harm if taken incorrectly, monitored insufficiently or as the result of errors,
9
accidents or communication problems”.[1] Meeting the challenge of insufficient monitoring
10
will demand innovation and change to current practice. Most adverse drug reactions (ADRs)
11
or side-effects [glossary, supplementary file 1] are due to poor monitoring, not poor
12
prescribing.[2-6]
13
ee
rp
Fo
14
Preventable adverse drug reactions (ADRs) have proved an intractable problem over the last
15
decade, causing 5-8% of unplanned UK hospital admissions,[7-8] costing the NHS £1bn-
16
2.5bn each year.[9] The problem is at least as extensive in developing countries, at ~10% of
17
admissions.[10] Most adverse drug events (ADEs) [glossary, supplementary file 1], adverse
18
drug reactions (ADRs) [glossary, supplementary file 1], and medicines’ mismanagement
19
(including errors by patients and professionals) are preventable,[8, 11] but there are no
20
comprehensive systematic approaches to the problem.
iew
ev
rr
21
on
22
Some 50% of residents in UK care homes [glossary, supplementary file 1] are prescribed
23
mental-health medicines,[12] doses in care homes[13], and primary care[14] are often
24
excessive,4.8-37% of older people with cognitive impairment have ADRs[15], and the
25
proportion of care home residents exposed to inappropriate medications (any) ranges from
26
34% (definition from the Swedish National Board of Health and Welfare) [16] to >50%
27
(definitions based on instruments selected by each study author) [17]. ADRs to mental-
28
health medicines can be life-threatening (e.g. cardiac arrhythmias, cardiac hypo-function),
29
or debilitating (e.g. drug-induced Parkinsonism, ataxia, postural hypotension) or subtle, and
30
mistaken for signs of ageing or underlying pathology. They can be overlooked, leading to
31
behaviour problems, xerostomia, constipation, poor food and/ or fluid intake, tremor,
32
restlessness, sedation, pain, double incontinence or other problems, all causing potential
ly
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Page 4 of 50
4 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
Page 5 of 50
1
loss of comfort and dignity.[18-19] Eighteen percent of 13,699 UK primary care incident
2
reports and 24% of 996 deaths or serious harms recorded 2005-13 were attributed to
3
prescription medicines (any), mainly avoidable ADRs, largely due to inadequate monitoring,
4
communication or decision-making.[20] We suggest this care gap can be closed by
5
formalised structured medicines monitoring.[19, 21-24]
6 7
A consensus is emerging around over-prescribing in care homes,[13-14,16,25-26] and this
8
work is now a priority for Welsh Government. However, there is less agreement regarding
9
the changes needed in routine care[1, 27-29] and reviewers indicate that evidence
Fo
10
supporting single-profession interventions is equivocal.[11, 29-34] The UK Department of
11
Health’s National Dementia Strategy, launched 2009[13], and Medicines and Healthcare
12
products Regulatory Agency (MHRA) recommendations[35] have not reduced antipsychotic
13
prescribing[36], whilst the Adverse Drug Reaction (ADRe) Profile succeeded in a randomised
14
controlled trial.[19] ADRe, formerly WWADR, is available, with further information, on our
15
website: http://www.swansea.ac.uk/adre/ . It has potential to reduce costs,[19] whilst
16
addressing concerns over care quality,[25, 27-28, 37] medicines’ over-use,[14] and the
17
responsibility of those administering medicines to report patients’ changes to prescribers,
18
despite time constraints limiting face-to-face multidisciplinary team meetings.[38]
19
The FDA warning on antipsychotic prescribing was followed by a shift towards increased use
20
of benzodiazepines,[39] and there is no evidence of benefit from long-term antidepressants
21
in older adults,[40] therefore, to ensure a comprehensive approach, ADRe includes all
22
current mental health medicines. When used by nurses, both registered nurses and nursing
23
assistants, ADRe has improved quality of care by addressing physical health issues for all
24
patients monitored and identifying and addressing serious adverse events in ~10% of
25
patients. Examples of previously unsuspected problems that we identified and addressed
26
include: cardiac arrhythmias and severe hypertension,[21] drug-induced Parkinsonism,[23]
27
respiratory tract infections,[41] pain and nausea,[19] chest pain and valproate-induced
28
pancreatitis.[24] No harms have been reported from use of ADRe. We now aim to explore
29
what is needed to optimise clinical gains and sustain implementation of ADRe in routine
30
practice. (Figure 1).
iew
ev
rr
ee
rp
ly
on
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
BMJ Open
5 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
BMJ Open
2
Study design and Methods This evaluation will integrate data from observations and interviews to explore clinical gains
3
and any challenges in delivering the intervention, differences between intentions and
4
delivery, the best way to embed medicines’ monitoring into practice, and relationships
5
between ADRe, clinical contexts and processes and outcomes of care.[42-43]
6 7
Setting We are working with 10 care homes in Abertawe Bro Morgannwg University Health Board
8
(ABMUHB) whose management teams have volunteered to participate. This includes all 5
9
care homes involved in a previous study, who are best placed to report on sustainability [19]
1
Fo
10
and 5 new care homes. ABMUHB is in a region of South West Wales that receives EU
11
convergence funding because GDP is below 75% of the community mean.[44] It serves a
12
population of 525,000 (33,000 aged 75-84, and 13,000 over 85).[45] Care homes are
13
governed by legislation[46] and regularly inspected to ensure they meet pre-specified
14
standards.[47] Regularity of contact between care homes and pharmacists, consultants and
15
GPs varies across South West Wales.
16 17
Participants Inclusion criteria for care homes are: providing residential or nursing care or both to >4
18
service users meeting inclusion criteria (vi) and willing to use ADRe in routine practice. We
19
excluded three homes participating in a previous feasibility study, as they are affiliated to a
20
home is already participating, which would have introduced ties into the data,[23] and
21
homes with