1Danner M, et al. BMJ Open 2020;10:e037575. doi:10.1136/bmjopen-2020-037575

Open access

Making shared decision- making (SDM) a reality: protocol of a large- scale long- term SDM implementation programme at a Northern German University Hospital

Marion Danner ,1 Friedemann Geiger,1,2 Kai Wehkamp,1,2 Jens Ulrich Rueffer,2,3 Christine Kuch,1 Leonie Sundmacher,4 Tove Skjelbakken,5 Anne Rummer,1 Anna Novelli ,4 Marie Debrouwere,1 Fueloep Scheibler,1,2 On behalf of the SHARE TO CARE (S2C) Project Team

To cite: Danner M, Geiger F, Wehkamp K, et al. Making shared decision- making (SDM) a reality: protocol of a large- scale long- term SDM implementation programme at a Northern German University Hospital. BMJ Open 2020;10:e037575. doi:10.1136/bmjopen-2020-037575

► Prepublication history for this paper is available online. To view these files, please visit the journal online (http:// dx. doi. org/ 10. 1136/ bmjopen- 2020- 037575).

Received 10 February 2020Revised 28 June 2020Accepted 21 September 2020

For numbered affiliations see end of article.

Correspondence toDr Marion Danner; marion. danner@ uksh. de

Protocol

© Author(s) (or their employer(s)) 2020. Re- use permitted under CC BY- NC. No commercial re- use. See rights and permissions. Published by BMJ.

ABSTRACTIntroduction Shared decision- making (SDM) is not yet widely used when making decisions in German hospitals. Making SDM a reality is a complex task. It involves training healthcare professionals in SDM communication and enabling patients to actively participate in communication, in addition to providing sound, easy to understand information on treatment alternatives in the form of evidence- based patient decision aids (EbPDAs). This project funded by the German Innovation Fund aims at designing, implementing and evaluating a multicomponent, large- scale and integrative SDM programme—called SHARE TO CARE (S2C)—at all clinical departments of a University Hospital Campus in Northern Germany within a 4- year time period.Methods and analysis S2C tackles the aforementioned components of SDM: (1) training physicians in SDM communication, (2) activating and empowering patients, (3) developing EbPDAs in the most common/relevant diseases and (4) training other healthcare professionals in SDM coaching. S2C is designed together with patients and providers. The physicians’ training programme entails an online and an in situ training module. The decision coach training is based on a similar but less comprehensive approach. The development of online EbPDAs follows the International Patient Decision Aid Standards and includes written, graphical and video- based information. Validated outcomes of SDM implementation are measured in a preintervention and postintervention evaluation design. Process evaluation accompanies programme implementation. Health economic impact of the intervention is investigated using a propensity- score- matched approach based on potentially preference- sensitive hospital decisions.Ethics and dissemination Ethics committee review approval has been obtained from Medical Ethics Committee of the Medical Faculty of the Christian- Albrechts- University Kiel. Project information and results will be disseminated at conferences, on project- hosted websites at University Hospital Medical Center Schleswig Holstein and by S2C as well as in peer- reviewed and professional journals.

INTRODUCTIONShared decision- making (SDM) between healthcare professionals like physicians or nurses and patients is currently not a standard in German hospitals.1 2 SDM has rather been implemented sporadically in individual indi-cations and healthcare settings.3 4 This lack of SDM in routine settings might be due to a range of provider, patient, organisational, economic and contextual factors.1 2 5 On the other hand, German legislation with the Patients’ Rights Act gave SDM a more promi-nent role in German healthcare in 2013.6 The act implies that healthcare professionals and patients follow SDM communication rules. For example, physicians have to compre-hensively inform their patients about rele-vant treatment alternatives (§630e).6 In this context, the law points out that written mate-rial like patient decision aids may support

Strengths and limitations of this study

► This study is the first large- scale long- term imple-mentation of share decision- making (SDM) in an en-tire University Hospital involving all stakeholders in patient care in a multicomponent intervention.

► Due to the size of our target intervention unit, a com-parative study randomising comparable hospitals was neither feasible nor affordable.

► This study aims to detect important SDM implemen-tation barriers and supporting factors in a busy and profit- oriented hospital setting.

► One limitation might be that there are no strong in-centives for healthcare professionals and patients to contribute to the implementation of SDM.

► Another limitation is that no patients were involved in the design of this study.

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Open access

professionals in meeting these legal requirements. While legislation in Germany hence seems to be ready for SDM and supporting instruments such as evidence- based patient decision aids (EbPDAs), stakeholders in daily practice are not yet routinely implementing it.

For SDM to be effective, the patients’ and the health-care providers’ ability and willingness to participate in SDM are crucial.2 7 To make SDM a reality in any health-care setting is an ambitious endeavour and a complex multilevel task.5 It involves training physicians and other healthcare professionals in SDM communication skills as well as encourage patients to actively participate in communication, in addition to providing evidence- based, easy to understand information on treatment alternatives to patients and their physicians.8 To be effective in daily practice, SDM should be codesigned with involved stake-holders to gain acceptance and recognition.3 In addition, it needs an inner (ie, within the institution that wants to do SDM) and an outer (concerning the external condi-tions in which the institution works) settings, in which programme implementation is possible, as defined, for example, by the Consolidated Framework for Implemen-tation Research (CFIR) (see table 1 for this project).9 The Norwegian ‘Decision Aid (DA) Factory’ approach of the University Hospital North Norway, in which researchers and developers of SDM components—so- called ‘knowl-edge producers’—work in close cooperation with the physicians and patients—so- called ‘knowledge users’—inspired implementation processes in this project.10

Individual components of SDM such as SDM training for healthcare professionals, patient activation/empow-erment programmes or decision aids have all been previ-ously tested in specific indications, populations and using different study designs.11–15 Their effectiveness and impact on decision processes have been assessed. For example, according to a recent systematic review of 115 randomised controlled trials (RCTs) with about 35 000 patients alto-gether, the use of only EbPDAs to inform patients in specific indications led to improved health education/literacy, more active participation and value congruent choices, more accurate expectations regarding course of disease and risk perceptions, more treatment satisfac-tion and better adherence to treatment.14 This finding has been reinforced by reviews in other specific popula-tions.16 However, while most of the EbPDAs were previ-ously tested in RCTs, they were often not subsequently used in the settings they were developed in.3 A recent study by Stacey et al3 concluded that ‘To improve subse-quent use, researchers should codesign EbPDAs with end users to ensure fit with clinical practice and develop an implementation plan’. That study surveyed EbPDA devel-opers who reported that the lack of physicians supporting and agreeing with the EbPDAs often hindered successful implementation. Training physicians in SDM in theory and practice has equally demonstrated to be effective, but the certainty of this evidence is low and limited to specific treatment settings.15 17–19 While there may still be a lack of evidence regarding the effectiveness of SDM

on patient- relevant clinical endpoints, there is growing agreement and consensus that SDM is a necessity, a patients’ and a citizen’s right, and an ethical imperative.7

It has also become clear that effectiveness to a large extent will depend on effective implementation strategies and consistent stakeholder involvement.3 5 Hence, given a growing body of evidence supporting the effectiveness of individual SDM interventions, the next step on the ‘continuum of increasing evidence’ according to Camp-bell et al20 21 would be to roll out the combined imple-mentation of SDM interventions on a larger- scale in a long- term implementation study. Few programmes until now have addressed the simultaneous implementation of a range of SDM components at the same time (see eg, Sondergaard et al,22 Steffensen et al23), some are currently ongoing (see eg, Scholl24), but none have yet introduced a multicomponent SDM programme at all departments of a hospital at a time. Therefore, in this publicly funded project, the objective was to design, implement and eval-uate a multicomponent, large- scale and integrative SDM programme—called SHARE TO CARE (S2C)—at the University Hospital Medical Center Schleswig Holstein (UKSH), Campus Kiel, within a 4- year time period—from October 2017 until 30 September 2021. The project is designed and implemented in cooperation between the UKSH, Kiel, Germany and the University Hospital of Northern Norway, Tromsø, Norway.

METHODS AND ANALYSISStudy designThis study implies the large- scale implementation of SDM at the University Hospital Campus Kiel within a 4- year time period based on the S2C intervention programme. It includes comprehensive outcome evaluation with measurement of (1) SDM level in patient–physician interactions based on patients’ and external observers’ perceptions before and after S2C implementation and (2) measuring the impact of the S2C intervention on healthcare use and costs in comparison to a propensity- score- matched comparison population not exposed to S2C. The programme will be accompanied by a process evaluation based on the recommendations of the Medical Research Council Guidance and using the CFIR to guide development and implementation activities.9 25

The term ‘multicomponent’ in the S2C programme refers to four different interventions (components) designed and implemented simultaneously in several clinical departments. This includes (1) SDM training for physicians,17–19 26 (2) SDM qualification as ‘decision coach’ for other healthcare professionals like nurses or physiotherapists,18 27 (3) the Ask Three Questions programme that aims at patient activation and empow-erment and28 29 (4) development of online EbPDAs.14 These components and the respective responsible S2C project teams are depicted in figure 1.

The term ‘large- scale’ means that the programme will sequentially be implemented at the University Hospital

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Open access

Tab

le 1

C

onso

lidat

ed F

ram

ewor

k fo

r Im

ple

men

tatio

n R

esea

rch

(CFI

R),

S2C

pro

ject

- sp

ecifi

c in

form

atio

n fo

r ev

iden

ce- b

ased

dec

isio

n ai

ds

and

SD

M t

rain

ing

for

phy

sici

ans/

trai

ning

pro

gram

me

for

dec

isio

n co

achi

ng fo

r ot

her

heal

thca

re p

rofe

ssio

nals

*

Co

nstr

uct

Eb

PD

As

SD

M t

rain

ing

fo

r p

hysi

cian

s/tr

aini

ng p

rog

ram

me

for

‘dec

isio

n co

achi

ng’

I.Int

erve

ntio

n ch

arac

teris

tics

In

terv

entio

n so

urce

Eb

PD

As

are

dev

elop

ed in

tern

ally

by

the

S2C

tea

m. T

opic

s fo

r ne

w E

bP

DA

s ar

e ge

nera

ted

to

geth

er w

ith t

he p

hysi

cian

s b

ased

on

the

DA

fact

ory

app

roac

h. P

atie

nts

are

invo

lved

ea

rly o

n vi

a ne

eds

asse

ssm

ents

to

info

rm E

bP

DA

dev

elop

men

t. E

vid

ence

syn

thes

es

are

cond

ucte

d b

y w

ell-

know

n b

est-

in c

lass

ext

erna

l con

sulta

nt g

roup

s (E

BS

CO

, US

A

(pro

duc

ers

of t

he D

ynaM

ed p

oint

in c

are

serv

ices

, wel

l- kn

own

to U

KS

H p

hysi

cian

s, a

nd

Kle

ijnen

Sys

tem

atic

Rev

iew

s (K

SR

), U

K).

The

trai

ning

for

phy

sici

ans

was

dev

elop

ed a

nd v

alid

ated

by

mem

ber

s of

the

S2C

tea

m.17

18

26 T

he d

ecis

ion

coac

hing

tra

inin

g is

dev

elop

ed b

y th

e S

2C t

eam

in li

ne w

ith t

he p

hysi

cian

tr

aini

ng a

nd b

ased

on

exis

ting

dec

isio

n co

achi

ng p

rogr

amm

es.27

52 W

ith a

gro

up o

f p

sych

olog

ists

/coa

chin

g sp

ecia

lists

, the

tra

iner

tea

m c

omb

ines

sci

entifi

c an

d p

ract

ical

ex

per

tise

to t

rain

diff

eren

t ty

pes

of h

ealth

care

pro

vid

ers

in S

DM

com

mun

icat

ion/

dec

isio

n co

achi

ng s

kills

.

E

vid

ence

str

engt

h an

d q

ualit

yA

cur

rent

sys

tem

atic

rev

iew

dem

onst

rate

s th

at d

ecis

ion

aid

s im

pro

ve d

ecis

ion

and

in

dic

atio

n q

ualit

y.14

Our

Eb

PD

As

follo

w t

he In

tern

atio

nal P

atie

nt D

ecis

ion

Aid

Sta

ndar

ds

(IPD

AS

)37 3

8 and

pro

vid

e b

alan

ced

and

eas

y to

und

erst

and

info

rmat

ion

on t

he p

ros

and

co

ns o

f tre

atm

ent

alte

rnat

ives

to

pat

ient

s. W

ith t

he P

atie

nts’

Rig

hts

Law

in p

lace

in

Ger

man

y si

nce

2013

, the

S2C

pro

ject

with

its

Eb

PD

As

also

put

s th

e p

atie

nts’

rig

hts

into

p

ract

ice.

The

trai

ning

pro

gram

me

for

phy

sici

ans

was

dev

elop

ed/v

alid

ated

by

Gei

ger

et a

l.17 1

8 26

Th

is p

rogr

amm

e gu

ided

the

dev

elop

men

t of

dec

isio

n co

ach

trai

ning

for

othe

r he

alth

care

p

rofe

ssio

nals

. Fur

ther

evi

den

ce s

upp

orte

d t

he r

efine

men

t an

d a

dap

tatio

n of

the

coa

chin

g p

rogr

amm

e to

mee

t th

e sp

ecifi

c d

eman

ds

in d

ifficu

lt in

dic

atio

ns/t

arge

t p

opul

atio

ns in

a

hosp

ital s

ettin

g.27

52

R

elat

ive

adva

ntag

eTh

e fo

rmat

of o

nlin

e E

bP

DA

s w

ith e

asy

to u

nder

stan

d w

ritte

n/gr

aphi

cal i

nfor

mat

ion,

vid

eos

with

pat

ient

nar

rativ

es, a

nd v

ideo

s w

ith p

hysi

cian

s fr

om t

he U

KS

H e

xpla

inin

g d

isea

se o

r tr

eatm

ent

conc

epts

are

like

ly a

ttra

ctiv

e to

pat

ient

s an

d p

hysi

cian

s. W

hile

phy

sici

ans

are

invo

lved

in d

evel

opm

ent

and

inve

st t

ime

into

it, E

bP

DA

s w

ill fa

cilit

ate

bet

ter

info

rmed

d

ialo

gue

with

pat

ient

s. B

y p

rovi

din

g m

ore

stru

ctur

e to

the

dia

logu

e, E

bP

DA

s ar

e ex

pec

ted

to

mak

e co

mm

unic

atio

n m

ore

effic

ient

.48

The

onlin

e S

DM

tra

inin

g is

a r

elat

ivel

y q

uick

and

eas

y- to

- do

trai

ning

pro

gram

me

teac

hing

S

DM

bas

ics

to p

hysi

cian

s. T

he v

ideo

- fee

d- b

ack-

bas

ed t

rain

ing

is h

ighl

y in

div

idua

lised

an

d b

ased

on

r eal

pat

ient

–phy

sici

an c

omm

unic

atio

n al

low

ing

a th

orou

gh S

DM

lear

ning

ex

per

ienc

e. T

he t

rain

ing

for

dec

isio

n co

achi

ng fo

cuse

s on

pro

vid

ing

sup

por

t w

ith E

bP

DA

us

e to

pat

ient

, esp

ecia

lly if

pat

ient

s ar

e em

otio

nally

or

phy

sica

lly n

ot a

ble

to

effe

ctiv

ely

use

Eb

PD

As

with

out

sup

por

t.

A

dap

tab

ility

The

form

at o

f the

Eb

PD

As

follo

ws

a st

and

ard

str

uctu

re. H

owev

er, t

his

stru

ctur

e is

flex

ible

. It

allo

ws

for

top

ic- s

pec

ific

or c

linic

- sp

ecifi

c ad

apta

tions

. Onl

ine

dec

isio

n ai

ds

will

be

adm

inis

tere

d t

o p

atie

nts

via

prin

ted

acc

ess

cod

es t

hat

pat

ient

s re

ceiv

e in

an

enve

lop

e.

Eac

h E

bP

DA

will

con

tain

a p

rinta

ble

sum

mar

y sh

eet

on a

ll re

leva

nt a

spec

ts o

f alte

rnat

ives

(q

uest

ions

and

ans

wer

s sh

eet).

Thi

s p

aper

- bas

ed v

ersi

on c

an b

e us

ed in

com

mun

icat

ion

with

pat

ient

s no

t w

illin

g or

ab

le t

o us

e th

e on

line

Eb

PD

As.

Trai

ning

uni

ts a

re fl

exib

le a

nd a

dap

tab

le t

o sp

ecifi

c d

eman

ds.

The

onl

ine

trai

ning

can

be

easi

ly in

tegr

ated

into

a b

usy

phy

sici

an s

ched

ule.

If p

hysi

cian

s d

o no

t w

ant

to d

o p

erso

nal

trai

ning

in a

gro

up s

ettin

g, it

can

be

don

e w

ith p

hysi

cian

s in

div

idua

lly. I

f hea

lthca

re

pro

vid

ers

are

not

will

ing

to v

ideo

- tap

e in

tera

ctio

ns w

ith t

heir

pat

ient

s, t

rain

ers

may

offe

r p

artic

ipat

ing

obse

rvat

ion

inst

ead

and

rat

e ‘li

ve’ p

atie

nt–p

hysi

cian

inte

ract

ions

. Oth

er

adap

tatio

ns m

ight

be

need

ed t

hrou

ghou

t.

Tr

iala

bili

tyE

ach

clin

ic s

tart

s w

ith o

ne o

r tw

o E

bP

DA

s. If

a c

linic

is in

tere

sted

to

sup

por

t fu

rthe

r to

pic

s,

add

ition

al E

bP

DA

s m

ay b

e d

evel

oped

. If a

clin

ic is

rat

her

unw

illin

g to

sup

por

t th

e p

roje

ct,

no p

ress

ure

will

be

exer

ted

but

the

clin

ic m

ay r

ejoi

n E

bP

DA

dev

elop

men

t at

a la

ter

poi

nt

in t

ime.

Als

o, s

ince

the

clin

ical

dep

artm

ents

are

ap

pro

ache

d in

a s

tep

wis

e ap

pro

ach,

le

arni

ngs

from

one

clin

ic m

ight

be

tran

sfer

red

. Fea

ture

s of

the

Eb

PD

As

may

be

adap

ted

ac

cord

ing

to s

pec

ific

clin

ic o

r p

atie

nt n

eed

s (le

ngth

of t

exts

, num

ber

of fi

lms,

gra

phi

cs,

des

crip

tion

of c

linic

al s

tud

ies,

str

engt

h of

evi

den

ce, e

tc)

It is

not

an

imp

erat

ive

for

UK

SH

sta

ff to

und

ergo

SD

M t

rain

ing

sess

ions

, but

clin

ic d

irect

ors

are

aske

d t

o m

otiv

ate

thei

r st

aff t

o ta

ke p

art

in t

hese

. Als

o, c

linic

dire

ctor

s ar

e as

ked

to

mak

e su

re t

hat

trai

ning

ses

sion

s ca

n b

e d

one

with

in w

orki

ng h

ours

.If

a cl

inic

is u

nwill

ing

to s

upp

ort

the

pro

ject

at

a sp

ecifi

c p

oint

in t

ime

or t

o p

rovi

de

the

time

to t

heir

phy

sici

ans

to u

nder

go t

rain

ing,

no

furt

her

pre

ssur

e w

ill b

e ex

erte

d. I

n se

lect

ed

inst

ance

s (e

g, if

phy

sici

ans

of a

dep

artm

ent

are

und

er e

xtre

me

time

pre

ssur

e), S

DM

tra

inin

g m

ight

rem

ain

limite

d t

o on

line

sess

ions

.

C

omp

lexi

tyP

atie

nts

will

hav

e to

inve

st a

t le

ast

30–6

0 m

in t

o go

thr

ough

one

Eb

PD

A. T

his

mig

ht b

e tir

ing

to s

ome

pat

ient

s. T

he p

atie

nt- f

riend

ly a

nd fl

exib

le fo

rmat

of E

bP

DA

s ad

dre

sses

th

is is

sue

in p

arts

. Ava

ilab

ility

via

the

bed

sid

e—‘In

fota

inm

ent’

-sys

tem

at

UK

SH

and

via

p

orta

ble

tab

lets

will

mak

e ac

cess

to

Eb

PD

As

easy

for

pat

ient

s. P

hysi

cian

s ha

ve t

o in

vest

tim

e fo

r E

bP

DA

s. T

hey

mig

ht n

ot in

itial

ly a

pp

reci

ate

that

Eb

PD

As

can

help

sav

e tim

e in

pat

ient

com

mun

icat

ion.

Als

o, t

he d

epar

tmen

ts/p

hysi

cian

s w

ill h

ave

to in

tegr

ate

the

Eb

PD

As

into

pat

ient

pat

hway

s. T

his

mig

ht n

ot a

lway

s b

e ea

sy in

a b

usy

hosp

ital s

ettin

g an

d m

ake

pat

hway

ad

apta

tions

nec

essa

ry.

Trai

ning

ses

sion

s fo

r p

hysi

cian

s an

d d

ecis

ion

coac

hes

are

time-

cons

umin

g, b

etw

een

1 an

d

2 fu

ll d

ays

for

phy

sici

ans

and

for

thos

e w

ho u

nder

go t

rain

ing

as d

ecis

ion

coac

hes.

Thi

s tim

e ne

eds

to b

e p

rovi

ded

by

clin

ic d

irect

ors

but

it m

ight

stil

l be

diffi

cult

to in

tegr

ate

trai

ning

se

ssio

ns in

to a

bus

y cl

inic

sch

edul

e. H

ealth

care

sta

ff m

ight

ref

use

vid

eota

pin

g th

emse

lves

in

pat

ient

inte

ract

ion

for

vario

us r

easo

ns (e

g, w

orrie

s ab

out

an e

xter

nal r

atin

g of

the

ir p

erfo

rman

ce).

Eve

n fo

r w

ell-

trai

ned

phy

sici

ans

or d

ecis

ion

coac

hes,

it m

ight

som

etim

es

be

diffi

cult

to in

tegr

ate

SD

M a

nd d

ecis

ion

coac

hing

into

inte

ract

ions

/tre

atm

ent

pat

hway

s.

Ad

apta

tions

of t

reat

men

t p

athw

ays

mig

ht b

e ne

eded

.

D

esig

n q

ualit

y an

d p

acka

ging

The

Eb

PD

A is

dev

elop

ed b

y a

high

ly p

rofe

ssio

nal S

2C t

eam

of m

edic

al w

riter

s w

orki

ng

acco

rdin

g to

the

sta

ndar

ds

of e

vid

ence

- bas

ed p

atie

nt in

form

atio

n an

d a

pro

fess

iona

l film

te

am w

ith w

ide

exp

erie

nce

in p

atie

nt fi

lmin

g. E

vid

ence

syn

thes

es a

re d

one

by

bes

t- in

cla

ss

exte

r nal

con

sulta

nts

toge

ther

with

the

S2C

evi

den

ce t

eam

. All

Eb

PD

As

stric

tly a

dhe

re t

o th

e IP

DA

S c

riter

ia.37

38

All

trai

ning

ses

sion

s w

ere

dev

elop

ed a

nd a

re c

ond

ucte

d b

y a

grou

p o

f tra

ined

and

ex

per

ienc

ed p

sych

olog

ists

/coa

ches

.Th

e on

line

trai

ning

was

dev

elop

ed a

nd r

ealis

ed b

y th

e S

2C t

rain

er t

eam

in c

oop

erat

ion

with

the

S2C

film

tea

m. A

ll tr

aini

ng e

valu

atio

ns s

tric

tly a

dhe

re t

o th

e ra

ting

crite

ria o

f the

M

AP

PIN

’SD

M in

stru

men

t18 2

6

Con

tinue

d

on August 6, 2021 by guest. P

rotected by copyright.http://bm

jopen.bmj.com

/B

MJ O

pen: first published as 10.1136/bmjopen-2020-037575 on 10 O

ctober 2020. Dow

nloaded from

4 Danner M, et al. BMJ Open 2020;10:e037575. doi:10.1136/bmjopen-2020-037575

Open access

Co

nstr

uct

Eb

PD

As

SD

M t

rain

ing

fo

r p

hysi

cian

s/tr

aini

ng p

rog

ram

me

for

‘dec

isio

n co

achi

ng’

C

ost

Cos

ts o

f the

inte

rven

tion

and

cos

ts a

ssoc

iate

d w

ith im

ple

men

tatio

n ar

e co

vere

d b

y a

gran

t of

the

Ger

man

Inno

vatio

n Fo

nds

(IF).

The

IF is

hos

ted

at

the

Fed

eral

Joi

nt C

omm

ittee

. O

pp

ortu

nity

cos

ts w

ill o

ccur

sin

ce p

atie

nts

and

phy

sici

ans

have

to

inve

st t

ime

in d

ecis

ion

aid

pro

duc

tion

and

/or

use.

Res

earc

h in

dic

ates

tha

t us

ing

Eb

PD

As

in p

atie

nt–p

hysi

cian

in

tera

ctio

n ca

n m

ake

com

mun

icat

ion

and

dec

isio

ns m

ore

effe

ctiv

e an

d m

ore

effic

ient

.14 4

8

As

for

the

Eb

PD

As,

all

cost

s re

late

d t

o th

e d

evel

opm

ent

of t

rain

ing

sess

ions

are

cov

ered

b

y th

e IF

. Fur

ther

mor

e, p

hysi

cian

s ha

ve t

o in

vest

tim

e in

to t

he d

iffer

ent

trai

ning

ses

sion

s.

Idea

lly, t

hese

can

be

don

e w

ithin

the

ir w

orki

ng h

ours

. Phy

sici

ans

are

rew

ard

ed b

y co

ntin

ued

med

ical

ed

ucat

ion

cred

its b

y th

e G

erm

an M

edic

al A

ssoc

iatio

ns. H

ealth

car

e st

aff

und

ergo

ing

trai

ning

as

dec

isio

n co

ache

s w

ill n

eed

to

inve

st 2

full

day

s.

II. O

uter

set

ting

P

atie

nt n

eed

s an

d r

esou

rces

As

prim

ary

coop

erat

ion

par

tner

in t

he S

2C p

roje

ct, t

he a

dm

inis

trat

ion

of U

KS

H a

ckno

wle

dge

s th

e ne

ed fo

r b

ette

r p

atie

nt p

artic

ipat

ion

and

the

res

ultin

g ne

ed fo

r ch

ange

. Whi

le it

p

uts

no fo

rmal

pre

ssur

e on

its

phy

sici

ans

to c

oop

erat

e in

the

pro

ject

, the

dire

ctor

s of

eac

h d

epar

tmen

t ar

e en

cour

aged

to

pro

vid

e su

pp

ort

by

sign

ing

spec

ific

SD

M g

oal a

ttai

nmen

t co

ntra

cts.

In t

hese

, the

y ag

ree

to h

ave

thei

r st

aff u

nder

go t

rain

ing

sess

ions

with

in w

orki

ng h

ours

and

to

mot

ivat

e th

eir

phy

sici

ans/

othe

r st

aff t

o su

pp

ort

the

S2C

pro

gram

me.

C

osm

o- p

olita

nism

UK

SH

and

the

S2C

pro

ject

tea

m w

ork

in c

lose

coo

per

atio

n w

ith o

ther

(int

er) n

atio

nal p

laye

rs in

the

fiel

d o

f evi

den

ce- b

ased

Med

icin

e an

d S

DM

. Coo

per

atio

n is

initi

ated

or

ongo

ing

with

, for

exa

mp

le, t

he G

erm

an In

stitu

te fo

r Q

ualit

y an

d E

ffici

ency

in H

ealth

Car

e (IQ

WiG

, ges

und

heits

info

rmat

ion.

de)

and

the

evi

den

ce- b

ased

gui

del

ine

dev

elop

ers

with

in t

he G

erm

an

Ass

ocia

tion

of t

he S

cien

tific

Med

ical

Soc

ietie

s (A

WM

F), p

rimar

ily t

ryin

g to

avo

id t

he r

edun

dan

t p

rod

uctio

n of

pat

ient

con

tent

or

evid

ence

rev

iew

s. A

t th

e In

tern

atio

nal l

evel

, UK

SH

and

th

e p

roje

ct t

eam

get

eng

aged

for

exam

ple

, in

the

Inte

rnat

iona

l Sha

red

Dec

isio

n M

akin

g S

ocie

ty.

P

eer

pre

ssur

eTh

is is

the

firs

t fu

ll im

ple

men

tatio

n of

SD

M a

t a

Uni

vers

ity H

osp

ital i

n G

erm

any.

Nev

erth

eles

s S

DM

is b

ecom

ing

incr

easi

ngly

dem

and

ed, t

hat

is, i

t is

on

the

Ger

man

pol

itica

l age

nda.

Fo

r ex

amp

le, t

he A

WM

F es

tab

lishe

d a

com

mitt

ee t

o ad

d E

bP

DA

s to

its

evid

ence

- bas

ed c

linic

al g

uid

elin

es. T

he G

erm

an b

ranc

h of

Cho

osin

g W

isel

y cl

aim

s to

car

ry fo

rwar

d S

DM

. The

N

atio

nal C

ance

r P

lan

and

the

Nat

iona

l Pla

n fo

r H

ealth

Lite

racy

dem

and

for

SD

M. A

lso,

pat

ient

org

anis

atio

ns a

nd t

he G

erm

an In

dep

end

ent

Pat

ient

Cou

ncil

stip

ulat

e S

DM

in h

ealth

care

.

E

xter

nal p

olic

y an

d in

cent

ives

The

obje

ctiv

e of

IF- f

und

ed p

r oje

cts

in G

erm

any

is t

o te

st n

ew fo

rms

of h

ealth

care

pro

visi

on, t

o sc

ale

them

up

and

to

final

ly t

rans

fer

thes

e in

to g

ener

al s

tatu

tory

hea

lth in

sura

nce

fund

ing

(in c

ase

of s

ucce

ssfu

l im

ple

men

tatio

n). T

here

fore

, the

S2C

pro

ject

can

be

cons

ider

ed a

‘lig

htho

use’

pro

ject

, gai

ning

a lo

t of

att

entio

n in

the

med

ia a

lread

y. In

the

con

text

of t

he P

atie

nts’

R

ight

s La

w a

nd w

ith S

DM

bei

ng a

gen

eral

ly a

pp

rove

d c

once

pt

in G

erm

an p

oliti

cs, t

his

pro

ject

aim

s to

ser

ve a

s a

role

mod

el fo

r ot

her

hosp

itals

and

set

tings

. Coo

per

atio

n w

ith o

ther

N

atio

nal p

laye

rs (e

g, A

WM

F, IQ

WiG

, Ger

man

Soc

iety

of E

vid

ence

Bas

ed M

edic

ine,

Ger

man

Soc

iety

for

Hea

lth L

itera

cy) a

ims

to s

upp

ort

this

dev

elop

men

t to

war

ds

mor

e S

DM

- bas

ed

pat

ient

car

e.

III. I

nner

set

ting

S

truc

tura

l cha

ract

eris

tics

The

UK

SH

is a

ter

tiary

car

e ho

spita

l with

27

clin

ical

dep

artm

ents

. Eac

h of

the

se d

epar

tmen

ts a

nd a

ll p

hysi

cian

s w

ill b

e in

volv

ed. S

ince

the

UK

SH

is v

ery

hier

arch

ical

ly s

truc

ture

d, o

ur

app

roac

h is

to

get

dep

artm

ents

invo

lved

in t

he p

roje

ct in

a t

op- d

own

app

r oac

h. C

linic

dire

ctor

s ge

t in

volv

ed fi

rst,

follo

wed

by

the

phy

sici

ans

at t

he n

ext-

low

er le

vels

in t

he h

iera

r chy

. O

ne p

hysi

cian

in e

ach

clin

ic w

ill b

e ch

osen

tog

ethe

r w

ith t

he d

irect

or t

o b

e th

e d

esig

nate

d ‘S

DM

res

pon

sib

le’ w

ho o

vers

ees

activ

ities

in t

he r

esp

ectiv

e cl

inic

(eg,

tra

inin

g ac

tiviti

es,

Eb

PD

A d

evel

opm

ent,

pat

ient

act

ivat

ion

activ

ities

). O

ther

phy

sici

ans

will

be

resp

onsi

ble

for

ind

ivid

ual E

bP

DA

top

ics

and

it is

ass

umed

tha

t ea

rly in

volv

emen

t of

phy

sici

ans

in E

bP

DA

d

evel

opm

ent

will

incr

ease

the

ir ac

cep

tanc

e an

d s

upp

ort.

At

the

sam

e tim

e, t

he U

KS

H E

mp

loye

e C

omm

ittee

and

ind

ivid

ual m

ultip

liers

(‘cl

inic

al c

ham

pio

ns’)

will

be

invo

lved

ear

ly in

the

p

roje

ct.

N

etw

orks

and

com

mun

icat

ions

At

the

leve

l of p

hysi

cian

s, t

he h

iera

r chi

cal s

truc

ture

s ne

ed t

o b

e re

spec

ted

and

tak

en in

to a

ccou

nt. I

f the

dire

ctor

sup

por

ts S

DM

, it

is a

ssum

ed t

o b

e m

ore

likel

y th

at t

he e

ntire

clin

ic

sup

por

ts S

DM

. At

the

pat

ient

leve

l, th

e U

KS

H o

ffers

the

Info

tain

men

t sy

stem

whi

ch c

an b

e us

ed t

o m

ake

Eb

PD

As

avai

lab

le t

o p

atie

nts

at t

he b

edsi

de.

Im

ple

men

tatio

n cl

imat

eO

ur o

bje

ctiv

e in

thi

s p

roje

ct is

not

hing

less

tha

n to

initi

ate

a p

arad

igm

shi

ft t

owar

ds

mor

e S

DM

- bas

ed h

ealth

care

in a

n en

tire

hosp

ital s

ettin

g. W

hile

the

UK

SH

is o

pen

for

chan

ge a

t an

ad

min

istr

ativ

e le

vel,

time

and

eco

nom

ic c

onst

rain

ts m

ight

lim

it th

e p

hysi

cian

s’ w

illin

gnes

s an

d p

erce

ived

lib

erty

to

sup

por

t th

e p

roje

ct. I

mp

lem

enta

tion

clim

ate

will

be

asse

ssed

usi

ng

sum

mat

ive

(Pat

ient

que

stio

nnai

re; M

AP

PIN

’SD

M e

valu

atio

n) a

nd p

roce

ss e

valu

atio

n co

mp

onen

ts (b

ased

on

the

CFI

R c

onst

ruct

s an

d N

PT)

as

des

crib

ed.

R

ead

ines

s fo

r ch

ange

Whi

le t

he U

KS

H is

op

en fo

r ch

ange

at

an a

dm

inis

trat

ive

leve

l, tim

e an

d e

cono

mic

co n

stra

ints

mig

ht li

mit

the

phy

sici

ans’

will

ingn

ess

and

per

ceiv

ed li

ber

ty t

o su

pp

ort

the

pro

ject

.

IV. C

hara

cter

istic

s of

ind

ivid

uals

K

now

led

ge a

nd b

elie

fs a

bou

t th

e in

terv

entio

nP

relim

inar

y re

sear

ch in

dic

ates

tha

t m

any

pat

ient

s in

the

UK

SH

set

ting

mig

ht n

ot y

et b

e re

gula

rly in

volv

ed in

dec

isio

ns, b

ut a

re o

pen

to

mor

e in

form

atio

n an

d m

ore

invo

lvem

ent.

In

div

idua

ls’ a

ttitu

des

tow

ard

the

SD

M in

terv

entio

ns a

nd t

heir

role

in it

will

be

mea

sure

d in

the

pre

–pos

t ev

alua

tion

by

(1)u

sing

a r

ange

of p

atie

nt- b

ased

inst

rum

ents

to

asse

ss p

atie

nt-

phy

sici

an in

tera

ctio

n an

d t

he p

erce

ived

rol

e of

the

pat

ient

bef

ore

and

aft

er t

he in

terv

entio

ns, a

nd (2

) usi

ng t

he M

AP

PIN

’SD

M in

stru

men

t to

get

a r

evie

wer

per

spec

tive

on w

heth

er

inte

rven

tions

/tra

inin

gs in

fluen

ce/im

pro

ve p

atie

nt–p

hysi

cian

inte

ract

ion.

Phy

sici

ans

mig

ht o

ften

rat

her

focu

s on

the

dem

and

s p

lace

d o

n th

em b

y th

e S

2C p

roje

ct t

eam

and

less

on

the

pot

entia

l ad

vant

ages

/tim

e sa

ving

s in

pat

ient

com

mun

icat

ion.

NP

T- b

ased

que

stio

nnai

res/

inte

rvie

ws

to a

sses

s ke

y st

akeh

old

er/p

hysi

cian

per

cep

tions

of t

he in

terv

entio

n th

roug

hout

im

ple

men

tatio

n w

ill b

e us

ed.

V. P

roce

ss

P

lann

ing

The

ind

ivid

ual c

omp

onen

ts o

f the

S2C

pro

gram

me

have

bee

n te

sted

/val

idat

ed p

revi

ousl

y in

oth

er c

onte

xts

and

will

be

imp

lem

ente

d b

y a

team

of i

mp

lem

enta

tion

exp

erts

.

E

ngag

ing

The

S2C

tea

m c

onsi

sts

of fo

ur t

eam

s: t

he e

vid

ence

tea

m, t

he d

ecis

ion

aid

tea

m (w

orki

ng c

lose

ly t

oget

her

on d

ecis

ion

aid

s), t

he t

rain

er t

eam

(phy

sici

an t

rain

ing,

tra

inin

g fo

r ‘d

ecis

ion

coac

hing

’), a

nd t

he im

ple

men

tatio

n te

am (e

ngag

ing

at a

ll le

vels

in im

ple

men

tatio

n- re

late

d a

ctiv

ities

in t

he h

osp

ital,

for

exam

ple

, rec

ruiti

ng p

atie

nts

for

need

s as

sess

men

ts, r

emin

din

g p

hysi

cian

s or

oth

er h

ealth

care

pro

fess

iona

ls t

o un

der

go t

rain

ings

etc

). B

esid

es, t

he la

tter

will

rea

lise

pat

ient

act

ivat

ion

and

oth

er m

arke

ting/

exch

ange

initi

ativ

es t

o fo

ster

eng

agem

ent

and

iden

tifica

tion

with

the

S2C

con

cep

t am

ong

pat

ient

s an

d h

ealth

care

sta

ff.

Tab

le 1

C

ontin

ued

Con

tinue

d

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Campus Kiel involving 27 clinical departments with more than 650 physicians. The aim is to develop 83 EbPDAs enrolling new clinical departments into the programme every 6 months and identifying EbPDA topics at each clinic (figure 2). At the same time, each physician in the respective clinic undergoes SDM training. The Ask Three Questions patient activation is implemented simultane-ously. In addition, in selected departments, a total of 150 other healthcare professionals will be trained as decision coaches to facilitate EbPDA use in specific patient target groups.

The term ‘integrative’ in S2C means that patients and healthcare professionals will be actively involved from the very beginning and throughout implementation, most actively not only in EbPDA development but also, for example, in training evaluation and in the patient acti-vation programme.10 The integrative approach begins with identifying new topics together with physicians and conducting needs assessments with patients. It ends with having physicians distribute EbPDAs to patients in their clinical departments. Sample patients will also user test the EbPDAs before these will be administered to patients in daily practice.

Patient and public involvementNo patient was involved in the development or design of this study.

Theoretical frameworkAt the microlevel (level of healthcare professionals or patients), the S2C programme is designed and imple-mented on the grounds of the Theory of Planned Behavior suggesting behaviour is a result of motivation (intention) and ability (perceived behaviour control).30 31 C

ons

truc

tE

bP

DA

sS

DM

tra

inin

g f

or

phy

sici

ans/

trai

ning

pro

gra

mm

e fo

r ‘d

ecis

ion

coac

hing

’

O

pin

ion

lead

ers

The

dire

ctor

s of

eac

h cl

inic

and

oth

er ‘S

DM

cha

mp

ions

’ are

imp

orta

nt t

o ac

tivel

y su

pp

ort

the

S2C

inte

rven

tion

and

eng

age

thei

r p

hysi

cian

s to

follo

w t

hem

. Als

o, t

he ‘S

DM

phy

sici

an’

at e

ach

clin

ic p

lays

a c

ruci

al r

ole

in t

his

cont

ext.

In

tern

al im

ple

men

tatio

n le

ader

sO

ne p

hysi

cian

in e

ach

clin

ic w

ill b

e th

e d

esig

nate

d ‘S

DM

phy

sici

an’ w

ho o

vers

ees

activ

ities

in t

he r

esp

ectiv

e cl

inic

. For

eac

h E

bP

DA

top

ic, o

ne p

hysi

cian

or

a gr

oup

of p

hysi

cian

s w

ill

be

nom

inat

ed t

o ca

rry

prim

ary

resp

onsi

bili

ty fr

om a

clin

ical

poi

nt o

f few

. The

se p

hysi

cian

s ar

e ex

pec

ted

to

sup

por

t th

e S

2C t

eam

and

driv

e p

roje

ct a

ctiv

ities

forw

ard

in t

he r

esp

ectiv

e d

epar

tmen

t.

C

ham

pio

nsTh

e ‘p

erso

nal fl

agsh

ip’ o

f the

pro

ject

, Dr

Eck

hart

von

Hirs

chha

usen

, is

a ve

ry p

rom

inen

t TV

phy

sici

an, c

omed

ian

and

mod

erat

or. H

e w

ill p

lay

a ve

ry a

ctiv

e ro

le in

pro

ject

mar

ketin

g. H

e w

ill b

e p

rese

nt in

vid

eos

and

on

pos

ters

and

dem

onst

rate

his

sup

por

t of

the

S2C

pro

gram

me

at a

ll le

vels

and

in a

ll its

com

pon

ents

. Dr

von

Hirs

chha

usen

is a

lso

an o

ffici

al c

oop

erat

ion

par

tner

in t

he p

roje

ct.

E

xecu

ting

The

Ger

man

Inno

vatio

n Fu

nd a

s na

tiona

l sp

onso

r re

qui

res

regu

lar

mile

ston

e re

por

ts o

n p

roje

ct s

ucce

ss e

very

6 m

onth

s.

R

eflec

ting

and

eva

luat

ing

All

S2C

tea

ms

will

con

tinuo

usly

rep

ort

on t

he p

rogr

ess

of im

ple

men

ting

S2C

in t

heir

resp

ectiv

e d

omai

n an

d d

ocum

ent

issu

es, p

rob

lem

s or

hig

hlig

hts

thro

ugho

ut t

he c

ours

e of

pro

ject

tim

e (fi

eld

not

es/d

ocum

enta

tion)

*The

inte

rven

tion

com

pon

ent

‘pat

ient

act

ivat

ion

pro

gram

me’

is n

ot s

epar

atel

y d

escr

ibed

in t

he C

FIR

tab

le b

ut in

the

pub

licat

ion

text

onl

y, g

iven

tha

t th

is p

rogr

amm

e is

lim

ited

to

acco

mp

anyi

ng m

arke

ting

and

info

rmat

ion

stra

tegi

es w

ithin

eac

h cl

inic

us

ing

pos

tcar

ds,

pos

ters

and

sta

nd- u

p b

oard

s.C

FIR

, Con

solid

ated

Fra

mew

ork

for

Imp

lem

enta

tion

Res

earc

h; E

bP

DA

s, e

vid

ence

- bas

ed p

atie

nt d

ecis

ion

aid

s; M

AP

PIN

'SD

M, m

ultif

ocal

ap

pr o

ach

to s

harin

g in

sha

red

dec

isio

n- m

akin

g; N

PT ,

nor

mal

isat

ion

pro

cess

the

ory;

S2C

, SH

AR

E T

O C

AR

E;

SD

M, s

hare

d d

ecis

ion-

mak

ing.

Tab

le 1

C

ontin

ued

Figure 1 Project components and respective S2C project teams. S2C, SHARETO CARE, SDM, shared decision- making.

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6 Danner M, et al. BMJ Open 2020;10:e037575. doi:10.1136/bmjopen-2020-037575

Open access

Accordingly, the S2C programme aims to induce attitude and perception changes by training physicians and other healthcare professionals in SDM and by informing patients to enable simultaneous behaviour change at the level of patients and healthcare providers. The interac-tive process of EbPDA- development also aims at changing attitudes at the individual physician level. The implemen-tation of the S2C programme is at the microlevel guided by the concept of normalisation process theory (NPT). The four components of the NPT are coherence (does the programme make sense to those who are involved?), participation (how do relevant stakeholders participate in implementation?), collective action (what to do to make implementation successful?) and reflexive monitoring (how do the involved individuals judge implementation processes?).32 As part of a process evaluation, these ques-tions/constructs will be addressed with key stakeholders at specific points in time throughout the 4- year project time to continuously monitor implementation processes at the level of all involved stakeholders at the University Hospital Campus Kiel.

The complexity of this project taking into account context and processes of project implementation is depicted in table 1 following the CFIR (https:// cfir-guide. org/). This framework comprises five domains (intervention characteristics, outer setting, inner setting, characteristics of individuals and process) and 39 related constructs.9 33 34 The constructs of the CFIR were used to describe the status quo of relevant project characteristics, project settings and potential interactions between these at project initiation. CFIR will also guide our implemen-tation processes as described later.

Setting and study populationCampus Kiel as part of the UKSH Medical Center is a tertiary care hospital with more than 200 000 cases treated each year. Twenty- seven clinical departments with more than 650 physicians and more than 150 other healthcare professionals and their patients will be part of either training modules or development and use of decision aids or both. New clinical departments and their patients will be sequentially enrolled in the study (figure 2).

S2C intervention componentsIntervention ‘SDM training for physicians’This module aims at providing structured SDM training in three steps to a minimum of 80% of physicians working at the UKSH (ie, at least 520 physicians should receive training). The module is based on the pretested and validated training approach that has demonstrated to be effective and lead to an increased patient, physician and observer perception of involvement in decision- making.17 18 Preceding training, each physician has to take a baseline video of him or herself with a patient in a real decision- making interaction. The physician then under-goes an online video tutorial that contains general infor-mation on SDM and its application in clinical practice. It also contains fictional interactions between physician and patient actors teaching physicians to differentiate ‘good’ from SDM communication ‘in need of improvement’. For the subsequent video- based small group training sessions, the baseline video recording of a patient–physi-cian interaction and a second recording (following online training) are rated by the S2C trainer team (see table 2 for additional information). In the subsequent group training, each physician receives video- based trainer

Figure 2 Sequential quarterly enrolment of new clinical departments.

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Open access

Tab

le 2

D

etai

ls o

n ou

tcom

e m

easu

rem

ent

Out

com

e,in

stru

men

tO

utco

me

defi

niti

on

Targ

et p

op

ulat

ion

Mea

sure

men

t sc

ale

Rea

sons

fo

r ch

oic

e o

f in

stru

men

tA

sses

smen

t sc

hed

ule/

mo

de

(tim

e p

oin

ts, T

0, T

1, T

2)P

lann

ed n

umb

er o

f in

terv

iew

ed in

div

idua

ls

Out

com

es e

licit

ed f

rom

pat

ient

per

spec

tive

via

pat

ient

que

stio

nnai

re

Prim

ary

Out

com

e M

easu

re1 :

Per

ceiv

ed In

volv

emen

t in

Car

e S

cale

s (P

ICS

) (th

ird s

ubsc

ale

used

as

prim

ary

outc

ome

mea

sure

)41 4

5

Per

ceiv

ed in

volv

emen

t in

p

atie

nt–p

hysi

cian

inte

ract

ion

from

pat

ient

per

spec

tive

Sam

ple

of U

KS

H

pat

ient

s re

ceiv

ing

pat

ient

que

stio

nnai

res

(all

clin

ical

d

epar

tmen

ts o

r sp

ecifi

c d

epar

tmen

ts)

Thre

e su

bsc

ales

:1.

D

octo

r fa

cilit

atio

n of

pat

ient

in

volv

emen

t2.

Le

vel o

f pat

ient

’s a

ctiv

e in

form

atio

n se

ekin

g3.

P

erce

ived

pat

ient

invo

lvem

ent

Ind

ivid

ual s

core

s ra

nge

from

1 (n

o ag

reem

ent)

to 4

(tot

al a

gree

men

t)

Mea

sure

s p

atie

nt p

erce

ptio

n of

invo

lvem

ent

in d

ecis

ion-

m

akin

g w

ith p

hysi

cian

in

gene

ral,

not

rest

ricte

d t

o or

focu

sed

on

one

spec

ific

dec

isio

n si

tuat

ion;

tak

es t

he

per

spec

tive

of a

pat

ient

and

is

not

lim

ited

to

asse

ssin

g th

e p

atie

nt p

erce

ived

deg

ree

of

phy

sici

an’s

end

eavo

ur

T0: b

efor

e p

rogr

amm

e st

arts

(b

asel

ine)

T1: a

fter

com

ple

tion

of p

rogr

amm

e in

eac

h d

epar

tmen

t; im

med

iate

effe

ctT2

: 6 m

onth

s b

efor

e th

e en

d

of t

he p

roje

ct: s

usta

inab

ility

of

‘effe

ct’

1.60

0 at

T0

and

T2,

re

spec

tivel

y; a

min

imum

of 4

0 p

er c

linic

at

T1;

Diff

eren

t sa

mp

les

are

take

n at

ea

ch m

easu

rem

ent

Sec

ond

ary

outc

ome

mea

sure

:P

rep

arat

ion

for

Dec

isio

n M

akin

g S

cale

(PR

EP

- DM

- S

cale

)42

Per

ceiv

ed le

vel o

f ind

ivid

ual

pre

par

atio

n fo

r d

ecis

ion

situ

atio

n

sam

e as

for

PIC

Ste

n ite

ms

Ind

ivid

ual s

core

s in

pat

ient

q

uest

ionn

aire

ran

ge fr

om 1

(no

agre

emen

t) to

5 (t

otal

agr

eem

ent)

Mea

sure

s p

atie

nt p

erce

ptio

n of

invo

lvem

ent

in d

ecis

ion-

m

akin

g go

ing

bey

ond

pat

ient

–p

hysi

cian

com

mun

icat

ion,

fo

r ex

amp

le, b

roch

ures

, d

ecis

ion

aid

s, in

form

atio

n p

rovi

ded

via

oth

er h

ealth

care

p

rofe

ssio

nals

.

T0, T

1, T

2S

ame

as fo

r P

ICS

Sec

ond

ary

outc

ome

mea

sure

:co

llab

o- R

ATE

43P

erce

ived

leve

l of a

ttem

pts

b

eing

mad

e b

y p

hysi

cian

s to

ac

tivel

y in

volv

e p

atie

nts

in

dec

isio

n- m

akin

g

Sam

e as

for

PIC

Sth

ree

item

sIn

div

idua

l sco

res

in p

atie

nt

que

stio

nnai

re r

ange

from

1 (r

ecei

ved

no

att

entio

n) t

o 5

(rece

ived

muc

h at

tent

ion)

Allo

ws

com

par

ison

with

ot

her

stud

ies,

sin

ce t

his

que

stio

nnai

re is

wid

ely

used

in

tern

atio

nally

.

T0, T

1, T

2S

ame

as fo

r P

ICS

Out

com

es e

licit

ed f

rom

ob

serv

er p

ersp

ecti

ve*

Prim

ary

outc

ome

mea

sure

2 : M

AP

PIN

’ SD

M- O

- dya

d17

–19

Ob

serv

er- b

ased

ass

essm

ent

of h

ow w

ell t

he p

hysi

cian

–p

atie

nt in

tera

ctio

n is

p

erfo

rmed

with

res

pec

t to

the

M

AP

PIN

’SD

M c

riter

iaC

ond

ucte

d b

y tr

aine

d r

ater

s b

ased

on

vid

eos

of s

pec

ific

inte

ract

ions

.

Pat

ient

s an

d

phy

sici

ans

in a

p

erso

nal d

ecis

ion-

r e

late

d in

tera

ctio

n

Bas

ed o

n a

MA

PP

IN’S

DM

rat

er

man

ual.

Six

item

s re

flect

ing

the

six

step

s in

sh

ared

dec

isio

n m

akin

gIte

m 1

: pro

ble

m d

efini

tion

Item

2: k

ey S

DM

mes

sage

Item

3a:

op

tions

(str

uctu

re)

Item

3b

: op

tions

(con

tent

)Ite

m 3

c: o

ptio

ns (q

ualit

y of

in

form

atio

n)Ite

m 4

: pat

ient

exp

ecta

tions

and

w

orrie

sIte

m 5

: dec

isio

n m

akin

gIte

m 6

: fur

ther

ste

ps

Pro

vid

es a

n ‘o

bje

ctiv

e’

asse

ssm

ent

of t

he p

atie

nt–

phy

sici

an in

tera

ctio

n b

y an

ind

epen

den

t ra

ter,

with

re

spec

t to

bot

h in

tera

ctio

n p

artic

ipan

ts, t

he p

atie

nt a

nd

the

phy

sici

an (‘

dya

d’)

T0, T

1In

div

idua

l pat

ient

–phy

sici

an

enco

unte

rs a

t cl

inic

al

dep

artm

ents

*R

ater

is b

lind

ed t

o th

e tim

ing

of t

he v

ideo

tak

en.

200–

220

pat

ient

–phy

sici

an

inte

ract

ions

(all

phy

sici

ans

at s

even

invo

lved

clin

ical

d

epar

tmen

ts w

ill s

ubm

it on

e vi

deo

at

each

mea

sure

men

t tim

e p

oint

)*P

hysi

cian

s ar

e m

ostly

the

sa

me

at e

ach

mea

sure

men

t b

ut p

atie

nts

in in

tera

ctio

n ar

e d

iffer

ent.

*Eva

luat

ed c

linic

al d

epar

tmen

ts a

t th

e U

nive

rsity

Hos

pita

l Cam

pus

Kie

l are

: gen

eral

sur

gery

, int

erna

l med

icin

e I (

gast

roen

tero

logy

, hep

atol

ogy,

pne

umol

ogy,

inte

rnal

inte

nsiv

e ca

re m

edic

ine,

end

ocrin

olog

y, in

fect

iolo

gy, r

heum

atol

ogy,

nut

ritio

nal a

nd

agei

ng m

edic

ine)

, rad

ioth

erap

y, in

tern

al m

edic

ine

II (h

aem

atol

ogy,

onc

olog

y), t

raum

a su

rger

y an

d o

rtho

pae

dic

s, g

ynae

colo

gy a

nd u

rolo

gy.

MA

PP

IN'S

DM

, Mul

tifoc

al a

pp

roac

h to

sha

ring

in s

hare

d d

ecis

ion-

mak

ing. on A

ugust 6, 2021 by guest. Protected by copyright.

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j.com/

BM

J Open: first published as 10.1136/bm

jopen-2020-037575 on 10 October 2020. D

ownloaded from

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Open access

and group feedback. The aim is to provide an interac-tive and common SDM learning experience to physician. To increase their motivation, training participation is rewarded by continued medical education credits by the German Medical Associations.

Intervention ‘activation of patients’The ‘Ask Three Questions’ programme has originally been developed in Australia and tested in European countries.28 29 Patients are instructed and motivated to actively participate in communication by asking their doctors questions regarding their specific (treatment) situation. Our patient activation concept communicates the message ‘Ask Three questions—decide together’ in a unique design at all departments using various distri-bution channels: paper postcards, posters/stand- up displays and screen- based messages inside UKSH. It will be embedded in several other interventions, like a patient homepage within the UKSH- homepage, the bedside info-tainment system, information screens and special SDM- days in the central lobby.

Intervention ‘(online) EbPDAs’Eigthy- three online EbPDAs will be developed, at least 1 in each department. The number is arbitrary, as there is no recommended number per department. We calculated the maximum possible number given the resources and the time frame of our grant. Consistent with the DA (deci-sion aid) factory approach implementation starts with the identification of EbPDA topics together with physi-cians. Topics should be important for physicians, involve at least two preference- sensitive treatment alternatives and occur frequently. Topic specification with respect to target patient population, relevant treatment options and patient- relevant outcomes/issues of treatment is done based on a literature/guideline review and in exchange with physicians and patients. Needs assessments are conducted with about four to eight patients per topic to guide and structure EbPDAs as closely to patient needs as possible. Development of EbPDAs involves a system-atic search and assessment of best available evidence for all relevant interventions, focusing on systematic reviews and evidence- based guidelines. Methods are based on the German standards of evidence- based patient informa-tion and the methods of evidence generation in patient information.35 36 Text information on disease and treat-ment will be accompanied by video sequences with UKSH physicians and patients. In these sequences, physicians explain treatments and patients share their experience in decision- making. The latter is to motivate users of the online DAs to actively participate in decision- making. To avoid bias by testimonials, patients do not rate the different interventions in their video sequences but limit themselves to talking about their experience with the disease and their individual decision process. The process of DA development follows the International Patient Decision Aids Standards criteria ( www. ipdas. ohri. ca37 38). Each EbPDA undergoes external review.

Intervention ‘SDM Training for other healthcare professionals to be decision coach’This qualification module provides SDM training to about 150 nurses or other healthcare professionals in specific indications, where patients most likely will need support in using EbPDAs. Training principles are based on the physician training and decision coaching application in specific settings.12 13 27 39 The goal is to train healthcare staff like nurses or physiotherapists to act as ‘decision coaches’ for their patients when using EbPDAs, that is, to simultaneously provide emotional, psychological and technical support. The qualification consists of 2 work-shop days communicating the principles of SDM and EbPDAs and including two individual decision coaching sessions for each participant. In addition, each decision coach will be asked to videotape coaching communica-tions with a patient two times and receive individual SDM trainer feedback. The communication between decision coaches and patients will always centre around a specific EbPDA.

Study outcome and outcome measuresThe primary intervention outcome is whether and to what degree SDM- based interaction is provided to patients at UKSH. To cover different perspectives, we focus on two types of outcome measures, one providing the patient perspective and one providing an observer- based perspective (table 2). The primary outcome is based on a validated SDM measurement instrument, the Perceived Involvement in Care Scales (PICS).40 41 It is a patient- reported outcome instrument translated and validated in Germany and consists of three subscales with 4–5 items each. The subscales are (1) patient activation by doctors (five items) (2) active information- seeking behaviour (four items) and (3) perceived patient participation in decision- making (five items). Each item is measured on a scale from 1=‘do not agree at all’ to 4=‘totally agree’. The second primary outcome consists in an observer rating of patient- physician interaction before and after the inter-vention using the MAPPIN’SDM (multifocal approach to sharing in shared decision making)- O(Observer)- dyad instrument.17 18 26 MAPPIN’SDM- O- dyad measures the degree of SDM performance realised by the doctor–patient dyad (ie, by the unit made up of patient and physi-cian) as rated by independent observers. The instrument consists of nine items assessing the process and quality of SDM. Each item is scored from ‘0’ (‘the indicator is not present’) to ‘4’ (‘the indicator is present at an excellent standard’). The observer ratings are provided by inde-pendent but trained raters who rate video recordings of patient–physician interactions before and after the inter-vention (see ‘data collection and analyses’). All observers are blinded to the measurement objects and time points of video recordings.

Additional secondary outcomes included in the patient questionnaire are two validated and widely used ques-tionnaires, the Preparation for Decision Making Scale (PrepDM: 10 items; 5- point scale)42 and collaboRATE43

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(three items; 5- point scale). All outcome measures are detailed in table 2.

Data collectionPrimary outcome data collection is conducted via patient questionnaire (including the PICS instrument) before (T0) and two times after the intervention (T1, T2). The data collection and evaluation schedule are depicted in figure 3.

The first patient questionnaire/PICS measurement (T0) is scheduled at study initiation. The second (T1) is taken after completion of the S2C intervention at each depart-ment to assess immediate intervention effect. The inter-vention is considered complete at the department level when at least 80% of physicians have undergone training, EbPDAs are developed and in use, and the patient activa-tion programme is in place. The last measurement (T2) is scheduled 6 months before study completion. It aims to appraise the sustainability of the S2C intervention. At T0 and T2, the patient questionnaire is mailed to a consecutive sample of patients who were hospitalised at the UKSH Kiel campus within the preceding weeks with a return envelope included in each mailing. At T1, the questionnaire is sent to a respective sample of patients from a clinical department who completed the inter-vention. Patients who do not return the questionnaire within a 2- week or 4- week time frame, respectively, will get a reminder either one or two times. Based on the Total Design Method approach by Dillmann et al,44 final response rates of at least 60%–70% are expected.

The observer- based outcome measurement via MAPPIN’SDM- O- dyad is performed two times throughout the 4- year study period, at T0 and T1. To minimise work-load for physicians, who must videotape encounters with patients to facilitate the MAPPIN’SDM- O- dyad evaluation, these assessments focus on central domains of hospital medicine (internal medicine, oncology, gynaecology,

surgery, orthopaedics) being covered by specific clinical departments (departments of general surgery, internal medicine, radiotherapy, oncology & haematology,gy-naecology, trauma surgery & orthopaedics, urology, gynaecology).

Sample size calculation and data analysesSample size calculation for the patient- based primary outcome is based on published PICS data.41 45 An assumed difference of 0.4 in the PICS outcome at T1 versus T0 and a SD of 0.7 yields a sample size of about 40 for each clin-ical department at each measurement, using an indepen-dent sample t test and assuming a power of 80% and a level of significance of 5% (one- sided, assuming a positive effect of the SDM intervention). This yields a campus- wide sample of 1080 patients (27 clinics, 40 patients per clinic). A difference in PICS scores of 0.4 comparing before and after measurement is considered relevant (Hedges g>0.5, which corresponds to a medium size effect). If the distribution does not allow the assumption of normality, appropriate non- parametric tests will be applied in data analyses.

A presumed response rate of 60%–70% to the patient questionnaire mailings leads us to target about 1600 patients at measurement point T0 and T2 the campus level to finally achieve at least about 1000 patient ques-tionnaires returned, yielding on average between 30 and 60 returned questionnaires per clinical department. These numbers will allow to measure significant differ-ences in the primary endpoint not only at the campus but also at the individual department level (at least in the larger ones). At T1, a minimum of 65–70 patients has to be contacted to have at least 40 questionnaires returned.

Sample size for the second primary outcome assess-ment (MAPPIN’SDM observer assessment) is given by the number of physicians at the involved clinical depart-ments. Seven of the 27 UKSH departments will be part

Figure 3 Project stages and data collection schedule for SDM evaluation. PICS, Perceived Involvement in Care Scales; S2C SHARE TO CARE; SDM, shared decision- making; MAPPIN'SDM, multifocal approach to sharing in shared decision- making.

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of the MAPPIN’SDM assessment. Physicians in these departments sum up to 200–220 in total. Each physi-cian will deliver a patient–physician interaction video for outcome measurement at each measurement point. This analysis includes general surgery (n=30–40 physi-cians), internal medicine (n=62), radiotherapy (n=16), oncology/haematology (n=21), orthopaedics (n=27), gynaecology (n=34) and urology (n=10–20). Based on a previous study including training of physicians only,18 we aim at an effect size of d=0.5 (Hedges g). To yield a power of 80% (alpha=5%), minimal sample size should be n=51. Assuming a response rate above 60% (n≥120), the sampling strategy leads to a sufficient sample size. It is hypothesised that in 80% of patient–physician interac-tions, patients will receive satisfactory SDM- based treat-ment at the second department- wide measurement (T1) compared with less than 80% before the intervention (T0). To answer the latter study hypothesis, a MAPPIN- SDM- O- dyad mean value of greater or equal to 1.5 was defined as satisfactory basic patient involvement in decision- making based on previous validation research.18

Health economic evaluationIn addition to the pre SDM post SDM evaluation, an economic evaluation will be conducted. This anal-ysis will be based on insurance claims data provided by the largest German Health Insurance provider (Tech-niker Krankenkasse (TK)). In Germany, approximately 88% of the population (72.8 million) is covered under the comprehensive statutory health insurance system. The TK provides health insurance for approximately 9.8 million people (13% of the statutory contributors) and routinely collects data for reimbursement purposes on hospital stays, physician visits, medical procedures, medication and medical diagnoses. In the economic eval-uation, incremental costs and use of specific services of patients admitted to the UKSH with preference- sensitive conditions in specific clinical departments (intervention group) will be compared with a matched population (control group) drawn from the administrative dataset from the TK. The control group includes patients with a hospital admission to another German University or Educational hospital (tertiary medical centre). From this sample population, patients will be matched to the intervention group using exact matching, propensity score matching or a combination of exact and propensity score matching.46 47 Matching criteria will include patient characteristics like age and sex, the main diagnosis of the hospital admission as well as measures of morbidity within 12 months preceding hospital admission. In line with previous research,48 variables that are compared across groups include preference- sensitive surgery rates, imaging rates, inpatient costs, total medical costs and hospital and emergency department admissions within 12 months after the admission to the hospital. To account for systematic differences between intervention and control group, the analysis will focus on the comparison of the difference in outcomes measured at two points in

time, before and after the implementation of the SDM intervention. The analysis will be limited to about 10–15 frequently occurring and preference- sensitive conditions. These conditions will include but are not limited to cardi-ologic diseases, benign prostatic hyperplasia and other urologic diseases, benign uterine diseases and obstetrics, neurosurgery/back pain and orthopaedic diseases such as knee or hip replacement.

Process evaluationStarting point for our evaluation is that the CFIR constructs as depicted in table 1. They summarise each study component, involved stakeholders, context (inner/outer setting) and processes at study initiation. Each construct is followed up throughout the course of the study aiming to (1) identify areas where adaptations to initially planned implementation might be needed and2 (2) better understand which clinical departments might be more/less accessible to the SDM interventions and why. Process evaluation is done by using (a) documen-tation (eg, documentation of decision aid use by simply counting click/user numbers and times or documentation of number of physician trainings performed per clinical department) and (b) interview or structured question-naire data. Interviews and structured questionnaires with stakeholders regarding implementation processes will be developed based on the described four concepts of the NPT theory.49–51 In addition, field notes are used by the respective project teams (figure 1) to adapt implementa-tion strategies and processes to the specific demands of individual department’s circumstances during the inter-vention phase.

ETHICS AND DISSEMINATIONThe Medical Ethics Committee of the Medical Faculty of the Christian- Albrechts- University (CAU) Kiel has provided ethics approval to this study (reference number A111/18). This study will be conducted in accordance with German laws and regulations of the Medical Ethics Committee of the CAU, Kiel, Germany. Eligible patients or healthcare providers will be fully informed about the study and asked to participate in each part of the study: conducting personal interviews with patients (needs assessment), or video sequences with physicians/patients or involving physicians in training sessions. Patients/providers will receive a respective information letter and will be informed about the implications of participation. They will have sufficient opportunity to ask questions and to consider the implications of the study before deciding to participate. Before participation, all individuals will provide written informed consent, compliant with the local and ethical data regulations. Patients and clinical staff will be allowed to withdraw from the study without giving a reason, at any time. The results arising from this implementation study will be presented at scientific meet-ings, on project- hosted websites at UKSH and by S2C as well as published in peer- reviewed journals. There is no

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intention to use professional writers and authorship will be based on the International Committee of Medical Journal Editors Guidelines.

Author affiliations1SHARE TO CARE Team, University Medical Center Schleswig- Holstein Campus Kiel, Kiel, Germany2SHARE TO CARE, Patientenzentrierte Kommunikation GmbH, Cologne, Germany3TAKEPART Media & Sciences GmbH, Cologne, Germany4Ludwig- Maximilians- Universitat Munchen, Munchen, Germany5Universitetet i Tromso Helsevitenskapelige fakultet Helsefak, Tromso, Norway

Acknowledgements The authors acknowledge Juergen Kasper and Katrin Liethmann for their tremendous contributions to the development of the study concept and intervention program.

Collaborators Corinna Knauff, Divna Tafelski, Johanna Gärtner, Stefanie Mevis, Heike Klein, Lea Kruse, Salim Greven, Gesine Steinbock, Kristina Blankenburg, Gerhard Koch, Claudia Hacke, Olga Kopeleva, Carmen Wiencke, Anja Schuldt, Christina Gesine Sommer, Barbara Kreidler, Constanze Stolz, Christine Wagner- Ullrich, Thorsten Duit, Michael Schipper, Lars Jacobsen, Christian Weymayr, Svenja Ludwig, Roya Shar- Yazdi, Ryan Naglatzki, Julia Bossert, Karoline Weik

Contributors FG, FS, KW and JUR developed the study concept and methods, designed the intervention program and are responsible for its implementation. LS and AN developed the evaluation concept and are responsible for its realisation. TS and CK provided substantial scientific and methodological contribution. AR and MDe provided methodological input and critically revised the manuscript. MD drafted the manuscript and provided scientific and methodological input to the study concept.

Funding This work was supported by a grant of the German Innovation Fonds (hosted by the Federal Joint Committee), grant number 01NVF17009.

Competing interests None declared.

Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Patient consent for publication Not required.

Provenance and peer review Not commissioned; externally peer reviewed.

Open access This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY- NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non- commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non- commercial. See: http:// creativecommons. org/ licenses/ by- nc/ 4. 0/.

ORCID iDsMarion Danner http:// orcid. org/ 0000- 0002- 0653- 4092Anna Novelli http:// orcid. org/ 0000- 0002- 4600- 0183

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