PROTOCOL
Spouses involvement in older patients fast-track programmes during
total hip replacement using case management intervention. A study
protocol of the SICAM-trial
Connie Bttcher Berthelsen & Jimmie Kristensson
Accepted for publication 18 November 2014
Correspondence to C.B. Berthelsen:
e-mail: cb@ph.au.dk
Connie Bttcher Berthelsen MScN PhD RN
Post Doctoral Fellow, Assistant Professor
Orthopaedic Department, Regional Hospital
of Kge, Denmark and Section of Nursing,
Institute of Public Health, Aarhus
University, Denmark
Jimmie Kristensson PhD RN
Associate Professor
Department of Health Sciences, Lund
University, Sweden and The Swedish
Institute for Health Sciences, Lund
University, Sweden
2015 John Wiley & Sons Ltd
B E R T H E L S E N C . B . & K R I S T E N S S O N J . ( 2 0 1 5 ) Spouses involvement in older
patients fast-track programmes during total hip replacement using case manage-
ment intervention. A study protocol of the SICAM-trial. Journal of Advanced
Nursing 71(5), 11691180. doi: 10.1111/jan.12602
Abstract
Aim. To present the protocol of a two-group quasi-experimental study of
spouses involvement through case management (The SICAM-trial) in older
patients fast-track programmes during total hip replacement.
Background. Patients in fast-track programmes are required to take an active
part in their treatment and rehabilitation. Spouses of older patients can often
provide valued practical and emotional support, reducing stress, pain and length
of stay yet they are seldom invited to participate in a supporting role.
Design. A two-group quasi-experimental design with pre-test and repeated post-
test measures (protocol approved in November 2012).
Methods. A total of 120 patients aged 65 years or older going through a fast-
track programme for a total hip replacement and their spouses will be recruited
from one Danish orthopaedic ward. We will initially include the control group
for data collection and subsequently include the intervention group to avoid
contamination of the control group. A case manager will be recruited to perform
the case management intervention. Data will be collected from both groups at
baseline, 2 weeks and 3 months after surgery. Outcome measures for patients
include: functional status, nutrition, pain, depression and healthcare
consumptions; and for spouses: caregiver satisfaction and difficulties and anxiety.
Conclusion. The intervention will give further evidence on the need for relatives
participation in the patients fast-track programmes and the results will contribute
to education of the health professionals in their need to include relatives in fast-
track programmes. The study was funded by the Novo Nordisk Foundation and
the Regional Health Scientific Foundation of Sealand.
Keywords: caregiver satisfaction, case management, fast-track programmes, func-
tional status, intervention, nursing, older patients, protocol, spouses, total hip
replacement
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C.B. Berthelsen and J. Kristensson
Why is this study needed?
 Older patients in fast-track programmes may occasionally
lack cognitive and practical abilities to manage their treat-
ment and rehabilitation, which is why spouses active sup-
port is essential.
 Previous studies report that relatives involvement in fast-
track programmes is associated with a decrease in patients
stress, depression, pain, anxiety and length of stay.
Introduction
Relatives often have a substantial role as caregivers for
older patients as they help and support their family mem-
bers through difficult times (Norlyk & Harder 2011, Ber-
thelsen et al. 2014b). They often feel responsible for taking
care of practical issues (Lindhardt et al. 2008) and their
involvement is associated with the alleviation of patients
stress and depression (Mitchinson et al. 2008), pain and
anxiety (Prouty et al. 2006) and with a decrease in length
of stay (Theiss et al. 2011). However, less attention has
been paid to how spouses can be actively involved as care-
givers in older patients care trajectories, despite statistical
evidence showing that in 30 years time 25% of the Danish
population will consist of the over-65s (Danish Statistics
2011).
In orthopaedic fast-track programmes, patients are
required to take an active part and be responsible for their
treatment and rehabilitation (Kehlet & Sballe 2010).
However, some patients lack the necessary cognitive and
physical abilities, which is why spouses active support
could be essential. We present a study protocol of a case
management intervention, where we aim to investigate the
effect of spouses involvement in older patients fast-track
programmes during total hip replacement to improve the
patients postdischarge functional status and spousal care-
giver satisfaction.
Background
Indications for a total hip replacement are often osteoar-
thritis accompanied by excessive pain and loss of mobility
(Kehlet & Sballe 2010). In Denmark, total hip replace-
ments have been performed through fast-track programmes
for the past 20 years (Stinchfield & White 1971, Harris &
Sledge 1990). The fast-track programmes are based on sub-
stantial evidence of improving multi-modal components rel-
evant for surgery and recovery to enhance surgical stress
reduction, mobilization, information, pain management and
nutrition (Husted et al. 2010). The fast-track programme
1170
runs from the initial pre-surgical planning interview in the
out-patient facilities to discharge; the estimated length of
stay is 12 days with standardized care provided to enhance
quality of care (Kehlet & Sballe 2010). The prognosis for
quick recovery after surgery is significant (Becker et al.
2011, Mariconda et al. 2011) and the average patient satis-
faction is considered good to excellent (Lindgren et al.
2014). Overall effectiveness in terms of improvement in
health-related quality of life dimensions is seen after total
joint replacement (Ethgen et al. 2004) with substantial
improvements in physical health, such as pain and physical
functioning (Kehlet & Sballe 2010).
In Denmark 49% of patients undergoing total hip
replacement are over 70 years of age (The Danish Hip Allo-
plasty Register 2013). Older patients often have an
extended length of stay (Husted et al. 2011) and are fragile
after discharge because of pain and poor mobility (Hunt
et al. 2009). An American study (Theiss et al. 2011) of
1722 observations in four hospitals revealed that social sup-
port by relatives before, during and after total joint replace-
ment, has a significant effect on patient outcomes. Length
of stay was measurably lower for patients with high or very
high numbers of relatives involved and the percentage of
patients achieving the transfer-out-of-bed-goal was signifi-
cantly higher for patients with a high social support (Theiss
et al. 2011). Research has also indicated that patients need
spouses involvement and participation with practical and
emotional support during the fast-track programme (Norlyk
& Harder 2011, Berthelsen 2013) and that health profes-
sionals allow involvement of spouses if they are well-
informed and comply with programme principles and stan-
dards (Berthelsen et al. 2014a).
Involving and educating spouses as active caregivers by
simply providing information is not sufficient, but combin-
ing it with case management seems to be a promising
approach (Rosemann et al. 2007). Case management is a
collaborative process of assessment, planning, facilitation
and advocacy for options and services to meet an individ-
uals holistic needs through communication and available
resources; it is described as an integral link in the process
of care coordination of services for complex patients and
families (Schifalacqua et al. 2000). Even though case man-
agement has been applied with success to patients (Gensi-
chen et al. 2006, Rosemann et al. 2007, Sandberg 2013)
very few case management studies include support and edu-
cation for relatives through a family-oriented approach
(Hallberg & Kristensson 2004).
The case management intervention presented in this study
was initiated by current grounded theory research that
showed how relatives were keen on participating in the
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JAN: PROTOCOL
older patients fast-track programmes if needed by the
patients (Berthelsen et al. 2014b). The results also indicated
how older patients were selective about involving their rela-
tives, but married patients expressed a specific need for the
presence of their spouses (Berthelsen 2013). The interven-
tion presented in this protocol is designed using current
research results from a systematic review of the content,
dissemination and effects of case management interventions
by informal caregivers to older adults (Berthelsen &
Kristensson 2014). The case management intervention dis-
semination and components with the best effects were
retrieved from the studies of Lenz and Perkins (2000) and
Buckwalter et al. (1999) and used to develop the interven-
tion in our study.
The study
Aims
This study aims to present the protocol of a two-group
quasi-experimental study of spouses involvement through
case management (the SICAM-trial) in older patients fast-
track programmes during total hip replacement.
Hypothesis
We hypothesize that spouses involvement through case
management in older patients fast-track programmes dur-
ing total hip replacement can:
Increase patients postdischarge functional status
Improve patients nutritional status
Decrease patients postsurgical pain
Decrease patients level of depression
Decrease patients healthcare consumptions
Increase spouses caregiver satisfaction
Decrease spouses caregiver difficulties
Decrease spouses level of anxiety.
Within group tests
C Group C Group C Group
baseline 2-weeks 3-months
Duration
Between group tests
Figure 1 Design of the SICAM-trial and planned data analyses.
2015 John Wiley & Sons Ltd
The study protocol of the SICAM-trial
Design
A two-group quasi-experimental design with pre-test and
repeated post-test measures (Shadish et al. 2002) was cho-
sen for the SICAM-trial (Figure 1).
Randomization was not considered feasible for this study,
because of the risk of contaminating data between the inter-
vention group and the control group. Conversations
between spouses in the two groups are inevitable and
information given to the intervention group by the case
manager can easily be spread. Our purpose was therefore
initially to include the control group for data collection and
subsequently to include the intervention group to avoid the
contamination of the control group.
Study settings
The SICAM-trial will be allocated in an orthopaedic ward
in a Danish Regional hospital specializing in total hip
replacement surgery. In 2012, the ward performed a total
of 308 primary hip replacements. Patients consisted of 40%
males and 60% females with an average age of 70 (The
Danish Hip Alloplasty Register 2013).
Study sample
Characteristics of the sample will be assessed at baseline via
questions about age, living conditions, number of medica-
tions, educational level and financial status, to enhance
homogeneity in the intervention group and the control group.
The study sample will consist of spouse-patient dyads.
Patients will be included if they are 65 years of age or older
and undergoing a total hip replacement due to arthritis. The
patients must live with their spouses and be able to speak,
read and understand Danish without an interpreter. They
cannot receive home care, be placed in a nursing home or be
permanent users of wheelchairs. Patients must furthermore
Within group tests
I Group I Group I Group
baseline 2-weeks 3-months
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C.B. Berthelsen and J. Kristensson
have their spouses present at the mandatory pre-information
meeting in the outpatient facilities. The pre-information
meeting is standard procedure in fast-track programmes and
is designed to provide a two-hour information s
eance for
patients and their relatives about surgical procedure, pain
medication, anaesthetics, physiotherapy and the nursing
issues in the fast-track trajectory. Spouses will be included if
they fit the patient inclusion criteria. Exclusion criteria for
both spouses and patients is >24 assessed on the Mini-Mental
Stats Examination (MMSE) (Folstein et al. 1975) and/or a
Charlson Comorbidity Index score of <6 recommended by
Charlson and colleagues (Charlson et al. 1987).
Recruitment of spouse-patient dyads
Firstly the control group will be included by the first author,
who is responsible for the recruitment and data collection of
the control group and secondly the case manager will recruit
the intervention group according to our study design.
Recruitment procedures will be consistently performed to
include both control and intervention groups. The spouse-
patient dyads will be included at the pre-information meeting
in the out-patient facilities. First, the patients charts will be
checked for age and reason for surgery and we will ascertain
whether their spouse is present. The spouses and patients
meeting the inclusion criteria in the charts will receive verbal
and written information about the study and will be invited
to participate in the study. The patients and spouses cogni-
tive status will be assessed on the 12-item Mini-Mental State
Examination test (MMSE) (Folstein et al. 1975), which is a
short assessment of the persons orientation to time and place
and memory. The total score ranges from 0 (maximum cog-
nitive deficit) - 30 (no cognitive deficit). The patients and
spouses comorbidity status will be assessed by the 19-item
Charlson Comorbidity Index (Charlson et al. 1987) to pre-
dict an expected reduction in life to less than 1 year by
100%. Each item is given a weighting of 16 and the sum of
weights ranges from 0107. If both patient and spouse have
a MMSE-score of <25 and a Charlson Comorbidity Score of
>5 they will be asked to give informed consent for participa-
tion. If one of them does not pass the dyad will be excluded.
The trial intervention
The control group usual care and information
Spouses and patients in the control group will receive usual
care and written and oral information about the fast-track
programme and principles in general from the nursing staff.
The usual care and information is provided before admis-
sion in the out-patient facilities (Table 1) and during admis-
sion (Table 2).
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The usual care provided by the health professionals from
standardized daily routines during admission includes daily
goals and achievements relating to exercise, nutrition, pain
management and discharge. The information consists of
descriptions about the possible and specific problem areas
that can occur after discharge, such as exercise and rehabili-
tation, medical administration, changing dressings, changes
in the appearance of the wound, signs of infection, pain
administration, constipation and nutritional advice. Spouses
are invited to the pre-information meeting, but are seldom
invited to participate in meetings where information is given
during the patients admission, such as the ward rounds or
the discharge preparation meeting (Berthelsen et al. 2014a).
Intervention case management
Spouses in the intervention group will receive usual care and
information from the nursing staff, but with additional care
and advice from the case manager. A Registered Nurse has
been recruited from the current fast-track staff to serve as case
manager for the spouse-patient dyads throughout the interven-
tion. The additional staff in the ward will be informed about
the intervention and will only be included through the coordi-
nation procedures if needed by the spouses.
The intervention will be carried out in three phases:
Before admission to the out-patient facilities (Table 1).
In addition to the pre-information meeting, the spouse-
patient dyads will take part in an interview with the
case manager who will assess the spouses needs during
admission. An individual care plan will be developed,
which will consist of and focus on problems, goals,
actions and follow-up.
During admission to the ward (Table 2). The case man-
agement component planning, assessing and coordinat-
ing will be performed by the case manager during the
morning of surgery and the first ward round after sur-
gery. Her tasks are to follow-up and assess the goals
and actions of the individual care plan and to coordi-
nate with other health professionals if the spouses wish
to be present at certain additional ward rounds or at
the exercise meeting with the physiotherapist. During
the discharge meeting, the case manager will give addi-
tional information to the spouse according to needs
assessed in the care plan. Furthermore, her task is to
teach the spouse techniques in changing the dressing,
observation of the wound, pain management, home
exercise etc.
After discharge (Table 3). The case manager will conduct
a follow-up telephone call for the spouse 34 days and
10 days after the patients discharge. The telephone call
will consist of information similar to that provided at the
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Table 1 The usual care given and the case management intervention elements provided before admission to the fast-track programme.
Usual care Case management intervention by case manager

Scheduled
meetings with
Trajectory the health Usual information given CM com-
timetable professionals to the patient ponent What is it about How to do it

Before The out- Pre-surgical Date of operation, None None None

admission patient planning surgical procedure and
facilities interview surgical complications
(with
surgeon)
Pre-admission Considerations according None None None
assessment to operation, need for
interview home care assessment,
(with nurse comorbidity, daily living
or licensed Written information
practical about the fast-track
nurse) trajectory and surgical
procedure
Pre- Prosthetics, surgical Assessment An assessment of the Interview of spouse with
information procedure and spouses need, during the patient present.
meeting Complications, sedation, and after the patients
(with ICU, needles, catheter, admission, for
surgeon, oxygen, drainage, days individualized
anaesthetist, of admission, visiting information and
nurse and hours, discharge criteria, participation at the ward
physical exercises before, during, rounds.
therapist) and after surgery and Planning Creating an individual The care plan will be
aids care plan for the spouse written by the case
during and after the manager, in
patients admission collaboration with both
regarding the spouses spouse and patient and
needs and teaching the the spouse will be
spouse techniques to provided with a copy.
support the patient in
their daily fast-track
treatment. The care plan
will be focusing on:
Problems
Goal
Actions
Follow-up
discharge meeting, support for the spouse and patient in actions were likely to have a positive effect. Check-lists that
problem-solving, assessment of the spouses psychosocial describe accurately which components must be provided at
well-being and the patients postsurgical issues and coor- a certain point in time will be developed for the case man-
dination regarding how the spouse can contact the case ager. Additional check-lists will be developed for the case
manager and other health professionals needed. manager to register which components were given at what
time to the spouses and for how long.
During the intervention the case manager will keep a
reflective diary of experiences and barriers and her observa-
Outcome measures and instruments
tions of which components and situations were successful
or not and in what way. These notes will provide important Primary outcome
information in the process evaluation of the intervention The primary outcome measure for patients is postdischarge
and will describe which components and case management functional status. Measurements of functional status include

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C.B. Berthelsen and J. Kristensson

Table 2 The usual care and the case management intervention elements provided during admission in the fast-track programme.
Usual care Case management intervention for spouses

Scheduled
meetings
with the
Trajectory health pro- Usual information given
timetable fessionals to the patient Component What is it about How to do it

During Day 1 of The Before surgery: Planning Follow-up on goals and Conversation
admission admission morning of Surgical procedure actions in care plan after with the spouse
surgery Momentary stay at ICU the patient comes back and with the
(with the Trajectory procedure from surgery patient present
nurse or After surgery: Assessment Assessing the spouses Conversation
licensed Mobilization after surgery individual goals with the spouse
practical Standardized medication Providing individual and with the
nurse) information about patient present
problems that occur
Coordination Communication with other Contacting
health professionals at the surgeons and
ward for spouses to be nurses
present at the ward rounds responsible for
concerning the patient. the patients
care
Day 2 of First ward About the surgical procedure, Planning Follow-up on goals and Conversation
admission round after the tubes attached (needles, actions in care plan after with the spouse
surgery catheter, oxygen, drainage), the patient comes back and with the
(with the dressing and cicatrices, the from surgery patient present
surgeon pain medication given and Assessment Assessing the spouses Conversation
and nurse) nutritional guidelines individual goals with the spouse
Providing individual and with the
information about patient present
problems that occur
Coordination Communication with other Contacting
health professionals at the surgeons and
ward for spouses to be nurses
present at the ward rounds responsible for
concerning the patient the patients
care
Exercise Introduction to exercises, Coordination Communication with the Contacting the
meeting written material about physiotherapist about the physiotherapist
(with exercises during admission spouses presence at the responsible for
physical and after discharge exercise meeting the patients
therapist) How to get in and out of bed exercise
Day 3 of The Tiredness after surgery, Information Information to the spouse Individual
admission discharge nutritional guidelines and according to the individual meeting with
preparation protein shakes, quitting pain care plan, regarding: the spouse and
meeting medication gradually, care of Wound observation with the
(with nurse swollen leg, bruises and Changing dressings patient present
or haemogens, risk of blood-clot, Pain management and
licensed changing dressings, avoiding medication
practical constipation and anti- Nutrition
nurse) coagulation Mobility/exercises
Follow-up calls

overall function and ability to perform the basic activities der, toilet use, transfer, mobility and stairs, will be mea-
of daily living (ADLs). Patients abilities to perform ADLs, sured by the Barthel-100 (Shah et al. 1989), which is a 10-
such as feeding, bathing, grooming, dressing, bowels, blad- item scale that ranges from unable to independent, resulting

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Table 3 The usual care and the case management intervention elements provided after discharge from the fast-track programme.
Usual care Case management intervention by case manager

Scheduled meetings
with the health Usual information
professionals given to the patient CM component What is it about How to do it

After discharge None None Information Overall information about Follow-up telephone call
what happens after discharge 34 days after discharge
and in the near future. 10 days after discharge
Information about how to
contact the case manager if
needed.
Support How the spouse can facilitate Follow-up telephone call
support to the patient in 34 days after discharge
areas such as exercise, pain 10 days after discharge
management, nutrition,
observation of the wound
Assessment Structured questions as a Follow-up telephone call
follow-up on the information 34 days after discharge
from the individual discharge 10 days after discharge
meeting with the spouse,
regarding:
psycho-emotional well-
being
patients current post-sur-
gical issues
Problem-solving If any problems occur Follow-up telephone call
regarding the patients or the 34 days after discharge
spouses well-being 10 days after discharge
Coordination Coordinating contact with Follow-up telephone call
health professionals if needed 34 days after discharge
by the patient or spouse 10 days after discharge

in a continuous total score ranging from 0100. A total

Secondary outcomes
score of 020 suggests total dependency, 2160 severe
The secondary outcome measures for patients will be nutri-
dependency, 6190 moderate dependency and 9199 slight
tional improvements, pain management, depression and
dependency and a score of 100 indicates totally indepen-
healthcare consumptions:
dent of assistance from others (Shah et al. 1989). Cron-
bachs coefficient alpha of internal consistency ranged from Nutritional improvements will be measured using the
0 870 93 (Shah et al. 1989). Mini Nutritional Assessment tool (MNA-SF) (Ruben-
The primary outcome for spouses was their caregiver sat- stein et al. 2001), which identifies possible malnourish-
isfaction. Spouses satisfaction with caring will be assessed ment or risk of malnutrition in geriatric patients aged
using the 30-item Carers Assessment of Satisfaction Index 65 and above (Kaiser et al. 2009). The instrument con-
(CASI) (Nolan et al. 1998). The 30 statements of issues that sists of six questions with a maximum screening score
gave the caregiver satisfaction were divided into five catego- of 14 points (1214: normal nutritional status; 811: at
ries (Fulfilling oneself through caring, A way of control- risk of malnutrition; 07: malnourished). A Youden
ling through caring, Widening my horizon through index (sensitivity + specificity-1) of at least 0
7 indi-
caring, Reciprocal engagement, Personal growth through cated good overall diagnostic accuracy (Kaiser et al.
caring) and there were four response alternatives to 2009).
whether it was true for the spouse (This is very true for Pain improvements will be measured using the separate
me, quite true for me, not very true for me and not at patient-relevant dimension of pain in the Hip Disability
all true for me) (Nolan et al. 1998). Cronbachs alpha val- and Osteoarthritis Outcome Score (HOOS) (Nilsdotter
ues for the factors in CASI varied from 0.760.83 (Ekwall et al. 2003). The HOOS pain dimension consists of 10
& Halberg 2007). items using a five-point Likert scale (no, mild, moder-

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C.B. Berthelsen and J. Kristensson
ate, severe, extreme). The HOOS is proved more useful
to evaluate patient-relevant outcomes after total hip
replacement and is more responsive than the generally
used WOMACK LK 3
0 (Nilsdotter et al. 2003).
The Geriatric Depression Scale (GDS-15) (Kurlowich
& Greenberg 2007) is a 15-item short form binary
reported measurement (yes or no), which will be used
to assess patients level of depression throughout the
trial. ROC curves showed a 92% sensitivity and 89%
specificity when evaluated against diagnostic criteria
(Kurlowich & Greenberg 2007).
Data on healthcare consumptions will be collected
from patient journals and national registers about acute
and planned inpatient and outpatient care, length of
stay, ICD-10 codes, emergency department visits and
home care visits during a total of 6 months for each
patient 3 months before the date of operation and
3 months after, consistent with the last follow-up date.
Secondary outcomes for spouses will be caregiving diffi-
culties and general anxiety.
Spouses difficulties in caring will be assessed through
15 items selected from the 30-item Carers Assessment
of Difficulties (CADI) (Nolan et al. 1990, 1998) in
three categories (The person I care for gives me prob-
lems, Social problems, Practical problems). The Taking into account a possible drop-out rate of approxi-
items were selected due to their appropriateness for
spouses to our category of patients. Four response
alternatives to whether the item was true for the spouse
was given (This is very true for me, quite true for
me, not very true for me and not at all true for me) Data will be analysed by means of descriptive and analyti-
(Nolan et al. 1998). Cronbachs alpha values for all the
factors in CADI varied from 0.600.89 (Ekwall & Hal-
berg 2007).
Generalized anxiety disorder (GAD-7) (L owe et al.
2008) will be used to assess spouses level of anxiety,
ranging from mild anxiety (05) to severe anxiety (17
21), during the trajectory and after patients discharge.
Cronbachs alpha of internal consistency was 0.92
(Spitzer et al. 2006).
Outcomes will be measured for both the control group
and the intervention group at baseline when the spouse-
patient dyads are recruited, 2 weeks after surgery for the
patients suture removal in the outpatient facilities and
3 months after discharge for the patients control of surgery
with the surgeon. The first author will collect all data from
the control group. Data from the intervention group will
be collected at baseline by the case manager and the
first author will collect data 2 weeks and 3 months after
1176
surgery, to avoid contamination. (Outcome measures,
instruments and time frame of assessments are illustrated in
Table 4).
The MMSE-test (Krner et al. 2008), Barthel-100 (Mari-
bo et al. 2006), MNA-SF (Nestl
e Nutrition Institute 2009),
HOOS (Beyer et al. 2008) and GDS-15 (Djernes et al.
2004) have all been validated in Danish. The instruments in
English: Charlson Comorbidity Index, CASI, CADI and
GAD-7 were validated by being translated back to English
after the Danish translation.
Statistical methods
Sample size
According to the primary endpoint of improving patients
postdischarge functional status, change will be measured and
compared in each group, assessed with Barthel-100 index, to
detect an increase of patients functional status of 7 points in
the intervention group (pre-test: 62 points, post-test: 69
points) and an increase of 3 points in the control group (pre-
test: 62 points, post-test: 65 points). According to a power
analysis using a two-tailed test of significance with an alpha
of 0
05 and a beta of 0
10 to detect the difference of 4 points
in ADL functional status (standard deviation = 3), a sample
size of 49 spouse-patient dyads is required in each group.
mately 1015% after 3 months of follow-up, this corre-
sponds to approximately 60 dyads in each group.
Statistical analysis
cal statistics. Comparisons will be made between groups
using baseline data and between and within groups using
data from the follow ups. Parametric tests will be used on
ratio data and non-parametric tests will be employed on
nominal and ordinal data or skewed ratio data. Intention-
to-treat analysis will be performed using the last observa-
tion carried forward principle.
Ethical considerations
The study has been approved by The Danish Data Protection
Agency (J.nr. 2013-41-2203). The Ethics Committee was
presented with the protocol and found no need for a formal
evaluation of the project. Prior to inclusion, the spouse-
patient dyads will be given oral and written information
about the SICAM-trial, the levels of participation and their
ethical rights of refusing to participate, withdrawing from
participation and their rights to anonymity. The spouses and
patients will be asked to give written informed consent prior
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Table 4 Outcome measures, instruments and time frame of assessments.

Measurements Instruments Time frame

Characteristics of the Cognitive status Mini-Mental State Examination Baseline

study population (MMSE)
Comorbidity status The Charlson Comorbidity Index Baseline
Primary outcome
Patients Functional status Activities of daily living Baseline
(Barthel-100) 2 weeks after discharge
3 months after discharge
Spouses Caregiver satisfaction Carers Assessment of Satisfaction Baseline
Index (CASI) 2 weeks after discharge
3 months after discharge
Secondary outcome
Patients Nutritional improvements Mini Nutrition Assessment Baseline
(MNA-SF) 2 weeks after discharge
Three months after discharge
Pain Management Patient-relevant dimension of pain Baseline
(HOOS) 2 weeks after discharge
3 months after discharge
Depression Geriatric Depression Scale Baseline
(GDS-15) 2 weeks after discharge
3 months after discharge
Healthcare consumptions Data collection from national 2 weeks after discharge
registers
Spouses Caregiver difficulties Carers Assessment of Difficulties Baseline
Index (CADI) 2 weeks after discharge
3 months after discharge
Anxiety General Anxiety Disorder Baseline
(GAD-7) 2 weeks after discharge
3 months after discharge

to allocation to the study. Patients will furthermore be asked
for written consent concerning their spouses participation
and for the retrieval of data about healthcare consumptions
from national registers. All data from the SICAM-trial will
be treated with confidentiality. The protocol, time frame,
information materials, instruments, publications and so forth
will be displayed on the trials home page, to keep informa-
tion accessible to the participants and others, as well as to
promote the SICAM-trial to the public.
not feasible in this study, we will enhance homogeneity
between the control and intervention group by using strict
inclusion criteria supported by the Mini-Mental State
Examination (Folstein et al. 1975) and Charlson Comorbid-
ity Index (Charlson et al. 1987). Data will furthermore be
collected on subject characteristics before the independent
variables. All instruments used for data collection have a
Cronbachs alpha from 0.600.93 or a specificity above
89% and a sensitivity above 92%.

Validity and reliability Discussion

To enhance validity all data will be collected through face-
to-face interviews with the spouse-patient dyads at baseline,
2 weeks after the patients surgery and 3 months after sur-
gery, when the dyads are present at the hospital. The
advantages of interviews over self-report questionnaires are
a higher response rate and the opportunity to bring clarity
to the questions asked (Polit & Beck 2008). Data from the
intervention group will be collected by the first author after
the intervention, instead of the case manager, to avoid con-
tamination of the dyads answers. As randomization was
We have presented a protocol explaining the SICAM-trial.
The study will give important evidence of the effect of
spouses involvement in older patients fast-track pro-
grammes through case management in relation to patients
postdischarge functional status and spouses caregiver satis-
faction. The intervention was based on grounded theories
about relatives, patients and health professionals patterns
of behaviour (Berthelsen 2013) and further builds on a sys-
tematic review of case management interventions to infor-
mal caregivers.

2015 John Wiley & Sons Ltd 1177

C.B. Berthelsen and J. Kristensson
The intervention will provide further evidence on the need
for relatives involvement and participation in the patients
orthopaedic trajectories. The results will contribute to educat-
ing health professionals in the necessity of including relatives
in fast-track programmes. The most significant outcome of
the study will be the older patients postdischarge functional
status measured with the Barthel-100 (Shah et al. 1989).
When patients receive a total hip replacement, rehabilitation
and ongoing mobility-enhancing exercise are essential to a
speedy recovery (Bandholm & Kehlet 2012, Kehlet 2013).
By now, the study has commenced and the first 10
spouse-patient dyads have been included in the control
group. Baseline measures and the first follow-up have been
performed and further recruitment and data collection is
well underway and working according to the protocol.
Limitations
There can be some disadvantages and possibilities of con-
founding factors by using a quasi-experimental design, such
as rival hypotheses competing with experimental manipula-
tion as explanations for the results. The plausibility of any
one threat cannot be answered unequivocally. It is usually a
situation where judgment must be exercised (Polit & Beck
2008). The strength of a quasi-experimental design is its
practical nature, which is needed in nursing research, where
innovative treatment is delivered to some people but not to
others (Shadish et al. 2002).
Our reason for choosing the quasi-experimental study
over a randomized controlled study was because of the pos-
sible contamination between the control and the interven-
tion group. Since the intervention is based on direct contact
with a case manager during admission, it would be difficult
to avoid information being given by the intervention group
to the participants in the control group. Studies show that
patients interact with each other during hospitalization and
share experiences and information (Birkelund & Larsen
2013, Larsen et al. 2014). By including first the control
group and second the intervention group we would be able
to limit this confounder.
Acknowledgements
We thank Angela Heath-Larsen for proof-reading this pro-
tocol.
Funding
The protocol is a part of first authors post doctoral research
project: The SICAM-trial: Spouses Involvement through
1178
Case Management. Improving older patients post-discharge
functional status after total hip replacement in fast-track pro-
grammes. The project has been funded by the NOVO Nordic
Foundation with a post doctoral fellowship grant (http://
www.novonordiskfonden.dk/en/grantrecipients?field_date_-
value%5Bvalue%5D%5Byear%5D=2012&field_date_valu
e_1%5Bvalue%5D%5Byear%5D=2013&field_related_cen-
ter_tid=90&keys=&=Search) and by the Health Scientific
Research Foundation of Region Sealand, Denmark through
three research grants.
Conflict of interest
No conflict of interest has been declared by the authors.
Author contributions
All authors have agreed on the final version and meet at
least one of the following criteria [recommended by the IC-
MJE (http://www.icmje.org/ethical_1author.html)]:
substantial contributions to conception and design,
acquisition of data, or analysis and interpretation of
data;
drafting the article or revising it critically for important
intellectual content.
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