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We hypothesize that spouses involvement through case Characteristics of the sample will be assessed at baseline via
management in older patients fast-track programmes dur- questions about age, living conditions, number of medica-
ing total hip replacement can: tions, educational level and financial status, to enhance
Increase patients postdischarge functional status homogeneity in the intervention group and the control group.
Improve patients nutritional status The study sample will consist of spouse-patient dyads.
Decrease patients postsurgical pain Patients will be included if they are 65 years of age or older
Decrease patients level of depression and undergoing a total hip replacement due to arthritis. The
Decrease patients healthcare consumptions patients must live with their spouses and be able to speak,
Increase spouses caregiver satisfaction read and understand Danish without an interpreter. They
Decrease spouses caregiver difficulties cannot receive home care, be placed in a nursing home or be
Decrease spouses level of anxiety. permanent users of wheelchairs. Patients must furthermore
Duration
have their spouses present at the mandatory pre-information The usual care provided by the health professionals from
meeting in the outpatient facilities. The pre-information standardized daily routines during admission includes daily
meeting is standard procedure in fast-track programmes and goals and achievements relating to exercise, nutrition, pain
is designed to provide a two-hour information seance for management and discharge. The information consists of
patients and their relatives about surgical procedure, pain descriptions about the possible and specific problem areas
medication, anaesthetics, physiotherapy and the nursing that can occur after discharge, such as exercise and rehabili-
issues in the fast-track trajectory. Spouses will be included if tation, medical administration, changing dressings, changes
they fit the patient inclusion criteria. Exclusion criteria for in the appearance of the wound, signs of infection, pain
both spouses and patients is >24 assessed on the Mini-Mental administration, constipation and nutritional advice. Spouses
Stats Examination (MMSE) (Folstein et al. 1975) and/or a are invited to the pre-information meeting, but are seldom
Charlson Comorbidity Index score of <6 recommended by invited to participate in meetings where information is given
Charlson and colleagues (Charlson et al. 1987). during the patients admission, such as the ward rounds or
the discharge preparation meeting (Berthelsen et al. 2014a).
Recruitment of spouse-patient dyads
Firstly the control group will be included by the first author, Intervention case management
who is responsible for the recruitment and data collection of Spouses in the intervention group will receive usual care and
the control group and secondly the case manager will recruit information from the nursing staff, but with additional care
the intervention group according to our study design. and advice from the case manager. A Registered Nurse has
Recruitment procedures will be consistently performed to been recruited from the current fast-track staff to serve as case
include both control and intervention groups. The spouse- manager for the spouse-patient dyads throughout the interven-
patient dyads will be included at the pre-information meeting tion. The additional staff in the ward will be informed about
in the out-patient facilities. First, the patients charts will be the intervention and will only be included through the coordi-
checked for age and reason for surgery and we will ascertain nation procedures if needed by the spouses.
whether their spouse is present. The spouses and patients The intervention will be carried out in three phases:
meeting the inclusion criteria in the charts will receive verbal Before admission to the out-patient facilities (Table 1).
and written information about the study and will be invited In addition to the pre-information meeting, the spouse-
to participate in the study. The patients and spouses cogni- patient dyads will take part in an interview with the
tive status will be assessed on the 12-item Mini-Mental State case manager who will assess the spouses needs during
Examination test (MMSE) (Folstein et al. 1975), which is a admission. An individual care plan will be developed,
short assessment of the persons orientation to time and place which will consist of and focus on problems, goals,
and memory. The total score ranges from 0 (maximum cog- actions and follow-up.
nitive deficit) - 30 (no cognitive deficit). The patients and During admission to the ward (Table 2). The case man-
spouses comorbidity status will be assessed by the 19-item agement component planning, assessing and coordinat-
Charlson Comorbidity Index (Charlson et al. 1987) to pre- ing will be performed by the case manager during the
dict an expected reduction in life to less than 1 year by morning of surgery and the first ward round after sur-
100%. Each item is given a weighting of 16 and the sum of gery. Her tasks are to follow-up and assess the goals
weights ranges from 0107. If both patient and spouse have and actions of the individual care plan and to coordi-
a MMSE-score of <25 and a Charlson Comorbidity Score of nate with other health professionals if the spouses wish
>5 they will be asked to give informed consent for participa- to be present at certain additional ward rounds or at
tion. If one of them does not pass the dyad will be excluded. the exercise meeting with the physiotherapist. During
the discharge meeting, the case manager will give addi-
tional information to the spouse according to needs
The trial intervention
assessed in the care plan. Furthermore, her task is to
The control group usual care and information teach the spouse techniques in changing the dressing,
Spouses and patients in the control group will receive usual observation of the wound, pain management, home
care and written and oral information about the fast-track exercise etc.
programme and principles in general from the nursing staff. After discharge (Table 3). The case manager will conduct
The usual care and information is provided before admis- a follow-up telephone call for the spouse 34 days and
sion in the out-patient facilities (Table 1) and during admis- 10 days after the patients discharge. The telephone call
sion (Table 2). will consist of information similar to that provided at the
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
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
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
ate, severe, extreme). The HOOS is proved more useful surgery, to avoid contamination. (Outcome measures,
to evaluate patient-relevant outcomes after total hip instruments and time frame of assessments are illustrated in
replacement and is more responsive than the generally Table 4).
used WOMACK LK 30 (Nilsdotter et al. 2003). The MMSE-test (Krner et al. 2008), Barthel-100 (Mari-
The Geriatric Depression Scale (GDS-15) (Kurlowich bo et al. 2006), MNA-SF (Nestle Nutrition Institute 2009),
& Greenberg 2007) is a 15-item short form binary HOOS (Beyer et al. 2008) and GDS-15 (Djernes et al.
reported measurement (yes or no), which will be used 2004) have all been validated in Danish. The instruments in
to assess patients level of depression throughout the English: Charlson Comorbidity Index, CASI, CADI and
trial. ROC curves showed a 92% sensitivity and 89% GAD-7 were validated by being translated back to English
specificity when evaluated against diagnostic criteria after the Danish translation.
(Kurlowich & Greenberg 2007).
Data on healthcare consumptions will be collected Statistical methods
from patient journals and national registers about acute
and planned inpatient and outpatient care, length of Sample size
stay, ICD-10 codes, emergency department visits and According to the primary endpoint of improving patients
home care visits during a total of 6 months for each postdischarge functional status, change will be measured and
patient 3 months before the date of operation and compared in each group, assessed with Barthel-100 index, to
3 months after, consistent with the last follow-up date. detect an increase of patients functional status of 7 points in
the intervention group (pre-test: 62 points, post-test: 69
Secondary outcomes for spouses will be caregiving diffi- points) and an increase of 3 points in the control group (pre-
culties and general anxiety. test: 62 points, post-test: 65 points). According to a power
Spouses difficulties in caring will be assessed through analysis using a two-tailed test of significance with an alpha
15 items selected from the 30-item Carers Assessment of 005 and a beta of 010 to detect the difference of 4 points
of Difficulties (CADI) (Nolan et al. 1990, 1998) in in ADL functional status (standard deviation = 3), a sample
three categories (The person I care for gives me prob- size of 49 spouse-patient dyads is required in each group.
lems, Social problems, Practical problems). The Taking into account a possible drop-out rate of approxi-
items were selected due to their appropriateness for mately 1015% after 3 months of follow-up, this corre-
spouses to our category of patients. Four response sponds to approximately 60 dyads in each group.
alternatives to whether the item was true for the spouse
was given (This is very true for me, quite true for Statistical analysis
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 cal statistics. Comparisons will be made between groups
factors in CADI varied from 0.600.89 (Ekwall & Hal- using baseline data and between and within groups using
berg 2007). data from the follow ups. Parametric tests will be used on
ratio data and non-parametric tests will be employed on
Generalized anxiety disorder (GAD-7) (L owe et al.
2008) will be used to assess spouses level of anxiety, nominal and ordinal data or skewed ratio data. Intention-
ranging from mild anxiety (05) to severe anxiety (17 to-treat analysis will be performed using the last observa-
21), during the trajectory and after patients discharge. tion carried forward principle.
Cronbachs alpha of internal consistency was 0.92
(Spitzer et al. 2006). Ethical considerations
Outcomes will be measured for both the control group The study has been approved by The Danish Data Protection
and the intervention group at baseline when the spouse- Agency (J.nr. 2013-41-2203). The Ethics Committee was
patient dyads are recruited, 2 weeks after surgery for the presented with the protocol and found no need for a formal
patients suture removal in the outpatient facilities and evaluation of the project. Prior to inclusion, the spouse-
3 months after discharge for the patients control of surgery patient dyads will be given oral and written information
with the surgeon. The first author will collect all data from about the SICAM-trial, the levels of participation and their
the control group. Data from the intervention group will ethical rights of refusing to participate, withdrawing from
be collected at baseline by the case manager and the participation and their rights to anonymity. The spouses and
first author will collect data 2 weeks and 3 months after patients will be asked to give written informed consent prior
to allocation to the study. Patients will furthermore be asked not feasible in this study, we will enhance homogeneity
for written consent concerning their spouses participation between the control and intervention group by using strict
and for the retrieval of data about healthcare consumptions inclusion criteria supported by the Mini-Mental State
from national registers. All data from the SICAM-trial will Examination (Folstein et al. 1975) and Charlson Comorbid-
be treated with confidentiality. The protocol, time frame, ity Index (Charlson et al. 1987). Data will furthermore be
information materials, instruments, publications and so forth collected on subject characteristics before the independent
will be displayed on the trials home page, to keep informa- variables. All instruments used for data collection have a
tion accessible to the participants and others, as well as to Cronbachs alpha from 0.600.93 or a specificity above
promote the SICAM-trial to the public. 89% and a sensitivity above 92%.
The intervention will provide further evidence on the need Case Management. Improving older patients post-discharge
for relatives involvement and participation in the patients functional status after total hip replacement in fast-track pro-
orthopaedic trajectories. The results will contribute to educat- grammes. The project has been funded by the NOVO Nordic
ing health professionals in the necessity of including relatives Foundation with a post doctoral fellowship grant (http://
in fast-track programmes. The most significant outcome of www.novonordiskfonden.dk/en/grantrecipients?field_date_-
the study will be the older patients postdischarge functional value%5Bvalue%5D%5Byear%5D=2012&field_date_valu
status measured with the Barthel-100 (Shah et al. 1989). e_1%5Bvalue%5D%5Byear%5D=2013&field_related_cen-
When patients receive a total hip replacement, rehabilitation ter_tid=90&keys=&=Search) and by the Health Scientific
and ongoing mobility-enhancing exercise are essential to a Research Foundation of Region Sealand, Denmark through
speedy recovery (Bandholm & Kehlet 2012, Kehlet 2013). three research grants.
By now, the study has commenced and the first 10
spouse-patient dyads have been included in the control
Conflict of interest
group. Baseline measures and the first follow-up have been
performed and further recruitment and data collection is No conflict of interest has been declared by the authors.
well underway and working according to the protocol.
Author contributions
Limitations
All authors have agreed on the final version and meet at
There can be some disadvantages and possibilities of con- least one of the following criteria [recommended by the IC-
founding factors by using a quasi-experimental design, such MJE (http://www.icmje.org/ethical_1author.html)]:
as rival hypotheses competing with experimental manipula-
tion as explanations for the results. The plausibility of any substantial contributions to conception and design,
one threat cannot be answered unequivocally. It is usually a acquisition of data, or analysis and interpretation of
situation where judgment must be exercised (Polit & Beck data;
2008). The strength of a quasi-experimental design is its drafting the article or revising it critically for important
practical nature, which is needed in nursing research, where intellectual content.
innovative treatment is delivered to some people but not to
others (Shadish et al. 2002). References
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