Cost-effectiveness of specialized nursing interventions for patients with Parkinson*s disease

Despite optimal medical management with medication or brain surgery, most
patients with Parkinson*s disease (PD) experience progressive disability that
increasingly influences their quality of life. This creates tremendous
challenges in advanced disease stages, and even early in the course of PD.
There is increasing evidence that non-pharmacological management offers
symptomatic relief of symptoms that are otherwise difficult to treat. For this
an integral, multidisciplinary approach is needed, in which, among others, the
Parkinson's Disease Nurse Specialist (PDNS) plays an essential role. The PDNS
was introduced to bridge the gap between medical management and the unique
personal needs of patients. The recent Dutch guideline on PDNS care (2015)
clearly describes the roles of a PDNS, including diagnostic strategies (e.g.
detection of urinary retention or orthostatic hypotension) and therapeutic
interventions (e.g. optimising medication compliance, or strategies to
alleviate orthostatic intervention). Also, the PDNS assists patients and carers
in their selfmanagement, need of support, information, access to services and
coordination of care.

The Dutch Multidisciplinary Guideline for PD recommends that each PD patient
should have access to PDNS care. Based on this recommendation, almost all Dutch
hospitals now offer PDNS treatment to their patients. However, many hospitals
lack the nursing capacity that is needed to offer PDNS care to all patients,
creating an undesirable inequality in access to care. Consequently, care
delivery remains suboptimal, fragmented and ineffective for many patients,
presumably leading to unnecessary disability and avoidable costs.

Crucially, this situation offers a unique opportunity to now, for the first
time, study the cost-effectiveness of PDNS intervention. Indeed, existing
evidence indicates that PDNS care may improve patient wellbeing, physical
functioning and general health status, and reduce anxiety and depression. Also,
scenario analyses (performed to estimate the potential cost-effectiveness of
PDNS intervention) showed that PDNS treatment can be cost-effective, provided
the patients* quality of life improves. Furthermore, expert opinion dictates
that all PD patients can benefit from PDNS intervention, including those with
early-stage disease where e.g. delivery of information, advice about exercise,
education about medication compliance, and support in self-management are
critical. However, there is little evidence to show that quality of life
actually improves after PDNS intervention.

Therefore, here we will study the cost-effectiveness of treatment by a PDNS. We
expect that the results will show higher quality of life of patients with PD
and reduced caregiver burden, hopefully leading to broad implementation of PDNS
care and consequently equal access to care for all patients with PD.

We aim to study the cost-effectiveness of specialized nursing care provided by
a Parkinson Disease Nurse Specialist (PDNS) as compared to no PDNS care for
patients with Parkinson's disease in all disease stages.

We will also perform a subgroup analysis to gain more insight into the exact
interventions used per disease stage and the effects of PDNS care in these
different groups of patients:
- Disease duration of <5 years (early, relatively uncomplicated phase)
- Disease duration of 5-10 years (phase of response fluctuations)
- Disease duration of >10 years (complicated phase)

Our expectation is that offering more patients access to a PDNS will, in line
with literature, lead to higher quality of life with equal costs. Increasing
direct medical costs (for nurse staffing) will be offset by a reduced number of
visits to the neurologist and telephone consultations with the general
practitioner. These short-term goals are the focus of the present project
proposal. In addition to these short-term effects, we also expect that
long-term benefits may arise, including a reduction in the number of nursing
home admissions. If such effects can indeed be demonstrated, then this will
reduce total costs substantially. However, this latter hypothesis related to
the long-term benefits will not be tested in the present study.

We will perform an 18-month Randomized Controlled Trial (RCT) in eight regional
community hospitals in the Netherlands. We consider this a monocenter study,
because all research activities are carried out by a researcher from the
Radboudumc. The neurologists in the community hospitals only refer patients for
inclusion and are not included in the research team.

We have selected hospitals where, due to lack of sufficient PDNS staff, only a
proportion of PD patients currently has access to PDNS care:
- Maasziekenhuis Pantein in Boxmeer
- Gelre Ziekenhuis in Zutphen
- BovenIJ Ziekenhuis in Amsterdam
- Careyn/St. Antonius Ziekenhuis in Utrecht
- Waterlandziekenhuis in Purmerend
- Rode Kruis Ziekenhuis in Beverwijk
- TweeSteden/Elisabeth Ziekenhuis in Tilburg
- Maxima Medisch Centrum in Eindhoven

This gives us a unique opportunity to identify patients who currently have no
access to PDNS care, and to randomize them within hospitals, and at the patient
level, between PDNS care versus no nursing care. A total of 240 patients (and
their caregivers) will be included, which means 30 patients in each hospital.
Eligible patients will be allocated randomly using a computerized sequence, in
a 1:1 ratio, to either PDNS care or no nursing intervention. A blinded
researcher from the Radboudumc will perform an assessment of PD motor symptoms
(Movement Disorders Society-sponsored revision of the Unified Parkinson*s
Disease Rating Scale), mobility (Timed up and Go Test) and bradykinesia
(Pegboard Test) at three time points: at baseline, prior to randomization (t0),
after 12 months (t1) and after 18 months (t2). Caregivers will be asked whether
they also agree to fill out questionnaires. Subsequently, patients and their
caregivers will complete online questionnaires (e.g. about non-motor symptoms
and caregiver burden) at home at t0, t1 and t2. Furthermore, patients and their
caregivers will complete a short questionnaire about healthcare utilization and
healthcare costs every three months.

Importantly, for the purpose of this study, we will implement an increase in
nursing staff capacity of the existing nurses in the participating hospitals.
This will allow us to study the real impact of current usual care (this could
not be achieved by adding a new set of specifically trained research nurses to
the existing PDNS staff). These PDNSs are all graduated nurses (education level
according to the European Qualifications Framework 6 or 7) with a certificate
in Parkinson*s Nursing. Furthermore, they have achieved a standard of
competences as described in the PD guideline.

The PDNS intervention will be performed according to the Dutch Guideline on
PDNS care (2015). The intervention is not standardized, but tailored to the
patients* and caregivers* needs. This includes the following aspects:

1. Assessment of individual care needs of PD patients and their caregivers. The
PDNS performs a specific nursing assessment related to the medical, physical,
psychological and social domains.
2. Development of a patient-centered treatment plan that supports patients and
caregivers in self-management. The PDNS composes a multidisciplinary care plan,
based on the results of the assessments, and as prioritized by the patient and
caregiver themselves (shared decision making).
3. Specific nursing interventions. The nursing intervention varies across
different disease stages and are always tailored to the specific problems and
needs of individual patients and their caregivers. The PD nursing guideline
describes specific interventions for the following problems: mental functions,
fatigue, sleep, urogenital functions, sexuality, medication adherence,
orthostatic hypotension, caregiver burden, coping, mobility,
self-management, and dietary issues. Three general important PDNS nursing
interventions include providing information and education, disease management
(e.g. monitoring treatment effects, considering advanced treatment options such
as Deep Brain Stimulation) and monitoring (e.g. screening for motor- and
non-motor symptoms, caregiver burden).
4. Collaboration with other healthcare professionals. The PDNS stimulates and
supports multidisciplinary collaboration between healthcare professionals based
on the individual patient-centered plan.

Patients have regular contact with their PDNS about the progress and
realization of their personal goals, mostly by telephone, but also during
face-to-face contacts and sometimes during additional home visits. The optimal
frequency of contact varies, depending on the disease stage and individual
needs and preferences.

The control group will continue usual care that is otherwise comparable, but
without a nursing intervention. Specifically, there are no restrictions to any
other medical treatments or contact with other healthcare professionals.
Comparable care can be achieved by randomizing comparable patients within
hospitals, so that other important elements (including in particular the
treating neurologist) remain identical between the two intervention arms.

The burden for patients is limited and consists of the following:
-Three visits to the researcher during the research period (in the patient's
own hospital), taking approximately 60 minutes each visit
- Completing questionnaires at home three times during the study period
(baseline, after 12 months and after 18 months), taking approximately 60
minutes each time. For caregivers this will take approximately 30 minutes each
time. This can be done online or on paper.
- Completing a questionnaire about healthcare utilization and costs every three
months during the study period. This questionnaire will take approximately 30
minutes to complete for patients, and 20 minutes for caregivers.

The vast majority of the questionnaires can be completed at home, online or on
paper.

The intervention evaluated in this study is non invasive and of very low risk,
which therefore causes the risks associated with this study to be negligible.
The risk not associated with the intervention itself, but rather with the
organization of PDNS care in the Netherlands, consists of the following: during
the study, each hospital receives budget to increase their PDNS capacity to
provide care to 15 patients in the intervention group. However, when the study
is finished, there is a chance that PDNS care for these patients will be
cancelled because the extra nursing capacity is no longer paid by the study.
Each hospital will, in the end, make its own decisions regarding the
continuation of care for the patients participating in the study. The 15
patients in the control group will not be allowed to receive PDNS care during
the study period.

However, PDNS care is currently only partially implemented in the Netherlands,
and therefore not 'usual care'. The 240 patients included in this study do not
receive PDNS care at the moment, mainly due to a lack of scientific evidence of
its cost-effectiveness. With positive results, it is more likely that PDNS care
will be further implemented for all PD patients. In addition, it is possible
that, in the case of positive patient experiences, participating hospitals will
increase their own budget for increasing PDNS capacity. Furthermore, besides
PDNS care, there are no restrictions to other medical treatments for the
patients in the control group, and they can visit all other available
healthcare providers (such as physiotherapists or psychologists).