The aim of the project is to investigate whether the Nova contributes to cost-effective, client-oriented incontinence care for people with a profound disability, based on a cluster randomized study with a waiting list control group and a pragmatic…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of leaks (subdivided into leaks with change of clothing and / or
bedding) per client per week is the primary outcome measure. Leaks with
associated changing activities are very disruptive for clients. Moreover, this
has the most impact on the workload (changing clothes and bedding is
time-intensive and physically demanding) of caregivers.
Secondary outcome
Quality of life of the client
Quality of life (Mood Interest and Pleasure Questionnaire (MIPQ) recommended in
the "Basic Minimum Data Set for intellectual disability of ZonMw") is an
important secondary outcome measure. The MIPQ has been developed to validate
and evaluate the state of mind of adults with profound multiple disabilities in
a valid and reliable way through observation. The MIPQ will be completed by
both the caregiver and an informal caregiver.
Work-related well-being
Work-related well-being will be assessed by means of an interview with the care
providers (qualitative data). Topics include experienced work pace and work
quantity, involvement, job satisfaction, interactions with colleagues, mental
and physical strain.
Parameters incontinence care
During the study, data on incontinence care will be collected at all
measurement moments during one week in both the intervention condition (use of
the Nova) and in the waiting list control condition (standard care): number of
changes per 24 hours; number of unnecessary changes; time investment of a
change; skin health and any skin problems / care for skin problems; material
and washing costs. This data are also important for the cost-effectiveness and
utility analysis.
Cost-effectiveness analysis
The economic evaluation concerns a combination of a cost-effectiveness analysis
(KEA) and a cost-utility analysis (KUA). In the KEA, the incremental
cost-effectiveness ratio (IKER) is expressed as the incremental cost per
improvement on number of leaks per week.
Background summary
Incontinence is common in long-term care for people with disabilities. Clients
with profound multiple disability are often incontinent and, due to a low
developmental age, cannot go to the toilet independently and cannot feel and /
or make clear that change is necessary. The project is based on a practical
need for client-oriented incontinence care for urine. The current standard
incontinence care consists of fixed change rounds in which all clients are
changed on fixed times. This results in a number of disadvantages: (1) leaks
occur, which means that not only the incontinence care productl but also all
clothing and commandments must be changed, costs extra time, demands a lot from
the client (stress, anxiety) and the care provider (time-intensive, physically
demanding) and leave less time for non-incontinence-related care aspects; (2)
change takes place before the incontinence care product is not yet saturated,
causes extra stress for clients and for caregivers causing heavy labor; (3)
Clients wear saturated incontinence care productsl for too long, which causes
skin irritations and requires extra time and resources for example wound care
The current project aims to optimize incontinence care for people with profound
disabilities - who cannot feel for themselves or indicate that change is needed
- by using an innovative incontinence care product equipped with a sensor (the
Abena Nova).
Hypothesis
Sustainable implementation of the Abena Nova reduces the number of leaks, with
associated disruptive change work on clothing and / or bedding. This improves
the quality of life of clients and the work-related well-being of caregivers
and reduces healthcare costs compared to a regular incontinence care product
that does not contain a sensor
Study objective
The aim of the project is to investigate whether the Nova contributes to
cost-effective, client-oriented incontinence care for people with a profound
disability, based on a cluster randomized study with a waiting list control
group and a pragmatic step-by-step implementation at six disability care
institutions. The study consists of four parts:
1. Implementation process: process evaluation of sustainable implementation of
the Nova in the care for people with a profound disability
2. Effect: effectiveness of the Nova on the number of leaks, the quality of
life of clients and on the work-related well-being of care providers
3. Efficiency: cost-effectiveness and cost-utility measurements of healthcare
costs
4. Knowledge dissemination: broad dissemination of the knowledge resulting from
this project, also outside the intramural care setting
Study design
The study design takes into account the context of the care of people with
disabilities and therefore a cluster randomized study with a waiting list
control group and a pragmatically step-by-step implementation has been chosen.
The cost-effectiveness of the Nova is examined compared to standard care in
which regular care is provided with incontinence care products without a
sensor.
In month 6 of the study, the 6 participating institutions (6 clusters) are
randomized to the intervention condition (3 months use of the Nova) or to the
waiting list control condition (3 months of standard incontinence care and then
3 months use of the Nova). Measurements are made in both conditions before the
start of the use of the Nova / start of the waiting list (T0), after 1.5 months
(T1) and after three months of the use of the Nova or three months waiting list
(T2). For the cost-effectiveness analysis, a follow-up measurement (T3) takes
place after 6 months in the first two intervention conditions. This measurement
takes place in the natural setting. During the follow-up period there will no
longer be any supervision from the project team.
As indicated, the design is approached pragmatically:
Waiting list control condition: Each participating care institution has
indicated that they want to implement the Nova. By using a waiting list control
condition, a possible improvement in client-oriented incontinence care is only
postponed for the institutions in the waitinglist control condition, not
withheld. Ultimately the Nova will be implemented within each participating
care institution. From an ethical point of view, this does not compromise the
quality of care within the six institutions.
Cluster randomization: Implementation has been chosen at the institutional
level (not at the individual level). Optimally implementing the Nova requires
changes in the organization of care. Instead of routine care, the Nova offers
the possibility of providing client-oriented care. For an optimal
implementation, an entire department must be included in this change process.
Step-by-step implementation: Three pairs are created in chronological order of
randomization, a care institution that is assigned to the intervention
condition is linked to a care institution that is assigned to the waiting list
control condition. The implementation of the Nova within these three pairs
takes place in stages. Through this step-by-step implementation, we promote
learning during the study, lessons learned at one care institution can be used
to optimize implementation in the next care institution. In addition,
simultaneously implementing the Nova within multiple care institutions is
labor-intensive and makes the research too expensive.
Intervention
The Abena Nova makes client-oriented incontinence care possible. Thanks to
MediSens Wireless's sensor technology, the moisture content in the incontinence
care product can be accurately measured to the milliliter, thereby determining
the degree of saturation. When a threshold value is reached, the care provider
receives a message via a special app indicating that change of the incontinence
care product has to happen. A suitable threshold value of saturation is
determined for each client in order to meet individual needs. Clients who have
incontinence injury can, for example, be changed when the incontinence care
product is less saturated. The use of the Nova naturally goes hand in hand with
adjustments in the organization of care. These are also part of the project.
Study burden and risks
In the current study, the Abena Nova is offered as regular care with the
benefit that incontinence care is more tailored to the needs of the client.
Should the use of Abena Nova in any way cause inconvenience to the client, the
standard incontinence care product without sensor can immediately be used
again.
A possible burden associated with participation in the study, is the time
investment for caregivers. Over a period of three month, three assessment
moments are planned. Each moment requires about 2 hours of assessment spread
over one week.
No other disadvantages/risks are known
Kemperbergerweg 139e
Arnhem 6816RP
NL
Kemperbergerweg 139e
Arnhem 6816RP
NL
Listed location countries
Age
Inclusion criteria
Clients with a severe multiple disability
Clients who cannot feel themselves and / or indicate that change of
incontinence care product is necessary.
The care provider (in consultation with the client's legal representative)
indicates that the use of the Abena Nova meets the care needs of the client.
Healthcare providers
Healthcare provider who provides care for a client who participates in this
study and is willing to collect data: number of leaks, quality of life of the
client through observation, and anwering questions on work-related well-being
Informal caregiver
An informal caregiver of a participating client who is willing to evaluate the
quality of life of the client through observation.
Exclusion criteria
not applicable, ref. inclusion criteria
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72751.091.20 |