Interprofessional Education for Venous Leg Ulcer Patients Clinical Trial
Official title:
A Targeted Interprofessional Education Intervention to Address Therapeutic Adherence of Venous Leg Ulcer Persons (TIEIVLU): Study Protocol for a Randomized Controlled Trail
Venous leg ulcers (VLU) are slow healing wounds. They have a high recurrence rate and are
associated with pain, infection, smell and exudate. 60% of VLU become chronic. Current
therapeutic approaches are multifaceted and focus on improving wound healing and preventing
recurrences. As those approaches include compression therapy, leg elevation, specific
exercises for the foot/ ankle region and a protein rich diet/ nutrition plan a
multidisciplinary team of health care professionals such as nursing, physiotherapy,
occupational therapy and nutrition specialists. Most persons with VLU have a knowledge
deficit in regards to therapeutic measures and hence have difficulties with adherence to
treatment protocols/ management plans. It is of utmost importance, and best practice, that
the treatment team provides effective patient education and support during the learning
phase.
However, there is little evidence and no published studies that describe and evaluate
effective multidisciplinary educational interventions that target compliance/ adherence to
the treatment plan in patients with VLU. Therefore the investigators propose to develop an
evidence-based interprofessional educational intervention and evaluate its feasibility first
in a pilot study and subsequently in a randomized controlled trail.
Method/Design: Firstly, the development of an evidence based education intervention in
collaboration with an expert panel and secondly a randomized controlled pilot study in one
wound care outpatient clinic is proposed. Data will be analyzed using SPSS version 23.
Univariate and bivariate analysis will be conducted according to the data level and
distribution of the data.
Discussion: The TIEIVLU will firstly develop an evidenced based educational intervention and
secondly examine the feasibility of implementing this education intervention in a realistic
care context in patients with VLU. The results will inform the final design of a following
RCT which will examine the effectiveness of the educational intervention. An intervention
that enhances patient adherence to therapy and hence reduces the negative outcomes of VLU
would be beneficial to individual patients as well as society as a whole.
Background: Venous leg ulcers (VLU) are slow healing wounds. They have a high recurrence rate
and are associated with pain, infection, smell and exudate. 60% of VLU become chronic. The
signs and symptoms of VLU are not only a burden on those who are affected by it but also on
the health care system and society in general. While the prevalence of VLU in the general
population is 1%, it rises to 3% in the over 80 age group. The cost of treatment and care for
VLU is estimated to be 2 to 3% of the overall health expenditure. Current therapeutic
approaches are multifaceted and focus on improving wound healing and preventing recurrences.
As those approaches include compression therapy, leg elevation, specific exercises for the
foot/ ankle region and a protein rich diet/ nutrition plan a multidisciplinary team of health
care professionals such as nursing, physiotherapy, occupational therapy and nutrition
specialists. Most person with VLU have a knowledge deficit in regards to therapeutic measures
and hence have difficulties with adherence to treatment protocols/ management plans. It is of
utmost importance, and best practice, that the treatment team provides effective patient
education and support during the learning phase.
However, there is little evidence and no published studies that describe and evaluate
effective multidisciplinary educational interventions that target compliance/ adherence to
the treatment plan in patients with VLU. Therefore the investigators propose to develop an
evidence-based interprofessional educational intervention and evaluate its feasibility first
in a pilot study and subsequently in a randomized controlled trail.
Method/Design: Firstly, the development of an evidence based education intervention in
collaboration with an expert panel and secondly a randomized controlled pilot study in one
wound care outpatient clinic is proposed. Data will be analyzed using SPSS version 23.
Univariate and bivariate analysis will be conducted according to the data level and
distribution of the data.
Discussion: The TIEIVLU will firstly develop an evidenced based educational intervention and
secondly examine the feasibility of implementing this education intervention in a realistic
care context in patients with VLU. The results will inform the final design of a following
RCT which will examine the effectiveness of the educational intervention. An intervention
that enhances patient adherence to therapy and hence reduces the negative outcomes of VLU
would be beneficial to individual patients as well as society as a whole.
;