Short summary

Spasticity is a servere symptom for many patients suffering from diseases of the central nervous system. Intrathechal baclofen via an implantable infusing systems is a highly specialized treatment to manage spasticity and allows individuel dosing through careful programming. Severely immobilized and cognitive impaired patients are often unaccompanied by caregivers to the hospital which leaves the hospital staff poor equiped to assess the effect of treatment.

Rationale

Background

Spasticity is a symptom of many diseases of the central nervous system, such as spinal cord injury, cerebral palsy, multiple sclerosis and stroke. The result is stiff muscles with reduced movement, severe disability and pain. Spasticity is treated with muscle relaxants like baclofen either orally or directly into the spinal canal through an implantable infusion system, called intrathecal baclofen treatment (ITB).

ITB requires the patient to visit the hospital 4-5 times per year for system checkups and medication refills. This makes severely immobilized and cognitively impaired patients with poor communication skills to travel to OUH, often unaccompanied, making it difficult to assess the patient's needs and effect of treatment. In addition, the stress and discomfort of the journey may exacerbate the spasticity, leading to suboptimal dosing and necessary information and education of caregivers is not possible.

During the corona epidemic, hospital visits have proved particularly challenging as most patients are fragile and at high risk. Therefore, the Department of Neurology, OUH has temporarily tested a ITB home service solution. This has previously been attempted in Denmark, but has always been discontinued, despite Dutch experiments showing that ITB home service result in high quality and safety and is cost-neutral. This emphasizes the need for more data on solutions for homecare treatment in Denmark.

Participatory design (PD) is a research method that has proven to be extremely suitable for health science issues and for creating and implementing new health technology solutions. PD requires a high degree of user involvement across sectors and involves both users of new solutions as well as the organization in which they are implemented. PD is therefore a research method that is well suited to projects involving interdisciplinary teams in health-related issues and is well suited to change, improve and present evidence behind clinical practice.

Aim

This project aim to design an ITB home service solution in collaboration with patients, caregivers and hospital staff and investigate how this can benefit the patient.

Methods:

By PD, the needs and possibilities of the users (patients, caregivers and nurse practitioners) are identified. The project is divided into the following phases:

Phase 1: Uncovering experiences with existing ITB home service solutions in Denmark and in the Netherlands. Individual semi-structured interviews with 2-5 patients, caregivers, nursing staff at residences and nurses in Denmark and the Netherlands about experiences with ITB treatment such as hospital visits and their needs and possibilities for a home treatment.

Phase 2: Design and develop a sustainable ITB home service solution. Data collected from Phase 1 will serve as a basis for designing a prototype. The home service solution will be developed in collaboration with nurses from OUH, patients and caregivers with an interest in the design process using workshops. The number of workshops is estimated at 3 but will depend on the process.

Phase 3: Test in clinical practice Adult patients treated with ITB at the Department of Neurology, OUH and their caregivers will be invited to participate. It is estimated that 45 patients and 45 caregivers can be included in the study. The ITB home treatment is performed in min. one year. Patients are estimated to receive min. 3 home visits in the test phase.

The home service solution is evaluated at inclusion and after one year through clinical scores of spasticity, a handheld portable spasticity assessment unit and the EQ-5D-5L questionaire of health-related quality of life. Knowledge about ITB is examined by individual semi-structured interviews with patients and caregivers. The nurses' perspectives on the ITB home care solution are evaluated using focus group interviews.

The socio-economic costs of transportion and time spend by caregivers will also be included in the evaluation.

Description of the cohort

Patients > 18 years of age treated with ITB at the department of Neurology, OUH ; Caregivers; Nursepractitioners and Physicians

Data and biological material

Diagnosis, age, gender, adress and medical treatment

Collaborating researchers and departments

Department of Neurology, Odense University Hospital

• Helle Hvilsted Nielsen, MD, Associate Professor, PhD

Medical Department, Odense University Hospital, Svendborg

• Post.Doc., PhD Anne Dichmann Sorknæs