The IMPROVE study is a randomized, controlled, cross-over trial designed to compare intrathecal pump refills performed at home with those carried out in the hospital. Intrathecal drug delivery (IDD) is used in patients with chronic pain or severe spasticity. Use of IDD requires the performance of pump refills about 4-6 times a year which may be a burdensome and stressful experience for patients and their caregivers. Hospital visits can increase stress, pain, and caregiver strain, while early pilot studies suggest home-based refills may be both safe and more comfortable. Eighty-two adult patients in Belgium with an implanted intrathecal pump will be enrolled in the IMPROVE study. Each participant will undergo four refill procedures: two at home and two at the hospital, in randomized order.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Intrathecal pump refill procedure conducted at the hospital
Intrathecal pump refill procedure conducted at the home of the patient
UZ Brussel
Jette, Belgium
RECRUITINGPatient Comfort
Patient comfort is evaluated with the General Comfort Questionnaire (GCQ), a self-reported instrument consisting of 48 items that reflect the physical, spiritual, environmental and social dimension. Responses are rated on a four-point Likert scale ranging from "strongly disagree" to "strongly agree". Some items are reverse scored during data processing, with higher overall scores indicating greater levels of comfort.
Time frame: At baseline and immediately after each intervention.
Quality of life
The McGill Quality of Life Questionnaire (MQOL) will measure quality of life and consists of 17 questions. Higher scores reflect a better quality of life.
Time frame: At baseline and immediately after each intervention.
Health-related quality of life
The EuroQol with five dimensions and five levels (EQ-5D-5L) will be assessed to measure health-related quality of life. Higher scores reflect a better quality of life.
Time frame: At baseline and immediately after each intervention.
Pain intensity
The Visual Analogue Scale (VAS - 100 mm) in electronic format will be used for the assessment of current pain intensity.
Time frame: At baseline and immediately after each intervention.
Pain interference
The NIH-funded Patient-Reported Outcomes Measurement Information System Pain Interference measure assesses the impact of pain on key aspects of an individual's life. It evaluates the extent to which pain disrupts engagement in social, cognitive, emotional, physical, and recreational activities.
Time frame: At baseline and immediately after each intervention.
Stress
Saliva samples will be collected to measure cortisol levels with synthetic salivettes.
Time frame: 5 minutes before the refill, immediately after the refill and 10 minutes after the refill procedure.
Anxiety
Patient anxiety will be assessed through the State Trait Anxiety Inventory (STAI). This questionnaire consists of 40 Likert-type items on a four-point scale. Higher scores are indicating higher levels of anxiety.
Time frame: At baseline and immediately after each intervention.
Self-efficacy
The General Self-Efficacy (GSE) Scale is a 10-item self-report questionnaire used to assess perceived self-efficacy.
Time frame: At baseline and immediately after each intervention.
Caregiver burden
To evaluate caregiver burden, the Zarit Burden Interview (ZBI) questionnaire will be completed. This 12-item self-report instrument assesses caregiver burden and is a shortened version of the original 22-item Zarit Burden Scale. The total score ranges from 0 to 48, with higher totals reflecting more significant caregiver burden.
Time frame: At baseline and immediately after each intervention.
Patient satisfaction
Patient satisfaction is evaluated with a seven-point Likert scale asking the patient to rate the overall level of satisfaction with the refill at home.
Time frame: Immediately after each refill procedure at home (intervention).
Tele-monitoring quality
The quality of tele-monitoring will only be evaluated after a home-filling. This will be examined using three different Likert scales to score 1) quality of audio, 2) quality of video, and 3) overall quality of the teleconsultation.
Time frame: Immediately after each refill procedure at home (intervention).
Duration of refill
The time required for the full procedure will be recorded.
Time frame: Immediately after each intervention.
Safety of the refill procedure at home
Patients will evaluate the overall safety of the procedure using a seven-point Likert scale. In addition, the researcher will assess safety on three levels: (1) overall perceived safety of the procedure using a seven-point Likert scale; (2) environmental safety, assessed through an open-ended question addressing any situations perceived as unsafe; and (3) the ability to perform the procedure in a clean and sterile manner, also evaluated via an open-ended question.
Time frame: Immediately after each refill procedure at home (intervention).
Health expenditure
Expenditures related to in hospital care will be extracted from hospital claims data. All other healthcare-related costs will be gathered through telephone interviews with patients, conducted four weeks after the first and second medication refills. During these calls, researchers will ask patients whether they have had any medical consultations, hospital admissions, adverse events, changes in medication, or incurred any additional healthcare costs.
Time frame: Four weeks after the first and second intervention.
Patient preference
After the fourth refill procedure, patients will be asked to indicate their preference (refill at home, refill in the hospital, no preference or other) for the location of their refills in the future.
Time frame: Immediately after the final study intervention
Discrete choice experiment
After the fourth refill procedure, patients will be presented with a discrete choice experiment to evaluate their preferences across several scenarios.
Time frame: Immediately after the final study intervention
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