Intrathecal Pump Refill
Conditions
Keywords
Intrathecal drug delivery, intrathecal pump therapy, neuromodulation, refill, patient comfort, telemedicine, remote care, hospital to home transition
Brief summary
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.
Interventions
PROCEDURERefill at the hospital
Intrathecal pump refill procedure conducted at the hospital
PROCEDURERefill at home
Intrathecal pump refill procedure conducted at the home of the patient
Sponsors
Moens Maarten
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
Only the statistician will be masked to the acquired data.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Actively receiving Intrathecal drug delivery * Stable medication dosage for at least 3 months * Dutch, French or English speaking adults
Exclusion criteria
* Life expectancy \< 6 months * Patients planned for but not yet received Intrathecal drug delivery implant * No residence in Belgium
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Comfort | At baseline and immediately after each intervention. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | At baseline and immediately after each intervention. | 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. |
| Health-related quality of life | At baseline and immediately after each intervention. | 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. |
| Pain intensity | At baseline and immediately after each intervention. | The Visual Analogue Scale (VAS - 100 mm) in electronic format will be used for the assessment of current pain intensity. |
| Pain interference | At baseline and immediately after each intervention. | 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. |
| Stress | 5 minutes before the refill, immediately after the refill and 10 minutes after the refill procedure. | Saliva samples will be collected to measure cortisol levels with synthetic salivettes. |
| Anxiety | At baseline and immediately after each intervention. | 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. |
| Self-efficacy | At baseline and immediately after each intervention. | The General Self-Efficacy (GSE) Scale is a 10-item self-report questionnaire used to assess perceived self-efficacy. |
| Caregiver burden | At baseline and immediately after each intervention. | 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. |
| Patient satisfaction | Immediately after each refill procedure at home (intervention). | 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. |
| Tele-monitoring quality | Immediately after each refill procedure at home (intervention). | 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. |
| Duration of refill | Immediately after each intervention. | The time required for the full procedure will be recorded. |
| Safety of the refill procedure at home | Immediately after each refill procedure at home (intervention). | 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. |
| Health expenditure | Four weeks after the first and second intervention. | 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. |
| Patient preference | Immediately after the final study intervention | 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. |
| Discrete choice experiment | Immediately after the final study intervention | After the fourth refill procedure, patients will be presented with a discrete choice experiment to evaluate their preferences across several scenarios. |
Countries
Belgium
Contacts
CONTACTMaarten Moens, MD PhD
CONTACTLisa Goudman, PhD
Outcome results
None listed