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The aim of this pilot study is to evaluate the feasibility, safety and effectiveness of intrathecal pump refill procedures at home. It is our hypothesis that a refill at home will be safe, effectiveness and feasible, as is demonstrated in The Netherlands, and preferred by patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refill at home | Experimental | Patients will have one pump refill at home instead of at the hospital. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pump refill procedure at home | Procedure | Implantable pump refill is performed at home |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | A seven-point Likert scale asking the patient to rate the overall level of satisfaction with the refill at home will be used. | Once, at the moment of the study visit, immediately after the pump refill |
| Successful pump refill | A binary variable to indicate success or failure of this intervention, reported by the physician. | Once, at the moment of the study visit, immediately after the pump refill |
| Patient safety | A seven-point Likert scale asking the patient to rate the overall level of safety with the refill at home will be used. | Once, at the moment of the study visit, immediately after the pump refill |
| Physician safety | A seven-point Likert scale asking the physician to rate the overall level of safety with the refill at home will be used. | Once, at the moment of the study visit, immediately after the pump refill |
| Measure | Description | Time Frame |
|---|---|---|
| Environmental safety | An open question in which the physician can indicate whether there were any situations that were not safe. | Once, at the moment of the study visit, immediately after the pump refill |
| Clean, sterile procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Jette | 1090 | Belgium |
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An open question in which the physician can mention all potential risks.
| Once, at the moment of the study visit, immediately after the pump refill |
| An objective confirmation of correct injection in the pump by ultrasound. | After the refill procedure is performed, an ultrasound will be made to visually ensure that the refill was correctly performed without loss of liquor outside the pump. | Once, at the moment of the study visit, immediately after the pump refill |
| Adverse events | All adverse events will systematically be reported by the physician. | Once, at the moment of the study visit, immediately after the pump refill |
| Patient feasibility | A seven-point Likert scale asking the patient to rate the overall level of feasibility with the refill at home will be used. | Once, at the moment of the study visit, immediately after the pump refill |
| Quality of teleconsultant connection by teleconsultant | Quality of the internet connection will be evaluated by the teleconsultant. | Once, at the moment of the study visit, immediately after the pump refill |
| Time burden for teleconsultant | The time will be measured from the beginning until the end of the call. | Once, at the moment of the study visit, immediately after the pump refill |
| Physician feasibility | A seven-point Likert scale asking the physician to rate the overall level of feasibility with the refill at home will be used. | Once, at the moment of the study visit, immediately after the pump refill |
| Quality of teleconsultant connection by physician | Quality of the internet connection will be evaluated by the physician. | Once, at the moment of the study visit, immediately after the pump refill |
| Time burden for physician | The time will be measured from the beginning until the end of the call. | Once, at the moment of the study visit, immediately after the pump refill |
| Patient preference | Patients will be asked to indicate whether they prefer to have their next refill at home. | Once, at the moment of the study visit, immediately after the pump refill |