TBM project: Intrathecal pump refills at home or at the hospital : a randomised multicenter cross-over trial

Chronic pain, with a prevalence ranging between 20% to 50%, presents a significant health burden associated with drastic reductions in health-related quality of life. Intrathecal analgesia through intrathecal drug delivery (IDD) is a therapeutic option for patients with prolonged periods of pain who do not achieve adequate analgesia despite high doses of opioids. After pump implantation, successful therapy requires pump refills at regular time intervals (4-6 times per year). These refills entail the transportation of severely immobilized patients to the hospital for a refill procedure of approximately 10 minutes, while these refill procedures could also be performed in the home-setting of patients through hospital-at-home. In this project, we propose to perform pump refill procedures at home, whereby a nurse performs the procedure at home under supervision of the physician in the hospital through telemonitoring as the new treatment strategy for patients with IDD. This allows us to tackle the high burden of transportation costs to the hospital, long waiting times, and increased pain due to transportation, by proceeding towards a more logical treatment trajectory to increase patient well-being. A multicenter randomized cross-over trial will be conducted to evaluate if intrathecal pump refills at home (Intervention) are better for patient comfort (Outcome) compared to intrathecal pump refills at the hospital (Comparison) in patients who receive IDD (Population). In total, patients will be included in the study during a period of 4 pump refills, whereby 2 refills will be performed at home and 2 at the hospital (randomized order). Besides patient comfort as primary outcome measure, several secondary outcome measurements will be collected namely quality of life,
perceived stress, anxiety, pain intensity, pain interference, self-efficacy, burden of caregivers, patient satisfaction, patient preference, effectiveness of the refill procedure, safety and health expenditure.