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Clinical Trial Summary

Hotspotters are patients with complex care needs, defined by problems in multiple life domains and high acute care use. These patients often receive mismatched care, resulting in overuse of care and increased healthcare costs. Reliable data on (cost-)effective interventions for these patients are scarce. The goal of this study is to assess the cost-effectiveness of pro-active and integrated care. This approach includes: an intake consultation with Positive Health; multidisciplinary meetings with physician, mental healthcare nurse, social worker and the patient; a personalised care plan and proactive care management. We aim to include 200 patients, divided over 20 primary care practices.


Clinical Trial Description

People with complex problems on multiple life domains, so called 'hotspotters', receive fragmented care. This is difficult to manage by patients and care providers , leading to little effect of care and persistent unmet needs. The accumulation and complexity of problems often leads to high medical expenses. Next to their high medical spending levels, hotspotters´ experiences with the healthcare system are low as the healthcare system is not (yet) successful in dealing with their needs. Interventions aimed at the complex situation of hotspotters in our current healthcare system might benefit by applying a Triple Aim approach. This approach aims to simultaneously improve the individual experience of care, reduce the cost of care per capita and improve the health of populations by offering proactive integrated care. Is proactive integrated care costeffective and does it result in better patients experience than usual care after 12 months for patients with problems on multiple life domains? The intervention consists of: intake consultation assessing health on multiple domains using positive health or similar tool; multidisciplinary meetings with physician, mental healthcare nurse, social worker and patient, personalised care plan and proactive care management. This stepped wedge cluster RCT aims to include 200 patients, divided over 20 primary care practices. All practices start with an observation period (2-8months), followed by the intervention (12 months) and follow-up (2-8months). Total duration of intervention is 22 months. We define Hotspotters as patients with at least two incidents of acute care utilisation (defined as out-of-office GP consultations, acute psychiatric care, emergency department visits and unplanned admissions) during the past year, and problems on two out of three health domains (chronic somatic, mental and/or social problems) based on diagnosis (coded with the International Classification of Primary Care) or medication (ATC) coding. Primary outcome: Incremental cost-effectiveness from a societal perspective. Information on cost will be based on patient-reported data obtained by questionnaires supplied with data from the GP medical files (Huisarts informatie system, HIS) and CBSmicrodata. To assess the effectiveness the EQ-5D-5L will be used for determining quality of life. Secondary outcomes: Insight into patients experience of care, quality of life, proactive coping, and self-efficacy. This information will be gathered using interviews, focus groups and questionnaires (SF-12, UPCC, PAM-13 and SE+IN itemlist). Process evaluation with the involved care professionals, integration level, the nature of the communication between healthcare provider and patient (HCCQ, OPTION5), and acceptability (AIM), appropriateness (IAM), feasibility (FIM) ,and perceived and experienced effectiveness of the intervention. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05878054
Study type Interventional
Source Leiden University Medical Center
Contact
Status Enrolling by invitation
Phase N/A
Start date August 2, 2023
Completion date December 31, 2026

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