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Clinical Trial Summary

People with complex problems on multiple life domains receive fragmented care. The accumulation and complexity of problems is difficult to manage for patients and care providers, and leads to high medical spending with little effect of care. In this study the investigators will evaluate the costeffectiveness and experience of care of integrated, proactive and personalized care for patients with problems on 2 out of 3 life domains and at least 2 acute care contacts in the previous year. A stepped wedge randomised controlled trial will be performed in 20 general practices that do not yet offer such an approach.


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? A stepped-wedge cluster randomised controlled trial (RCT) design will be used This study will be performed in 20 general practices that do not yet offer proactive integrated care for hotspotters. Data on cost-effectiveness will be quantitatively assessed. Patient experience will be qualitatively assessed through focus groups and quantitative using validated questionnaires. Besides, the process will be both qualitatively and quantitatively evaluated using interviews or focusgroups, observations (audio recording) with care professionals on common themes of process evaluatation and a validated questionnaire. In total 200 hotspotters will be included. Hotspotters are individuals 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. The proactive integrated care intervention that will be used consists of five steps: 1. Active invitation of the patient from the practice. 2. Consult of 45 minutes with a trained Practice Nurse Mental Health Care based on the Positive Health Methodology. 3. Multidisciplinary team meeting based on the spider web with domain specific explanation to create a personalised care plan and assign a care coordinator to each patient. 4. Execution of the personalised care plan and frequent pro-active contact between care coordinator and the patient. In the first 12 weeks there is a minimum of 3 contact moments, however more frequent contact is expected. The proactive nature of this contact is emphasized. 5. Follow-up of the personalised care plan using clinical review and at least one multidisciplinary meeting. If needed, ad hoc additional meetings can be organised. ;


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 September 6, 2022
Completion date December 31, 2025

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