Hotspotters Project: a study protocol for a stepped wedge cluster RCT on the cost-effectiveness of 12-month proactive, integrated and personalised care for patients with problems on multiple life domains and high acute care use

Introduction ‘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. As reliable data on effective interventions for this popul...

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Main Authors: Mattijs E Numans, Marc Abraham Bruijnzeels, Rimke C Vos, Elske M van den Akker-van Marle, Mark van der Wel, Vera Tiemes, Kimberley A Leming, Hanneke Borgdorff, Laurens C van Gestel, Marieke A Adriaanse
Format: Article
Language:English
Published: BMJ Publishing Group 2025-08-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/8/e087940.full
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author Mattijs E Numans
Marc Abraham Bruijnzeels
Rimke C Vos
Elske M van den Akker-van Marle
Mark van der Wel
Vera Tiemes
Kimberley A Leming
Hanneke Borgdorff
Laurens C van Gestel
Marieke A Adriaanse
author_facet Mattijs E Numans
Marc Abraham Bruijnzeels
Rimke C Vos
Elske M van den Akker-van Marle
Mark van der Wel
Vera Tiemes
Kimberley A Leming
Hanneke Borgdorff
Laurens C van Gestel
Marieke A Adriaanse
author_sort Mattijs E Numans
collection DOAJ
description Introduction ‘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. As reliable data on effective interventions for this population are scarce, the goal of this study is to assess the cost-effectiveness of proactive, personalised, integrated care for this group.Methods and analysis The Hotspotters Project is planned as a stepped wedge cluster randomised controlled trial in 20 primary care practices in the Netherlands. All practices and participants will begin with standard care during the control period (2–8 months), followed by an intervention (12 months) consisting of a positive health intake with goal setting, multidisciplinary meetings, a personalised care plan and proactive care management. The study will conclude with a follow-up (2–8 months), resulting in a total study duration of 22 months. We plan to include 200 patients with (a) problems on two or more life domains and (b) at least two acute care encounters in the previous year. Possible Hotspotters are identified using an Adjusted Clinical Groups-based algorithm or via a local primary healthcare team.Outcomes Questionnaires and routine care data will be used to gather data on cost-effectiveness, which will then be assessed using multilevel analysis, with levels for the individual, cluster and duration of control period. Secondary outcomes will include psychological outcomes on self-regulation (proactive coping, patient activation, self-efficacy and intention), experience of care (satisfaction, perceived autonomy support and qualitative data from focus groups) and quality of life, qualitative analysis of the Positive Health approach, implementation outcomes and process evaluation including integration of care.Ethics and dissemination The Ethics Committee of Leiden University Medical Centre granted approval (METC-LDD, P21.123). Results will be shared through peer-reviewed publication and (inter)national conference presentations.Trial registration number NCT05878054.
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spelling doaj-art-39c5574a1aec453db6f61afda551d1fb2025-08-20T03:41:19ZengBMJ Publishing GroupBMJ Open2044-60552025-08-0115810.1136/bmjopen-2024-087940Hotspotters Project: a study protocol for a stepped wedge cluster RCT on the cost-effectiveness of 12-month proactive, integrated and personalised care for patients with problems on multiple life domains and high acute care useMattijs E Numans0Marc Abraham Bruijnzeels1Rimke C Vos2Elske M van den Akker-van Marle3Mark van der Wel4Vera Tiemes5Kimberley A Leming6Hanneke Borgdorff7Laurens C van Gestel8Marieke A Adriaanse9Department of Public Health and Primary Care/Health Campus the Hague, Leiden University Medical Center (LUMC), Leiden, The NetherlandsDepartment of Public Health and Primary Care/Health Campus the Hague, Leiden University Medical Center (LUMC), Leiden, The NetherlandsDepartment of Public Health and Primary Care/Health Campus the Hague, Leiden University Medical Center (LUMC), Leiden, The NetherlandsBiomedical Data Sciences, Leiden University Medical Center, Leiden, NetherlandsRadboud Institute of Health Sciences, Department of Primary and Community Care, Radboud University Medical Center, Nijmegen, Gelderland, NetherlandsDepartment of Public Health and Primary Care/Health Campus the Hague, Leiden University Medical Center (LUMC), Leiden, The NetherlandsDepartment of Public Health and Primary Care/Health Campus the Hague, Leiden University Medical Center (LUMC), Leiden, The NetherlandsDepartment of Public Health and Primary Care/Health Campus the Hague, Leiden University Medical Center (LUMC), Leiden, The NetherlandsDepartment of Health, Medical and Neuropsychology, Universiteit Leiden, Leiden, NetherlandsDepartment of Public Health and Primary Care/Health Campus the Hague, Leiden University Medical Center (LUMC), Leiden, The NetherlandsIntroduction ‘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. As reliable data on effective interventions for this population are scarce, the goal of this study is to assess the cost-effectiveness of proactive, personalised, integrated care for this group.Methods and analysis The Hotspotters Project is planned as a stepped wedge cluster randomised controlled trial in 20 primary care practices in the Netherlands. All practices and participants will begin with standard care during the control period (2–8 months), followed by an intervention (12 months) consisting of a positive health intake with goal setting, multidisciplinary meetings, a personalised care plan and proactive care management. The study will conclude with a follow-up (2–8 months), resulting in a total study duration of 22 months. We plan to include 200 patients with (a) problems on two or more life domains and (b) at least two acute care encounters in the previous year. Possible Hotspotters are identified using an Adjusted Clinical Groups-based algorithm or via a local primary healthcare team.Outcomes Questionnaires and routine care data will be used to gather data on cost-effectiveness, which will then be assessed using multilevel analysis, with levels for the individual, cluster and duration of control period. Secondary outcomes will include psychological outcomes on self-regulation (proactive coping, patient activation, self-efficacy and intention), experience of care (satisfaction, perceived autonomy support and qualitative data from focus groups) and quality of life, qualitative analysis of the Positive Health approach, implementation outcomes and process evaluation including integration of care.Ethics and dissemination The Ethics Committee of Leiden University Medical Centre granted approval (METC-LDD, P21.123). Results will be shared through peer-reviewed publication and (inter)national conference presentations.Trial registration number NCT05878054.https://bmjopen.bmj.com/content/15/8/e087940.full
spellingShingle Mattijs E Numans
Marc Abraham Bruijnzeels
Rimke C Vos
Elske M van den Akker-van Marle
Mark van der Wel
Vera Tiemes
Kimberley A Leming
Hanneke Borgdorff
Laurens C van Gestel
Marieke A Adriaanse
Hotspotters Project: a study protocol for a stepped wedge cluster RCT on the cost-effectiveness of 12-month proactive, integrated and personalised care for patients with problems on multiple life domains and high acute care use
BMJ Open
title Hotspotters Project: a study protocol for a stepped wedge cluster RCT on the cost-effectiveness of 12-month proactive, integrated and personalised care for patients with problems on multiple life domains and high acute care use
title_full Hotspotters Project: a study protocol for a stepped wedge cluster RCT on the cost-effectiveness of 12-month proactive, integrated and personalised care for patients with problems on multiple life domains and high acute care use
title_fullStr Hotspotters Project: a study protocol for a stepped wedge cluster RCT on the cost-effectiveness of 12-month proactive, integrated and personalised care for patients with problems on multiple life domains and high acute care use
title_full_unstemmed Hotspotters Project: a study protocol for a stepped wedge cluster RCT on the cost-effectiveness of 12-month proactive, integrated and personalised care for patients with problems on multiple life domains and high acute care use
title_short Hotspotters Project: a study protocol for a stepped wedge cluster RCT on the cost-effectiveness of 12-month proactive, integrated and personalised care for patients with problems on multiple life domains and high acute care use
title_sort hotspotters project a study protocol for a stepped wedge cluster rct on the cost effectiveness of 12 month proactive integrated and personalised care for patients with problems on multiple life domains and high acute care use
url https://bmjopen.bmj.com/content/15/8/e087940.full
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