NCT05878054

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Aug 2023Dec 2026

First Submitted

Initial submission to the registry

March 8, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 2, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

3.4 years

First QC Date

March 8, 2023

Last Update Submit

February 21, 2026

Conditions

Keywords

high care utilizercomplex patientproblems on multiple life domainsfrequent flyerhotspotterhigh needs patientintegrated careproactive carepersonalised carepersonalised care planpositive health toolmultimorbiditypsychosocial problem

Outcome Measures

Primary Outcomes (2)

  • Costs of care

    Costs of care from a societal perspective is the summ of costs of care and loss of productivity due to illness or disease. Data on frequency and type of care utilization is gathered from the GP medical file, supplied with questions on mental health care use and need for addiction care. Productivity loss is determined via questionnaire. This data will be translated into cost using standard cost prices from the Dutch guideline for economic evaluations. Cost of care, together with Quality of life, will be used to assess cost-effectiveness from a societal perspective.

    22 months

  • Quality adjusted life years

    QALY measured by recurring EQ-5D-5L. Quality of life, together with cost of care, will be used to assess cost-effectiveness from a societal perspective.

    22 months

Secondary Outcomes (13)

  • Self-regulation: Patient activation measure (PAM-13)

    22 months

  • Self-regulation: Utrechtse Proactive Coping Compentence scale (UPCC)

    22 months

  • Self-regulation: self-efficacy and intention itemlist (SE+IN itemlist)

    22 months

  • Experience of care: Healthcare climate questionnaire (HCCQ)

    22 months

  • Experience of care: modified Net Promotor scale (mNPS)

    22 months

  • +8 more secondary outcomes

Study Arms (4)

Control period 2 months

OTHER

2 months control period, followed by 12 months intervention, followed by 8 months observation

Other: Proactive, integrated and personalised care

Control period 4 months

OTHER

4 months control period, followed by 12 months intervention, followed by 6 months observation

Other: Proactive, integrated and personalised care

Control period 6 months

OTHER

6 months control period, followed by 12 months intervention, followed by 4 months observation

Other: Proactive, integrated and personalised care

Control period 8 months

OTHER

8 months control period, followed by 12 months intervention, followed by 2 months observation

Other: Proactive, integrated and personalised care

Interventions

During the intervention patients receive proactive, integrated and personalised care. An intake consultation using Positive Health tool, or a similar method, the needs of each patient is assessed. In a multidisciplinary meeting with the GP, mental health care practice nurse, a social worker and the patient, a personalised care plan is made. The personal is executed and a care coordinator maintains proactive contact with the patient. Clinical follow-up will be done via a second multidisciplinary meeting.

Control period 2 monthsControl period 4 monthsControl period 6 monthsControl period 8 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients are ≥ 18yrs
  • The patients are registered within one of the participating GP practices.
  • Patients with at least two acute care encounters in the past 12 months. Acute care encounter is defined as an encounter with out-of-hours GP service, emergency care or acute mental health care.Patients have problems registered in the GP Information system on at least two out of three of the following domains: somatic, mental or social. Somatic problems is having at least one ICPC code on the problem list. Mental problems is having at least one ICPC code from the "P"-chapter on either the problem list, as a reason for encounter, and/or having medication prescribed related to mental health problems. Social problems is having at least one ICPC code from the "Z"-chapter or as reason for encounter, and/or having medication prescribed related to social problems.

You may not qualify if:

  • The patient is terminal.
  • The patient is living in a residential home.
  • The patient has dementia or a disability that prevents them from communicating effectively.The patient already has experience with the positive health tool.
  • The patient is not competent to make decisions concerning their health. This wil be assessed by the patient's own general practitioner.
  • Veto of the GP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical centre, department of Public Healht and Primary care (PHEG), location Health Campus The Hague

Leiden, 2333ZA, Netherlands

Location

Related Publications (1)

  • Tiemes V, Leming KA, Borgdorff H, Bruijnzeels MA, van Gestel LC, Adriaanse MA, van der Wel M, van den Akker-van Marle EM, Numans ME, Vos RC. 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. 2025 Aug 10;15(8):e087940. doi: 10.1136/bmjopen-2024-087940.

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rimke Vos, dr

    Leiden University medical centre, health campus The Hague

    PRINCIPAL INVESTIGATOR
  • Marc Bruijnzeels, dr

    Leiden University medical centre, health campus The Hague

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Stepped wedge cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Programma Manager Research

Study Record Dates

First Submitted

March 8, 2023

First Posted

May 26, 2023

Study Start

August 2, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations