Clinical trial NCT05878054: Pursuing the Triple Aim in Hotspotters: Identification and Integrated Care
Official title: The Hotspotters Project. Pursuing the Triple Aim in Hotspotters: Identification and Integrated Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Complex Patient
Multimorbidity
Psychosocial Problem
Chronic Disease
Keywords: high care utilizer
complex patient
problems on multiple life domains
frequent flyer
hotspotter
high needs patient
integrated care
proactive care
personalised care
personalised care plan
positive health tool
multimorbidity
psychosocial problem
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped wedge cluster randomized controlled trial
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Costs of care
timeFrame: 22 months
measure: Quality adjusted life years
timeFrame: 22 months
Secondary outcomes:
measure: Patients' experience of care
timeFrame: 22 months
measure: Self-efficacy
timeFrame: 22 months
measure: Proactive coping
timeFrame: 22 months
measure: Health related quality of life
timeFrame: 22 months
measure: Level of shared decision making
timeFrame: 22 months
measure: Acceptability of Intervention Measure (AIM)
timeFrame: 22 months
measure: Intervention Appropriateness Measure (IAM)
timeFrame: 22 months
measure: Feasibility of Intervention Measure (FIM)
timeFrame: 22 months
measure: Level of care integration
timeFrame: 22 months
measure: Administering of Positive Health methodology
timeFrame: 22 months
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical centre, department of Public Healht and Primary care (PHEG), location Health Campus The Hague
Study officials:
affiliation: Leiden University medical centre, health campus The Hague
name: Rimke Vos, dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Leiden University medical centre, health campus The Hague
name: Marc Bruijnzeels, dr
role: PRINCIPAL_INVESTIGATOR
References: