Pursuing the Triple Aim in Hotspotters: Identification and Integrated Care

Chronic Disease Clinical Trial

Official title:

The Hotspotters Project. Pursuing the Triple Aim in Hotspotters: Identification and Integrated Care

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05878054
• Other study ID #: HTSPT
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 2, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Complex Patient
• Multimorbidity
• Psychosocial Problem

Intervention

Other:
• Proactive, integrated and personalised care
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Patients' experience of care	Researchers evaluate patients experiences with the personalised, integrated and proactive care approach using two methods. First, using questionnaires. An adapted Net Promotor Scale and the Health Care Climate Questionnaire (HCCQ) will be administered 6 months after the new care approach starts.; Second, a focusgroup is organised to gather insight into the experiences of patients.	22 months
Secondary	Self-efficacy	Self-efficacy will be measured using two different instruments. The first is the validated Patient activation Measure (PAM-13). This is a 13-item instrument that measures self-reported knowledge, skills and confidence in managing one's health.; The second questionnaire is the Self-efficacy and Intention itemlist (SE+IN Itemlist). This itemlist, specifically created for this study, measures (action and maintenance) self-management self-efficacy, the intention to perform certain self-management behaviors and the presence of certain self-management behaviors.	22 months
Secondary	Proactive coping	The presence of proactive coping skills will be quantitively measured with the Utrechtse Proactieve Coping Competentie lijst (UPCC). This is a 21-item questionnaire that measures self-rated proactive coping competences. This questionnaire is administered thrice: at the start and end of intervention, and two months after ending the intervention.	22 months
Secondary	Health related quality of life	Quality of life will also be assessed using the validated SF-12(12-items), including 8 dimensions, namely: bodily, pain, vitality (energy and fatigue), general mental health (psychological distress and well-being), general health perceptions, limitations in physical activities because of health problems, limitations in social activities because of physical or emotional problems, limitations in usual role activities because of emotional problems, and limitations in usual role activities because of physical health problems.; This questionnaire is administered thrice: at the start and end of intervention, and two months after ending the intervention.	22 months
Secondary	Level of shared decision making	Level of shared decision making will be based on audio recordings which will be scored by two independent observers using the validated OPTION5 questionnaire. If a participant is not comfortable with these recordings, the recordings may be skipped without further consequence for study participation.	22 months
Secondary	Acceptability of Intervention Measure (AIM)	Acceptability, appropriateness, and feasibility will be measured using the The Acceptability of Intervention Measure (AIM). This will be done before the intervention starts and right after the intervention for each group of GP's. This information will be gathered from care professionals from participating as well as non-participating practices.	22 months
Secondary	Intervention Appropriateness Measure (IAM)	Intervention Appropriateness Measure (IAM), together with Feasibility of Intervention Measure (FIM), measures implementation outcomes that are often considered "leading indicators" of implementation success. This will be done before the intervention starts and right after the intervention for each group of GP's. This information will be gathered from care professionals from participating as well as non-participating practices.	22 months
Secondary	Feasibility of Intervention Measure (FIM)	Feasibility of Intervention Measure (FIM), together with Intervention Appropriateness Measure (IAM), measures implementation outcomes that are often considered "leading indicators" of implementation success. This information will be gathered from care professionals from participating as well as non-participating practices.	22 months
Secondary	Level of care integration	Professionals fill in the integrationmeter at the start and end of the intervention, resulting in a degree of care integration	22 months