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临床试验/NCT05878054
NCT05878054
进行中(未招募)
不适用

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

Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 41 人2023年8月2日

概览

阶段
不适用
干预措施
Proactive, integrated and personalised care
疾病 / 适应症
Complex Patient
发起方
Leiden University Medical Center
入组人数
41
试验地点
1
主要终点
Costs of care
状态
进行中(未招募)
最后更新
2个月前

概览

简要总结

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.

详细描述

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 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.

注册库
clinicaltrials.gov
开始日期
2023年8月2日
结束日期
2026年12月31日
最后更新
2个月前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

发起方
Leiden University Medical Center
责任方
Principal Investigator
主要研究者

rcvos

Associate Professor, Programma Manager Research

Leiden University Medical Center

入排标准

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Control period 2 months

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

干预措施: Proactive, integrated and personalised care

Control period 4 months

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

干预措施: Proactive, integrated and personalised care

Control period 6 months

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

干预措施: Proactive, integrated and personalised care

Control period 8 months

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

干预措施: Proactive, integrated and personalised care

结局指标

主要结局

Costs of care

时间窗: 22 months

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.

Quality adjusted life years

时间窗: 22 months

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.

次要结局

  • 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)
  • Experience of care: qualitative assessment(22 months)
  • Administering of Positive Health methodology(22 months)
  • Health-related quality of life: short-form 12 health survey(22 months)
  • Acceptability of Intervention Measure (AIM)(22 months)
  • Level of shared decision making(22 months)
  • Intervention Appropriateness Measure (IAM)(22 months)
  • Feasibility of Intervention Measure (FIM)(22 months)
  • Level of care integration(22 months)
  • Process evaluation following RE-AIM framework: reach, effectiveness, adoption, implementation and maintenance(22 months)

研究点 (1)

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