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临床试验/NCT06735339
NCT06735339尚未招募不适用

A New Organisation of Healthcare for Multimorbidity

Central Jutland Regional Hospital2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
2
主要终点
Need-based quality of life (MMQ-1 questionnaire)

研究概览

简要总结

The purpose of this study is to investigate:

  1. the implementation and 2) the effects of an outpatient program for patients with complex multimorbidity. The investigators intend to integrate care from various health professionals across medical specialties and sectors, promote person-centered care, and ensure a holistic approach. Specifically, the investigators have redesigned the existing clinic, the Clinic for Multimorbidity, which has been operational since 2012 without any protocol-based evaluation. The new version introduces differentiated care options based on general practitioners needs for support.

Multimorbidity, defined as the presence of two or more chronic diseases in an individual, poses a significant challenge for healthcare systems globally. There is an urgent need for targeted interventions for those with high complexity, such as due to interacting diseases and polypharmacy, particularly in light of an aging population, where on-fourth has multimorbid. Although the care for individuals with multimorbidity often may be perceived as fragmented, there is limited evidence on how to best organize the care. Effective, evidence-based strategies to ensure integration are lacking.

The population will consist of adults with complex multimorbidity from the Central Denmark Region, referred to the Clinic for Multimorbidity from general practice. Using a stepped wedge randomized controlled design, the project will encompass two studies.

  1. The implementation study will be based on implementation outcomes by Proctor et al: acceptability, adoption, appropriateness, feasibility, fidelity, and penetration. Data will be collected through interviews with patients and general practitioners, as well as measurements related to referral practices, costs, and feasibility.
  2. The effectiveness study will include outcome measures such as questionnaire-based patient experiences regarding health-related quality of life, treatment burden, depression, and anxiety. Additionally, the investigators will assess effects on inappropriate medication, symptoms, mortality, treatment continuity, healthcare utilization, and the initiation of health-promoting initiatives.

The investigators anticipate demonstrating that multimorbid patients will benefit from an interdisciplinary, cross-sector collaborative model. Furthermore, the investigators expect that this new organization will support general practitioners, municipalities, and hospitals in their management of these patients, addressing differentiated treatment needs in accordance with the recommendations of the Danish Health Structure Commission.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged18 years or older
  • Multimorbidity: = 2 chronic conditions (minimum 6 months' duration per condition)
  • Polypharmacy (= 5 medications)
  • Complexity: Complex multimorbidity refers to the patient suffering from multiple concurrent, chronic diseases/conditions creating additional challenges. Complexity can be of physical, mental, social character and due to medication, high treatment burden, frailty, frequent healthcare visits or a special need for joint healthcare collaboration.

排除标准

  • Diagnostically unresolved conditions and patients whose primary issues require focused management of chronic pain, psychiatric disorders, alcohol misuse, and other addiction-related challenges.

结局指标

主要结局

Need-based quality of life (MMQ-1 questionnaire)

时间窗: From enrollment to 3 months after have undergone a trajectory at Clinic for Multimorbidity

Will be assessed using the MultiMorbidity Questionnaire MMQ-1 measuring needs-based QoL: physical ability (6 items), worries (6 items), limitations in everyday life (10 items), social life (6 items), self-image (6 items), and personal finances (3 items). -in total 31 items. The questionnaire was deveoped by Bissenbakker et al. and has been validated in Danish settings for patients living with multimorbidity: the MMQ1 is a condition-specific PROM with adequate psychometric properties designed to measure needs-based QoL.

次要结局

未报告次要终点

研究者

发起方
Central Jutland Regional Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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