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临床试验/NCT02541474
NCT02541474Unknown不适用

Effectiveness and Cost-effectiveness of Interdisciplinary Teamwork in Medical Emergencies: The PAtient-Centred Team (PACT) Service Model. Effect and Cost Effectiveness Evaluation

University Hospital of North Norway2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2016年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
1,200
试验地点
2
主要终点
SF-12, physical dimension

研究概览

简要总结

There is an urgent need to develop new care models for patients with long-term and complex needs. Our goal is services that are seamless, pro-active and person-oriented.

Intervention:

The Patient-centered health care team (PACT) is a service model for frail elderly patients with multiple long term conditions. PACT is a seamless and proactive health service model that aims to ensure safe early discharge and prevent hospital admissions for elderly frail patients. The four pivotal elements are are supported by theoretical and empirical underpinnings: 1) Goal-oriented person centered approach 2) Inter-disciplinary comprehensive geriatric team: 3) Pro-active care plan.

Study Objective:

  1. To investigate whether the PACT model improves health-related quality of life and patient generated goals 2) carry out a health economic evaluation of PACT.

Design:

The evaluation model for complex interventions is our guiding evaluation framework. This is a non-randomized, matched control, before after study. The intervention unit, is the care organization, including four hospitals - municipality dyads. Two intervention dyads and two control dyads. Index patients from intervention hospitals will be matched age, sex and number of chronic conditions.

Intervention group: Patients with emergency admission to the UNN internal medicine department in Tromsø and Harstad who are age > 65, have three or more long-term conditions, an emergency admission within the last year, and an informed consent is given by patient or next of kin. (Approved by ethics board 07.05.2015). The exclusion criteria are: Language barriers, and less than 3 months life expectancy.

Controls: Recruited from the Nordlanssykehuset (Bodø) and UNN-Narvik internal medicine departments, matched to the index patient's sex, age, number of long-term conditions. Control patients will be subject to the same data-collection as intervention patients.

Data collections: All patient data will be collected at baseline, 6 and 12 months. Outcomes: The primary outcome is the adjusted differences in the change of Quality of Life, measured by Short Form-36 (SF-36), physical health dimension between intervention and control groups at 6 months after inclusion in study.

详细描述

Paradoxically, the very success of our health care system causes the number of patients with multiple are on the rise. Studies of European populations above 75 years of age show LTC-prevalences of more than 70%, and rates of multimorbidity around 40-50%(8-10). Patients with LTC-conditions accounted for 3/4ths of health care spending in an early US report, and patients with 4 or more co-morbidities consumed 5 times as much health services as those with no LTC in a recent Irish report. The current care system is designed to deliver disease specific, urgent/ episodic care, and is poorly suited to the needs this growing patient group

Best practice models for patients with Long Term conditions (LTCs) and complex needs have been developed. In medicine, the underlying models are often implicit, which can cause the misunderstanding that medical research is practical, factual and not theory driven. In complex interventions, underpinning theoretical models are considered essential for study design.. In the planning and design of this intervention, the investigators have chosen to use the Chronic Care Model (CCM). Other models of chronic care are either slightly overlapping or in alignment with the CCM, but none of them cover all the areas of the CCM. It is the only model with both a systems- a clinical- and a patient perspective. Furthermore it has a growing evidence base for its effects on both care-processes, health outcomes and cost-effectiveness. It continues to inspire care reform both in large international care organizations, and in our local northern Norwegian context. The CCM builds on two pillars: "The informed active patient" and "The pro-active prepared health care team", which are equal partners engaging in "productive interactions" for "health and functional outcomes". Evidence Based Medicine (EBM) is the basis for identification of appropriate actions. Integrated team care delivery is then tailored to the patients' needs, values and preferences. Both health management support and use of clinical information systems are included in the model as key supporting factors(33).

A recent report documents that the health care delivery in Helse Nord is far from the ideal CCM-care. The main challenges were a lack of attention to the patient's personal context and priorities, and a fragmented care delivery. A large-scale CCM inspired project which answers these challenges, is under development at the university Hospital of North Norway (UNN). Its dual focus is coordination of care through two core components: 1) the proactive, prepared interdisciplinary teams with personnel from both hospitals and the municipalities to address the current fragmented care delivery and 2) the informed active patient approach to care planning. The initiative, which will be funded by redeploying existing staff to work in the teams. The team will facilitate patient centered and integrated care by conducting a structured person centered need assessments, develop individual evidence based care plans, and provide service integration across levels of care.

Research questions, hypotheses and methods The CCM is currently established as best practice for LTC-care delivery. Yet, the evidence of effectiveness of the CCM in terms of health and functional outcomes in several systematic reviews remain inconsistent. All CCM interventions, must tailor the CCM to local historical, cultural and regulatory context. Thus the heterogeneity of CCM-interventions is large, which may explain the observed inconsistencies. In our review, the investigators noted that many CCM-interventions seemed to lose the link to the underlying theory in the operationalization process. Active two-way patient-provider dialogues and practical skills development in self-management are central for better outcomes. However "the informed active patient" and "self-management support" were often translated into passive one-way educational interventions. Furthermore, the content of many of the CCM-interventions was often inadequately described, making it difficult to ascertain their fidelity to the underlying theory.

Our research questions are: What is the effect of a theory driven CCM-implementation on:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

This is a registry based study design. The Primary outcome is extracted from routine data recorded by clinical and administrative personell who are unaware of study allocation in the electronic health care record.

The questionnaire outcome data can not be masked as the patient and study personell will be aware of treatment allocation group. To avoid preferential recording of these outcomes, study personell assist in data collection in either treatment or control groups - never both, so that they could not compare or favor one group above the other.

入排标准

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

入选标准

  • Patients who either received treatment in PACT team for > 24 hours (Treat group) or an emergency admission to the UNN (Control group) in Tromsø/ Harstad/ Narvik/ Bodø. Age >
  • Have complex long-term needs.

排除标准

  • Live outside of designated municipalities. Receive < 24 hours of care from PACT team.

研究组 & 干预措施

Integrated care

Other

All patients fitting inclusion criteria will receive care from The Patient -centered health care team ( PACT ) which is a service model for frail elderly patients with multiple long term conditions.

干预措施: Integrated care (Other)

Usual care

No Intervention

All patients in the Control hospitals (Bodø and Narvik) that match the index patient from the intervention group, and who consents to participate in the study. Eligible patients receive an invitation to participate from the local study nurse. Included controls receive usual care in control hospital and municipalities. Data collection in intervention and control groups are the same.

结局指标

主要结局

SF-12, physical dimension

时间窗: 3 months

The primary outcome is the adjusted differences in the change of Quality of Life, measured by SF-12, physical health dimension between intervention and control groups at 6 months after inclusion in study.

次要结局

  • SF-12(3 months)
  • EQ5D(3 months)
  • Rates of emergency consultations in secondary outpatient clinics(6 months)
  • Rates of consultations with General Practitioner outside of hours(6 months)
  • Mortality risk(3 and 6 months)
  • Rates of emergency admission days in hospital(6 months)
  • The patient generated index (PGI), open version(6 months)

研究者

发起方
University Hospital of North Norway
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gro Berntsen

Senior Researcher

University Hospital of North Norway

研究点 (2)

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