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临床试验/NCT05406193
NCT05406193招募中不适用

A New Care Model for Patients With Complicated Multimorbidity A Cluster-randomised Pilot Study in General Practice, Municipalities, and Hospitals

Slagelse Hospital22 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
350
试验地点
22
主要终点
Change from baseline Patient Assessment of Chronic Illness Care (PACIC) at 12 months

研究概览

简要总结

Patients with complex multimorbidity experience a high treatment burden, fragmentation of care and poor clinical outcomes. General practice is the key organizational setting in terms of offering these patients integrated, longitudinal, and patient-centered care. Therefore, we propose a new general practice based model to improve overview, patient involvement and integration of care. The new care model consist of a teaching session on multimorbidity for the health care professionals, a prolonged overview consultation for patients with complex multimorbidity with the general practitioner, resulting in an individual care plan shared with the municipalities and secondary care, access to cross-sectoral video conferences with secondary care specialists and. Control practices provide health care as usual. We evaluate the care model in a cluster-randomized non-blinded, parallel-group trial in general practice. Fourteen general practices are allocated 1:1 to either intervention or control. We evaluate the effectiveness of the intervention with patient-reported questionnaire at baseline, 6-month follow-up, and 12-month follow-up. Primary outcome measure is the Patient Assessment of Chronic Illness Care (PACIC). Secondary outcome measure includes patient-reported quality of life and the treatment burden for the patients with multimorbidity. Furthermore, the project include a process evaluation of the complex intervention with the objective to assess how the intervention is delivered and to identify important facilitators and barriers for implementing the intervention. The new model is integrated into the existing health care system structures and has the potential for a sustainable improvement in care for patients with complex multimorbidity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

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

  • Has more than one of the 3 common chronic diseases (diabetes, chronic obstructive pulmonary, chronic heart conditions)
  • Has been hospitalised, or visited an outpatient clinic due to their chronic diseases during the previous year
  • Take at least five different prescription drugs assessed from the Shared Medicine Card recording in the general practice
  • The general practitioner or the nurse in the practice recognise the patient as a "demanding" patient with complicated multimorbidity that will benefit from an overview consultation.

排除标准

  • Patients who cannot speak Danish,
  • Patients who cannot give informed consent,
  • Patients who have a life expectancy of less than 12 months

结局指标

主要结局

Change from baseline Patient Assessment of Chronic Illness Care (PACIC) at 12 months

时间窗: From baseline to 12-month follow-up

PACIC is a 20-item patient report instrument that assesses patient's receipt of clinical services and actions. Each item was scored on a 5-point scale ranging from 1 (no or never) to 5 (yes or always). Respondents rate how often they experienced the content described in each item. The scale range from 1-5 and is scored by averaging of items completed within that scale, and the overall PACIC is scored by averaging scores across all 20 items. Higher scores indicate higher patient assessment delivery of high-quality care for patients with chronic diseases.

次要结局

  • Change from baseline EuroQol-5 Domain (EQ-5D-5L) at 6 months(From baseline to 6-month follow-up)
  • Change from baseline EuroQol-5 Domain (EQ-5D-5L) at 12 months(From baseline to 12-month follow-up)
  • Change from baseline Multimorbidity Treatment Burden Questionnaire (MTBQ) at 6 months(From baseline to 6-month follow-up)
  • Change from baseline Multimorbidity Treatment Burden Questionnaire (MTBQ) at 12 months(From baseline to 12-month follow-up)
  • Change from baseline Patient Assessment of Chronic Illness Care (PACIC) at 6 months(From baseline to 6-month follow-up)

研究者

发起方
Slagelse Hospital
申办方类型
Other
责任方
Sponsor

研究点 (22)

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