跳至主要内容
临床试验/NCT05244590
NCT05244590已完成不适用

Development and Evaluation of a Mix-method Intervention Involving Training and a New Consultation Model for Patients With Palliative Care Needs in Primary Care - Before-After Study

University of Coimbra1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2022年4月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
1
主要终点
Impact of the intervention in patients' physical symptom burden evaluated using Integrated Palliative Outcome Scale (IPOS) - patient version's mean scores

研究概览

简要总结

Introduction General practitioners provide health care in the community, managing patients and families longitudinally, and there is some evidence that when they are involved in caring for people with palliative care needs alongside specialists, palliative care delivery may be more efficient. The investigators aim to determine the impact of a mix-method intervention involving training in PC and a new consultation model for patients with palliative care needs in primary care.

Methods and analysis A before-after study will be conducted in the centre health care region of Portugal. The study will involve 53 patients with palliative care needs from the list of patients of the GPs who accept to collaborate with the project. The mix-method intervention will consist of: (1) training in palliative care and (2) application of a newly developed consultation model for use in the primary care setting and consisting of medical consultation every 3 weeks for a period of 12 weeks. The primary outcome is physical symptom burden, evaluated by the Integrated Palliative Outcome Scale (IPOS) patient version. Secondary outcomes include psychological symptoms, and communication/practical issues (IPOS); number of consultations for acute disease both in the health care unit and emergency department, number of hospitalizations and referrals to hospital health care services.

详细描述

Study aim:

The investigators aim to develop, apply, and evaluate a mix-method intervention involving training in PC and a new consultation model in primary care for patients with PC needs.

Primary objective:

To determine the impact of the intervention on the physical symptom burden for patients.

Secondary objectives:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •GPs' eligibility criteria Inclusion criteria
  • •Working in the centre health care region in Portugal.
  • •Authorisation of the coordinator of each GP health care unit to integrate the study.
  • •Patients' eligibility criteria Inclusion criteria
  • •Belonging to the list of patients of the recruited GPs.
  • •18 years or older.
  • •Diagnosis of advanced stage neoplasm (ASN), Chronic Obstructive Pulmonary Disease (COPD) Gold III/IV, Congestive Heart Failure (CHF) NYHA III/IV, Chronic Kidney Disease (CKD) stage IV/V.

排除标准

  • •Refusal, at any time, to participate in the study.
  • •Level of understanding or execution that compromises taking part in the study and answering the IPOS patient version (evaluated using Mini Mental State Examination score).
  • •Level of disease severity requiring urgent intervention (GP clinical judgement).

研究组 & 干预措施

Intervention

Experimental

GPs' eligibility criteria

  • Working in the centre health care region in Portugal.
  • Authorisation of the coordinator of each GP health care unit to integrate the study.

Patients' eligibility criteria

Inclusion criteria

  • Belonging to the list of patients of the recruited GPs.
  • 18 years or older.
  • Diagnosis of advanced stage neoplasm (ASN), Chronic Obstructive Pulmonary Disease (COPD) Gold III/IV, Congestive Heart Failure (CHF) NYHA III/IV, Chronic Kidney Disease (CKD) stage IV/V.

Exclusion Criteria

  • Refusal, at any time, to participate in the study.
  • Level of understanding or execution that compromises taking part in the study and answering the IPOS patient version (evaluated using Mini Mental State Examination score).
  • Level of disease severity requiring urgent intervention (GP clinical judgement).

干预措施: Consultation model for patients with palliative care needs (Other)

结局指标

主要结局

Impact of the intervention in patients' physical symptom burden evaluated using Integrated Palliative Outcome Scale (IPOS) - patient version's mean scores

时间窗: 12 week

GPs enrolled will evaluate physical symptoms burden before and after the 12 week intervention.

次要结局

  • Impact of the intervention in patients' psychological symptoms burden evaluated using Integrated Palliative Outcome Scale (IPOS) - patient version's mean scores(12 week)
  • Impact of the intervention in patients' communication/practical issues evaluated using Integrated Palliative Outcome Scale (IPOS) - patient version's mean scores(12 week)
  • Impact of the intervention on number of consultations for acute disease both in the health care unit and emergency department, number of hospitalizations and referrals to hospital health care services(12 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Seiça Cardoso

Primary investigator

University of Coimbra

研究点 (1)

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