Study Evaluating the Effect of Person-centred Care for Patients Admitted for Inpatient Care at an Internal Medicine Unit
2018年10月29日 更新者：Göteborg University
Person-centred Inpatient Care - a Quasi-experimental Study Within an Internal Medicine Context
Patients admitted to internal medicine care environments have complex care needs and must be treated as persons with resources and responsibilities.
Person-centred care is defined as care in which the caregiver aims to get to know the patient as a person, and the care comprises a holistic approach to assess patients' needs and resources.
There is strong motivation for future health care to transform into an approach that acknowledges and endorses every patient's resources, interests and needs.
There is limited existing research on the benefit of implementing person-centred care in internal medicine care environments for all patients regardless of diagnosis or care pathway.
Little is known about the effects of person-centred inpatient care on patients' satisfaction with care.
This study includes adult patients admitted to an internal medicine inpatient unit regardless of reason for admission.
The aim of the study is to evaluate effects of person-centred inpatient care on care processes, in terms of satisfaction with care and person-centred content in medical records and to evaluate effects on self-reported health and self-efficacy.
研究概览
研究类型
介入性
注册 (实际的)
177
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Gothenburg、瑞典、41345
- Department of Medicine, Sahlgrenska University Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- acute or elective admission with a minimum projected in-hospital stay of 24 hours
- age ≥ 18 years
- conscious and alert, with no delay in response.
Exclusion Criteria:
- cognitive impairment or a judgment by the caregivers that inclusion was not in the best interests of the patient (e.g. end of life care, impaired psychological wellbeing).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Person-centred inpatient care
|
The intervention comprises three sequential steps in the care process. The first two steps follow one after the other in conjunction with admission to the ward: 1) person-centred assessment, and 2) creation of a person-centred health plan. Persistent person-centred inpatient care, the third step, is practiced throughout the hospital stay, and is a component of the quality and patient safety program. The model is systematically applied to all patients admitted to the unit. All staff are trained in PCC before implementation of the intervention. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Satisfaction with care comprise patients' evaluations of caregivers' identity-oriented approach and the sociocultural atmosphere at the ward.
大体时间：From date of admission until the date of discharge, up to 60 days of hospitalization.
|
The outcome is assessed with the questionnaire Quality from the Patient Perspective.
The questionnaire comprises four dimension of with two dimensions is used: Identity-oriented approach (13 items) and the sociocultural atmosphere (5 items).
One item from the medical competence subscale (effective pain relief) and one additional item on provision of information about medications is also used.
Two kinds of assessments are being made at each item: whether things were being done (perceived reality) and whether the right things were being done (subjective significance).
For the primary outcome only the assessments of perceived reality are being used.
Items are rated on a four-point response scale ranging from 1 (do not agree at all) to 4 (completely agree).
Each item also has a response option of "not applicable".
Subscales can be reported item by item or combined in a subscale score (average of all responses within the subscale).
|
From date of admission until the date of discharge, up to 60 days of hospitalization.
|
|
Person-centred content in medical records
大体时间：From date of admission until the date of discharge, up to 60 days of hospitalization.
|
Degree of person-centredness in medical records
|
From date of admission until the date of discharge, up to 60 days of hospitalization.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Self-reported health assessed with EQ-5D-5L
大体时间：at the date of discharge, an average of 5 days after inclusion
|
Self-reported health is measured with the EuroQual-5Dimensions-5Levels questionnaire (EQ- 5D- 5L).
The questionnaire comprises 1 item per dimension.
The dimensions of importance for health which are included are; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Patients rate each item on a scale ranging from 1 (no problems) to 5 (extreme problems/unable to).
A unique health state is defined by combining 1 level from each of the 5 dimensions.
The questionnaire also includes EQ-VAS, in which the patients grade their current health status on an analogue scale from 0 (worst health) to 100 (best health).
|
at the date of discharge, an average of 5 days after inclusion
|
|
Physical and psychological wellbeing assessed with the Quality from the Patient Perspective questionnaire
大体时间：at the date of discharge, an average of 5 days after inclusion
|
Patients rated their physical and psychological wellbeing on two separate five-point Likert scales ranging from "very good" (5) to "very bad" (1).
These two items are included in the Quality from the Patient Perspective questionnaire as two separate questions.
|
at the date of discharge, an average of 5 days after inclusion
|
|
Level of general self-efficacy assessed with the General Self-Efficacy scale
大体时间：at the date of discharge, an average of 5 days after inclusion
|
General self-efficacy measures confidence in one's ability to handle difficult challenges in life.
It includes 10 items, which are rated on a four- point Likert scale giving a summary score of 40 for the total scale (10-40).
|
at the date of discharge, an average of 5 days after inclusion
|
|
Quality of care measured with ratings of Medical-technical competence and physical conditions at the ward assessed with the questionnaire Quality from the Patient Perspective.
大体时间：From date of admission until the date of discharge, up to 60 days of hospitalization.
|
The questionnaire comprises four dimension of with the two rational dimensions was used for this specific aim: medical- technical competence (4 items) and physical-technical condition (3 items).
Two kinds of assessments are being made at each item: whether things were being done (perceived reality) and whether the right things were being done (subjective significance).
For this secondary outcome the assessments of perceived reality is being used.
A four-point response scale ranging from 1 (do not agree at all) to 4 (completely agree) forms the basis of ratings, each item also had a response option of "not applicable".
Subscales can be reported item by item or combined in a subscale score (average of all responses within the subscale).
|
From date of admission until the date of discharge, up to 60 days of hospitalization.
|
|
Clinical observations of pulse rate
大体时间：From date of admission until the date of discharge, up to 60 days of hospitalization.
|
Frequency of documented pulse rate during hospitalization.
The medical records are reviewed retrospectively.
|
From date of admission until the date of discharge, up to 60 days of hospitalization.
|
|
Quality of care assessed as documented information in medical records on current medication at a daily basis and at discharge
大体时间：From date of admission until the date of the discharge, up to 60 days of hospitalization.
|
All information in the medical records during hospitalization are reviewed retrospectively.
Rating is made regarding the presence (yes or no) of information on current medication at a daily basis and at discharge.
|
From date of admission until the date of the discharge, up to 60 days of hospitalization.
|
|
Quality of care assessed as documented information in medical records on planned medical care at discharge.
大体时间：From date of admission until the date of discharge, up to 60 days of hospitalization.
|
All information in the medical records during hospitalization are reviewed retrospectively.
Rating is made regarding the presence (yes or no) of information on planned medical care at discharge.
|
From date of admission until the date of discharge, up to 60 days of hospitalization.
|
|
Clinical observations of weight
大体时间：From date of admission until date of discharge, up to 60 days of hospitalization.
|
Frequency of documented clinical observations of weight (kg) during hospitalization.
The medical records are reviewed retrospectively.
|
From date of admission until date of discharge, up to 60 days of hospitalization.
|
|
Clinical observations of blood pressure
大体时间：From date of admission until the date of discharge, up to 60 days of hospitalization.
|
Frequency of documented clinical observations of systolic and diastolic blood pressure during hospitalization.
The medical records are reviewed retrospectively.
|
From date of admission until the date of discharge, up to 60 days of hospitalization.
|
|
Clinical observations of respiratory rate
大体时间：From date of admission until the date of discharge, up to 60 days of hospitalization.
|
Frequency of documented clinical observations of respiratory rate during hospitalization.
The medical records are reviewed retrospectively.
|
From date of admission until the date of discharge, up to 60 days of hospitalization.
|
|
Body temperature
大体时间：From date of admission until the date of discharge, up to 60 days of hospitalization.
|
Frequency of documented clinical observations of body temperature (degrees celsius) during hospitalization.
The medical records are reviewed retrospectively.
|
From date of admission until the date of discharge, up to 60 days of hospitalization.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Eva Jakobsson Ung, Associate professor、Department of Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden and Institute of Health and Care Sciences, Sahlgrenska Academy at the University of Gothenburg
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年11月9日
初级完成 (实际的)
2016年6月30日
研究完成 (实际的)
2016年6月30日
研究注册日期
首次提交
2018年10月16日
首先提交符合 QC 标准的
2018年10月29日
首次发布 (实际的)
2018年10月31日
研究记录更新
最后更新发布 (实际的)
2018年10月31日
上次提交的符合 QC 标准的更新
2018年10月29日
最后验证
2018年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.