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.
調査の概要
研究の種類
介入
入学 (実際)
177
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Gothenburg、スウェーデン、41345
- Department of Medicine, Sahlgrenska University Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Satisfaction with care comprise patients' evaluations of caregivers' identity-oriented approach and the sociocultural atmosphere at the ward.
時間枠：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
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-reported health assessed with EQ-5D-5L
時間枠：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
時間枠：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
時間枠：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.
時間枠：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
時間枠：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
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：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
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2015年11月9日
一次修了 (実際)
2016年6月30日
研究の完了 (実際)
2016年6月30日
試験登録日
最初に提出
2018年10月16日
QC基準を満たした最初の提出物
2018年10月29日
最初の投稿 (実際)
2018年10月31日
学習記録の更新
投稿された最後の更新 (実際)
2018年10月31日
QC基準を満たした最後の更新が送信されました
2018年10月29日
最終確認日
2018年10月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- Person-centred care
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。