search
Back to results

Study Evaluating the Effect of Person-centred Care for Patients Admitted for Inpatient Care at an Internal Medicine Unit

Primary Purpose

Endocrine System Diseases, Gastrointestinal Diseases

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Person-centred inpatient care
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Endocrine System Diseases focused on measuring Person-centred care, Intervention, Inpatient care, Satisfaction of care, quasi-experimental, internal medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Department of Medicine, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Person-centred inpatient care

Arm Description

Person-centred inpatient care

Outcomes

Primary Outcome Measures

Satisfaction with care comprise patients' evaluations of caregivers' identity-oriented approach and the sociocultural atmosphere at the ward.
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).
Person-centred content in medical records
Degree of person-centredness in medical records

Secondary Outcome Measures

Self-reported health assessed with EQ-5D-5L
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).
Physical and psychological wellbeing assessed with the Quality from the Patient Perspective questionnaire
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.
Level of general self-efficacy assessed with the General Self-Efficacy scale
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).
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.
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).
Clinical observations of pulse rate
Frequency of documented pulse rate during hospitalization. The medical records are reviewed retrospectively.
Quality of care assessed as documented information in medical records on current medication at a daily basis and at discharge
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.
Quality of care assessed as documented information in medical records on planned medical care at discharge.
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.
Clinical observations of weight
Frequency of documented clinical observations of weight (kg) during hospitalization. The medical records are reviewed retrospectively.
Clinical observations of blood pressure
Frequency of documented clinical observations of systolic and diastolic blood pressure during hospitalization. The medical records are reviewed retrospectively.
Clinical observations of respiratory rate
Frequency of documented clinical observations of respiratory rate during hospitalization. The medical records are reviewed retrospectively.
Body temperature
Frequency of documented clinical observations of body temperature (degrees celsius) during hospitalization. The medical records are reviewed retrospectively.

Full Information

First Posted
October 16, 2018
Last Updated
October 29, 2018
Sponsor
Göteborg University
search

1. Study Identification

Unique Protocol Identification Number
NCT03725813
Brief Title
Study Evaluating the Effect of Person-centred Care for Patients Admitted for Inpatient Care at an Internal Medicine Unit
Official Title
Person-centred Inpatient Care - a Quasi-experimental Study Within an Internal Medicine Context
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 9, 2015 (Actual)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
June 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocrine System Diseases, Gastrointestinal Diseases
Keywords
Person-centred care, Intervention, Inpatient care, Satisfaction of care, quasi-experimental, internal medicine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A quasi- experimental study with non-equivalent control group design, pretest-posttest study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Person-centred inpatient care
Arm Type
Experimental
Arm Description
Person-centred inpatient care
Intervention Type
Other
Intervention Name(s)
Person-centred inpatient care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Satisfaction with care comprise patients' evaluations of caregivers' identity-oriented approach and the sociocultural atmosphere at the ward.
Description
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).
Time Frame
From date of admission until the date of discharge, up to 60 days of hospitalization.
Title
Person-centred content in medical records
Description
Degree of person-centredness in medical records
Time Frame
From date of admission until the date of discharge, up to 60 days of hospitalization.
Secondary Outcome Measure Information:
Title
Self-reported health assessed with EQ-5D-5L
Description
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).
Time Frame
at the date of discharge, an average of 5 days after inclusion
Title
Physical and psychological wellbeing assessed with the Quality from the Patient Perspective questionnaire
Description
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.
Time Frame
at the date of discharge, an average of 5 days after inclusion
Title
Level of general self-efficacy assessed with the General Self-Efficacy scale
Description
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).
Time Frame
at the date of discharge, an average of 5 days after inclusion
Title
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.
Description
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).
Time Frame
From date of admission until the date of discharge, up to 60 days of hospitalization.
Title
Clinical observations of pulse rate
Description
Frequency of documented pulse rate during hospitalization. The medical records are reviewed retrospectively.
Time Frame
From date of admission until the date of discharge, up to 60 days of hospitalization.
Title
Quality of care assessed as documented information in medical records on current medication at a daily basis and at discharge
Description
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.
Time Frame
From date of admission until the date of the discharge, up to 60 days of hospitalization.
Title
Quality of care assessed as documented information in medical records on planned medical care at discharge.
Description
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.
Time Frame
From date of admission until the date of discharge, up to 60 days of hospitalization.
Title
Clinical observations of weight
Description
Frequency of documented clinical observations of weight (kg) during hospitalization. The medical records are reviewed retrospectively.
Time Frame
From date of admission until date of discharge, up to 60 days of hospitalization.
Title
Clinical observations of blood pressure
Description
Frequency of documented clinical observations of systolic and diastolic blood pressure during hospitalization. The medical records are reviewed retrospectively.
Time Frame
From date of admission until the date of discharge, up to 60 days of hospitalization.
Title
Clinical observations of respiratory rate
Description
Frequency of documented clinical observations of respiratory rate during hospitalization. The medical records are reviewed retrospectively.
Time Frame
From date of admission until the date of discharge, up to 60 days of hospitalization.
Title
Body temperature
Description
Frequency of documented clinical observations of body temperature (degrees celsius) during hospitalization. The medical records are reviewed retrospectively.
Time Frame
From date of admission until the date of discharge, up to 60 days of hospitalization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Jakobsson Ung, Associate professor
Organizational Affiliation
Department of Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden and Institute of Health and Care Sciences, Sahlgrenska Academy at the University of Gothenburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study Evaluating the Effect of Person-centred Care for Patients Admitted for Inpatient Care at an Internal Medicine Unit

We'll reach out to this number within 24 hrs