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

October 29, 2018 updated by: 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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gothenburg, Sweden, 41345
        • Department of Medicine, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with care comprise patients' evaluations of caregivers' identity-oriented approach and the sociocultural atmosphere at the ward.
Time Frame: 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
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported health assessed with EQ-5D-5L
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2015

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

June 30, 2016

Study Registration Dates

First Submitted

October 16, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (Actual)

October 31, 2018

Study Record Updates

Last Update Posted (Actual)

October 31, 2018

Last Update Submitted That Met QC Criteria

October 29, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastrointestinal Diseases

Clinical Trials on Person-centred inpatient care

Subscribe