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CompletedNCT03725813Updated Oct 31, 2018

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

An interventional study of Person-centred inpatient care in Endocrine System Diseases and Gastrointestinal Diseases, sponsored by Göteborg University. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-31.

Sponsored by Göteborg University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Nov 2015, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
177
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Endocrine System Diseases
  • Gastrointestinal Diseases

Keywords

  • Person-centred care
  • Intervention
  • Inpatient care
  • Satisfaction of care
  • quasi-experimental
  • internal medicine
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In context

Gastrointestinal Diseases

628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.

This study's enrollment of 177 is above the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.

Browse Gastrointestinal Diseases studies →

Lead sponsor

Göteborg University is the lead sponsor of 265 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
177 participants (actual)

Study arms

  • Experimental
    Person-centred inpatient care

    Person-centred inpatient care

    Other: Person-centred inpatient care

Interventions

  • OtherPerson-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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: From date of admission until the date of discharge, up to 60 days of hospitalization.

  2. Person-centred content in medical records

    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 outcomes

  1. 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).

    Time frame: at the date of discharge, an average of 5 days after inclusion

  2. 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.

    Time frame: at the date of discharge, an average of 5 days after inclusion

  3. 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).

    Time frame: at the date of discharge, an average of 5 days after inclusion

  4. 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).

    Time frame: From date of admission until the date of discharge, up to 60 days of hospitalization.

  5. Clinical observations of pulse rate

    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.

  6. 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.

    Time frame: From date of admission until the date of the discharge, up to 60 days of hospitalization.

  7. 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.

    Time frame: From date of admission until the date of discharge, up to 60 days of hospitalization.

  8. Clinical observations of weight

    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.

  9. Clinical observations of blood pressure

    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.

  10. Clinical observations of respiratory rate

    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.

  11. Body temperature

    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.

07

Study locations

1 site
  • Department of Medicine, Sahlgrenska University Hospital
    Gothenburg, 41345, Sweden
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03725813
Lead sponsor
Göteborg University
Responsible party
Sponsor
First posted
Oct 31, 2018
Start date
Nov 9, 2015
Primary completion
Jun 30, 2016
Completion
Jun 30, 2016
Last update
Oct 31, 2018

Study contacts

Eva Jakobsson Ung, Associate professor
principal investigator · Department of Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden and Institute of Health and Care Sciences, Sahlgrenska Academy at the University of Gothenburg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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