NCT03725813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

8 months

First QC Date

October 16, 2018

Last Update Submit

October 29, 2018

Conditions

Keywords

Person-centred careInterventionInpatient careSatisfaction of carequasi-experimentalinternal medicine

Outcome Measures

Primary Outcomes (2)

  • 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).

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

  • Person-centred content in medical records

    Degree of person-centredness in medical records

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

Secondary Outcomes (11)

  • Self-reported health assessed with EQ-5D-5L

    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

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

  • Level of general self-efficacy assessed with the General Self-Efficacy scale

    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.

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

  • Clinical observations of pulse rate

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

  • +6 more secondary outcomes

Study Arms (1)

Person-centred inpatient care

EXPERIMENTAL

Person-centred inpatient care

Other: Person-centred inpatient care

Interventions

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.

Person-centred inpatient care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Endocrine System DiseasesGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: A quasi- experimental study with non-equivalent control group design, pretest-posttest study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2018

First Posted

October 31, 2018

Study Start

November 9, 2015

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

October 31, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations