Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03725813
Other study ID # Person-centred care
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 9, 2015
Est. completion date June 30, 2016

Study information

Verified date October 2018
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 177
Est. completion date June 30, 2016
Est. primary completion date June 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
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.

Locations

Country Name City State
Sweden Department of Medicine, Sahlgrenska University Hospital Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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 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). at the date of discharge, an average of 5 days after inclusion
Secondary 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. at the date of discharge, an average of 5 days after inclusion
Secondary 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). at the date of discharge, an average of 5 days after inclusion
Secondary 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). From date of admission until the date of discharge, up to 60 days of hospitalization.
Secondary Clinical observations of pulse rate 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.
Secondary 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. From date of admission until the date of the discharge, up to 60 days of hospitalization.
Secondary 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. From date of admission until the date of discharge, up to 60 days of hospitalization.
Secondary Clinical observations of weight 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.
Secondary Clinical observations of blood pressure 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.
Secondary Clinical observations of respiratory rate 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.
Secondary Body temperature 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.
See also
  Status Clinical Trial Phase
Terminated NCT02541357 - Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Colorectal Surgery N/A
Active, not recruiting NCT02358122 - Determining the Potential of Wholegrain Wheat and Rye to Improve Gut HealTh N/A
Active, not recruiting NCT02442115 - Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
Enrolling by invitation NCT00943345 - Validation of New Tests for Gastrointestinal (GI) Permeability Phase 0
Completed NCT00612404 - Symptoms and Endoscopic Results in Consideration of Pretreatment N/A
Completed NCT01127711 - Cohort of Swedish Men N/A
Recruiting NCT05712525 - Gut Recovery In Patients Following Surgery
Recruiting NCT06094153 - Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function N/A
Recruiting NCT05322486 - Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases
Completed NCT02486146 - GI Biorepository of Tissue and Bodily Fluids N/A
Completed NCT01816607 - Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
Completed NCT00247715 - Comparison of a "Step-Up" Versus a "Step-Down" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study) N/A
Completed NCT00035334 - Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis Phase 2/Phase 3
Recruiting NCT06286865 - Improving Quality of ICD-10 Coding Using AI: Protocol for a Crossover Randomized Controlled Trial N/A
Active, not recruiting NCT01037049 - Optimum Timing for Surgery After Pre-operative Radiotherapy 6 vs 12 Weeks Phase 2
Recruiting NCT05640401 - Holographic Screens as a Replacement of Monitors During GI Endoscopies N/A
Completed NCT02865564 - Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics N/A
Completed NCT02651857 - Exploratory Study of Upper and Lower Endoscopic Fuse System N/A
Active, not recruiting NCT01984034 - Trial to Assess the Effectiveness of Educational Outreach in Prescription Guidelines N/A
Completed NCT01463319 - Warm Water and Unsedated Colonoscopy Phase 0