Endocrine System DiseasesNCT03725813
Study Evaluating the Effect of Person-centred Care for Patients Admitted for Inpatient Care at an Internal Medicine Unit
A study testing Person-centred inpatient care in people with Endocrine System Diseases and Gastrointestinal Diseases, run by Göteborg University at 1 site in Sweden.
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'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocrine System Diseases, Gastrointestinal Diseases
- What is being tested?
- Person-centred inpatient care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteSweden
- Study dates
- 9 Nov 2015to 30 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Medicine, Sahlgrenska University Hospital
Gothenburg, 41345
About this study
Official title: 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.
- Being tested
- Person-centred inpatient care
- Keywords
- Person-centred care, Intervention, Inpatient care, Satisfaction of care, quasi-experimental, internal medicine
- Medical subject headings
- Endocrine System Diseases, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-centred inpatient careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Person-centred inpatient care | Experimental | Person-centred inpatient care Receives: Other: Person-centred inpatient care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
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).
Measured: 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
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.
Measured: at the date of discharge, an average of 5 days after inclusion
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).
Measured: 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.
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).
Measured: From date of admission until the date of discharge, up to 60 days of hospitalization.
Clinical observations of pulse rate
Frequency of documented pulse rate during hospitalization. The medical records are reviewed retrospectively.
Measured: 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
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.
Measured: 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.
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.
Measured: From date of admission until the date of discharge, up to 60 days of hospitalization.
Clinical observations of weight
Frequency of documented clinical observations of weight (kg) during hospitalization. The medical records are reviewed retrospectively.
Measured: From date of admission until date of discharge, up to 60 days of hospitalization.
Clinical observations of blood pressure
Frequency of documented clinical observations of systolic and diastolic blood pressure during hospitalization. The medical records are reviewed retrospectively.
Measured: From date of admission until the date of discharge, up to 60 days of hospitalization.
Clinical observations of respiratory rate
Frequency of documented clinical observations of respiratory rate during hospitalization. The medical records are reviewed retrospectively.
Measured: From date of admission until the date of discharge, up to 60 days of hospitalization.
Body temperature
Frequency of documented clinical observations of body temperature (degrees celsius) during hospitalization. The medical records are reviewed retrospectively.
Measured: From date of admission until the date of discharge, up to 60 days of hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start9 Nov 2015
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine System DiseasesStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A quasi- experimental study with non-equivalent control group design, pretest-posttest study.
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725813
- Sponsor's protocol ID
- Person-centred care
- Status last verified
- Oct 2018
- First submitted
- 16 Oct 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Person-centred Inpatient Care - a Quasi-experimental Study Within an Internal Medicine Context
- ClinicalTrials.gov ID
- NCT03725813
- Acronym / sponsor ID
- Person-centred care
- Keywords
- Person-centred care, Intervention, Inpatient care, Satisfaction of care, quasi-experimental, internal medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 9 Nov 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A quasi- experimental study with non-equivalent control group design, pretest-posttest study.
| Arm | Type | Receives |
|---|---|---|
| Person-centred inpatient care | Experimental | Other: Person-centred inpatient carePerson-centred inpatient care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Person-centred inpatient careThe 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. | Other | Person-centred inpatient care |
Primary outcome
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).
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
11 secondary outcomes
Self-reported health assessed with EQ-5D-5L
Time frame: 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
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
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.
Clinical observations of pulse rate
Time frame: 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.
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.
Clinical observations of weight
Time frame: 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.
Clinical observations of respiratory rate
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Person-centred inpatient care in people with Endocrine System Diseases and Gastrointestinal Diseases, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.