- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03140618
The Light- and Environment Project in Psychiatric Inpatient Care (LEPPIC)
The care environment influences both patients' experiences of care as well as staff's experiences of the work environment. A radical change in physical environment is planned at a psychiatric ward, aiming at creating a care environment that supports patients' opportunities for recovery from mental ill-health and to create a better and more attractive work environment for the staff. The rebuilding involves a new ward layout and new innovations such as light installations, a comfort room and an activity room.
The study uses a single-system design to evaluate the effects of the intervention - the rebuilt ward. Both quantitative and qualitative data will be used in the evaluation. Data will be collected using questionnaires measuring dimensions of patients' well-being and experiences of the care environment, staff's experiences of work-related stress and work environment, quality of care, a device measuring physical activity, existing clinical registers and data from medical files, staff' sick leave, participant observations, and semi-structured interviews.
This evaluation study, to our knowledge the first of it's kind in Sweden, is expected to generate important knowledge of the effect of the change process that can be used at other psychiatric wards to design the inpatient care environment. In the long run, the study could lead to a better reputation of psychiatric nursing and to more attractive workplaces.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Umeå, Sweden, SE-90187
- Umeå University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for Patients
- 18 years or older
- Admitted to the wards during either A phase, B phase and/or follow-up
Exclusion Criteria for Patients
- Does not master the Swedish language well enough to complete questionnaires and participate in interviews
Inclusion Criteria for Staff:
- Regularly employed at the ward during A and B phase and/or follow-up.
Exclusion Criteria for Staff:
- Staff employed by the hour
Study Plan
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: LEPPIC
The light and environment project in psychiatric inpatient care
|
Complete rebuilding of a hospital ward. The ward layout is remodeled and different devices and services are installed such as light, sound, and color settings, increased opportunities for physical activity, social harmony, privacy, peace, and quiet. A comfort room and a activity room will be built. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Outcome Rating Scale [patients]
Time Frame: Changes during baseline and intervention period (measured regularly for 12 weeks)
|
The Outcome Rating Scale measures self-assessed satisfaction with life on four visual-analogue scales.
|
Changes during baseline and intervention period (measured regularly for 12 weeks)
|
|
Perceived stress [staff]
Time Frame: Changes during baseline and intervention period (measured regularly for 12 weeks)
|
PSS consists of 10 items answered on a 5-point Likert scale
|
Changes during baseline and intervention period (measured regularly for 12 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of interactions [patients]
Time Frame: Changes during baseline and intervention period (measured regularly for 12 weeks)
|
This is measured using The Caring Professional Scale (CPS) that consists of 14 items answered on a 5-point Likert scale.
|
Changes during baseline and intervention period (measured regularly for 12 weeks)
|
|
Anxiety and depressive symptoms [patients]
Time Frame: Changes during baseline and intervention period (measured regularly for 12 weeks)
|
The Hospital Anxiety and Depression Scale (HAD) will be used to measure anxiety and depressive symptoms.
All items are scored on a 4-point scale.
|
Changes during baseline and intervention period (measured regularly for 12 weeks)
|
|
Quality in psychiatric care [patients]
Time Frame: Changes during baseline and intervention period (measured regularly for 12 weeks)
|
The QPC-IP measures quality of care on 30 items using a 4-point scale.
|
Changes during baseline and intervention period (measured regularly for 12 weeks)
|
|
Stress of Conscience [staff]
Time Frame: Changes during baseline and intervention period (measured regularly for 12 weeks)
|
The Stress of Conscience Questionnaire (SCQ) will be used to measure the frequencies of stressful situations and the degree to which these lead to stress of conscience among staff.
|
Changes during baseline and intervention period (measured regularly for 12 weeks)
|
|
Quality of care [staff]
Time Frame: Changes during baseline and intervention period (measured regularly for 12 weeks)
|
The Quality in Psychiatric Care- Inpatient Staff (QPC-IPS) questionnaire will be used to measure quality of care.
|
Changes during baseline and intervention period (measured regularly for 12 weeks)
|
|
Physical activity [patients and staff]
Time Frame: Changes in physical activity between baseline and intervention
|
An electronic device measuring physical activity will be carried by participants during one week before and after rebuilding the ward.
|
Changes in physical activity between baseline and intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Britt-Marie Lindgren, Umeå University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 3500LJUSMILJO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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