- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02981563
Time Together: A Multi-site Nursing Intervention Project Using a Single System Experimental Design (TT)
The aim of this project is to test and evaluate a nursing intervention, Time Together (TT), created to enable quality interactions between patients and staff in psychiatric inpatient care. The research questions are:
Does TT influence the quality of interactions between staff and patients? Does TT influence patients' levels of anxiety and depressive symptoms? Does TT influence staffs' levels of perceived stress and levels of stress of conscience? Does TT influence the prevalence of coercive measures, mean length of hospital stay and the use of PRN medication?
In parallel, a process evaluation will be conducted, answering questions such as:
How do staff and patients describe their experiences of the intervention and how do contextual factors influence the effects of the intervention? What are the relationship between the outcome variables and the degree of compliance with the intended intervention? What problems are there with recruitment and dropouts?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND:
Despite the long known significance of the nurse-patient relationship, research in psychiatric inpatient care still reports on unfulfilled expectations of, and difficulties in interactions and relationships between patients and staff. As one solution to the contemporary circumstances, interventions that creates structures that allow quality interactions between patients and staff are needed.
INTERVENTION TT is an intervention, developed from the intervention Protected Engagement Time. The structure of TT is that staff, for a fixed time during the day, dedicates their time to exclusively engage with the patients. Other duties of more administrative nature, visits and meetings are organized to be performed at other times during the day. This structure will be tested at three psychiatric inpatient care wards in the north of Sweden.
DESIGN AND METHODS An experimental single system design (A-B-Follow-up) will be used. As TT will be introduced as a routine ward activity during the B phase, all patients and staff on the participating wards will be participating in TT. However, participating in the evaluation will be voluntary. Data will be collected through questionnaires once every seventh weekday during 5 weeks for the A phase, and 12 weeks during B phase.
In parallel, a process evaluation will be conducted using semi structured interviews and participating observations.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
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
- Experience of at least one TT session is required to participate in the B phase
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.
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: Time Together
Time Together as described under "Interventions"
|
For a fixed time during the day, staff dedicates their time to exclusively engage with the patients.
Different activities will be offered to both patients and staff, such as playing board games, taking a walk, or having individual conversations.
Other duties of more administrative nature, visits and meetings will be performed at other times during the day.
Through this, opportunities for interaction are both created and protected.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of interactions [patients]
Time Frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 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 every seventh week day for a total of 16 weeks)
|
Perceived stress [staff]
Time Frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
|
PSS consists of 10 items answered on a 5-point Likert scale
|
Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global quality of interactions [patients, staff]
Time Frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
|
A 100 mm Visual Analogue Scale expressing the most positive and the most negative rating will be anchored at each end
|
Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
|
Anxiety and depressive symptoms [patients]
Time Frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 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 every seventh week day for a total of 16 weeks)
|
Stress of Conscience [staff]
Time Frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 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 every seventh week day for a total of 16 weeks)
|
Quality of care [staff]
Time Frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 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 every seventh week day for a total of 16 weeks)
|
Number of PRN medications given
Time Frame: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
|
Data will be retrieved from ward registers.
|
Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
|
Length of hospital stay
Time Frame: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
|
Data will be retrieved from ward registers.
|
Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
|
Use of coercion and violent situations
Time Frame: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
|
Data will be retrieved from ward registers.
|
Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
- 350000210
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.
Clinical Trials on Nurse-Patient Relations
-
University of MichiganEnrolling by invitationNurse-Patient Relations | Nurse RoleUnited States
-
Shanghai Zhongshan HospitalNot yet recruitingNurse-Patient Relations | Patient ExperienceChina
-
University of British ColumbiaCompletedCommunication | Satisfaction | Physician-Patient Relations | Nurse-patient RelationsCanada
-
Guiyang Maternal and Child Health Care HospitalCompletedNurse-Patient RelationsChina
-
Acibadem UniversityCompletedPatient Satisfaction | Patient Relations, NurseTurkey
-
Saglik Bilimleri UniversitesiNot yet recruiting
-
University of BorasVastra Gotaland Region; Netherlands Instititute for Health Services Research; Mälardalen UniversityRecruiting
-
Tung Wah CollegeCompleted
-
Mari PakkonenCompletedNurse-Patient RelationsFinland
-
Alexandria UniversityCompletedNurse-Patient Relations | Patient Satisfaction | CaringEgypt
Clinical Trials on Time Together
-
University of TorontoUniversity Health Network, Toronto; University of Western Ontario, Canada; Institute... and other collaboratorsCompletedStroke | Activities of Daily Living | Mobility Limitation | BalanceCanada
-
York UniversityMcMaster University; University of TorontoCompletedFamily Conflict | Internet-Based InterventionCanada
-
York UniversityMcMaster University; University of TorontoActive, not recruitingMarital Relationship | Family Conflict | Internet-Based Intervention | Interparental Conflict | Marital ConflictCanada
-
University of ConnecticutNational Heart, Lung, and Blood Institute (NHLBI); Worcester Polytechnic InstituteCompleted
-
University of British ColumbiaPublic Health Agency of Canada (PHAC); The Bridge Youth and Family Services...CompletedOverweight and Obesity | Health Knowledge, Attitudes, PracticeCanada
-
Caroline RowlandCompletedLanguage DevelopmentUnited Kingdom
-
Michigan State UniversityUniversity of Michigan; Wake Forest University Health Sciences; Babes-Bolyai...CompletedUsual Care | Telemedicine: Smoking Cessation App Only | Telemedicine: Smoking Cessation Counseling | Telemedicine: App + CounselingRomania
-
Dominique JANUELRecruiting
-
University of California, San DiegoFamily Health Centers of San Diego; UCSD Center for Community HealthRecruitingStress | Childhood ObesityUnited States
-
Johns Hopkins Bloomberg School of Public HealthNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruiting