Mental Health NursingTTNCT02981563
Time Together: A Multi-site Nursing Intervention Project Using a Single System Experimental Design
A study testing Time Together in people with Mental Health Nursing and Nurse-Patient Relations, run by Umeå University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Nursing, Nurse-Patient Relations
- What is being tested?
- Time Together
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Nov 2017
- 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
- 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
- Regularly employed at the ward during A and B phase and/or follow-up.
Who cannot join
- Does not master the Swedish language well enough to complete questionnaires and participate in interviews.
About this study
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?
Read more
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?
Read the 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.
- Conditions
- Mental Health Nursing, Nurse-Patient Relations
- Being tested
- Time Together
- Keywords
- engagement, psychiatric in-patient care, mental health nursing, quality interactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time TogetherOther
Also called Protected Engagement Time
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.
| Study group | Role | What they receive |
|---|---|---|
| Time Together | Experimental | Time Together as described under "Interventions" Receives: Other: Time Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of interactions [patients]
This is measured using The Caring Professional Scale (CPS) that consists of 14 items answered on a 5-point Likert scale.
Measured: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
Perceived stress [staff]
PSS consists of 10 items answered on a 5-point Likert scale
Measured: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
Secondary outcomes (7)
Global quality of interactions [patients, staff]
A 100 mm Visual Analogue Scale expressing the most positive and the most negative rating will be anchored at each end
Measured: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
Anxiety and depressive symptoms [patients]
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.
Measured: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
Stress of Conscience [staff]
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.
Measured: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
Quality of care [staff]
The Quality in Psychiatric Care- Inpatient Staff (QPC-IPS) questionnaire will be used to measure quality of care.
Measured: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
Number of PRN medications given
Data will be retrieved from ward registers.
Measured: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
Length of hospital stay
Data will be retrieved from ward registers.
Measured: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
Use of coercion and violent situations
Data will be retrieved from ward registers.
Measured: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2017
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health NursingStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981563
- Sponsor's protocol ID
- 350000210
- Acronym
- TT
- Status last verified
- Nov 2016
- First submitted
- 1 Dec 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Molin J, Lindgren BM, Graneheim UH, Ringner A. Does 'Time Together' increase quality of interaction and decrease stress? A study protocol of a multisite nursing intervention in psychiatric inpatient care, using a mixed method approach. BMJ Open. 2017 Aug 28;7(8):e015677. doi: 10.1136/bmjopen-2016-015677.
PubMed 28851774
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Together: A Multi-site Nursing Intervention Project Using a Single System Experimental Design
- ClinicalTrials.gov ID
- NCT02981563
- Acronym / sponsor ID
- TT / 350000210
- Conditions
- Mental Health Nursing, Nurse-Patient Relations
- Keywords
- engagement, psychiatric in-patient care, mental health nursing, quality interactions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2017 (actual)
- Study completion
- Nov 2017 (estimated)
- First posted
- 5 Dec 2016 (estimated)
- 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.
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?
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Time Together | Experimental | Other: Time TogetherTime Together as described under "Interventions" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- Regularly employed at the ward during A and B phase and/or follow-up.
Key exclusion criteria (1 listed)
- Does not master the Swedish language well enough to complete questionnaires and participate in interviews.
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 |
|---|---|---|
| Time TogetherAlso: Protected Engagement TimeFor 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 | Time Together |
Primary outcome
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.
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
7 secondary outcomes
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)
Anxiety and depressive symptoms [patients]
Time frame: 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)
Quality of care [staff]
Time frame: 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)
Length of hospital stay
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Derived from this study: PubMed 28851774Molin J, Lindgren BM, Graneheim UH, Ringner A. Does 'Time Together' increase quality of interaction and decrease stress? A study protocol of a multisite nursing intervention in psychiatric inpatient care, using a mixed method approach. BMJ Open. 2017 Aug 28;7(8):e015677. doi: 10.1136/bmjopen-2016-015677.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Time Together in people with Mental Health Nursing and Nurse-Patient Relations, run by Umeå University.
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 4 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: status not confirmed, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Quality of interactions [patients] (time frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)). 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?
On the ClinicalTrials.gov record for NCT02981563, which also lists 1 linked publication.
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 26 Oct 2017.