Clinical trial NCT02981563: Time Together: A Multi-site Nursing Intervention Project Using a Single System Experimental Design
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Nursing
Nurse-Patient Relations
Keywords: engagement
psychiatric in-patient care
mental health nursing
quality interactions
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of interactions [patients]
timeFrame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
measure: Perceived stress [staff]
timeFrame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
Secondary outcomes:
measure: Global quality of interactions [patients, staff]
timeFrame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
measure: Anxiety and depressive symptoms [patients]
timeFrame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
measure: Stress of Conscience [staff]
timeFrame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
measure: Quality of care [staff]
timeFrame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
measure: Number of PRN medications given
timeFrame: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
measure: Length of hospital stay
timeFrame: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
measure: Use of coercion and violent situations
timeFrame: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.