Time Together: A Multi-site Nursing Intervention Project Using a Single System Experimental Design

Nurse-Patient Relations Clinical Trial

— TT  

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02981563
• Other study ID #: 350000210
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 1, 2016
• Last updated: October 24, 2017
• Start date: January 2017
• Est. completion date: November 2017

Study information

• Verified date: November 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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?

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3
• Est. completion date: November 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Nursing
• Nurse-Patient Relations

Intervention

Other:
• Time Together
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
Primary	Perceived stress [staff]	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	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	Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
Secondary	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.	Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
Secondary	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.	Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
Secondary	Quality of care [staff]	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)
Secondary	Number of PRN medications given	Data will be retrieved from ward registers.	Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
Secondary	Length of hospital stay	Data will be retrieved from ward registers.	Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
Secondary	Use of coercion and violent situations	Data will be retrieved from ward registers.	Changes during baseline and intervention period (measured weekly for a total of 16 weeks)