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

October 24, 2017 updated by: Umeå University

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

Unknown

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

Interventional

Enrollment (Anticipated)

3

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Protected Engagement Time

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

June 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

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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