<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02981563</url>
  </required_header>
  <id_info>
    <org_study_id>350000210</org_study_id>
    <nct_id>NCT02981563</nct_id>
  </id_info>
  <brief_title>Time Together: A Multi-site Nursing Intervention Project Using a Single System Experimental Design</brief_title>
  <acronym>TT</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Umeå University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umeå University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this project is to test and evaluate a nursing intervention, Time Together (TT),&#xD;
      created to enable quality interactions between patients and staff in psychiatric inpatient&#xD;
      care. The research questions are:&#xD;
&#xD;
      Does TT influence the quality of interactions between staff and patients? Does TT influence&#xD;
      patients' levels of anxiety and depressive symptoms? Does TT influence staffs' levels of&#xD;
      perceived stress and levels of stress of conscience? Does TT influence the prevalence of&#xD;
      coercive measures, mean length of hospital stay and the use of PRN medication?&#xD;
&#xD;
      In parallel, a process evaluation will be conducted, answering questions such as:&#xD;
&#xD;
      How do staff and patients describe their experiences of the intervention and how do&#xD;
      contextual factors influence the effects of the intervention? What are the relationship&#xD;
      between the outcome variables and the degree of compliance with the intended intervention?&#xD;
      What problems are there with recruitment and dropouts?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND:&#xD;
&#xD;
      Despite the long known significance of the nurse-patient relationship, research in&#xD;
      psychiatric inpatient care still reports on unfulfilled expectations of, and difficulties in&#xD;
      interactions and relationships between patients and staff. As one solution to the&#xD;
      contemporary circumstances, interventions that creates structures that allow quality&#xD;
      interactions between patients and staff are needed.&#xD;
&#xD;
      INTERVENTION TT is an intervention, developed from the intervention Protected Engagement&#xD;
      Time. The structure of TT is that staff, for a fixed time during the day, dedicates their&#xD;
      time to exclusively engage with the patients. Other duties of more administrative nature,&#xD;
      visits and meetings are organized to be performed at other times during the day. This&#xD;
      structure will be tested at three psychiatric inpatient care wards in the north of Sweden.&#xD;
&#xD;
      DESIGN AND METHODS An experimental single system design (A-B-Follow-up) will be used. As TT&#xD;
      will be introduced as a routine ward activity during the B phase, all patients and staff on&#xD;
      the participating wards will be participating in TT. However, participating in the evaluation&#xD;
      will be voluntary. Data will be collected through questionnaires once every seventh weekday&#xD;
      during 5 weeks for the A phase, and 12 weeks during B phase.&#xD;
&#xD;
      In parallel, a process evaluation will be conducted using semi structured interviews and&#xD;
      participating observations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of interactions [patients]</measure>
    <time_frame>Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)</time_frame>
    <description>This is measured using The Caring Professional Scale (CPS) that consists of 14 items answered on a 5-point Likert scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived stress [staff]</measure>
    <time_frame>Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)</time_frame>
    <description>PSS consists of 10 items answered on a 5-point Likert scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global quality of interactions [patients, staff]</measure>
    <time_frame>Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)</time_frame>
    <description>A 100 mm Visual Analogue Scale expressing the most positive and the most negative rating will be anchored at each end</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depressive symptoms [patients]</measure>
    <time_frame>Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress of Conscience [staff]</measure>
    <time_frame>Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of care [staff]</measure>
    <time_frame>Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)</time_frame>
    <description>The Quality in Psychiatric Care- Inpatient Staff (QPC-IPS) questionnaire will be used to measure quality of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of PRN medications given</measure>
    <time_frame>Changes during baseline and intervention period (measured weekly for a total of 16 weeks)</time_frame>
    <description>Data will be retrieved from ward registers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Changes during baseline and intervention period (measured weekly for a total of 16 weeks)</time_frame>
    <description>Data will be retrieved from ward registers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of coercion and violent situations</measure>
    <time_frame>Changes during baseline and intervention period (measured weekly for a total of 16 weeks)</time_frame>
    <description>Data will be retrieved from ward registers.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">3</enrollment>
  <condition>Mental Health Nursing</condition>
  <condition>Nurse-Patient Relations</condition>
  <arm_group>
    <arm_group_label>Time Together</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Time Together as described under &quot;Interventions&quot;</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Time Together</intervention_name>
    <description>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.</description>
    <arm_group_label>Time Together</arm_group_label>
    <other_name>Protected Engagement Time</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for patients:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Admitted to the wards during either A phase, B phase and/or follow-up&#xD;
&#xD;
          -  Experience of at least one TT session is required to participate in the B phase&#xD;
&#xD;
        Exclusion criteria for patients:&#xD;
&#xD;
        - Does not master the Swedish language well enough to complete questionnaires and&#xD;
        participate in interviews.&#xD;
&#xD;
        Inclusion criteria for staff:&#xD;
&#xD;
        - Regularly employed at the ward during A and B phase and/or follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>engagement</keyword>
  <keyword>psychiatric in-patient care</keyword>
  <keyword>mental health nursing</keyword>
  <keyword>quality interactions</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02981563
org study id: 350000210
nct id: NCT02981563
lead sponsor: 
has dmc: No
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?
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Quality of interactions [patients]
time frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
description: This is measured using The Caring Professional Scale (CPS) that consists of 14 items answered on a 5-point Likert scale.
measure: Perceived stress [staff]
time frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
description: PSS consists of 10 items answered on a 5-point Likert scale
measure: 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)
description: A 100 mm Visual Analogue Scale expressing the most positive and the most negative rating will be anchored at each end
measure: Anxiety and depressive symptoms [patients]
time frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
description: 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.
measure: Stress of Conscience [staff]
time frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
description: 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.
measure: Quality of care [staff]
time frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
description: The Quality in Psychiatric Care- Inpatient Staff (QPC-IPS) questionnaire will be used to measure quality of care.
measure: Number of PRN medications given
time frame: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
description: Data will be retrieved from ward registers.
measure: Length of hospital stay
time frame: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
description: Data will be retrieved from ward registers.
measure: Use of coercion and violent situations
time frame: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
description: Data will be retrieved from ward registers.
arm group label: Time Together
arm group type: Experimental
description: Time Together as described under "Interventions"
intervention type: Other
intervention name: Time Together
description: 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.
arm group label: Time Together
other name: Protected Engagement Time
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor