<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/NCT02983136</url>
  </required_header>
  <id_info>
    <org_study_id>Safe Hands</org_study_id>
    <nct_id>NCT02983136</nct_id>
  </id_info>
  <brief_title>Safe Hands at the Sharp End- Implementing Aseptic Technique in the Operating Room</brief_title>
  <official_title>Safe Hands at the Sharp End- Implementing Aseptic Technique in the Operating Room, A Prospective Controlled Study With an Embedded Process Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Gothenburg Center for Person-Centred Care, GPCC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Landstingens Ömsesidiga Försäkringsbolag (Löf)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Göteborg University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this integrated Knowledge Translation (iKT) study is to develop and test a&#xD;
      multifaceted implementation intervention for feasibility, acceptability and effectiveness.&#xD;
      The intervention will be tailored to fit the context of the operating room (OR), to promote&#xD;
      OR team members' use of aseptic techniques during the care of frail persons undergoing acute&#xD;
      fracture surgery of the hip.&#xD;
&#xD;
      Through the use of an iKT approach, the investigators hypothesise that building on leadership&#xD;
      support, partnership between researchers, managers/clinical leaders and healthcare&#xD;
      professionals, a solid foundation for the sustained implementation of patient safety&#xD;
      innovations can be created.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PROJECT DESCRIPTION&#xD;
&#xD;
      Aim The aim of this iKT study is to develop and test a multifaceted implementation&#xD;
      intervention for feasibility, acceptability and effectiveness.The intervention will be&#xD;
      tailored to fit the inner context of the operating department, to promote anaesthetic&#xD;
      providers use of aseptic techniques.&#xD;
&#xD;
      Theory In designing the present study, the investigators followed the four iterative phases&#xD;
      as identified by the UK Medical Research Council (MRC) framework for developing and&#xD;
      evaluating complex interventions(1): *Review of the theoretical basis for the innovation and&#xD;
      the context *Conducting pre studies and designing the intervention,*The exploratory trial&#xD;
      i.e. the intervention implementation and evaluation.&#xD;
&#xD;
      The aim of the leadership intervention is to support the leaders in developing a&#xD;
      participatory and effective leadership behaviours that promote the OR team's use of aseptic&#xD;
      techniques and facilitate inter professional learning. The middle and front-line leaders of&#xD;
      the study OR will participate in an intervention based on an iKT model inspired by&#xD;
      person-centeredness (2) social construction and complexity thinking (3). The care&#xD;
      professionals participating in this in this study are considered active partners and&#xD;
      co-creators of the implementation process and activities. This type of collaborative approach&#xD;
      means that the researchers, leaders and the OR team work closely together throughout the&#xD;
      research process in order to produce findings that are relevant for users and context (4).&#xD;
      Using this innovative approach represents a major departure from the concept of 'compliance'&#xD;
      and a shift towards change as a result of a participatory and mindful processes (5). In the&#xD;
      inter-professional dialogues, the following principles will underpin the process:&#xD;
&#xD;
        -  All partners are experts with various professional experiences,&#xD;
&#xD;
        -  Power differentials among partners are acknowledged and sensitively addressed,&#xD;
&#xD;
        -  All partners discuss potential benefits and harm of the innovation, research and&#xD;
           implementation strategy,&#xD;
&#xD;
        -  The process is capacity-building for everyone and encompasses opportunities for mutual&#xD;
           learning (4).&#xD;
&#xD;
      DESIGN This is a mixed methods prospective controlled implementation study with an embedded&#xD;
      process evaluation. Two similar sized surgical departments will be included; one will be&#xD;
      selected as experimental department and the other, as the control. In addition to standard&#xD;
      education on HH the experimental ward will participate in an iKT intervention&#xD;
&#xD;
      Participants&#xD;
&#xD;
        1. Leaders and staff at two orthopaedic OR departments within two similar sized university&#xD;
           hospitals in the western region of Sweden and Skåne will be invited to take part in the&#xD;
           study. Each OR performs approximately 800-900 trauma induced acute hip surgeries&#xD;
           annually. One will be selected as the study department and one as the control;&#xD;
           approximately 135 persons are employed on each department. Of these, 75% are anaesthetic&#xD;
           providers (physicians, nurses and nurse assistants). Both the experimental and the&#xD;
           control OR will receive the hospital's standard strategy for infection control: audit&#xD;
           and feedback, reminders and computerised education on hand hygiene and the same lecture&#xD;
           on Infection Control given by the experts in the area.&#xD;
&#xD;
        2. 1500 patients undergoing fracture surgery of the hip will be invited at each site to&#xD;
           take part in a registry study on post-operative complications and satisfaction with the&#xD;
           care given.&#xD;
&#xD;
      THE INTERVENTION&#xD;
&#xD;
      Components of the intervention will include:&#xD;
&#xD;
        -  Two workshops, consisting of educational sessions covering the state of the art&#xD;
           regarding person-centeredness, prevention of infections, leadership, and implementation.&#xD;
           The educational component and results of pre-studies will work as frameworks for the&#xD;
           dialogues between the front-line leaders and the research group. In dialogues the&#xD;
           participants will be given the opportunity to reflect on barriers to and enablers of&#xD;
           change; and&#xD;
&#xD;
        -  The participants will be supported in creating an action plan aimed at facilitating the&#xD;
           anaesthesia providers' change of practice by &quot;1) support, visibility and communication;&#xD;
           (2) creating a positive milieu through vision, role modelling and change; and (3)&#xD;
           influencing organisational structures and processes through resources, policies and&#xD;
           monitoring&quot;(6). The action plan will be executed over 6 months and include 6-8 learning&#xD;
           laboratories, led by clinical leaders and facilitated by researchers.&#xD;
&#xD;
      OUTCOME Primary outcome: Process evaluation: Assessing, dose, reach fidelity, acceptability,&#xD;
      feasibility and unforeseen consequences of the implementation strategy Secondary outcomes: a)&#xD;
      The application of hand hygiene and aseptic techniques during invasive procedures b)&#xD;
      Complications after hip surgery&#xD;
&#xD;
      DATA COLLECTION&#xD;
&#xD;
      Process evaluation:&#xD;
&#xD;
      A key element in this project is the process evaluation assessing acceptability, feasibility&#xD;
      and unforeseen consequences of the implementation through interviews and ethnographic&#xD;
      fieldwork. Ethnographic fieldwork (7) is particularly suited to understanding culture and&#xD;
      complexity and finding explanations of why and how specific intervention strategies have&#xD;
      failed or succeeded. Participant observations (8) will be made throughout the implementation&#xD;
      process. The purpose of using this method is to capture talks and events in relation to the&#xD;
      implementation strategies and to understand basic assumptions regarding team-work and patient&#xD;
      safety strategies the OR. Attention will be paid to practices that may work as barriers to,&#xD;
      and enablers for change. In addition, purposively selected key staff and informal leaders of&#xD;
      all professional categories (to ensure maximum variation) will be asked in interviews to give&#xD;
      their perspectives on the implementation strategies and activities. The interviews will be&#xD;
      audio-taped and transcribed verbatim. In addition to the ethnographic method, structured&#xD;
      observations will be used to determine the &quot;dose&quot; of the intervention components given and&#xD;
      received, as well as fidelity to the intervention (9).&#xD;
&#xD;
      The use of of hand hygiene/aseptic technique:&#xD;
&#xD;
      The direct observation of hand hygiene is regarded as the gold standard and will be used in&#xD;
      this study (10). Adherence to hand hygiene guidelines and aseptic techniques will be measured&#xD;
      using a pre-tested and modified version of the World Health Organisation's observational tool&#xD;
      (11). The form has been modified to match the OR context (12). An opportunity for hand&#xD;
      hygiene is defined as a situation requiring hand disinfection in accordance with national and&#xD;
      local guidelines (13). A hand hygiene application is defined as the use of an alcohol-based&#xD;
      hand rub in relation to an opportunity. The amount of product used and the duration of its&#xD;
      application will not be recorded. Adherence will be recorded in relation to professional&#xD;
      category and type of indication. Based on power estimation of 90% power with an alpha level&#xD;
      of 5% and an estimated difference before and after the intervention of 10% between the study&#xD;
      sites and time periods, 100 care procedures requiring HH and AT will be observed at each time&#xD;
      point for each department&#xD;
&#xD;
      Pre-intervention data will be collected in the experimental and the control wards in close&#xD;
      connection with the intervention. Post-intervention data will be collected 6 and 12 months&#xD;
      after the completed leadership intervention.&#xD;
&#xD;
      Postoperative complications:&#xD;
&#xD;
      The nurses responsible for the discharge will, after on informed consent collect information,&#xD;
      from the patients' medical chart on post-operative urinary- and respiratory tract infections,&#xD;
      bloodstream and surgical wound infections, pressure-ulcers and confusion. A research&#xD;
      assistant will perform chard audits on every 20th included patient to validate data.&#xD;
&#xD;
      Six weeks and 12 months after discharge the patients will be sent by regular mail a survey on&#xD;
      patient satisfaction and treatment with antibiotics for wound infection.&#xD;
&#xD;
      Data analysis Interviews and field notes: Inductive content analysis will be used for&#xD;
      analysis of qualitative data derived from interviews and participant observations. The texts&#xD;
      will be read and re-read to obtain a full understanding and gain a sense of the whole.&#xD;
      Meaning units will be extracted, condensed, and labelled with a code, with the aim of the&#xD;
      study kept in mind. The code assigned reflected the meaning unit and serves as a tool for&#xD;
      viewing the data in a new way. The codes will be compared and grouped into sub-themes. This&#xD;
      analysis will continue by interpreting the underlying meaning in relation to time and context&#xD;
      with the support of the theoretical framework.&#xD;
&#xD;
      Observational and registry data: The types of statistics used in data analysis will be driven&#xD;
      by the level of the data and its distribution. Descriptive statistics will be used to&#xD;
      summarize data on AT and inferential statistics used for comparisons between groups and time&#xD;
      periods.&#xD;
&#xD;
      Ethics The study will be conducted with approval by the Regional Ethics Review Board in&#xD;
      Gothenburg, Sweden. Informed consent will be obtained from the ward managers prior to&#xD;
      observation. The project will be conducted in line with the four principal requirements of&#xD;
      the Helsinki Declaration; autonomy, non-malfeasance, beneficence, and justice (54). Both oral&#xD;
      and written information will be given to the participants and written consent will be sought&#xD;
      (appendix 4:1-3). In those cases when potential participating patients suffer from conditions&#xD;
      that impede their possibilities to give informed consent, their next of kin will be asked to&#xD;
      consider giving consent for participation. All data will be analyzed and reported on group&#xD;
      lever. The participant's confidentiality and privacy will be maintained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical site infections</measure>
    <time_frame>1 year</time_frame>
    <description>At discharge, after 6 weeks and 1 year data will be collect on post-operative infections.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hand hygiene and Aseptic techniques</measure>
    <time_frame>At baseline, 6, 12 and 18 month after the start of the intervention</time_frame>
    <description>Adherence to hand hygiene guidelines and aseptic techniques will be measured using a pre-tested and modified version of the World Health Organisation's observational tool (11). The form has been modified to match the OR context (12). An opportunity for hand hygiene is defined as a situation requiring hand disinfection in accordance with national and local guidelines (13). A hand hygiene application is defined as the use of an alcohol-based hand rub in relation to an opportunity. The amount of product used and the duration of its application will not be recorded. Adherence will be recorded in relation to professional category and type of indication. Based on power estimation of 90% power with an alpha level of 5% and an estimated difference before and after the intervention of 10% between the study sites and time periods, 100 care procedures requiring HH and AT will be observed at each time point for each department</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Process evaluation</measure>
    <time_frame>1 year</time_frame>
    <description>Process data will be collected using structured observations and ethnographic fieldwork</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Surgical Wound Infection</condition>
  <arm_group>
    <arm_group_label>Study site</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study arm will consist of managers and staff at at the operating department of a University hospital in western Sweden' The intervention is based on partnership, dialogue and inter-professional learning</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control site</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The Control arm will consist of managers and staff at at the operating department of a University hospital in south Sweden</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dialogue and inter-professional learning</intervention_name>
    <description>The middle and front-line leaders of the study OR will participate in an intervention based on an iKT model. Components of the intervention will include:&#xD;
Two workshops, consisting of educational sessions covering the state of the art regarding person-centeredness, prevention of infections, leadership, and implementation. The educational component and results of pre-studies will work as frameworks for the dialogues between the front-line leaders and the research group. In dialogues the participants will be given the opportunity to reflect on barriers to and enablers of change; and&#xD;
The participants will be supported in creating an action plan aimed at facilitating the anaesthesia providers' change of practice.</description>
    <arm_group_label>Study site</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All staff currently working at the intervention site and control site are eligibly for&#xD;
             inclusion&#xD;
&#xD;
        All patient that are undergoing hip fracture surgery at the control and study site and have&#xD;
        given informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ongoing infection before surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sahlgrenska Academy, University of Gothenburg</name>
      <address>
        <city>Gothenburg</city>
        <zip>405 30</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hand Hygiene</keyword>
  <keyword>Implementation</keyword>
  <keyword>Partnership</keyword>
  <keyword>Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <!-- 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/NCT02983136
org study id: Safe Hands
nct id: NCT02983136
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The aim of this integrated Knowledge Translation (iKT) study is to develop and test a
      multifaceted implementation intervention for feasibility, acceptability and effectiveness.
      The intervention will be tailored to fit the context of the operating room (OR), to promote
      OR team members' use of aseptic techniques during the care of frail persons undergoing acute
      fracture surgery of the hip.

      Through the use of an iKT approach, the investigators hypothesise that building on leadership
      support, partnership between researchers, managers/clinical leaders and healthcare
      professionals, a solid foundation for the sustained implementation of patient safety
      innovations can be created.
PROJECT DESCRIPTION

      Aim The aim of this iKT study is to develop and test a multifaceted implementation
      intervention for feasibility, acceptability and effectiveness.The intervention will be
      tailored to fit the inner context of the operating department, to promote anaesthetic
      providers use of aseptic techniques.

      Theory In designing the present study, the investigators followed the four iterative phases
      as identified by the UK Medical Research Council (MRC) framework for developing and
      evaluating complex interventions(1): *Review of the theoretical basis for the innovation and
      the context *Conducting pre studies and designing the intervention,*The exploratory trial
      i.e. the intervention implementation and evaluation.

      The aim of the leadership intervention is to support the leaders in developing a
      participatory and effective leadership behaviours that promote the OR team's use of aseptic
      techniques and facilitate inter professional learning. The middle and front-line leaders of
      the study OR will participate in an intervention based on an iKT model inspired by
      person-centeredness (2) social construction and complexity thinking (3). The care
      professionals participating in this in this study are considered active partners and
      co-creators of the implementation process and activities. This type of collaborative approach
      means that the researchers, leaders and the OR team work closely together throughout the
      research process in order to produce findings that are relevant for users and context (4).
      Using this innovative approach represents a major departure from the concept of 'compliance'
      and a shift towards change as a result of a participatory and mindful processes (5). In the
      inter-professional dialogues, the following principles will underpin the process:

        -  All partners are experts with various professional experiences,

        -  Power differentials among partners are acknowledged and sensitively addressed,

        -  All partners discuss potential benefits and harm of the innovation, research and
           implementation strategy,

        -  The process is capacity-building for everyone and encompasses opportunities for mutual
           learning (4).

      DESIGN This is a mixed methods prospective controlled implementation study with an embedded
      process evaluation. Two similar sized surgical departments will be included; one will be
      selected as experimental department and the other, as the control. In addition to standard
      education on HH the experimental ward will participate in an iKT intervention

      Participants

        1. Leaders and staff at two orthopaedic OR departments within two similar sized university
           hospitals in the western region of Sweden and Skåne will be invited to take part in the
           study. Each OR performs approximately 800-900 trauma induced acute hip surgeries
           annually. One will be selected as the study department and one as the control;
           approximately 135 persons are employed on each department. Of these, 75% are anaesthetic
           providers (physicians, nurses and nurse assistants). Both the experimental and the
           control OR will receive the hospital's standard strategy for infection control: audit
           and feedback, reminders and computerised education on hand hygiene and the same lecture
           on Infection Control given by the experts in the area.

        2. 1500 patients undergoing fracture surgery of the hip will be invited at each site to
           take part in a registry study on post-operative complications and satisfaction with the
           care given.

      THE INTERVENTION

      Components of the intervention will include:

        -  Two workshops, consisting of educational sessions covering the state of the art
           regarding person-centeredness, prevention of infections, leadership, and implementation.
           The educational component and results of pre-studies will work as frameworks for the
           dialogues between the front-line leaders and the research group. In dialogues the
           participants will be given the opportunity to reflect on barriers to and enablers of
           change; and

        -  The participants will be supported in creating an action plan aimed at facilitating the
           anaesthesia providers' change of practice by "1) support, visibility and communication;
           (2) creating a positive milieu through vision, role modelling and change; and (3)
           influencing organisational structures and processes through resources, policies and
           monitoring"(6). The action plan will be executed over 6 months and include 6-8 learning
           laboratories, led by clinical leaders and facilitated by researchers.

      OUTCOME Primary outcome: Process evaluation: Assessing, dose, reach fidelity, acceptability,
      feasibility and unforeseen consequences of the implementation strategy Secondary outcomes: a)
      The application of hand hygiene and aseptic techniques during invasive procedures b)
      Complications after hip surgery

      DATA COLLECTION

      Process evaluation:

      A key element in this project is the process evaluation assessing acceptability, feasibility
      and unforeseen consequences of the implementation through interviews and ethnographic
      fieldwork. Ethnographic fieldwork (7) is particularly suited to understanding culture and
      complexity and finding explanations of why and how specific intervention strategies have
      failed or succeeded. Participant observations (8) will be made throughout the implementation
      process. The purpose of using this method is to capture talks and events in relation to the
      implementation strategies and to understand basic assumptions regarding team-work and patient
      safety strategies the OR. Attention will be paid to practices that may work as barriers to,
      and enablers for change. In addition, purposively selected key staff and informal leaders of
      all professional categories (to ensure maximum variation) will be asked in interviews to give
      their perspectives on the implementation strategies and activities. The interviews will be
      audio-taped and transcribed verbatim. In addition to the ethnographic method, structured
      observations will be used to determine the "dose" of the intervention components given and
      received, as well as fidelity to the intervention (9).

      The use of of hand hygiene/aseptic technique:

      The direct observation of hand hygiene is regarded as the gold standard and will be used in
      this study (10). Adherence to hand hygiene guidelines and aseptic techniques will be measured
      using a pre-tested and modified version of the World Health Organisation's observational tool
      (11). The form has been modified to match the OR context (12). An opportunity for hand
      hygiene is defined as a situation requiring hand disinfection in accordance with national and
      local guidelines (13). A hand hygiene application is defined as the use of an alcohol-based
      hand rub in relation to an opportunity. The amount of product used and the duration of its
      application will not be recorded. Adherence will be recorded in relation to professional
      category and type of indication. Based on power estimation of 90% power with an alpha level
      of 5% and an estimated difference before and after the intervention of 10% between the study
      sites and time periods, 100 care procedures requiring HH and AT will be observed at each time
      point for each department

      Pre-intervention data will be collected in the experimental and the control wards in close
      connection with the intervention. Post-intervention data will be collected 6 and 12 months
      after the completed leadership intervention.

      Postoperative complications:

      The nurses responsible for the discharge will, after on informed consent collect information,
      from the patients' medical chart on post-operative urinary- and respiratory tract infections,
      bloodstream and surgical wound infections, pressure-ulcers and confusion. A research
      assistant will perform chard audits on every 20th included patient to validate data.

      Six weeks and 12 months after discharge the patients will be sent by regular mail a survey on
      patient satisfaction and treatment with antibiotics for wound infection.

      Data analysis Interviews and field notes: Inductive content analysis will be used for
      analysis of qualitative data derived from interviews and participant observations. The texts
      will be read and re-read to obtain a full understanding and gain a sense of the whole.
      Meaning units will be extracted, condensed, and labelled with a code, with the aim of the
      study kept in mind. The code assigned reflected the meaning unit and serves as a tool for
      viewing the data in a new way. The codes will be compared and grouped into sub-themes. This
      analysis will continue by interpreting the underlying meaning in relation to time and context
      with the support of the theoretical framework.

      Observational and registry data: The types of statistics used in data analysis will be driven
      by the level of the data and its distribution. Descriptive statistics will be used to
      summarize data on AT and inferential statistics used for comparisons between groups and time
      periods.

      Ethics The study will be conducted with approval by the Regional Ethics Review Board in
      Gothenburg, Sweden. Informed consent will be obtained from the ward managers prior to
      observation. The project will be conducted in line with the four principal requirements of
      the Helsinki Declaration; autonomy, non-malfeasance, beneficence, and justice (54). Both oral
      and written information will be given to the participants and written consent will be sought
      (appendix 4:1-3). In those cases when potential participating patients suffer from conditions
      that impede their possibilities to give informed consent, their next of kin will be asked to
      consider giving consent for participation. All data will be analyzed and reported on group
      lever. The participant's confidentiality and privacy will be maintained.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Surgical site infections
time frame: 1 year
description: At discharge, after 6 weeks and 1 year data will be collect on post-operative infections.
measure: Hand hygiene and Aseptic techniques
time frame: At baseline, 6, 12 and 18 month after the start of the intervention
description: Adherence to hand hygiene guidelines and aseptic techniques will be measured using a pre-tested and modified version of the World Health Organisation's observational tool (11). The form has been modified to match the OR context (12). An opportunity for hand hygiene is defined as a situation requiring hand disinfection in accordance with national and local guidelines (13). A hand hygiene application is defined as the use of an alcohol-based hand rub in relation to an opportunity. The amount of product used and the duration of its application will not be recorded. Adherence will be recorded in relation to professional category and type of indication. Based on power estimation of 90% power with an alpha level of 5% and an estimated difference before and after the intervention of 10% between the study sites and time periods, 100 care procedures requiring HH and AT will be observed at each time point for each department
measure: Process evaluation
time frame: 1 year
description: Process data will be collected using structured observations and ethnographic fieldwork
arm group label: Study site
arm group type: Experimental
description: The study arm will consist of managers and staff at at the operating department of a University hospital in western Sweden' The intervention is based on partnership, dialogue and inter-professional learning
arm group label: Control site
arm group type: No Intervention
description: The Control arm will consist of managers and staff at at the operating department of a University hospital in south Sweden
intervention type: Behavioral
intervention name: Dialogue and inter-professional learning
description: The middle and front-line leaders of the study OR will participate in an intervention based on an iKT model. Components of the intervention will include:
Two workshops, consisting of educational sessions covering the state of the art regarding person-centeredness, prevention of infections, leadership, and implementation. The educational component and results of pre-studies will work as frameworks for the dialogues between the front-line leaders and the research group. In dialogues the participants will be given the opportunity to reflect on barriers to and enablers of change; and
The participants will be supported in creating an action plan aimed at facilitating the anaesthesia providers' change of practice.
arm group label: Study site
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Wound Infection
mesh term: Surgical Wound Infection
mesh term: Surgical Wound