<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/NCT03269487</url>
  </required_header>
  <id_info>
    <org_study_id>v1 01.04.2015</org_study_id>
    <nct_id>NCT03269487</nct_id>
  </id_info>
  <brief_title>PERFECTED WP2: Implementing Optimised Hospital Care</brief_title>
  <acronym>PERFECTED</acronym>
  <official_title>PERFECTED WP2: Implementing the Optimisation of Hospital Care Delivery to Older Adults by NHS Staff Via Action Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of East Anglia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of East Anglia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is part of the 5-year long (2013-18) PERFECTED (Peri-operative Enhanced Recovery&#xD;
      hip-fracture Care of paTiEnts with Dementia) National Institute for Health Research (NIHR)&#xD;
      funded research programme.&#xD;
&#xD;
      PERFECTED's aim is to develop and pilot an evidence-based intervention to improve the&#xD;
      hospital care of patients living with dementia who have fractured their hip. This protocol&#xD;
      relates to Work Package 2 (WP2) of PERFECTED only.&#xD;
&#xD;
      By working collaboratively with local clinicians and stakeholders, an action research&#xD;
      (plan-do-study-act) approach will be used to generate knowledge to understand how to best&#xD;
      implement the intervention (PERFECTED Enhanced Recovery Pathway), which was developed from&#xD;
      learning and research undertaken as part of Work Package 1. During the current study the&#xD;
      PERFECTED Enhanced Recovery Pathway (ERP) will be used to optimise care on three&#xD;
      ortho-geriatric wards for 12 months. These wards are located in Norfolk, Nottinghamshire and&#xD;
      Yorkshire. The sole participants are NHS personnel delivering care on selected wards.&#xD;
&#xD;
      Data collection activities (observations, in-field interviews, documentary analysis and&#xD;
      quantitative data generated from the PERFECTED ERP implementation checklist) will determine&#xD;
      the staff training and cultural changes required to implement and maximise adherence to the&#xD;
      PERFECTED ERP. Simultaneously, enabling the identification and exploration of areas of&#xD;
      optimised, satisfactory and sub-optimal care. By working in partnership within and across the&#xD;
      partner wards, action plans to address sub-optimal care will be generated, implemented and&#xD;
      reviewed. Findings will inform the best ways to optimise care via the implementation of the&#xD;
      PERFECTED ERP. Knowledge generated during this study will be used to develop an ERP and staff&#xD;
      training manual. This will aid implementation of the intervention arm of a latter Cluster&#xD;
      Randomised Control Trial (Work Package 3), ensuring the PERFECTED ERP can be utilised in the&#xD;
      real world.&#xD;
&#xD;
      As part of PERFECTED's commitment to Public Patient Involvement (PPI), lay researchers will&#xD;
      be trained to assist with qualitative research activities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2015</start_date>
  <completion_date type="Actual">September 1, 2016</completion_date>
  <primary_completion_date type="Actual">July 1, 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>PERFECT-ER</measure>
    <time_frame>12 months</time_frame>
    <description>Improvement toolkit</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">270</enrollment>
  <condition>Implementation of Enhanced Recovery Pathway</condition>
  <arm_group>
    <arm_group_label>Healthcare professionals in partner sites</arm_group_label>
    <description>NHS employee or student nurse involved in the delivery of care to patients on partner wards in which the PERFECTED ERP is being implemented.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Sole participant group for this study are NHS employees involved in care delivery on&#xD;
        partner hospital wards.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NHS employee or student nurse&#xD;
&#xD;
          -  Involved in the delivery of care to patients on partner wards in which the PERFECTED&#xD;
             ERP is being implemented&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        * None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03269487
org study id: v1 01.04.2015
nct id: NCT03269487
lead sponsor: 
has dmc: No
This study is part of the 5-year long (2013-18) PERFECTED (Peri-operative Enhanced Recovery
      hip-fracture Care of paTiEnts with Dementia) National Institute for Health Research (NIHR)
      funded research programme.

      PERFECTED's aim is to develop and pilot an evidence-based intervention to improve the
      hospital care of patients living with dementia who have fractured their hip. This protocol
      relates to Work Package 2 (WP2) of PERFECTED only.

      By working collaboratively with local clinicians and stakeholders, an action research
      (plan-do-study-act) approach will be used to generate knowledge to understand how to best
      implement the intervention (PERFECTED Enhanced Recovery Pathway), which was developed from
      learning and research undertaken as part of Work Package 1. During the current study the
      PERFECTED Enhanced Recovery Pathway (ERP) will be used to optimise care on three
      ortho-geriatric wards for 12 months. These wards are located in Norfolk, Nottinghamshire and
      Yorkshire. The sole participants are NHS personnel delivering care on selected wards.

      Data collection activities (observations, in-field interviews, documentary analysis and
      quantitative data generated from the PERFECTED ERP implementation checklist) will determine
      the staff training and cultural changes required to implement and maximise adherence to the
      PERFECTED ERP. Simultaneously, enabling the identification and exploration of areas of
      optimised, satisfactory and sub-optimal care. By working in partnership within and across the
      partner wards, action plans to address sub-optimal care will be generated, implemented and
      reviewed. Findings will inform the best ways to optimise care via the implementation of the
      PERFECTED ERP. Knowledge generated during this study will be used to develop an ERP and staff
      training manual. This will aid implementation of the intervention arm of a latter Cluster
      Randomised Control Trial (Work Package 3), ensuring the PERFECTED ERP can be utilised in the
      real world.

      As part of PERFECTED's commitment to Public Patient Involvement (PPI), lay researchers will
      be trained to assist with qualitative research activities.
observational model: Other
time perspective: Other
measure: PERFECT-ER
time frame: 12 months
description: Improvement toolkit
arm group label: Healthcare professionals in partner sites
description: NHS employee or student nurse involved in the delivery of care to patients on partner wards in which the PERFECTED ERP is being implemented.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor