<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/NCT02236949</url>
  </required_header>
  <id_info>
    <org_study_id>1000026324</org_study_id>
    <nct_id>NCT02236949</nct_id>
  </id_info>
  <brief_title>Sustainability of a Knowledge Translation Intervention to Improve Paediatric Pain</brief_title>
  <official_title>Sustainability of a Multidimensional Knowledge Translation Intervention to Improve Paediatric Pain Practices and Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to evaluate the effectiveness of short refresher&#xD;
      sessions. &quot;Pain Practice Change Boosters&quot; given at regular intervals to sustain improved pain&#xD;
      process (assessment and management) and clinical outcomes (pain intensity) achieved during a&#xD;
      15 month knowledge translation intervention, Evidence-based Practice for Improving Quality&#xD;
      (EPIQ), in 8 children's hospitals in Canada; and to determine the factors that affect that&#xD;
      sustainability. The CIHR Team in Children's Pain (2006-2011) evaluated the effectiveness of&#xD;
      the EPIQ intervention in 32 hospital units (4 units at each hospital site). 16 hospital units&#xD;
      were allocated to the intervention group and 16 units continued with standard care. The&#xD;
      current study focuses on the 16 hospital units that implemented the EPIQ intervention only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an 8 hospital repeated measures Randomized Controlled Trial design using a centrally&#xD;
      controlled cluster random allocation of units with stratification by hospital. The sample&#xD;
      consisted of the 16 hospital units that implemented the EPIQ intervention in the CIHR Team in&#xD;
      Children's Pain study. Randomization was restricted so there was one intervention unit and&#xD;
      one standard care unit at each site. Outcomes were measured at 3 time points:12 months after&#xD;
      the completion of the EPIQ intervention: Baseline (Time 1); 12 months following the&#xD;
      implementation of the Booster intervention (Time 2); and 36 months following the&#xD;
      implementation of the Booster intervention (Time 3), including the frequency and proportion&#xD;
      of children receiving pain assessment and management strategies, children's pain intensity&#xD;
      during painful procedures, and health care professionals' perceptions of the context of&#xD;
      sustainability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>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>Pain Process Outcomes (pain assessment)</measure>
    <time_frame>T1 (Baseline)</time_frame>
    <description>Pain process outcomes included the proportion of children per unit whose pain was assessed and whether a validated pain measure was used. Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Factors Influencing Sustainability: The Alberta Context Tool (ACT)</measure>
    <time_frame>T1 (Baseline)</time_frame>
    <description>The Alberta Context Tool (ACT) (Estabrooks, 2011) was used to determine the factors that influence sustainability in each of the 16 participating hospital units, including organizational culture, leadership, readiness to change, organizational complexity, professional autonomy and support within the workplace. The ACT measures health care professionals' perceptions of these contextual factors at the unit and institutional levels. The tool was administered in survey form to staff on the participating units at 3 time points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Process Outcomes (pain assessment)</measure>
    <time_frame>T2 (12 months following the implementation of the Booster)</time_frame>
    <description>Pain process outcomes included the proportion of children per unit whose pain was assessed and whether a validated pain measure was used. Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Process Outcomes (pain assessment)</measure>
    <time_frame>T3 (24 months following the implementation of the Booster)</time_frame>
    <description>Pain process outcomes included the proportion of children per unit whose pain was assessed and whether a validated pain measure was used. Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Factors Influencing Sustainability: The Alberta Context Tool (ACT)</measure>
    <time_frame>T2 (12 months following the implementation of the Booster)</time_frame>
    <description>The Alberta Context Tool (ACT) was used to determine the factors that influence sustainability in each of the 16 participating hospital units, including organizational culture, leadership, readiness to change, organizational complexity, professional autonomy and support within the workplace. The ACT measures health care professionals' perceptions of these contextual factors at the unit and institutional levels. The tool was administered in survey form to staff on the participating units at 3 time points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Factors Influencing Sustainability: The Alberta Context Tool (ACT)</measure>
    <time_frame>T3 (24 months following the implementation of the Booster)</time_frame>
    <description>The Alberta Context Tool (ACT) was used to determine the factors that influence sustainability in each of the 16 participating hospital units, including organizational culture, leadership, readiness to change, organizational complexity, professional autonomy and support within the workplace. The ACT measures health care professionals' perceptions of these contextual factors at the unit and institutional levels. The tool was administered in survey form to staff on the participating units at 3 time points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Process Outcomes (pain management)</measure>
    <time_frame>T1 (Baseline)</time_frame>
    <description>Pain process outcomes included the proportion of children per unit who had painful procedures: (i) without pain management interventions, (ii) with pharmacological interventions, and (iii) with non-pharmacological interventions (i.e., physical or psychological). Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Process Outcomes (pain management)</measure>
    <time_frame>T2 (12 months following the implementation of the Booster)</time_frame>
    <description>Pain process outcomes included the proportion of children per unit who had painful procedures: (i) without pain management interventions, (ii) with pharmacological interventions, and (iii) with non-pharmacological interventions (i.e., physical or psychological). Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Process Outcomes (pain management)</measure>
    <time_frame>T3 (24 months following the implementation of the Booster)</time_frame>
    <description>Pain process outcomes included the proportion of children per unit who had painful procedures: (i) without pain management interventions, (ii) with pharmacological interventions, and (iii) with non-pharmacological interventions (i.e., physical or psychological). Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Pain Outcome: Pain Intensity</measure>
    <time_frame>T1 (Baseline)</time_frame>
    <description>Pain intensity was measured through patient observation during routinely scheduled painful procedures at 3 time points, using one of four validated, age-appropriate measures: Premature Infant Pain Profile (PIPP) (Stevens et al., 1996) Faces-Legs-Arms-Cry-Consolability Scale (FLACC) (Merkel et al., 1997), Faces Pain Scale-Revised (FPS-R) (Hicks et al., 2001), and Numerical Rating Scale (NRS) (Jensen et a., 1986). Data were collected by local pain experts, experienced pediatric clinicians, who were trained on the four measures to ensure accurate and standardized use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Pain Outcome: Pain Intensity</measure>
    <time_frame>T2 (12 months following the implementation of the Booster)</time_frame>
    <description>Pain intensity was measured through patient observation during routinely scheduled painful procedures at 3 time points, using one of four validated, age-appropriate measures: Premature Infant Pain Profile (PIPP) (Stevens et al., 1996) Faces-Legs-Arms-Cry-Consolability Scale (FLACC) (Merkel et al., 1997), Faces Pain Scale-Revised (FPS-R) (Hicks et al., 2001), and Numerical Rating Scale (NRS) (Jensen et a., 1986). Data were collected by local pain experts, experienced pediatric clinicians, who were trained on the four measures to ensure accurate and standardized use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Pain Outcome: Pain Intensity</measure>
    <time_frame>T3 (24 months following the implementation of the Booster)</time_frame>
    <description>Pain intensity was measured through patient observation during routinely scheduled painful procedures at 3 time points, using one of four validated, age-appropriate measures: Premature Infant Pain Profile (PIPP) (Stevens et al., 1996) Faces-Legs-Arms-Cry-Consolability Scale (FLACC) (Merkel et al., 1997), Faces Pain Scale-Revised (FPS-R) (Hicks et al., 2001), and Numerical Rating Scale (NRS) (Jensen et a., 1986). Data were collected by local pain experts, experienced pediatric clinicians, who were trained on the four measures to ensure accurate and standardized use.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3907</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Pain Practice Change Booster</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pain Practice Change Booster Intervention: 12 months after the EPIQ intervention, and every 4 months for 2 years, a 30-60 minute standardized booster session was delivered to a small group of champions in each hospital unit randomized to the intervention group. Two co-facilitators familiar with the EPIQ intervention conducted all booster sessions via teleconference. Booster sessions included reviewing the effectiveness knowledge translation strategies champions implemented over the past four months to sustain and improve targeted pain practices; determining the sustainability of the pain practice changes, developing a commitment to change plan of action for the next four months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No interventions associated with the study were conducted on these units.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pain Practice Change Booster Intervention</intervention_name>
    <description>See experimental arm for a description of the intervention</description>
    <arm_group_label>Pain Practice Change Booster</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Hospitals met the following inclusion criteria in at least four patient care units:&#xD;
&#xD;
          -  distinct geographic location and administrative structure;&#xD;
&#xD;
          -  minimum of 15 beds per unit;&#xD;
&#xD;
          -  care for children exposed to painful procedures for diagnostic or therapeutic&#xD;
             purposes; and&#xD;
&#xD;
          -  implementation of pharmacological and non-pharmacological interventions to manage&#xD;
             pain.&#xD;
&#xD;
        The 16 participating hospital units had implemented the EPIQ intervention in the CIHR Team&#xD;
        in Children's Pain study. Patients in the participating hospital units were eligible to be&#xD;
        included in the determination of the pain practice and clinical outcomes if they:&#xD;
&#xD;
          -  were between 32 weeks gestational age at birth and 18 years;&#xD;
&#xD;
          -  received skin breaking procedures; and&#xD;
&#xD;
          -  were admitted to the unit for &gt;24 hours.&#xD;
&#xD;
        Surveys used to determine factors influencing sustainability were administered to health&#xD;
        care professionals in all participating units, who had at least 1 year of professional&#xD;
        experience, had worked on the unit for at least 6 months, and spoke English or French.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bonnie Stevens, RN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stollery Chidlren's Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2G3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BC Children's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Winnipeg</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1S1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IWK Health Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 3J5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Eastern Ontario</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Children's Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3H 1P3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU St. Justine</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Stevens BJ, Yamada J, Estabrooks CA, Stinson J, Campbell F, Scott SD, Cummings G; CIHR Team in Children's Pain. Pain in hospitalized children: Effect of a multidimensional knowledge translation strategy on pain process and clinical outcomes. Pain. 2014 Jan;155(1):60-68. doi: 10.1016/j.pain.2013.09.007. Epub 2013 Sep 8.</citation>
    <PMID>24021861</PMID>
  </reference>
  <reference>
    <citation>Stevens BJ, Harrison D, Rashotte J, Yamada J, Abbott LK, Coburn G, Stinson J, Le May S; CIHR Team in Children's Pain. Pain assessment and intensity in hospitalized children in Canada. J Pain. 2012 Sep;13(9):857-65. doi: 10.1016/j.jpain.2012.05.010.</citation>
    <PMID>22958873</PMID>
  </reference>
  <reference>
    <citation>Stevens BJ, Abbott LK, Yamada J, Harrison D, Stinson J, Taddio A, Barwick M, Latimer M, Scott SD, Rashotte J, Campbell F, Finley GA; CIHR Team in Children's Pain. Epidemiology and management of painful procedures in children in Canadian hospitals. CMAJ. 2011 Apr 19;183(7):E403-10. doi: 10.1503/cmaj.101341. Epub 2011 Apr 4.</citation>
    <PMID>21464171</PMID>
  </reference>
  <reference>
    <citation>Estabrooks CA, Squires JE, Hutchinson AM, Scott S, Cummings GG, Kang SH, Midodzi WK, Stevens B. Assessment of variation in the Alberta Context Tool: the contribution of unit level contextual factors and specialty in Canadian pediatric acute care settings. BMC Health Serv Res. 2011 Oct 4;11:251. doi: 10.1186/1472-6963-11-251.</citation>
    <PMID>21970404</PMID>
  </reference>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>May 21, 2015</last_update_submitted>
  <last_update_submitted_qc>May 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Bonnie Stevens</investigator_full_name>
    <investigator_title>Bonnie Stevens RN PhD, Signy Hildur Eaton Chair in Paediatric Nursing, Associate Chief of Nursing Research, Senior Scientist Research Institute</investigator_title>
  </responsible_party>
  <keyword>pediatric pain</keyword>
  <keyword>intervention sustainability</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/NCT02236949
org study id: 1000026324
nct id: NCT02236949
lead sponsor: 
has dmc: Yes
The purpose of this research study is to evaluate the effectiveness of short refresher
      sessions. "Pain Practice Change Boosters" given at regular intervals to sustain improved pain
      process (assessment and management) and clinical outcomes (pain intensity) achieved during a
      15 month knowledge translation intervention, Evidence-based Practice for Improving Quality
      (EPIQ), in 8 children's hospitals in Canada; and to determine the factors that affect that
      sustainability. The CIHR Team in Children's Pain (2006-2011) evaluated the effectiveness of
      the EPIQ intervention in 32 hospital units (4 units at each hospital site). 16 hospital units
      were allocated to the intervention group and 16 units continued with standard care. The
      current study focuses on the 16 hospital units that implemented the EPIQ intervention only.
This is an 8 hospital repeated measures Randomized Controlled Trial design using a centrally
      controlled cluster random allocation of units with stratification by hospital. The sample
      consisted of the 16 hospital units that implemented the EPIQ intervention in the CIHR Team in
      Children's Pain study. Randomization was restricted so there was one intervention unit and
      one standard care unit at each site. Outcomes were measured at 3 time points:12 months after
      the completion of the EPIQ intervention: Baseline (Time 1); 12 months following the
      implementation of the Booster intervention (Time 2); and 36 months following the
      implementation of the Booster intervention (Time 3), including the frequency and proportion
      of children receiving pain assessment and management strategies, children's pain intensity
      during painful procedures, and health care professionals' perceptions of the context of
      sustainability.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Pain Process Outcomes (pain assessment)
time frame: T1 (Baseline)
description: Pain process outcomes included the proportion of children per unit whose pain was assessed and whether a validated pain measure was used. Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).
measure: Factors Influencing Sustainability: The Alberta Context Tool (ACT)
time frame: T1 (Baseline)
description: The Alberta Context Tool (ACT) (Estabrooks, 2011) was used to determine the factors that influence sustainability in each of the 16 participating hospital units, including organizational culture, leadership, readiness to change, organizational complexity, professional autonomy and support within the workplace. The ACT measures health care professionals' perceptions of these contextual factors at the unit and institutional levels. The tool was administered in survey form to staff on the participating units at 3 time points.
measure: Pain Process Outcomes (pain assessment)
time frame: T2 (12 months following the implementation of the Booster)
description: Pain process outcomes included the proportion of children per unit whose pain was assessed and whether a validated pain measure was used. Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).
measure: Pain Process Outcomes (pain assessment)
time frame: T3 (24 months following the implementation of the Booster)
description: Pain process outcomes included the proportion of children per unit whose pain was assessed and whether a validated pain measure was used. Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).
measure: Factors Influencing Sustainability: The Alberta Context Tool (ACT)
time frame: T2 (12 months following the implementation of the Booster)
description: The Alberta Context Tool (ACT) was used to determine the factors that influence sustainability in each of the 16 participating hospital units, including organizational culture, leadership, readiness to change, organizational complexity, professional autonomy and support within the workplace. The ACT measures health care professionals' perceptions of these contextual factors at the unit and institutional levels. The tool was administered in survey form to staff on the participating units at 3 time points.
measure: Factors Influencing Sustainability: The Alberta Context Tool (ACT)
time frame: T3 (24 months following the implementation of the Booster)
description: The Alberta Context Tool (ACT) was used to determine the factors that influence sustainability in each of the 16 participating hospital units, including organizational culture, leadership, readiness to change, organizational complexity, professional autonomy and support within the workplace. The ACT measures health care professionals' perceptions of these contextual factors at the unit and institutional levels. The tool was administered in survey form to staff on the participating units at 3 time points.
measure: Pain Process Outcomes (pain management)
time frame: T1 (Baseline)
description: Pain process outcomes included the proportion of children per unit who had painful procedures: (i) without pain management interventions, (ii) with pharmacological interventions, and (iii) with non-pharmacological interventions (i.e., physical or psychological). Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).
measure: Pain Process Outcomes (pain management)
time frame: T2 (12 months following the implementation of the Booster)
description: Pain process outcomes included the proportion of children per unit who had painful procedures: (i) without pain management interventions, (ii) with pharmacological interventions, and (iii) with non-pharmacological interventions (i.e., physical or psychological). Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).
measure: Pain Process Outcomes (pain management)
time frame: T3 (24 months following the implementation of the Booster)
description: Pain process outcomes included the proportion of children per unit who had painful procedures: (i) without pain management interventions, (ii) with pharmacological interventions, and (iii) with non-pharmacological interventions (i.e., physical or psychological). Data were collected from 30 patient charts on each unit for the previous 24 hours at 3 time points, using the Canadian Pediatric Pain Research (CPPR) database, which was used and validated in previous studies (Stevens, 2011, 2012, 2014).
measure: Clinical Pain Outcome: Pain Intensity
time frame: T1 (Baseline)
description: Pain intensity was measured through patient observation during routinely scheduled painful procedures at 3 time points, using one of four validated, age-appropriate measures: Premature Infant Pain Profile (PIPP) (Stevens et al., 1996) Faces-Legs-Arms-Cry-Consolability Scale (FLACC) (Merkel et al., 1997), Faces Pain Scale-Revised (FPS-R) (Hicks et al., 2001), and Numerical Rating Scale (NRS) (Jensen et a., 1986). Data were collected by local pain experts, experienced pediatric clinicians, who were trained on the four measures to ensure accurate and standardized use.
measure: Clinical Pain Outcome: Pain Intensity
time frame: T2 (12 months following the implementation of the Booster)
description: Pain intensity was measured through patient observation during routinely scheduled painful procedures at 3 time points, using one of four validated, age-appropriate measures: Premature Infant Pain Profile (PIPP) (Stevens et al., 1996) Faces-Legs-Arms-Cry-Consolability Scale (FLACC) (Merkel et al., 1997), Faces Pain Scale-Revised (FPS-R) (Hicks et al., 2001), and Numerical Rating Scale (NRS) (Jensen et a., 1986). Data were collected by local pain experts, experienced pediatric clinicians, who were trained on the four measures to ensure accurate and standardized use.
measure: Clinical Pain Outcome: Pain Intensity
time frame: T3 (24 months following the implementation of the Booster)
description: Pain intensity was measured through patient observation during routinely scheduled painful procedures at 3 time points, using one of four validated, age-appropriate measures: Premature Infant Pain Profile (PIPP) (Stevens et al., 1996) Faces-Legs-Arms-Cry-Consolability Scale (FLACC) (Merkel et al., 1997), Faces Pain Scale-Revised (FPS-R) (Hicks et al., 2001), and Numerical Rating Scale (NRS) (Jensen et a., 1986). Data were collected by local pain experts, experienced pediatric clinicians, who were trained on the four measures to ensure accurate and standardized use.
arm group label: Pain Practice Change Booster
arm group type: Experimental
description: Pain Practice Change Booster Intervention: 12 months after the EPIQ intervention, and every 4 months for 2 years, a 30-60 minute standardized booster session was delivered to a small group of champions in each hospital unit randomized to the intervention group. Two co-facilitators familiar with the EPIQ intervention conducted all booster sessions via teleconference. Booster sessions included reviewing the effectiveness knowledge translation strategies champions implemented over the past four months to sustain and improve targeted pain practices; determining the sustainability of the pain practice changes, developing a commitment to change plan of action for the next four months.
arm group label: Usual Care Group
arm group type: No Intervention
description: No interventions associated with the study were conducted on these units.
intervention type: Behavioral
intervention name: Pain Practice Change Booster Intervention
description: See experimental arm for a description of the intervention
arm group label: Pain Practice Change Booster
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bonnie Stevens, RN, PhD
role: Principal Investigator
affiliation: The Hospital for Sick Children
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
citation: Stevens BJ, Yamada J, Estabrooks CA, Stinson J, Campbell F, Scott SD, Cummings G; CIHR Team in Children's Pain. Pain in hospitalized children: Effect of a multidimensional knowledge translation strategy on pain process and clinical outcomes. Pain. 2014 Jan;155(1):60-68. doi: 10.1016/j.pain.2013.09.007. Epub 2013 Sep 8.
PMID: 24021861
citation: Stevens BJ, Harrison D, Rashotte J, Yamada J, Abbott LK, Coburn G, Stinson J, Le May S; CIHR Team in Children's Pain. Pain assessment and intensity in hospitalized children in Canada. J Pain. 2012 Sep;13(9):857-65. doi: 10.1016/j.jpain.2012.05.010.
PMID: 22958873
citation: Stevens BJ, Abbott LK, Yamada J, Harrison D, Stinson J, Taddio A, Barwick M, Latimer M, Scott SD, Rashotte J, Campbell F, Finley GA; CIHR Team in Children's Pain. Epidemiology and management of painful procedures in children in Canadian hospitals. CMAJ. 2011 Apr 19;183(7):E403-10. doi: 10.1503/cmaj.101341. Epub 2011 Apr 4.
PMID: 21464171
citation: Estabrooks CA, Squires JE, Hutchinson AM, Scott S, Cummings GG, Kang SH, Midodzi WK, Stevens B. Assessment of variation in the Alberta Context Tool: the contribution of unit level contextual factors and specialty in Canadian pediatric acute care settings. BMC Health Serv Res. 2011 Oct 4;11:251. doi: 10.1186/1472-6963-11-251.
PMID: 21970404
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Bonnie Stevens
investigator title: Bonnie Stevens RN PhD, Signy Hildur Eaton Chair in Paediatric Nursing, Associate Chief of Nursing Research, Senior Scientist Research Institute