<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/NCT03825822</url>
  </required_header>
  <id_info>
    <org_study_id>REB1000061599</org_study_id>
    <nct_id>NCT03825822</nct_id>
  </id_info>
  <brief_title>The Effectiveness of a Multifaceted Knowledge Translation Intervention on Pain in Hospitalized Infants</brief_title>
  <official_title>A Cluster Randomized Clinical Trial to Evaluate the Effectiveness of a Multifaceted Knowledge Translation Intervention in Hospitalized Infants: the Implementation of Infant Pain Practice Change (ImPaC) Resource</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hospitalized infants undergo multiple painful procedures daily. Despite generation of a&#xD;
      significant amount of evidence, procedural pain assessment and management in infants&#xD;
      continues to be suboptimal. Untreated pain at this vital developmental juncture is associated&#xD;
      with negative behavioural and neurodevelopmental consequences. To address this knowledge to&#xD;
      practice gap, the investigators developed the Implementation of Infant Pain Practice Change&#xD;
      (ImPaC) Resource (Resource) to guide change in health care professionals' pain practice&#xD;
      behaviour.&#xD;
&#xD;
      The aim of this study is (i) to evaluate the clinical effectiveness of the Resource&#xD;
      (primary), (ii) to evaluate the implementation effectiveness of the Resource (secondary), and&#xD;
      (iii) to explore how organizational context influences clinical and implementation outcomes&#xD;
      (other).&#xD;
&#xD;
      Eighteen Level 2 or Level 3 Neonatal Intensive Care Units (NICUs) with a minimum of 15 beds&#xD;
      across Canada will be included in a cluster randomized controlled trial (RCT). The NICUs will&#xD;
      be randomized following baseline data collection using a computer-generated random allocation&#xD;
      sequence (randomize.net) to either the intervention (INT) or standard practice (SP) arms.&#xD;
      Those in INT arm will receive the Resource for a 6-month period. NICUs in the SP arm will&#xD;
      continue as usual with their unit or institutional pain practices. They will be offered the&#xD;
      Resource following outcomes assessment. Clinical outcomes will be assessed six months after&#xD;
      randomization. Primary clinical outcomes include (1) the proportion of infants in the NICU&#xD;
      who have procedural pain assessed with a valid pain measure, (2) the proportion of infants in&#xD;
      the NICU who have procedural pain managed with an evidence-based pharmacological or physical&#xD;
      intervention, and (3) the total number of painful procedures per infant in the NICU.&#xD;
      Implementation outcomes will include feasibility, fidelity, cost, and reach. Organizational&#xD;
      context will be assessed by using the Alberta Context Tool.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 5, 2019</start_date>
  <completion_date type="Anticipated">July 5, 2023</completion_date>
  <primary_completion_date type="Actual">June 24, 2022</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Blinding will only be possible for the data analysts because no identifiable information about the sites, including the infants in the NICUs, will be available in the database or data extracted from the database. The code associating units with the data will be securely stored by the lead site, kept separate from the data, and only made available to the lead site Research Team for analyses purposes.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of infants with procedural pain assessed</measure>
    <time_frame>At 6 months after randomization</time_frame>
    <description>The proportion of infants in the NICU who have procedural pain assessed with a valid pain measure documented on clinical charts over a standardized 24-hour period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of infants with procedural pain management</measure>
    <time_frame>At 6 months after randomization</time_frame>
    <description>The proportion of infants in the NICU who have procedural pain managed with evidence-based pharmacological or physical interventions documented on clinical charts over a standardized 24-hour period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of painful procedures</measure>
    <time_frame>At 6 months after randomization</time_frame>
    <description>Total number of painful procedures (e.g. heel lance, arterial puncture, eye examination) per infant in the NICU documented in clinical charts over a standardized 24-hour period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Use of the Resource (Feasibility/Fidelity)</measure>
    <time_frame>At completion of 6-month intervention for INT arm</time_frame>
    <description>Feasibility and fidelity will be measured using Resource metrics that address (a) if all 7 steps of the Resource are completed (feasibility) and (b) if all the 7 steps are completed as intended in order (fidelity). Feasibility and fidelity metrics (data captured from the backend of the Resource website) will be electronically collected at the end of the 6-month implementation of the intervention. There is no specific measure to assess feasibility or fidelity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation costs</measure>
    <time_frame>At completion of 6-month intervention for INT arm</time_frame>
    <description>Implementation costs will be assessed in terms of (a) incidental costs (Canadian dollars) associated with knowledge translation and implementation activity (e.g., printing posters, refreshments for education sessions) documented in the Resource; and (b) time (hours/minutes) spent by each member of the Change Team in completing each step of the Resource. Time will be converted to actual costs by multiplying hours spent by the hourly wage of the Change Team members. Data will be captured from Resource metrics (data captured from the backend of the website) at the end of the 6-month implementation of the intervention. There is no specific measure to assess reach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Integration of the Resource into the practice (Reach)</measure>
    <time_frame>At completion of 6-month intervention for INT arm</time_frame>
    <description>Number of providers in the NICU who receive each knowledge translation and implementation activity that will be documented in the Resource website by the Change Team members. Data will be captured from the Resource website at the end of the 6-month implementation of the intervention. There is no specific measure to assess reach.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Context evaluation (ACT)</measure>
    <time_frame>Baseline</time_frame>
    <description>Local context characteristics will be assessed with the Alberta Context Tool completed by staff nurses.</description>
  </other_outcome>
  <other_outcome>
    <measure>Context evaluation (ACT)</measure>
    <time_frame>Prior to start of intervention for INT arm</time_frame>
    <description>Local context characteristics will be assessed with the Alberta Context Tool completed by Change Team members.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Pain</condition>
  <condition>Infant</condition>
  <arm_group>
    <arm_group_label>ImPaC Resource Intervention (INT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The INT arm will receive the 7-step web-based ImPaC intervention to use over 6 months. The intervention is divided into the Plan Stage and the Change Stage. The Plan Stage (steps 1-4) is expected to be completed in 1 month. The Change Stage (steps 5-7) is expected to be completed in 1-2 months. We anticipate that Change Teams will be able to complete 2 cycles of change over the 6-month intervention period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Practice (SP)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The SP arm will continue as usual with their unit or institutional standard pain practices and any strategies that they would normally use to improve them (e.g. new staff orientation).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ImPaC Resource Intervention (INT)</intervention_name>
    <description>A Change Team will lead the implementation process of the ImPaC Resource using the steps:&#xD;
Step 1: Complete a checklist to ensure its members can commit to responsibilities.&#xD;
Step 2: Reflect on the unit's readiness for change.&#xD;
Step 3: Perform an audit on 10 to 15 medical charts.&#xD;
Step 4: Identify a practice change based on audit results (pain assessment or pain treatment). Develop an aim statement for the practice change.&#xD;
Step 5: Select the KT strategies and plan the implementation.&#xD;
Step 6: Perform an audit on 10 to 15 medical charts.&#xD;
Step 7: Examine the effectiveness of the implementation and decide on the aim and KT strategies for the next cycle of change.</description>
    <arm_group_label>ImPaC Resource Intervention (INT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Practice (SP)</intervention_name>
    <description>The SP arm will continue as usual with their standard pain practices and will be offered the intervention 6 months after randomization and completion of data collection.</description>
    <arm_group_label>Standard Practice (SP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        NICUs in pediatric or general hospitals will be invited to participate in this study if&#xD;
        they:&#xD;
&#xD;
          -  are Level 2 or Level 3 NICUs in Canada,&#xD;
&#xD;
          -  have at least 15 beds, and&#xD;
&#xD;
          -  agree to participate for 24 months.&#xD;
&#xD;
        Infants' clinical charts data will be collected if infants:&#xD;
&#xD;
        • are hospitalized for the designated 24h period for chart review,&#xD;
&#xD;
        Infants' charts will be excluded if:&#xD;
&#xD;
          -  infant leaves the unit at any time (transfer, surgeries, procedures) during the&#xD;
             designated 24h period for chart review,&#xD;
&#xD;
          -  parents request to opt out of the study.&#xD;
&#xD;
        Staff members of the NICU will be eligible to participate on the ImPaC change team if they:&#xD;
&#xD;
          -  are a health care professional,&#xD;
&#xD;
          -  are English speaking,&#xD;
&#xD;
          -  have 3+ years of experience in the NICU,&#xD;
&#xD;
          -  have flexibility within their role to engage in the study, and&#xD;
&#xD;
          -  have leadership experience (e.g. in an advanced practice or clinical role). There is&#xD;
             no exclusion criteria.&#xD;
&#xD;
        Staff members of the NICU will be invited to complete the organizational context survey if&#xD;
        they:&#xD;
&#xD;
          -  have 6 months experience in the NICU, and&#xD;
&#xD;
          -  work 0.5 FTE or above. There is no exclusion criteria.&#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, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Brooke, J. (2013). SUS: A Retrospective. Journal of Usability Studies, 8(2), 29-40. https://doi.org/10.1074/jbc.R115.675280</citation>
  </reference>
  <reference>
    <citation>Brooke, J. (1996). SUS - A quick and dirty usability scale. Usability Evaluation in Industry, 189(194), 4-7. https://doi.org/10.1002/hbm.20701</citation>
  </reference>
  <reference>
    <citation>Cruz MD, Fernandes AM, Oliveira CR. Epidemiology of painful procedures performed in neonates: A systematic review of observational studies. Eur J Pain. 2016 Apr;20(4):489-98. doi: 10.1002/ejp.757. Epub 2015 Jul 29.</citation>
    <PMID>26223408</PMID>
  </reference>
  <reference>
    <citation>Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.</citation>
    <PMID>19664226</PMID>
  </reference>
  <reference>
    <citation>Estabrooks CA, Squires JE, Cummings GG, Birdsell JM, Norton PG. Development and assessment of the Alberta Context Tool. BMC Health Serv Res. 2009 Dec 15;9:234. doi: 10.1186/1472-6963-9-234.</citation>
    <PMID>20003531</PMID>
  </reference>
  <reference>
    <citation>Forman, J., &amp; Damschroder, L. (2007). Qualitative Content Analysis (pp. 39-62). https://doi.org/10.1016/S1479-3709(07)11003-7</citation>
  </reference>
  <reference>
    <citation>Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.</citation>
    <PMID>18929686</PMID>
  </reference>
  <reference>
    <citation>Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.</citation>
    <PMID>16204405</PMID>
  </reference>
  <reference>
    <citation>Landsverk, J., Brown, C. H., Smith, J. D., Chamberlain, P., Curran, G. M., Palinkas, L., … McCue Horwitz, S. (2018). Design and Analysis in Dissemination and Implementation Research. In: Lewis, C. C., Proctor, E. K., &amp; Brownson, R. C. (Eds.). Measurement Issues in Dissemination and Implementation Research (pp.201-227). Oxford University Press.</citation>
  </reference>
  <reference>
    <citation>Mayring, P. (2014). Qualitative Content Analysis Theoretical Foundation, Basic Procedures and Software Solution. Retrieved from http://nbn-resolving.de/urn:nbn:de:0168-ssoar-395173</citation>
  </reference>
  <reference>
    <citation>Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.</citation>
    <PMID>20957426</PMID>
  </reference>
  <reference>
    <citation>Squires, J. E., Hutchinson, A., Hayduk, L., Cranley, L. A., Cummings, G., Norton, P. G., &amp; Estabrooks, C. A. (2014). Alberta Context Tool User Manual 2014.</citation>
  </reference>
  <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, Yamada J, Promislow S, Stinson J, Harrison D, Victor JC; Members of the CIHR Team in Children's Pain. Implementation of multidimensional knowledge translation strategies to improve procedural pain in hospitalized children. Implement Sci. 2014 Nov 25;9:120. doi: 10.1186/s13012-014-0120-1.</citation>
    <PMID>25928349</PMID>
  </reference>
  <reference>
    <citation>Tariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing of the Acceptability E-scale for web-based patient-reported outcomes in cancer care. Appl Nurs Res. 2011 Feb;24(1):53-8. doi: 10.1016/j.apnr.2009.04.003. Epub 2009 Sep 18.</citation>
    <PMID>20974066</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</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>Senior Scientist</investigator_title>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Procedures</keyword>
  <keyword>Infants</keyword>
  <keyword>Assessment</keyword>
  <keyword>Management</keyword>
  <keyword>Knowledge translation</keyword>
  <keyword>Context</keyword>
  <keyword>Implementation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03825822
org study id: REB1000061599
nct id: NCT03825822
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hospitalized infants undergo multiple painful procedures daily. Despite generation of a
      significant amount of evidence, procedural pain assessment and management in infants
      continues to be suboptimal. Untreated pain at this vital developmental juncture is associated
      with negative behavioural and neurodevelopmental consequences. To address this knowledge to
      practice gap, the investigators developed the Implementation of Infant Pain Practice Change
      (ImPaC) Resource (Resource) to guide change in health care professionals' pain practice
      behaviour.

      The aim of this study is (i) to evaluate the clinical effectiveness of the Resource
      (primary), (ii) to evaluate the implementation effectiveness of the Resource (secondary), and
      (iii) to explore how organizational context influences clinical and implementation outcomes
      (other).

      Eighteen Level 2 or Level 3 Neonatal Intensive Care Units (NICUs) with a minimum of 15 beds
      across Canada will be included in a cluster randomized controlled trial (RCT). The NICUs will
      be randomized following baseline data collection using a computer-generated random allocation
      sequence (randomize.net) to either the intervention (INT) or standard practice (SP) arms.
      Those in INT arm will receive the Resource for a 6-month period. NICUs in the SP arm will
      continue as usual with their unit or institutional pain practices. They will be offered the
      Resource following outcomes assessment. Clinical outcomes will be assessed six months after
      randomization. Primary clinical outcomes include (1) the proportion of infants in the NICU
      who have procedural pain assessed with a valid pain measure, (2) the proportion of infants in
      the NICU who have procedural pain managed with an evidence-based pharmacological or physical
      intervention, and (3) the total number of painful procedures per infant in the NICU.
      Implementation outcomes will include feasibility, fidelity, cost, and reach. Organizational
      context will be assessed by using the Alberta Context Tool.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: Blinding will only be possible for the data analysts because no identifiable information about the sites, including the infants in the NICUs, will be available in the database or data extracted from the database. The code associating units with the data will be securely stored by the lead site, kept separate from the data, and only made available to the lead site Research Team for analyses purposes.
measure: Proportion of infants with procedural pain assessed
time frame: At 6 months after randomization
description: The proportion of infants in the NICU who have procedural pain assessed with a valid pain measure documented on clinical charts over a standardized 24-hour period.
measure: Proportion of infants with procedural pain management
time frame: At 6 months after randomization
description: The proportion of infants in the NICU who have procedural pain managed with evidence-based pharmacological or physical interventions documented on clinical charts over a standardized 24-hour period.
measure: Frequency of painful procedures
time frame: At 6 months after randomization
description: Total number of painful procedures (e.g. heel lance, arterial puncture, eye examination) per infant in the NICU documented in clinical charts over a standardized 24-hour period.
measure: Use of the Resource (Feasibility/Fidelity)
time frame: At completion of 6-month intervention for INT arm
description: Feasibility and fidelity will be measured using Resource metrics that address (a) if all 7 steps of the Resource are completed (feasibility) and (b) if all the 7 steps are completed as intended in order (fidelity). Feasibility and fidelity metrics (data captured from the backend of the Resource website) will be electronically collected at the end of the 6-month implementation of the intervention. There is no specific measure to assess feasibility or fidelity.
measure: Implementation costs
time frame: At completion of 6-month intervention for INT arm
description: Implementation costs will be assessed in terms of (a) incidental costs (Canadian dollars) associated with knowledge translation and implementation activity (e.g., printing posters, refreshments for education sessions) documented in the Resource; and (b) time (hours/minutes) spent by each member of the Change Team in completing each step of the Resource. Time will be converted to actual costs by multiplying hours spent by the hourly wage of the Change Team members. Data will be captured from Resource metrics (data captured from the backend of the website) at the end of the 6-month implementation of the intervention. There is no specific measure to assess reach.
measure: Integration of the Resource into the practice (Reach)
time frame: At completion of 6-month intervention for INT arm
description: Number of providers in the NICU who receive each knowledge translation and implementation activity that will be documented in the Resource website by the Change Team members. Data will be captured from the Resource website at the end of the 6-month implementation of the intervention. There is no specific measure to assess reach.
measure: Context evaluation (ACT)
time frame: Baseline
description: Local context characteristics will be assessed with the Alberta Context Tool completed by staff nurses.
measure: Context evaluation (ACT)
time frame: Prior to start of intervention for INT arm
description: Local context characteristics will be assessed with the Alberta Context Tool completed by Change Team members.
arm group label: ImPaC Resource Intervention (INT)
arm group type: Experimental
description: The INT arm will receive the 7-step web-based ImPaC intervention to use over 6 months. The intervention is divided into the Plan Stage and the Change Stage. The Plan Stage (steps 1-4) is expected to be completed in 1 month. The Change Stage (steps 5-7) is expected to be completed in 1-2 months. We anticipate that Change Teams will be able to complete 2 cycles of change over the 6-month intervention period.
arm group label: Standard Practice (SP)
arm group type: Other
description: The SP arm will continue as usual with their unit or institutional standard pain practices and any strategies that they would normally use to improve them (e.g. new staff orientation).
intervention type: Behavioral
intervention name: ImPaC Resource Intervention (INT)
description: A Change Team will lead the implementation process of the ImPaC Resource using the steps:
Step 1: Complete a checklist to ensure its members can commit to responsibilities.
Step 2: Reflect on the unit's readiness for change.
Step 3: Perform an audit on 10 to 15 medical charts.
Step 4: Identify a practice change based on audit results (pain assessment or pain treatment). Develop an aim statement for the practice change.
Step 5: Select the KT strategies and plan the implementation.
Step 6: Perform an audit on 10 to 15 medical charts.
Step 7: Examine the effectiveness of the implementation and decide on the aim and KT strategies for the next cycle of change.
arm group label: ImPaC Resource Intervention (INT)
intervention type: Other
intervention name: Standard Practice (SP)
description: The SP arm will continue as usual with their standard pain practices and will be offered the intervention 6 months after randomization and completion of data collection.
arm group label: Standard Practice (SP)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bonnie Stevens, PhD
role: Principal Investigator
affiliation: The Hospital for Sick Children
facility: 
country: Canada
citation: Brooke, J. (2013). SUS: A Retrospective. Journal of Usability Studies, 8(2), 29-40. https://doi.org/10.1074/jbc.R115.675280
citation: Brooke, J. (1996). SUS - A quick and dirty usability scale. Usability Evaluation in Industry, 189(194), 4-7. https://doi.org/10.1002/hbm.20701
citation: Cruz MD, Fernandes AM, Oliveira CR. Epidemiology of painful procedures performed in neonates: A systematic review of observational studies. Eur J Pain. 2016 Apr;20(4):489-98. doi: 10.1002/ejp.757. Epub 2015 Jul 29.
PMID: 26223408
citation: Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
PMID: 19664226
citation: Estabrooks CA, Squires JE, Cummings GG, Birdsell JM, Norton PG. Development and assessment of the Alberta Context Tool. BMC Health Serv Res. 2009 Dec 15;9:234. doi: 10.1186/1472-6963-9-234.
PMID: 20003531
citation: Forman, J., & Damschroder, L. (2007). Qualitative Content Analysis (pp. 39-62). https://doi.org/10.1016/S1479-3709(07)11003-7
citation: Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PMID: 18929686
citation: Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
PMID: 16204405
citation: Landsverk, J., Brown, C. H., Smith, J. D., Chamberlain, P., Curran, G. M., Palinkas, L., … McCue Horwitz, S. (2018). Design and Analysis in Dissemination and Implementation Research. In: Lewis, C. C., Proctor, E. K., & Brownson, R. C. (Eds.). Measurement Issues in Dissemination and Implementation Research (pp.201-227). Oxford University Press.
citation: Mayring, P. (2014). Qualitative Content Analysis Theoretical Foundation, Basic Procedures and Software Solution. Retrieved from http://nbn-resolving.de/urn:nbn:de:0168-ssoar-395173
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PMID: 20957426
citation: Squires, J. E., Hutchinson, A., Hayduk, L., Cranley, L. A., Cummings, G., Norton, P. G., & Estabrooks, C. A. (2014). Alberta Context Tool User Manual 2014.
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, Yamada J, Promislow S, Stinson J, Harrison D, Victor JC; Members of the CIHR Team in Children's Pain. Implementation of multidimensional knowledge translation strategies to improve procedural pain in hospitalized children. Implement Sci. 2014 Nov 25;9:120. doi: 10.1186/s13012-014-0120-1.
PMID: 25928349
citation: Tariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing of the Acceptability E-scale for web-based patient-reported outcomes in cancer care. Appl Nurs Res. 2011 Feb;24(1):53-8. doi: 10.1016/j.apnr.2009.04.003. Epub 2009 Sep 18.
PMID: 20974066
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Bonnie Stevens
investigator title: Senior Scientist
sharing ipd: No