<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/NCT04433650</url>
  </required_header>
  <id_info>
    <org_study_id>MTI2019-0011</org_study_id>
    <secondary_id>KP2018-0023</secondary_id>
    <nct_id>NCT04433650</nct_id>
  </id_info>
  <brief_title>Pictorial Support in Person-centred Care for Children (PicPecc)</brief_title>
  <acronym>PicPecc</acronym>
  <official_title>A Person-centred Approach to Pictorial Support in Care for Children (PicPecc)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swedish Childhood Cancer Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Göteborg University</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>
      Introduction: Person-centred care is based on the assumption that every person has resources&#xD;
      that should be used in the care situation. In order for this to happen the patient has to be&#xD;
      able to effectively communicate his/her symptoms. This protocol describes the analysis of a&#xD;
      digital picture-based tool for communication support for children with cancer aged 5-17&#xD;
      years, who undergo high-dose methotrexate treatment. The advantage of a non-linguistic based&#xD;
      platform, beside the expected clinical outcomes, is that it can be used in multiple national&#xD;
      studies with minimal translation.&#xD;
&#xD;
      Methods and analysis: Two studies will be conducted in a hybrid design, i.e., a crossover&#xD;
      design will be used for the intervention (effects), and a mixed-methods design will be used&#xD;
      for the process evaluation. Qualitative interviews will be carried out with children with&#xD;
      cancer, their legal guardians and case-related healthcare professionals as part of the&#xD;
      process evaluation.&#xD;
&#xD;
      The interviews will address the experiences of the intervention and frequency of use from the&#xD;
      child's perspective. Interview transcripts will be analyzed qualitative descriptively. The&#xD;
      digital communication tool will collect child self-reports of symptoms/emotions. The children&#xD;
      will be monitored for biomarkers of stress and pain (neuropeptides, neurosteroids and&#xD;
      peripheral steroids) in venous blood samples, in-app estimation levels for the children, drug&#xD;
      consumption. Person-centeredness will be evaluated with the questionnaire Visual CARE&#xD;
      Measure.&#xD;
&#xD;
      Ethics: Ethical approval was obtained from the Swedish Ethical Review Authority (ref&#xD;
      2019-02392; 2020-02601).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND Failure in symptom relief in children with cancer leads to physical and emotional&#xD;
      distress. Success in symptom relief is assumed to decrease distress. To initiate a&#xD;
      person-centred approach to child-centred care means to elucidate, listen to and affirm the&#xD;
      child´s story. Assessments of distress and symptoms are essential in symptom relief for&#xD;
      children with cancer. However, the exclusive assessment of pain intensity can be considered a&#xD;
      restrictive description of the experience. Novel assessment tools that give a broader&#xD;
      description of symptoms are needed. Self-reports of symptoms are the gold standard for&#xD;
      measuring symptoms, and strategies to achieve symptom relief to represent a dynamic and&#xD;
      interactive process. A complex intervention has been chosen, and the project follows the&#xD;
      Medical Research Council´s key principles and actions for consideration in the developing of&#xD;
      the intervention.&#xD;
&#xD;
      AIM This project aims to investigate whether a person-centred communication intervention&#xD;
      employing a new digital communication tool for children undergoing cancer treatment decrease&#xD;
      the children's self-reported distress&#xD;
&#xD;
      Research questions:&#xD;
&#xD;
      Does adding a digital reporting and communication tool, decrease distress in children with&#xD;
      cancer, aged 5-17 years, who undergo high-dose methotrexate treatment?&#xD;
&#xD;
      Does the adding of a digital reporting and communication tool, increase person-centredness in&#xD;
      children with cancer, aged 5-17 years, who undergo high-dose methotrexate treatment?&#xD;
&#xD;
      Hypothesis: (i) Person-centred communication with children undergoing cancer treatment,&#xD;
      applying a digital reporting and communication tool, will lead to reduced self-reported&#xD;
      distress on an analogue assessment tool (paper sheet) (primary outcome), a decrease in&#xD;
      neuropeptides, neurosteroids and peripheral steroids for stress and pain in blood, and an&#xD;
      increased person-centeredness (secondary outcomes) (effect).&#xD;
&#xD;
      (ii) The person-centred communication is performed in child-centred ways to proactively&#xD;
      assess children's symptoms (process) and will be evaluated with frequency of use and&#xD;
      feasibility.&#xD;
&#xD;
      METHODS/DESIGN Study design The children will participate in a cross-over design where they&#xD;
      are their own controls. This is a hybrid design, which evaluates both the effects and the&#xD;
      implementation (process).&#xD;
&#xD;
      The participant is given a code in a predetermined order; the code shows whether he or she&#xD;
      should start either with intervention (application) or with the control conditions.&#xD;
      Randomization of the codes occurs in advance at randomizer.org, and the researcher always&#xD;
      picks the codes in a predetermined order without knowing if it is intervention or control.&#xD;
      This is revealed when the participant has agreed to participate in the study. Participating&#xD;
      children participate twice, once as a control and once with e-health support Pictorial&#xD;
      support in Person-centered care for children (PicPecc).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Arm 1: Treatment 1 is control and treatment 2 is intervention. Arm 2: Treatment 1 is intervention and treatment 2 is control.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change is being assessed in self-reported distress</measure>
    <time_frame>The self-reported distress will be collected four hours before high-dose methotrexate (T-1), when the treatment start (T0), after 24 hours (T1) and after 48 hours (T2).</time_frame>
    <description>The primary outcome measure is change from baseline (T0) to 48 hours after (T2) on an 11-point NRS (0 [no distress] and 10 [worst possible distress]).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of pain and stress in blood.</measure>
    <time_frame>will be collected before start (T-1, T0) of the high-dose methotrexate treatment, 24 hours after start (T1), and 48 hours after start (T2).</time_frame>
    <description>Levels of neuropeptides, neurosteroids and peripheral steroids.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual CARE Measure</measure>
    <time_frame>This is evaluated on the VCM, which will be collected 48 hours after the start (T2) of the high-dose methotrexate treatment.</time_frame>
    <description>The purpose of VCM is to give legal guardians of children &lt;7 years old (VCM 10Q-Legal guardians), children aged 7-11 years (VCM 5Q) and adolescents aged 12 years and over (VCM 10Q) the opportunity to share their views about their experiences regarding both the meeting with the healthcare professional and their participation. If the child or the adolescent have linguistic and/or cognitive difficulties, the questionnaire for the legal guardian (10Q-Legal guardians) will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of assessments of symptoms</measure>
    <time_frame>T-1 (4 hours before treatment) - T2 (48 hours after start of treatment).</time_frame>
    <description>The A phase, we will use a checklist, and in the B phase, we will record in-app. assessment levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug consumption</measure>
    <time_frame>T-1 (4 hours before treatment) - T2 (48 hours after start of treatment).</time_frame>
    <description>Drug consumption for all types of symptom relief will be recorded from the patients' medical records.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Childhood Cancer</condition>
  <condition>Communication</condition>
  <condition>Symptoms and Signs</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The child will firstly undergo phase A without the digital reporting and communication tool.&#xD;
The child will secondly undergo phase B with the digital reporting and communication tool (i.e., A, B).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The child will firstly undergo phase B with the digital reporting and communication tool.&#xD;
The child will secondly undergo phase A without the digital reporting and communication tool (i.e., B, A).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pictorial support in person-centred care for children (PicPecc)</intervention_name>
    <description>Phase A: The child has the protocol for methotrexate treatment, the healthcare professionals have one workshop that containing person-centred care, universal design, distress, symptom management and the digital reporting and communication tool.&#xD;
Phase B: The child has everything in phase A. In addition, the child use the digital reporting and communication tool that has a thermometer (graded from zero (green) to ten (red)). The result of the assessment is visualized as a face (mimic and colour represents the intensity of the symptom and/or emotion (i.e., anxiety, appetite, fear/worries, how I´m feeling today, nausea, pain, sleep, and tiredness)). The digital reporting and communication tool has a body figure for location of pain, pictures for the type of pain, and an open question. There is an avatar and a gamification part, e.g., the child gets a pet after assessing the symptoms/emotions. The child reports in the app, and the child decides the frequency of assessments.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with cancer, 5-17 years&#xD;
&#xD;
          -  The children´s legal guardians&#xD;
&#xD;
          -  Healthcare professionals who take care of these children&#xD;
&#xD;
          -  The child needs to have a cognitive level of approximately five years (i.e., be able&#xD;
             to understand a numeric rating scale (NRS)).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Children 0-4 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan Nilsson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Health and Care Sciences, University of Gothenburg, Sweden</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jonas Bergquist, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Dept of Chemistry Biomedical Centre, Uppsala University, Sweden</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stefan Nilsson, PhD</last_name>
    <phone>+46738538951</phone>
    <email>stefan.nilsson.4@gu.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Joakim Öhlen, Professor</last_name>
    <email>joakim.ohlen@fhs.gu.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Gothenburg</name>
      <address>
        <city>Gothenburg</city>
        <zip>40530</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefan Nilsson, PhD</last_name>
      <phone>+46738538951</phone>
      <email>stefan.nilsson.4@gu.se</email>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>https://www.gu.se/forskning/picpecc-pictorial-support-in-person-centred-care-for-children</url>
    <description>Pictorial support in person-centred care for children</description>
  </link>
  <reference>
    <citation>Nilsson S, Bjorkman B, Almqvist AL, Almqvist L, Bjork-Willen P, Donohue D, Enskar K, Granlund M, Huus K, Hvit S. Children's voices--Differentiating a child perspective from a child's perspective. Dev Neurorehabil. 2015 Jun;18(3):162-8. doi: 10.3109/17518423.2013.801529. Epub 2013 Aug 7.</citation>
    <PMID>23924164</PMID>
  </reference>
  <reference>
    <citation>Lin B, Gutman T, Hanson CS, Ju A, Manera K, Butow P, Cohn RJ, Dalla-Pozza L, Greenzang KA, Mack J, Wakefield CE, Craig JC, Tong A. Communication during childhood cancer: Systematic review of patient perspectives. Cancer. 2020 Feb 15;126(4):701-716. doi: 10.1002/cncr.32637. Epub 2019 Dec 10.</citation>
    <PMID>31821552</PMID>
  </reference>
  <reference>
    <citation>Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.</citation>
    <PMID>22310560</PMID>
  </reference>
  <reference>
    <citation>O'Cathain A, Croot L, Duncan E, Rousseau N, Sworn K, Turner KM, Yardley L, Hoddinott P. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open. 2019 Aug 15;9(8):e029954. doi: 10.1136/bmjopen-2019-029954.</citation>
    <PMID>31420394</PMID>
  </reference>
  <reference>
    <citation>Nilsson S, Holstensson J, Johansson C, Thunberg G. Children's Perceptions of Pictures Intended to Measure Anxiety During Hospitalization. J Pediatr Nurs. 2019 Jan-Feb;44:63-73. doi: 10.1016/j.pedn.2018.10.015. Epub 2018 Nov 3.</citation>
    <PMID>30683283</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>August 13, 2022</last_update_submitted>
  <last_update_submitted_qc>August 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Childhood cancer</keyword>
  <keyword>Communication</keyword>
  <keyword>Digital application</keyword>
  <keyword>Intervention</keyword>
  <keyword>Pictorial support</keyword>
  <keyword>Symptoms and Signs</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/NCT04433650
org study id: MTI2019-0011
secondary id: KP2018-0023
nct id: NCT04433650
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction: Person-centred care is based on the assumption that every person has resources
      that should be used in the care situation. In order for this to happen the patient has to be
      able to effectively communicate his/her symptoms. This protocol describes the analysis of a
      digital picture-based tool for communication support for children with cancer aged 5-17
      years, who undergo high-dose methotrexate treatment. The advantage of a non-linguistic based
      platform, beside the expected clinical outcomes, is that it can be used in multiple national
      studies with minimal translation.

      Methods and analysis: Two studies will be conducted in a hybrid design, i.e., a crossover
      design will be used for the intervention (effects), and a mixed-methods design will be used
      for the process evaluation. Qualitative interviews will be carried out with children with
      cancer, their legal guardians and case-related healthcare professionals as part of the
      process evaluation.

      The interviews will address the experiences of the intervention and frequency of use from the
      child's perspective. Interview transcripts will be analyzed qualitative descriptively. The
      digital communication tool will collect child self-reports of symptoms/emotions. The children
      will be monitored for biomarkers of stress and pain (neuropeptides, neurosteroids and
      peripheral steroids) in venous blood samples, in-app estimation levels for the children, drug
      consumption. Person-centeredness will be evaluated with the questionnaire Visual CARE
      Measure.

      Ethics: Ethical approval was obtained from the Swedish Ethical Review Authority (ref
      2019-02392; 2020-02601).
BACKGROUND Failure in symptom relief in children with cancer leads to physical and emotional
      distress. Success in symptom relief is assumed to decrease distress. To initiate a
      person-centred approach to child-centred care means to elucidate, listen to and affirm the
      child´s story. Assessments of distress and symptoms are essential in symptom relief for
      children with cancer. However, the exclusive assessment of pain intensity can be considered a
      restrictive description of the experience. Novel assessment tools that give a broader
      description of symptoms are needed. Self-reports of symptoms are the gold standard for
      measuring symptoms, and strategies to achieve symptom relief to represent a dynamic and
      interactive process. A complex intervention has been chosen, and the project follows the
      Medical Research Council´s key principles and actions for consideration in the developing of
      the intervention.

      AIM This project aims to investigate whether a person-centred communication intervention
      employing a new digital communication tool for children undergoing cancer treatment decrease
      the children's self-reported distress

      Research questions:

      Does adding a digital reporting and communication tool, decrease distress in children with
      cancer, aged 5-17 years, who undergo high-dose methotrexate treatment?

      Does the adding of a digital reporting and communication tool, increase person-centredness in
      children with cancer, aged 5-17 years, who undergo high-dose methotrexate treatment?

      Hypothesis: (i) Person-centred communication with children undergoing cancer treatment,
      applying a digital reporting and communication tool, will lead to reduced self-reported
      distress on an analogue assessment tool (paper sheet) (primary outcome), a decrease in
      neuropeptides, neurosteroids and peripheral steroids for stress and pain in blood, and an
      increased person-centeredness (secondary outcomes) (effect).

      (ii) The person-centred communication is performed in child-centred ways to proactively
      assess children's symptoms (process) and will be evaluated with frequency of use and
      feasibility.

      METHODS/DESIGN Study design The children will participate in a cross-over design where they
      are their own controls. This is a hybrid design, which evaluates both the effects and the
      implementation (process).

      The participant is given a code in a predetermined order; the code shows whether he or she
      should start either with intervention (application) or with the control conditions.
      Randomization of the codes occurs in advance at randomizer.org, and the researcher always
      picks the codes in a predetermined order without knowing if it is intervention or control.
      This is revealed when the participant has agreed to participate in the study. Participating
      children participate twice, once as a control and once with e-health support Pictorial
      support in Person-centered care for children (PicPecc).
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Arm 1: Treatment 1 is control and treatment 2 is intervention. Arm 2: Treatment 1 is intervention and treatment 2 is control.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change is being assessed in self-reported distress
time frame: The self-reported distress will be collected four hours before high-dose methotrexate (T-1), when the treatment start (T0), after 24 hours (T1) and after 48 hours (T2).
description: The primary outcome measure is change from baseline (T0) to 48 hours after (T2) on an 11-point NRS (0 [no distress] and 10 [worst possible distress]).
measure: Biomarkers of pain and stress in blood.
time frame: will be collected before start (T-1, T0) of the high-dose methotrexate treatment, 24 hours after start (T1), and 48 hours after start (T2).
description: Levels of neuropeptides, neurosteroids and peripheral steroids.
measure: Visual CARE Measure
time frame: This is evaluated on the VCM, which will be collected 48 hours after the start (T2) of the high-dose methotrexate treatment.
description: The purpose of VCM is to give legal guardians of children <7 years old (VCM 10Q-Legal guardians), children aged 7-11 years (VCM 5Q) and adolescents aged 12 years and over (VCM 10Q) the opportunity to share their views about their experiences regarding both the meeting with the healthcare professional and their participation. If the child or the adolescent have linguistic and/or cognitive difficulties, the questionnaire for the legal guardian (10Q-Legal guardians) will be used.
measure: Frequency of assessments of symptoms
time frame: T-1 (4 hours before treatment) - T2 (48 hours after start of treatment).
description: The A phase, we will use a checklist, and in the B phase, we will record in-app. assessment levels.
measure: Drug consumption
time frame: T-1 (4 hours before treatment) - T2 (48 hours after start of treatment).
description: Drug consumption for all types of symptom relief will be recorded from the patients' medical records.
arm group label: Group 1
arm group type: Experimental
description: The child will firstly undergo phase A without the digital reporting and communication tool.
The child will secondly undergo phase B with the digital reporting and communication tool (i.e., A, B).
arm group label: Group 2
arm group type: Experimental
description: The child will firstly undergo phase B with the digital reporting and communication tool.
The child will secondly undergo phase A without the digital reporting and communication tool (i.e., B, A).
intervention type: Device
intervention name: Pictorial support in person-centred care for children (PicPecc)
description: Phase A: The child has the protocol for methotrexate treatment, the healthcare professionals have one workshop that containing person-centred care, universal design, distress, symptom management and the digital reporting and communication tool.
Phase B: The child has everything in phase A. In addition, the child use the digital reporting and communication tool that has a thermometer (graded from zero (green) to ten (red)). The result of the assessment is visualized as a face (mimic and colour represents the intensity of the symptom and/or emotion (i.e., anxiety, appetite, fear/worries, how I´m feeling today, nausea, pain, sleep, and tiredness)). The digital reporting and communication tool has a body figure for location of pain, pictures for the type of pain, and an open question. There is an avatar and a gamification part, e.g., the child gets a pet after assessing the symptoms/emotions. The child reports in the app, and the child decides the frequency of assessments.
arm group label: Group 1
arm group label: Group 2
criteria: 
gender: All
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: No
last name: Stefan Nilsson, PhD
role: Principal Investigator
affiliation: Institute of Health and Care Sciences, University of Gothenburg, Sweden
last name: Jonas Bergquist, Professor
role: Study Director
affiliation: Dept of Chemistry Biomedical Centre, Uppsala University, Sweden
last name: Stefan Nilsson, PhD
phone: +46738538951
email: stefan.nilsson.4@gu.se
last name: Joakim Öhlen, Professor
email: joakim.ohlen@fhs.gu.se
facility: 
status: Recruiting
contact: 
country: Sweden
url: https://www.gu.se/forskning/picpecc-pictorial-support-in-person-centred-care-for-children
description: Pictorial support in person-centred care for children
citation: Nilsson S, Bjorkman B, Almqvist AL, Almqvist L, Bjork-Willen P, Donohue D, Enskar K, Granlund M, Huus K, Hvit S. Children's voices--Differentiating a child perspective from a child's perspective. Dev Neurorehabil. 2015 Jun;18(3):162-8. doi: 10.3109/17518423.2013.801529. Epub 2013 Aug 7.
PMID: 23924164
citation: Lin B, Gutman T, Hanson CS, Ju A, Manera K, Butow P, Cohn RJ, Dalla-Pozza L, Greenzang KA, Mack J, Wakefield CE, Craig JC, Tong A. Communication during childhood cancer: Systematic review of patient perspectives. Cancer. 2020 Feb 15;126(4):701-716. doi: 10.1002/cncr.32637. Epub 2019 Dec 10.
PMID: 31821552
citation: Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
PMID: 22310560
citation: O'Cathain A, Croot L, Duncan E, Rousseau N, Sworn K, Turner KM, Yardley L, Hoddinott P. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open. 2019 Aug 15;9(8):e029954. doi: 10.1136/bmjopen-2019-029954.
PMID: 31420394
citation: Nilsson S, Holstensson J, Johansson C, Thunberg G. Children's Perceptions of Pictures Intended to Measure Anxiety During Hospitalization. J Pediatr Nurs. 2019 Jan-Feb;44:63-73. doi: 10.1016/j.pedn.2018.10.015. Epub 2018 Nov 3.
PMID: 30683283
responsible party type: Sponsor