<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/NCT04446728</url>
  </required_header>
  <id_info>
    <org_study_id>AK001</org_study_id>
    <nct_id>NCT04446728</nct_id>
  </id_info>
  <brief_title>Implementation of Family Psychosocial Risk Assessment in Pediatric Cancer</brief_title>
  <acronym>PAT</acronym>
  <official_title>Implementation of Family Psychosocial Risk Assessment in Pediatric Cancer With The Psychosocial Assessment Tool (PAT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nemours Children's Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nemours Children's Clinic</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>
      The diagnosis and treatment of pediatric cancer adversely affects multiple levels of the&#xD;
      social ecology, including patient and caregiver physical and psychosocial health. It is the&#xD;
      strong recommendation from the first Standard of the Psychosocial Standards of Care in&#xD;
      Pediatric Cancer that cancer centers engage in universal, systematic, psychosocial risk&#xD;
      screening for newly diagnosed patients and their families. Universal screening at diagnosis&#xD;
      fosters early identification of psychosocial risks and provides the opportunity to match&#xD;
      psychosocial care to the level of family need for more equitable, effective and integrated&#xD;
      services. However, few programs offer such care in an efficient, comprehensive, and&#xD;
      consistent manner, potentially resulting in insufficient care that magnifies inequities in&#xD;
      outcomes. To support pediatric cancer centers in their goal of meeting the first Standard of&#xD;
      Psychosocial Care, this study will compare two implementation strategies for the Psychosocial&#xD;
      Assessment Tool (PAT), a validated parent report screener of family psychosocial risk in&#xD;
      English and Spanish, in a cluster randomized trial across 18 pediatric cancer programs in the&#xD;
      United States.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Childhood cancer affects multiple levels of the social ecology, including social&#xD;
      determinants of health (e.g. financial and resource issues, child and family problems). The&#xD;
      2015 Standards of Psychosocial Care in Pediatric Cancer outline optimal psychosocial care,&#xD;
      starting with a standard devoted to assessment of psychosocial healthcare needs. The&#xD;
      Psychosocial Assessment Tool (PAT) is a validated family psychosocial risk screener now ready&#xD;
      for broad implementation. Method: The PAT will be implemented across a national sample of 18&#xD;
      pediatric cancer programs in a comparative effectiveness study, guided by the Interactive&#xD;
      Systems Framework for Dissemination and Implementation, comparing two Strategies. It is&#xD;
      hypothesized that implementation will be more successful at the patient/family, provider, and&#xD;
      institutional level when Training (Strategy I) is combined with Implementation Expanded&#xD;
      Resources (Strategy II). The trial will be informed by input from Stakeholders and will&#xD;
      result in a web-based Toolkit for dissemination nationally. Sites will be randomized to&#xD;
      cohort (one of three years) and strategy (Strategy I, II) for the trial. Outcomes include&#xD;
      adoption and penetration of screening (patient/family), staff job satisfaction/burnout&#xD;
      (provider), and cost effective use of resources consistent with family risk (institution).&#xD;
      Discussion Use of the PAT across children's cancer programs nationally can achieve the&#xD;
      assessment Standard and deliver psychosocial care matched to family need for all patients,&#xD;
      especially those most impacted by health inequities.&#xD;
&#xD;
      Based on the Interactive Systems Framework for Dissemination and Implementation (ISF), this&#xD;
      study is a comparative effectiveness trial of the two strategies at 18 childhood cancer&#xD;
      centers of three sizes based on new patients per year, examining family (penetration, health&#xD;
      equity), provider (feasibility, acceptability, burnout and job satisfaction), and institution&#xD;
      (adoption, sustainability, costs) implementation outcomes.7 Sites will be randomized to time&#xD;
      of implementation (three cohorts) and Strategy (two - I, II).&#xD;
&#xD;
      Aim. Compare the two theoretically based and empirically informed strategies to implement the&#xD;
      PAT in English and Spanish using a cluster randomized controlled trial. Compared to Training:&#xD;
&#xD;
      H1. At the patient/family level, TIER will be associated with: a) a higher proportion of&#xD;
      families of newly diagnosed children screened and provided with feedback (penetration); and&#xD;
      b) higher rates of screening for ethnic minority and socioeconomically diverse families&#xD;
      (health equity).&#xD;
&#xD;
      H2. At the provider level, TIER will be: a) more feasible and rated as appropriate and&#xD;
      acceptable; b) associated with greater engagement in addressing health disparities; and c)&#xD;
      associated with less burnout and better job satisfaction.&#xD;
&#xD;
      H3. At the institution level, TIER will be associated with: a) a higher rate of site&#xD;
      participation (adoption), b) more positive perceptions of implementation benefits and fewer&#xD;
      challenges (sustainability); and c) psychosocial care better matched to need demonstrating a&#xD;
      more equitable distribution of services and costs of care.&#xD;
&#xD;
      All sites, regardless of randomization to Strategy I or II, will participate in a 3-hour&#xD;
      professionally prepared internet based learning session (webinar) at the beginning of their&#xD;
      cohort. Each site PI, all staff who will be directly involved in screening, and the research&#xD;
      coordinator will participate. For sites randomized to Strategy II, the Champion will also&#xD;
      attend. The investigators will work with sites to identify the team that will participate in&#xD;
      screening and the Champion (in TIER) (&quot;individuals who dedicate themselves to supporting,&#xD;
      marketing, and driving through an implementation, overcoming indifference or resistance that&#xD;
      the intervention may encounter in an organization&quot;), recognizing that these determinations&#xD;
      will vary across programs. The webinar will be professionally prepared to be engaging and&#xD;
      effective as an educational approach with resource materials provided (Develop Educational&#xD;
      Materials, Distribute Educational Materials).&#xD;
&#xD;
      The training webinar will include all information necessary to access the web-based PAT.&#xD;
      Sites will be provided with a User Agreement, user manual, and access to the password&#xD;
      protected site. The completed PAT is scored immediately and a summary of the score and&#xD;
      clinical concerns identified is sent. Only de-identified data will be transmitted to the&#xD;
      study data core. Sites will be supported in the technical aspects of the implementation&#xD;
      related to using the web-based forms (Centralize Technical Assistance). If any pattern of&#xD;
      problems with technical aspects of implementation is identified, the study staff will&#xD;
      communicate with sites promptly. During training, each site PI and staff involved in&#xD;
      screening will develop a specific implementation plan, describing who will implement the PAT,&#xD;
      who will be screened, where results will be stored, how results will be communicated and how&#xD;
      results will be used (Develop a Formal Implementation Blueprint). For TIER, the Plan includes&#xD;
      questions about the Champion and the Consultation Calls.&#xD;
&#xD;
      Strategy I. For sites randomized to Strategy I (Training), the webinar is the implementation&#xD;
      condition. Sites will also receive technology support, as needed, throughout the one-year&#xD;
      implementation period. These strategies correspond to implementation strategies: creating a&#xD;
      structure for implementation including creating implementation teams, developing an&#xD;
      implementation plan.2&#xD;
&#xD;
      Strategy II. Strategy II, Training + Implementation Expanded Resources (TIER), includes the&#xD;
      same webinar and technical support as in Strategy I with the addition of two evidence-based&#xD;
      resources that may improve implementation (as finalized from analysis of Aim 1 interviews).&#xD;
      The Site PI and center staff conducting screening will participate in a monthly one-hour PAT&#xD;
      Implementation Consultation Call (Provide Ongoing Consultation, Create a Learning&#xD;
      Collaborative). The group format of this strategy is intended to foster group problem-solving&#xD;
      about common issues in implementation and provide peer support for those implementing the&#xD;
      PAT. The data regarding implementation progress and challenges from the calls will be&#xD;
      addressed in subsequent calls and will be considered in the development of the Toolkit.&#xD;
      Second, sites will identify a Champion for PAT implementation (Identify and Prepare&#xD;
      Champions), most likely be a division chief, nurse in a leadership role, or clinical&#xD;
      administrator.&#xD;
&#xD;
      At the Patient/Family level the following data for the English and Spanish versions of the&#xD;
      PAT will be reported monthly: new patients meeting eligibility requirements as outlined on&#xD;
      the PAT Implementation Plan (n); patients with documentation of PAT screening (n); patients&#xD;
      with evidence of family feedback letter (n); demographic data (race, ethnicity, zip code,&#xD;
      insurance). As part of the PAT Implementation Plan, the Site PI and Coordinator will&#xD;
      determine institution-specific ways to identify new patients and their demographic&#xD;
      characteristics.&#xD;
&#xD;
      At the Provider level the Site PI and staff identified as screeners will complete self-report&#xD;
      measures at baseline and at 6 and 12 months.&#xD;
&#xD;
      There are four outcomes at the Institution level. The first outcome is adoption, or the&#xD;
      intention of sites to use the PAT, by examining the site participation rate. To evaluate the&#xD;
      extent to which screening is perceived as an asset to the institution electronic health&#xD;
      record data (EHR) data will be extracted and aggregated at the site level for each family at&#xD;
      30, 60 and 90 days after screening. It provides a sum of hospital based services and external&#xD;
      referrals and the number and length of inpatient and outpatient visits, missed appointments&#xD;
      and evidence of non-adherence or difficulties in delivering care, allowing determination of&#xD;
      healthcare utilization or medical services delivered. Cost will be assessed to understand the&#xD;
      relationship among PAT risk level, psychosocial services provided, and aspects of medical&#xD;
      care that may reflect unnecessary or inefficient services. Because the care provided may be&#xD;
      related to the intensity of medical treatment, the Intensity of Treatment Scale will be used.&#xD;
&#xD;
      Analysis&#xD;
&#xD;
      H1. ANOVA will compare the effectiveness of the two implementation strategies on penetration&#xD;
      and health equity. The outcomes are proportions: families screened/families eligible,&#xD;
      families provided feedback/families screened, ethnic minority families screened/ethnic&#xD;
      minority families eligible, low socioeconomic status (SES) families screened/low SES families&#xD;
      eligible. Interclass Correlation Coefficients (ICC) among the clusters will be calculated and&#xD;
      used to adjust for the cluster effect.&#xD;
&#xD;
      H2. Three sets of outcome variables - perception of implementation, engagement in addressing&#xD;
      health disparities, and burnout/job satisfaction - will be tested. A two group analysis with&#xD;
      the framework of Structural Equation Modeling (SEM) will be conducted to compare the&#xD;
      effectiveness of the two strategies. To test the effect of time (T1, T2, T3), latent growth&#xD;
      curve analysis will be conducted; it is expected that provider outcomes will improve over&#xD;
      time. Analyses will be performed using Mplus 5.0 with ML estimation for outcome variables&#xD;
      that meet the distribution assumptions, and with Robust Least Weighted Squares (WLSMV)&#xD;
      estimation for outcome variables that do not. Potential mediating effects of favorable&#xD;
      perception of implementation on provider job satisfaction and burnout will be examined using&#xD;
      mediation models. TIER is expected to be associated with more favorable perceptions of&#xD;
      implementation, which in turn will lead to less burnout and higher job satisfaction.&#xD;
&#xD;
      H3. At the institution level adoption of the PAT will be measured by a ratio of sites that&#xD;
      initiate implementation/sites that agreed (H3a). If substitutions are necessary, sites that&#xD;
      are newly invited will be added to the denominator and adoption calculated by total&#xD;
      acceptances/total invited. ANOVA will be conducted to compare the effectiveness of the two&#xD;
      strategies. For H3b sustainability (PIQ perceptions of implementation benefits and&#xD;
      challenges), ANOVA will be conducted to compare the effectiveness of the two strategies on&#xD;
      benefits and challenges. For H3c the interest is in the extent to which psychosocial care is&#xD;
      matched to need and the extent to which intensive medical and psychosocial services are&#xD;
      delivered for those most in need. There has not yet been established a cost-effectiveness&#xD;
      threshold or criterion to which to compare costs of screening with these two implementation&#xD;
      strategies, necessitating our consideration of valued outcomes in the psychosocial screening&#xD;
      literature and resources available. ANOVA will be conducted to test whether psychosocial care&#xD;
      is matched with levels of psychosocial risks, resulting in a 2 (Strategy) x 3 (psychosocial&#xD;
      risks: clinical, targeted, universal) design on distribution of services and costs of care.&#xD;
      It is expected that the 3 levels of the Pediatric Psychosocial Preventative Health Model&#xD;
      (PPPHM) will be related to number and costs of services provided as measured on the&#xD;
      Psychosocial Services and Medical Treatment Checklist (PSMTC). Additional analyses will be&#xD;
      conducted to compare English speaking and Spanish speaking families, different ethnicity,&#xD;
      race, and SES and insurance status on the outcome variables.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This is an implementation trial in which institutions are assigned to conditions. There is no masking.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Families screened</measure>
    <time_frame>At conclusion of cohort year (12 months post baseline)</time_frame>
    <description>Number of families screened divided by number of families eligible</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Site Participation Rate</measure>
    <time_frame>At conclusion of the study (12 months post baseline)</time_frame>
    <description>Number of sites that completed the study divided by sites enrolled</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Families provided feedback</measure>
    <time_frame>At conclusion of cohort year (12 months post baseline)</time_frame>
    <description>Number of families provided feedback divided by number of families screened</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ethnic minority families screened</measure>
    <time_frame>At conclusion of cohort year (12 months post baseline)</time_frame>
    <description>Number of ethnic minority families screened divided by number of ethnic minority families eligible</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physician Engagement in Addressing Racial and Ethnic Health Care Disparities (AREA) scale</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
    <description>Changes in level of engagement in addressing health disparities as measured by the AREA, a 9 point scale with a 5 point likert response. Total scores range from 0 to 36 with higher scores indicating higher level of engagement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maslach Burnout Inventory (MBI)</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
    <description>Changes in burnout measured with this 22 item scale with a items on a 7 point Likert scale, higher scores indicate higher job satisfaction. Range of scores is from 0 to 42.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of Intervention Measure (AIM)</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Changes in acceptability of the PAT using this four item survey on a 5 point likert scale; range of scores is from 5 to 25; higher score is higher acceptability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Appropriateness Measure (IAM)</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Changes in perceived appropriateness of the PAT using this four item survey on a 5 point likert scale; range of scores is from 5 to 25; higher score is higher appropriateness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of Intervention Measure (FIM)</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Changes in perceptions of the feasibility of using the PAT measured with this four item survey on a 5 point likert scale; range of scores is from 5 to 25; higher score is higher feasibility</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Pediatric Cancer</condition>
  <arm_group>
    <arm_group_label>Strategy I.Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sites randomized to Strategy I will receive a three hour training webinar in preparing for implementation of the PAT in their center.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Strategy II.Training+Implementation Enhanced Resources (TIER)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sites randomized to Strategy II will identify a Champion for screening and will participate in a monthly consultation call in addition to completing the three hour training webinar for implementing the PAT in their center.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Training Webinar</intervention_name>
    <description>The training webinar is a three hour training. The purpose of the study is to implement the Psychosocial Assessment Tool (PAT) in their center.</description>
    <arm_group_label>Strategy I.Training</arm_group_label>
    <arm_group_label>Strategy II.Training+Implementation Enhanced Resources (TIER)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Training Webinar Plus Implementation Enhanced Resources (TIER)</intervention_name>
    <description>In addition the Training Webinar, sites randomized to Strategy II will identify a Champion and will participate in monthly consultation calls in support of implementation of the PAT</description>
    <arm_group_label>Strategy II.Training+Implementation Enhanced Resources (TIER)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sites were selected in advance based on data collected in a previous study regarding&#xD;
             psychosocial staffing in the pediatric cancer program.&#xD;
&#xD;
          -  Sites that were at or above the median for size of their psychosocial staff were&#xD;
             eligible. - --&#xD;
&#xD;
          -  Site selection took into consideration number of new pediatric cancer patients&#xD;
             annually, geographical representation and sites with significant proportions of&#xD;
             Spanish speaking families and/or families of low socioeconomic status.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Sites with psychosocial staffing below the median in the prior study were not eligible.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nemours Children's Health</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19083</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Families</keyword>
  <keyword>Psychosocial</keyword>
  <keyword>Health equity</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The investigators will share de-identified data upon reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>At conclusion of study</ipd_time_frame>
    <ipd_access_criteria>Data sharing will be considered with clinical leaders, investigators, policy makers and cancer advocates interested in implementation strategies for psychosocial screening and care.</ipd_access_criteria>
  </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/NCT04446728
org study id: AK001
nct id: NCT04446728
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The diagnosis and treatment of pediatric cancer adversely affects multiple levels of the
      social ecology, including patient and caregiver physical and psychosocial health. It is the
      strong recommendation from the first Standard of the Psychosocial Standards of Care in
      Pediatric Cancer that cancer centers engage in universal, systematic, psychosocial risk
      screening for newly diagnosed patients and their families. Universal screening at diagnosis
      fosters early identification of psychosocial risks and provides the opportunity to match
      psychosocial care to the level of family need for more equitable, effective and integrated
      services. However, few programs offer such care in an efficient, comprehensive, and
      consistent manner, potentially resulting in insufficient care that magnifies inequities in
      outcomes. To support pediatric cancer centers in their goal of meeting the first Standard of
      Psychosocial Care, this study will compare two implementation strategies for the Psychosocial
      Assessment Tool (PAT), a validated parent report screener of family psychosocial risk in
      English and Spanish, in a cluster randomized trial across 18 pediatric cancer programs in the
      United States.
Background: Childhood cancer affects multiple levels of the social ecology, including social
      determinants of health (e.g. financial and resource issues, child and family problems). The
      2015 Standards of Psychosocial Care in Pediatric Cancer outline optimal psychosocial care,
      starting with a standard devoted to assessment of psychosocial healthcare needs. The
      Psychosocial Assessment Tool (PAT) is a validated family psychosocial risk screener now ready
      for broad implementation. Method: The PAT will be implemented across a national sample of 18
      pediatric cancer programs in a comparative effectiveness study, guided by the Interactive
      Systems Framework for Dissemination and Implementation, comparing two Strategies. It is
      hypothesized that implementation will be more successful at the patient/family, provider, and
      institutional level when Training (Strategy I) is combined with Implementation Expanded
      Resources (Strategy II). The trial will be informed by input from Stakeholders and will
      result in a web-based Toolkit for dissemination nationally. Sites will be randomized to
      cohort (one of three years) and strategy (Strategy I, II) for the trial. Outcomes include
      adoption and penetration of screening (patient/family), staff job satisfaction/burnout
      (provider), and cost effective use of resources consistent with family risk (institution).
      Discussion Use of the PAT across children's cancer programs nationally can achieve the
      assessment Standard and deliver psychosocial care matched to family need for all patients,
      especially those most impacted by health inequities.

      Based on the Interactive Systems Framework for Dissemination and Implementation (ISF), this
      study is a comparative effectiveness trial of the two strategies at 18 childhood cancer
      centers of three sizes based on new patients per year, examining family (penetration, health
      equity), provider (feasibility, acceptability, burnout and job satisfaction), and institution
      (adoption, sustainability, costs) implementation outcomes.7 Sites will be randomized to time
      of implementation (three cohorts) and Strategy (two - I, II).

      Aim. Compare the two theoretically based and empirically informed strategies to implement the
      PAT in English and Spanish using a cluster randomized controlled trial. Compared to Training:

      H1. At the patient/family level, TIER will be associated with: a) a higher proportion of
      families of newly diagnosed children screened and provided with feedback (penetration); and
      b) higher rates of screening for ethnic minority and socioeconomically diverse families
      (health equity).

      H2. At the provider level, TIER will be: a) more feasible and rated as appropriate and
      acceptable; b) associated with greater engagement in addressing health disparities; and c)
      associated with less burnout and better job satisfaction.

      H3. At the institution level, TIER will be associated with: a) a higher rate of site
      participation (adoption), b) more positive perceptions of implementation benefits and fewer
      challenges (sustainability); and c) psychosocial care better matched to need demonstrating a
      more equitable distribution of services and costs of care.

      All sites, regardless of randomization to Strategy I or II, will participate in a 3-hour
      professionally prepared internet based learning session (webinar) at the beginning of their
      cohort. Each site PI, all staff who will be directly involved in screening, and the research
      coordinator will participate. For sites randomized to Strategy II, the Champion will also
      attend. The investigators will work with sites to identify the team that will participate in
      screening and the Champion (in TIER) ("individuals who dedicate themselves to supporting,
      marketing, and driving through an implementation, overcoming indifference or resistance that
      the intervention may encounter in an organization"), recognizing that these determinations
      will vary across programs. The webinar will be professionally prepared to be engaging and
      effective as an educational approach with resource materials provided (Develop Educational
      Materials, Distribute Educational Materials).

      The training webinar will include all information necessary to access the web-based PAT.
      Sites will be provided with a User Agreement, user manual, and access to the password
      protected site. The completed PAT is scored immediately and a summary of the score and
      clinical concerns identified is sent. Only de-identified data will be transmitted to the
      study data core. Sites will be supported in the technical aspects of the implementation
      related to using the web-based forms (Centralize Technical Assistance). If any pattern of
      problems with technical aspects of implementation is identified, the study staff will
      communicate with sites promptly. During training, each site PI and staff involved in
      screening will develop a specific implementation plan, describing who will implement the PAT,
      who will be screened, where results will be stored, how results will be communicated and how
      results will be used (Develop a Formal Implementation Blueprint). For TIER, the Plan includes
      questions about the Champion and the Consultation Calls.

      Strategy I. For sites randomized to Strategy I (Training), the webinar is the implementation
      condition. Sites will also receive technology support, as needed, throughout the one-year
      implementation period. These strategies correspond to implementation strategies: creating a
      structure for implementation including creating implementation teams, developing an
      implementation plan.2

      Strategy II. Strategy II, Training + Implementation Expanded Resources (TIER), includes the
      same webinar and technical support as in Strategy I with the addition of two evidence-based
      resources that may improve implementation (as finalized from analysis of Aim 1 interviews).
      The Site PI and center staff conducting screening will participate in a monthly one-hour PAT
      Implementation Consultation Call (Provide Ongoing Consultation, Create a Learning
      Collaborative). The group format of this strategy is intended to foster group problem-solving
      about common issues in implementation and provide peer support for those implementing the
      PAT. The data regarding implementation progress and challenges from the calls will be
      addressed in subsequent calls and will be considered in the development of the Toolkit.
      Second, sites will identify a Champion for PAT implementation (Identify and Prepare
      Champions), most likely be a division chief, nurse in a leadership role, or clinical
      administrator.

      At the Patient/Family level the following data for the English and Spanish versions of the
      PAT will be reported monthly: new patients meeting eligibility requirements as outlined on
      the PAT Implementation Plan (n); patients with documentation of PAT screening (n); patients
      with evidence of family feedback letter (n); demographic data (race, ethnicity, zip code,
      insurance). As part of the PAT Implementation Plan, the Site PI and Coordinator will
      determine institution-specific ways to identify new patients and their demographic
      characteristics.

      At the Provider level the Site PI and staff identified as screeners will complete self-report
      measures at baseline and at 6 and 12 months.

      There are four outcomes at the Institution level. The first outcome is adoption, or the
      intention of sites to use the PAT, by examining the site participation rate. To evaluate the
      extent to which screening is perceived as an asset to the institution electronic health
      record data (EHR) data will be extracted and aggregated at the site level for each family at
      30, 60 and 90 days after screening. It provides a sum of hospital based services and external
      referrals and the number and length of inpatient and outpatient visits, missed appointments
      and evidence of non-adherence or difficulties in delivering care, allowing determination of
      healthcare utilization or medical services delivered. Cost will be assessed to understand the
      relationship among PAT risk level, psychosocial services provided, and aspects of medical
      care that may reflect unnecessary or inefficient services. Because the care provided may be
      related to the intensity of medical treatment, the Intensity of Treatment Scale will be used.

      Analysis

      H1. ANOVA will compare the effectiveness of the two implementation strategies on penetration
      and health equity. The outcomes are proportions: families screened/families eligible,
      families provided feedback/families screened, ethnic minority families screened/ethnic
      minority families eligible, low socioeconomic status (SES) families screened/low SES families
      eligible. Interclass Correlation Coefficients (ICC) among the clusters will be calculated and
      used to adjust for the cluster effect.

      H2. Three sets of outcome variables - perception of implementation, engagement in addressing
      health disparities, and burnout/job satisfaction - will be tested. A two group analysis with
      the framework of Structural Equation Modeling (SEM) will be conducted to compare the
      effectiveness of the two strategies. To test the effect of time (T1, T2, T3), latent growth
      curve analysis will be conducted; it is expected that provider outcomes will improve over
      time. Analyses will be performed using Mplus 5.0 with ML estimation for outcome variables
      that meet the distribution assumptions, and with Robust Least Weighted Squares (WLSMV)
      estimation for outcome variables that do not. Potential mediating effects of favorable
      perception of implementation on provider job satisfaction and burnout will be examined using
      mediation models. TIER is expected to be associated with more favorable perceptions of
      implementation, which in turn will lead to less burnout and higher job satisfaction.

      H3. At the institution level adoption of the PAT will be measured by a ratio of sites that
      initiate implementation/sites that agreed (H3a). If substitutions are necessary, sites that
      are newly invited will be added to the denominator and adoption calculated by total
      acceptances/total invited. ANOVA will be conducted to compare the effectiveness of the two
      strategies. For H3b sustainability (PIQ perceptions of implementation benefits and
      challenges), ANOVA will be conducted to compare the effectiveness of the two strategies on
      benefits and challenges. For H3c the interest is in the extent to which psychosocial care is
      matched to need and the extent to which intensive medical and psychosocial services are
      delivered for those most in need. There has not yet been established a cost-effectiveness
      threshold or criterion to which to compare costs of screening with these two implementation
      strategies, necessitating our consideration of valued outcomes in the psychosocial screening
      literature and resources available. ANOVA will be conducted to test whether psychosocial care
      is matched with levels of psychosocial risks, resulting in a 2 (Strategy) x 3 (psychosocial
      risks: clinical, targeted, universal) design on distribution of services and costs of care.
      It is expected that the 3 levels of the Pediatric Psychosocial Preventative Health Model
      (PPPHM) will be related to number and costs of services provided as measured on the
      Psychosocial Services and Medical Treatment Checklist (PSMTC). Additional analyses will be
      conducted to compare English speaking and Spanish speaking families, different ethnicity,
      race, and SES and insurance status on the outcome variables.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
masking description: This is an implementation trial in which institutions are assigned to conditions. There is no masking.
measure: Families screened
time frame: At conclusion of cohort year (12 months post baseline)
description: Number of families screened divided by number of families eligible
measure: Site Participation Rate
time frame: At conclusion of the study (12 months post baseline)
description: Number of sites that completed the study divided by sites enrolled
measure: Families provided feedback
time frame: At conclusion of cohort year (12 months post baseline)
description: Number of families provided feedback divided by number of families screened
measure: Ethnic minority families screened
time frame: At conclusion of cohort year (12 months post baseline)
description: Number of ethnic minority families screened divided by number of ethnic minority families eligible
measure: Physician Engagement in Addressing Racial and Ethnic Health Care Disparities (AREA) scale
time frame: Baseline, 6 and 12 months
description: Changes in level of engagement in addressing health disparities as measured by the AREA, a 9 point scale with a 5 point likert response. Total scores range from 0 to 36 with higher scores indicating higher level of engagement
measure: Maslach Burnout Inventory (MBI)
time frame: Baseline, 6 and 12 months
description: Changes in burnout measured with this 22 item scale with a items on a 7 point Likert scale, higher scores indicate higher job satisfaction. Range of scores is from 0 to 42.
measure: Acceptability of Intervention Measure (AIM)
time frame: Baseline, 6 months, 12 months
description: Changes in acceptability of the PAT using this four item survey on a 5 point likert scale; range of scores is from 5 to 25; higher score is higher acceptability
measure: Intervention Appropriateness Measure (IAM)
time frame: Baseline, 6 months, 12 months
description: Changes in perceived appropriateness of the PAT using this four item survey on a 5 point likert scale; range of scores is from 5 to 25; higher score is higher appropriateness
measure: Feasibility of Intervention Measure (FIM)
time frame: Baseline, 6 months, 12 months
description: Changes in perceptions of the feasibility of using the PAT measured with this four item survey on a 5 point likert scale; range of scores is from 5 to 25; higher score is higher feasibility
arm group label: Strategy I.Training
arm group type: Active Comparator
description: Sites randomized to Strategy I will receive a three hour training webinar in preparing for implementation of the PAT in their center.
arm group label: Strategy II.Training+Implementation Enhanced Resources (TIER)
arm group type: Active Comparator
description: Sites randomized to Strategy II will identify a Champion for screening and will participate in a monthly consultation call in addition to completing the three hour training webinar for implementing the PAT in their center.
intervention type: Behavioral
intervention name: Training Webinar
description: The training webinar is a three hour training. The purpose of the study is to implement the Psychosocial Assessment Tool (PAT) in their center.
arm group label: Strategy I.Training
arm group label: Strategy II.Training+Implementation Enhanced Resources (TIER)
intervention type: Behavioral
intervention name: Training Webinar Plus Implementation Enhanced Resources (TIER)
description: In addition the Training Webinar, sites randomized to Strategy II will identify a Champion and will participate in monthly consultation calls in support of implementation of the PAT
arm group label: Strategy II.Training+Implementation Enhanced Resources (TIER)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: The investigators will share de-identified data upon reasonable request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: At conclusion of study
ipd access criteria: Data sharing will be considered with clinical leaders, investigators, policy makers and cancer advocates interested in implementation strategies for psychosocial screening and care.