<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/NCT03234608</url>
  </required_header>
  <id_info>
    <org_study_id>1R34MH111536-01</org_study_id>
    <nct_id>NCT03234608</nct_id>
  </id_info>
  <brief_title>Health System Integration of Tools to Improve Primary Care for Autistic Adults</brief_title>
  <official_title>Health System Integration of Tools to Improve Primary Care for Autistic Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Portland State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Portland State 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>
      The health system is ill-equipped to meet the needs of autistic adults. The Academic Autism&#xD;
      Spectrum Partnership in Research and Education (AASPIRE), an academic-community partnership&#xD;
      comprised of academics, autistic adults, healthcare providers, and supporters, has used a&#xD;
      community based participatory research (CBPR) approach to develop and test an online&#xD;
      healthcare toolkit aimed at improving primary care services for autistic adults. It was&#xD;
      specifically designed as a low-intensity, sustainable intervention that can realistically be&#xD;
      used in busy primary care practices that do not have a special focus on autism or other&#xD;
      developmental disabilities. The toolkit includes the Autism Healthcare Accommodations Tool&#xD;
      (AHAT)--an automated tool which allows patients and/or their supporters to create a&#xD;
      personalized accommodations report for their primary care provider (PCP)--and other targeted&#xD;
      resources, worksheets, checklists, and information. The investigators' pilot work has&#xD;
      demonstrated that the AHAT has strong construct validity and test-retest stability, the&#xD;
      toolkit is highly acceptable and accessible, and it has the potential to decrease barriers to&#xD;
      care and increase patient-provider communication. The investigators' long-term plan is to&#xD;
      conduct a hybrid effectiveness-implementation trial, using a cluster randomized trial design,&#xD;
      both to test the effectiveness of the AASPIRE Healthcare Toolkit in improving healthcare&#xD;
      quality and utilization and to assess the utility of implementation strategies in diverse&#xD;
      healthcare systems. The objective of this proposal is to use a CBPR approach to understand&#xD;
      how to integrate the toolkit into these health systems, collect more robust efficacy data,&#xD;
      and explore potential mechanisms of action. The investigators will do so by conducting a&#xD;
      6-month pilot study with patients assigned to intervention and control clinics in three&#xD;
      diverse health systems. The investigators will meet our objectives by achieving the following&#xD;
      specific aims: 1) to determine how to integrate use of the toolkit within diverse health&#xD;
      systems; 2) to test the effect of the toolkit on short-term healthcare outcomes; 3) to use a&#xD;
      mixed-methods approach to further explore the toolkit's mechanisms of action; and 4) to&#xD;
      refine the recruitment, retention, data collection, and system integration strategies in&#xD;
      preparation for the larger cluster-randomized trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite growing attention to the needs of autistic children, the health system is ill&#xD;
      equipped to meet the needs of autistic adults. The investigators' prior work has identified&#xD;
      significant healthcare disparities experienced by autistic adults, including greater unmet&#xD;
      healthcare needs, lower use of preventive services, and greater use of the Emergency&#xD;
      Department (ED). These disparities likely stem from a complex interaction between patient-,&#xD;
      provider-, and system-level factors. Autism entails atypical communication and interpersonal&#xD;
      relationships, and challenges with executive function - factors that are critically important&#xD;
      for effective healthcare interactions and health system navigation. Moreover, a majority of&#xD;
      primary care providers (PCPs) lack the skills needed to care for autistic adults, yet&#xD;
      competing priorities make it unlikely they will attend trainings on autism. The heterogeneity&#xD;
      of the autism spectrum may also make it challenging to understand a specific patient's needs.&#xD;
      Finally, autistic patients may be disproportionally affected by the complexity of the health&#xD;
      system, low socio-economic status, and societal biases, yet few systems can afford&#xD;
      autism-specific care coordination programs for adults.&#xD;
&#xD;
      The Academic Autism Spectrum Partnership in Research and Education (AASPIRE), an&#xD;
      academic-community partnership comprised of academics, autistic adults, healthcare providers,&#xD;
      and supporters, has used a community based participatory research (CBPR) approach to develop&#xD;
      and test an online healthcare toolkit aimed at improving primary care services for autistic&#xD;
      adults. It was specifically designed as a low-intensity, sustainable intervention that can&#xD;
      realistically be used in busy primary care practices that do not have a special focus on&#xD;
      autism or other developmental disabilities. The toolkit includes the Autism Healthcare&#xD;
      Accommodations Tool (AHAT)--an automated tool which allows patients and/or their supporters&#xD;
      to create a personalized accommodations report for their PCP--and other targeted resources,&#xD;
      worksheets, checklists, and information. A series of NIMH-funded studies demonstrated that&#xD;
      the AHAT has strong construct validity and test-retest stability, and that the toolkit is&#xD;
      highly acceptable and accessible. In a 1-month pre-post intervention comparison, the&#xD;
      investigators found a decrease in barriers to care and increases in patient-provider&#xD;
      communication and confidence in healthcare. Despite these promising preliminary results, more&#xD;
      data is needed to test its effectiveness and understand how to best integrate it into diverse&#xD;
      primary care practices and health systems.&#xD;
&#xD;
      The investigators' long-term plan is to conduct a hybrid effectiveness-implementation trial,&#xD;
      using a cluster randomized trial design, both to test the effectiveness of the AASPIRE&#xD;
      Healthcare Toolkit in improving healthcare quality and utilization and to determine the&#xD;
      potential utility of implementation strategies in diverse healthcare systems. The objective&#xD;
      of this proposal is to use a CBPR approach to understand how to best integrate the toolkit&#xD;
      into these health systems, collect more robust efficacy data, and explore potential&#xD;
      mechanisms of action. The investigators will do so by conducting a 6-month pilot study with&#xD;
      patients assigned to intervention and control clinics in three diverse health systems. The&#xD;
      investigators will meet our objectives by achieving the following specific aims:&#xD;
&#xD;
        1. To determine how to integrate use of the toolkit within diverse health systems. The&#xD;
           investigators' existing CBPR partnership will expand to include local patients,&#xD;
           providers, staff, and administrators from each system. Together, the investigators will&#xD;
           decide how to make patients and providers aware of the toolkit, integrate the AHAT into&#xD;
           the electronic medical record, and respond to recommendations. The investigators will&#xD;
           collaboratively develop implementation protocols and determine how to track them. The&#xD;
           investigators will then conduct a mixed-methods, formative process evaluation to&#xD;
           optimize the likelihood of success of future implementation efforts.'&#xD;
&#xD;
        2. To test the effect of the toolkit on short-term healthcare outcomes. The investigators&#xD;
           hypothesize that, over 6 months, the toolkit will increase satisfaction with&#xD;
           patient-provider communication and decrease barriers to healthcare in patients from&#xD;
           intervention clinics as compared to patients from control clinics.&#xD;
&#xD;
        3. To use a mixed-methods approach to further explore the toolkit's mechanisms of action.&#xD;
           Quantitative data will help the investigators refine and psychometrically test our&#xD;
           measures of patient self-advocacy and visit preparedness; provider/staff use of desired&#xD;
           accommodations and strategies; and patient and provider self-efficacy. Qualitative data&#xD;
           will allow the investigators to obtain a richer understanding of how the toolkit is&#xD;
           affecting care and potentially suggest additional mechanisms of action.&#xD;
&#xD;
        4. To refine our recruitment, retention, data collection, and system integration strategies&#xD;
           in preparation for the larger cluster-randomized trial. The investigators will use this&#xD;
           study to confirm or modify our change model, choose long-term health utilization&#xD;
           outcomes to be further studied in the R01, finalize study protocols and data collection&#xD;
           instruments, and develop a flexible implementation strategy that can be feasibly applied&#xD;
           to diverse primary care clinics.&#xD;
&#xD;
      Successful integration of this scalable and sustainable low-intensity intervention into&#xD;
      primary care practices within diverse health systems will empower patients and providers to&#xD;
      work together to improve health outcomes for a large, underserved and understudied population&#xD;
      with great barriers to care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 24, 2017</start_date>
  <completion_date type="Actual">December 15, 2019</completion_date>
  <primary_completion_date type="Actual">March 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>We will conduct the study in primary care clinics within three health systems. We will compare data from patients in 7 intervention clinics to patients from matched control clinics within the same systems.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Barriers to Healthcare</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Barriers to Healthcare Checklist-Short Form: The instrument is scored as a count of the total number of barriers endorsed from a checklist of 16 items. Scores can range from 0 to 16. The score depicts the number of barriers to healthcare the participants reports. A higher number of barriers is a worse outcome.&#xD;
Change in barriers to healthcare is calculated by subtracting the baseline score from the 6 month score. Negative scores depict an improvement (i.e. participant is reporting fewer barriers 6 months after the intervention than they did at baseline).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient-Provider Communication</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>AASPIRE Patient-Provider Communication Scale (PPCS-8): This scale is scored by summing responses the 8 items. Scores range from 8 to 40, with higher scores indicating higher satisfaction with patient-provider communication.&#xD;
Change in patient-provider communication is calculated by subtracting the score at baseline from the score at 6 months. Positive scores indicate an improved outcome (i.e. better patient-provider communication post-intervention than before).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Healthcare Self-Efficacy</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>AASPIRE Health and Healthcare Self-Efficacy Scale (HHSES-21): This is a 21-item scale about patient confidence in navigating the healthcare system and managing health problems. There are two sub-scales. The Individual Level Self-Efficacy Sub-scale consists of items 1, 2, 3, 4, 11, 13,14, 15, 16, and 17. The Relationship Dependent Self-Efficacy Sub-scale consists of items 5, 6, 7, 8, 9, 10, 12, 18, 19, 20, and 21. Each sub-scale is scored by summing responses to the items, and then dividing the sum by the number of items. The resulting sub-scales have a possible range of 1-10, with higher scores corresponding to higher self-efficacy.&#xD;
Change in healthcare self-efficacy is calculated by subtracting the baseline score from the score at 6 months. A positive score indicates an improved outcome (i.e. higher self-efficacy post-intervention).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visit Preparedness</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>AASPIRE Visit Preparedness Scale (VPS-6): The scale is scored by summing responses to the 6 items. It has a range of 6-30, with higher scores indicating higher visit preparedness. This scale measures how well-prepared patient felt for their most recent visit.&#xD;
Change in visit preparedness is calculated by subtracting the baseline score from the score at 6 months. Positive scores indicate an improved outcome (i.e. higher visit preparedness post-intervention).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Receipt of Healthcare Accommodations</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>AASPIRE Healthcare Accommodations Scale (HAS-8): The scale is scored by summing responses from the eight items. The resulting scale can range from 8 to 40, with higher scores indicating higher receipt of necessary accommodations. Patient report, using 8-item scale, of how well clinic providers and staff make necessary accommodations.&#xD;
Change in receipt of healthcare accommodations is calculated by subtracting the baseline score from the score at 6 months. A positive change in score indicates an improved outcome (i.e. greater receipt of necessary accommodations after the intervention).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Healthcare Use</measure>
    <time_frame>6 months</time_frame>
    <description>Patient self-report of use of preventive, outpatient, and emergency services; unmet healthcare needs</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction With Healthcare Toolkit</measure>
    <time_frame>6 months</time_frame>
    <description>Open- and closed-ended survey and interview questions about patient satisfaction with healthcare toolkit (intervention only)</description>
  </other_outcome>
  <other_outcome>
    <measure>Provider Confidence and Satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>Survey items on primary care provider's confidence in caring for autistic patients and satisfaction with toolkit</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">244</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>AASPIRE Healthcare Toolkit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will receive usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>AASPIRE Healthcare Toolkit</intervention_name>
    <description>The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff.</description>
    <arm_group_label>AASPIRE Healthcare Toolkit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnostic code in chart related to autism spectrum disorder or other communication&#xD;
             disability&#xD;
&#xD;
          -  Receiving care at one of participating clinics&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Can neither participate directly (with or without support), nor has an&#xD;
             English-speaking supporter who can answer surveys on their behalf.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina Nicolaidis, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Portland State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Permanente Northern California</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>97207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Legacy Health System</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 14, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <results_first_submitted>March 11, 2021</results_first_submitted>
  <results_first_submitted_qc>September 23, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 21, 2021</results_first_posted>
  <last_update_submitted>October 29, 2021</last_update_submitted>
  <last_update_submitted_qc>October 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Portland State University</investigator_affiliation>
    <investigator_full_name>Christina Nicolaidis</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Healthcare services</keyword>
  <keyword>Adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Participating in National Institute of Mental Health (NIMH) Data Archive</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>After study completion.</ipd_time_frame>
    <ipd_access_criteria>Determined by NIMH Data Archive</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 10, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03234608/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 27, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03234608/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>AASPIRE Healthcare Toolkit</title>
          <description>Patients will use the Academic Autism Spectrum Partnership in Research and Education (AASPIRE) Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Tool (AHAT) Report with their primary care provider.&#xD;
AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's Primary Care Provider (PCP) and other staff.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Patients will receive usual care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="127"/>
                <participants group_id="P2" count="117"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="104"/>
                <participants group_id="P2" count="96"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AASPIRE Healthcare Toolkit</title>
          <description>Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.&#xD;
AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff.</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Patients will receive usual care.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="127"/>
            <count group_id="B2" value="117"/>
            <count group_id="B3" value="244"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="127"/>
                    <count group_id="B2" value="117"/>
                    <count group_id="B3" value="244"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.32" spread="12.86"/>
                    <measurement group_id="B2" value="29.03" spread="10.94"/>
                    <measurement group_id="B3" value="30.22" spread="12.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <population>Participants with complete data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Gender</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="125"/>
                    <count group_id="B2" value="116"/>
                    <count group_id="B3" value="241"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="168"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>Participants with complete data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="124"/>
                    <count group_id="B2" value="115"/>
                    <count group_id="B3" value="239"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Non-Hispanic White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="147"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Hispanic Black / African-American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Hispanic Asian / Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Hispanic Multi-Racial</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="127"/>
                    <count group_id="B2" value="117"/>
                    <count group_id="B3" value="244"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="127"/>
                    <measurement group_id="B2" value="117"/>
                    <measurement group_id="B3" value="244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participant Residence</title>
          <population>Participants with complete data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="124"/>
                    <count group_id="B2" value="115"/>
                    <count group_id="B3" value="239"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Place they own or rent</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>With family</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="161"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Group home/Foster home</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participant need assistance from someone for medical care</title>
          <population>Participants with complete data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="114"/>
                    <count group_id="B2" value="107"/>
                    <count group_id="B3" value="221"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Always or often</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rarely or never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participant help with communication</title>
          <population>Participants with complete data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="115"/>
                    <count group_id="B3" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Communicate with providers by themselves</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Someone helps them some of the time</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Someone does most or all of the communication</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participant overall health</title>
          <population>Participants with complete data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="124"/>
                    <count group_id="B2" value="115"/>
                    <count group_id="B3" value="239"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Poor</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fair</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Excellent</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient-Provider Communication Scale (PPCS-8)</title>
          <description>AASPIRE Patient-Provider Communication Scale (PPCS-8): This scale is scored by summing responses to the 8 items. Scores range from 8 to 40, with higher scores indicating higher satisfaction with patient-provider communication.</description>
          <population>Participants with complete data</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="124"/>
                    <count group_id="B2" value="111"/>
                    <count group_id="B3" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.76" spread="5.71"/>
                    <measurement group_id="B2" value="33.14" spread="5.83"/>
                    <measurement group_id="B3" value="32.94" spread="5.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>The AASPIRE Visit Preparedness Scale (VPS-6)</title>
          <description>AASPIRE Visit Preparedness Scale (VPS-6): The scale is scored by summing responses to the 6 items. It has a range of 6-30, with higher scores indicating higher visit preparedness. This scale measures how well-prepared patient felt for their most recent visit.</description>
          <population>Participants with complete data</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="121"/>
                    <count group_id="B2" value="112"/>
                    <count group_id="B3" value="233"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.80" spread="3.76"/>
                    <measurement group_id="B2" value="23.90" spread="4.13"/>
                    <measurement group_id="B3" value="23.85" spread="3.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Barriers to Healthcare Checklist-Short Form</title>
          <description>Barriers to Healthcare Checklist-Short Form: The instrument is scored as a count of the total number of barriers endorsed from a checklist of 16 items. Scores can range from 0 to 16. The score depicts the number of barriers to healthcare the participants reports. Higher scores depict a worse outcome.</description>
          <population>Participants with complete data</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="116"/>
                    <count group_id="B3" value="239"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.63" spread="3.08"/>
                    <measurement group_id="B2" value="2.19" spread="2.34"/>
                    <measurement group_id="B3" value="2.42" spread="2.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Healthcare Accommodations Scale(HAS-8)</title>
          <description>AASPIRE Healthcare Accommodations Scale (HAS-8): The scale is scored by summing responses from the eight items. The resulting scale can range from 8 to 40, with higher scores indicating higher receipt of necessary accommodations. Patient report, using 8-item scale, of how well clinic providers and staff make necessary accommodations.</description>
          <population>Participants with complete data</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="118"/>
                    <count group_id="B2" value="107"/>
                    <count group_id="B3" value="225"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.88" spread="6.00"/>
                    <measurement group_id="B2" value="29.84" spread="6.27"/>
                    <measurement group_id="B3" value="29.34" spread="6.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Individual Level Healthcare Self Efficacy Sub-scale</title>
          <description>AASPIRE Health and Healthcare Self-Efficacy Scale (HHSES-21): This is a 21-item scale about patient confidence in navigating the healthcare system and managing health problems. There are two sub-scales. The Individual Level Self-Efficacy Sub-scale consists of items 1, 2, 3, 4, 11, 13,14, 15, 16, and 17. It is scored by summing responses to the items, and then dividing the sum by the number of items (10). The resulting sub-scale has a possible range of 1-10, with higher scores corresponding to higher self-efficacy.</description>
          <population>Participants with complete data</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="126"/>
                    <count group_id="B2" value="113"/>
                    <count group_id="B3" value="239"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.51" spread="1.67"/>
                    <measurement group_id="B2" value="7.72" spread="1.52"/>
                    <measurement group_id="B3" value="7.61" spread="1.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Relationship-Dependent Healthcare Self-Efficacy Sub-scale</title>
          <description>AASPIRE Health and Healthcare Self-Efficacy Scale (HHSES-21): This is a 21-item scale about patient confidence in navigating the healthcare system and managing health problems. There are two sub-scales. The Relationship Dependent Self-Efficacy Sub-scale consists of items 5, 6, 7, 8, 9, 10, 12, 18, 19, 20, and 21. It is scored by summing responses to the items, and then dividing the sum by the number of items (11). The resulting sub-scale has a possible range of 1-10, with higher scores corresponding to higher self-efficacy.</description>
          <population>Participants with complete data</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="126"/>
                    <count group_id="B2" value="113"/>
                    <count group_id="B3" value="239"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.26" spread="1.89"/>
                    <measurement group_id="B2" value="7.49" spread="1.82"/>
                    <measurement group_id="B3" value="7.37" spread="1.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Barriers to Healthcare</title>
        <description>Barriers to Healthcare Checklist-Short Form: The instrument is scored as a count of the total number of barriers endorsed from a checklist of 16 items. Scores can range from 0 to 16. The score depicts the number of barriers to healthcare the participants reports. A higher number of barriers is a worse outcome.&#xD;
Change in barriers to healthcare is calculated by subtracting the baseline score from the 6 month score. Negative scores depict an improvement (i.e. participant is reporting fewer barriers 6 months after the intervention than they did at baseline).</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with complete data</population>
        <group_list>
          <group group_id="O1">
            <title>AASPIRE Healthcare Toolkit</title>
            <description>Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.&#xD;
AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Patients will receive usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Barriers to Healthcare</title>
          <description>Barriers to Healthcare Checklist-Short Form: The instrument is scored as a count of the total number of barriers endorsed from a checklist of 16 items. Scores can range from 0 to 16. The score depicts the number of barriers to healthcare the participants reports. A higher number of barriers is a worse outcome.&#xD;
Change in barriers to healthcare is calculated by subtracting the baseline score from the 6 month score. Negative scores depict an improvement (i.e. participant is reporting fewer barriers 6 months after the intervention than they did at baseline).</description>
          <population>Participants with complete data</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.44" spread="1.92"/>
                    <measurement group_id="O2" value="-0.42" spread="2.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.56</p_value>
            <p_value_desc>The threshold for statistical significance was p&lt;0.05.</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>0.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.32</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.44</ci_lower_limit>
            <ci_upper_limit>0.81</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Patient-Provider Communication</title>
        <description>AASPIRE Patient-Provider Communication Scale (PPCS-8): This scale is scored by summing responses the 8 items. Scores range from 8 to 40, with higher scores indicating higher satisfaction with patient-provider communication.&#xD;
Change in patient-provider communication is calculated by subtracting the score at baseline from the score at 6 months. Positive scores indicate an improved outcome (i.e. better patient-provider communication post-intervention than before).</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with complete data</population>
        <group_list>
          <group group_id="O1">
            <title>AASPIRE Healthcare Toolkit</title>
            <description>Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.&#xD;
AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Patients will receive usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Patient-Provider Communication</title>
          <description>AASPIRE Patient-Provider Communication Scale (PPCS-8): This scale is scored by summing responses the 8 items. Scores range from 8 to 40, with higher scores indicating higher satisfaction with patient-provider communication.&#xD;
Change in patient-provider communication is calculated by subtracting the score at baseline from the score at 6 months. Positive scores indicate an improved outcome (i.e. better patient-provider communication post-intervention than before).</description>
          <population>Participants with complete data</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.49" spread="5.26"/>
                    <measurement group_id="O2" value="-0.48" spread="4.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.73</p_value>
            <p_value_desc>The threshold for statistical significance was p&lt;0.05.</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>0.28</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.79</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.28</ci_lower_limit>
            <ci_upper_limit>1.84</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Healthcare Self-Efficacy</title>
        <description>AASPIRE Health and Healthcare Self-Efficacy Scale (HHSES-21): This is a 21-item scale about patient confidence in navigating the healthcare system and managing health problems. There are two sub-scales. The Individual Level Self-Efficacy Sub-scale consists of items 1, 2, 3, 4, 11, 13,14, 15, 16, and 17. The Relationship Dependent Self-Efficacy Sub-scale consists of items 5, 6, 7, 8, 9, 10, 12, 18, 19, 20, and 21. Each sub-scale is scored by summing responses to the items, and then dividing the sum by the number of items. The resulting sub-scales have a possible range of 1-10, with higher scores corresponding to higher self-efficacy.&#xD;
Change in healthcare self-efficacy is calculated by subtracting the baseline score from the score at 6 months. A positive score indicates an improved outcome (i.e. higher self-efficacy post-intervention).</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with complete data</population>
        <group_list>
          <group group_id="O1">
            <title>AASPIRE Healthcare Toolkit</title>
            <description>Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.&#xD;
AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Patients will receive usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Healthcare Self-Efficacy</title>
          <description>AASPIRE Health and Healthcare Self-Efficacy Scale (HHSES-21): This is a 21-item scale about patient confidence in navigating the healthcare system and managing health problems. There are two sub-scales. The Individual Level Self-Efficacy Sub-scale consists of items 1, 2, 3, 4, 11, 13,14, 15, 16, and 17. The Relationship Dependent Self-Efficacy Sub-scale consists of items 5, 6, 7, 8, 9, 10, 12, 18, 19, 20, and 21. Each sub-scale is scored by summing responses to the items, and then dividing the sum by the number of items. The resulting sub-scales have a possible range of 1-10, with higher scores corresponding to higher self-efficacy.&#xD;
Change in healthcare self-efficacy is calculated by subtracting the baseline score from the score at 6 months. A positive score indicates an improved outcome (i.e. higher self-efficacy post-intervention).</description>
          <population>Participants with complete data</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Individual Level Self-Efficacy Sub-scale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="1.10"/>
                    <measurement group_id="O2" value="0.06" spread="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relationship Dependent Self-Efficacy Sub-scale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="1.30"/>
                    <measurement group_id="O2" value="0.08" spread="1.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for Individual Level Healthcare Self-Efficacy Sub-scale.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.94</p_value>
            <p_value_desc>The threshold for statistical significance was p&lt;0.05.</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>-0.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.35</ci_lower_limit>
            <ci_upper_limit>0.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for Relationship-Dependent Healthcare Self-Efficacy Sub-scale</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.65</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>0.10</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.33</ci_lower_limit>
            <ci_upper_limit>0.52</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Visit Preparedness</title>
        <description>AASPIRE Visit Preparedness Scale (VPS-6): The scale is scored by summing responses to the 6 items. It has a range of 6-30, with higher scores indicating higher visit preparedness. This scale measures how well-prepared patient felt for their most recent visit.&#xD;
Change in visit preparedness is calculated by subtracting the baseline score from the score at 6 months. Positive scores indicate an improved outcome (i.e. higher visit preparedness post-intervention).</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with complete data</population>
        <group_list>
          <group group_id="O1">
            <title>AASPIRE Healthcare Toolkit</title>
            <description>Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.&#xD;
AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Patients will receive usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Visit Preparedness</title>
          <description>AASPIRE Visit Preparedness Scale (VPS-6): The scale is scored by summing responses to the 6 items. It has a range of 6-30, with higher scores indicating higher visit preparedness. This scale measures how well-prepared patient felt for their most recent visit.&#xD;
Change in visit preparedness is calculated by subtracting the baseline score from the score at 6 months. Positive scores indicate an improved outcome (i.e. higher visit preparedness post-intervention).</description>
          <population>Participants with complete data</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="3.17"/>
                    <measurement group_id="O2" value="0.05" spread="3.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.66</p_value>
            <p_value_desc>The threshold for statistical significance was p&lt;0.05.</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>-0.23</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.52</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.25</ci_lower_limit>
            <ci_upper_limit>0.79</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Receipt of Healthcare Accommodations</title>
        <description>AASPIRE Healthcare Accommodations Scale (HAS-8): The scale is scored by summing responses from the eight items. The resulting scale can range from 8 to 40, with higher scores indicating higher receipt of necessary accommodations. Patient report, using 8-item scale, of how well clinic providers and staff make necessary accommodations.&#xD;
Change in receipt of healthcare accommodations is calculated by subtracting the baseline score from the score at 6 months. A positive change in score indicates an improved outcome (i.e. greater receipt of necessary accommodations after the intervention).</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with complete data</population>
        <group_list>
          <group group_id="O1">
            <title>AASPIRE Healthcare Toolkit</title>
            <description>Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.&#xD;
AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Patients will receive usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Receipt of Healthcare Accommodations</title>
          <description>AASPIRE Healthcare Accommodations Scale (HAS-8): The scale is scored by summing responses from the eight items. The resulting scale can range from 8 to 40, with higher scores indicating higher receipt of necessary accommodations. Patient report, using 8-item scale, of how well clinic providers and staff make necessary accommodations.&#xD;
Change in receipt of healthcare accommodations is calculated by subtracting the baseline score from the score at 6 months. A positive change in score indicates an improved outcome (i.e. greater receipt of necessary accommodations after the intervention).</description>
          <population>Participants with complete data</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" spread="5.10"/>
                    <measurement group_id="O2" value="-0.07" spread="4.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.85</p_value>
            <p_value_desc>The threshold for statistical significance was p&lt;0.05.</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>0.15</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.78</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.40</ci_lower_limit>
            <ci_upper_limit>1.69</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Healthcare Use</title>
        <description>Patient self-report of use of preventive, outpatient, and emergency services; unmet healthcare needs</description>
        <time_frame>6 months</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Satisfaction With Healthcare Toolkit</title>
        <description>Open- and closed-ended survey and interview questions about patient satisfaction with healthcare toolkit (intervention only)</description>
        <time_frame>6 months</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Provider Confidence and Satisfaction</title>
        <description>Survey items on primary care provider's confidence in caring for autistic patients and satisfaction with toolkit</description>
        <time_frame>6 months</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <desc>Adverse events reported during the duration of the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>AASPIRE Healthcare Toolkit</title>
          <description>Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.&#xD;
AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Patients will receive usual care.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study aimed to integrate the AASPIRE Healthcare Toolkit into 3 healthcare systems. The intervention relied on primary care providers receiving and using a patients' Autism Healthcare Accommodations Report (AHAT). Unfortunately, due to various implementation challenges, very few providers received the AHAT reports. As such, most participants in the intervention arm did not receive the intended intervention. Data cannot be used to assess intervention efficacy.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Christina Nicolaidis</name_or_title>
      <organization>Portland State University</organization>
      <phone>503-725-9603</phone>
      <email>nicol22@pdx.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03234608
org study id: 1R34MH111536-01
nct id: NCT03234608
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The health system is ill-equipped to meet the needs of autistic adults. The Academic Autism
      Spectrum Partnership in Research and Education (AASPIRE), an academic-community partnership
      comprised of academics, autistic adults, healthcare providers, and supporters, has used a
      community based participatory research (CBPR) approach to develop and test an online
      healthcare toolkit aimed at improving primary care services for autistic adults. It was
      specifically designed as a low-intensity, sustainable intervention that can realistically be
      used in busy primary care practices that do not have a special focus on autism or other
      developmental disabilities. The toolkit includes the Autism Healthcare Accommodations Tool
      (AHAT)--an automated tool which allows patients and/or their supporters to create a
      personalized accommodations report for their primary care provider (PCP)--and other targeted
      resources, worksheets, checklists, and information. The investigators' pilot work has
      demonstrated that the AHAT has strong construct validity and test-retest stability, the
      toolkit is highly acceptable and accessible, and it has the potential to decrease barriers to
      care and increase patient-provider communication. The investigators' long-term plan is to
      conduct a hybrid effectiveness-implementation trial, using a cluster randomized trial design,
      both to test the effectiveness of the AASPIRE Healthcare Toolkit in improving healthcare
      quality and utilization and to assess the utility of implementation strategies in diverse
      healthcare systems. The objective of this proposal is to use a CBPR approach to understand
      how to integrate the toolkit into these health systems, collect more robust efficacy data,
      and explore potential mechanisms of action. The investigators will do so by conducting a
      6-month pilot study with patients assigned to intervention and control clinics in three
      diverse health systems. The investigators will meet our objectives by achieving the following
      specific aims: 1) to determine how to integrate use of the toolkit within diverse health
      systems; 2) to test the effect of the toolkit on short-term healthcare outcomes; 3) to use a
      mixed-methods approach to further explore the toolkit's mechanisms of action; and 4) to
      refine the recruitment, retention, data collection, and system integration strategies in
      preparation for the larger cluster-randomized trial.
Despite growing attention to the needs of autistic children, the health system is ill
      equipped to meet the needs of autistic adults. The investigators' prior work has identified
      significant healthcare disparities experienced by autistic adults, including greater unmet
      healthcare needs, lower use of preventive services, and greater use of the Emergency
      Department (ED). These disparities likely stem from a complex interaction between patient-,
      provider-, and system-level factors. Autism entails atypical communication and interpersonal
      relationships, and challenges with executive function - factors that are critically important
      for effective healthcare interactions and health system navigation. Moreover, a majority of
      primary care providers (PCPs) lack the skills needed to care for autistic adults, yet
      competing priorities make it unlikely they will attend trainings on autism. The heterogeneity
      of the autism spectrum may also make it challenging to understand a specific patient's needs.
      Finally, autistic patients may be disproportionally affected by the complexity of the health
      system, low socio-economic status, and societal biases, yet few systems can afford
      autism-specific care coordination programs for adults.

      The Academic Autism Spectrum Partnership in Research and Education (AASPIRE), an
      academic-community partnership comprised of academics, autistic adults, healthcare providers,
      and supporters, has used a community based participatory research (CBPR) approach to develop
      and test an online healthcare toolkit aimed at improving primary care services for autistic
      adults. It was specifically designed as a low-intensity, sustainable intervention that can
      realistically be used in busy primary care practices that do not have a special focus on
      autism or other developmental disabilities. The toolkit includes the Autism Healthcare
      Accommodations Tool (AHAT)--an automated tool which allows patients and/or their supporters
      to create a personalized accommodations report for their PCP--and other targeted resources,
      worksheets, checklists, and information. A series of NIMH-funded studies demonstrated that
      the AHAT has strong construct validity and test-retest stability, and that the toolkit is
      highly acceptable and accessible. In a 1-month pre-post intervention comparison, the
      investigators found a decrease in barriers to care and increases in patient-provider
      communication and confidence in healthcare. Despite these promising preliminary results, more
      data is needed to test its effectiveness and understand how to best integrate it into diverse
      primary care practices and health systems.

      The investigators' long-term plan is to conduct a hybrid effectiveness-implementation trial,
      using a cluster randomized trial design, both to test the effectiveness of the AASPIRE
      Healthcare Toolkit in improving healthcare quality and utilization and to determine the
      potential utility of implementation strategies in diverse healthcare systems. The objective
      of this proposal is to use a CBPR approach to understand how to best integrate the toolkit
      into these health systems, collect more robust efficacy data, and explore potential
      mechanisms of action. The investigators will do so by conducting a 6-month pilot study with
      patients assigned to intervention and control clinics in three diverse health systems. The
      investigators will meet our objectives by achieving the following specific aims:

        1. To determine how to integrate use of the toolkit within diverse health systems. The
           investigators' existing CBPR partnership will expand to include local patients,
           providers, staff, and administrators from each system. Together, the investigators will
           decide how to make patients and providers aware of the toolkit, integrate the AHAT into
           the electronic medical record, and respond to recommendations. The investigators will
           collaboratively develop implementation protocols and determine how to track them. The
           investigators will then conduct a mixed-methods, formative process evaluation to
           optimize the likelihood of success of future implementation efforts.'

        2. To test the effect of the toolkit on short-term healthcare outcomes. The investigators
           hypothesize that, over 6 months, the toolkit will increase satisfaction with
           patient-provider communication and decrease barriers to healthcare in patients from
           intervention clinics as compared to patients from control clinics.

        3. To use a mixed-methods approach to further explore the toolkit's mechanisms of action.
           Quantitative data will help the investigators refine and psychometrically test our
           measures of patient self-advocacy and visit preparedness; provider/staff use of desired
           accommodations and strategies; and patient and provider self-efficacy. Qualitative data
           will allow the investigators to obtain a richer understanding of how the toolkit is
           affecting care and potentially suggest additional mechanisms of action.

        4. To refine our recruitment, retention, data collection, and system integration strategies
           in preparation for the larger cluster-randomized trial. The investigators will use this
           study to confirm or modify our change model, choose long-term health utilization
           outcomes to be further studied in the R01, finalize study protocols and data collection
           instruments, and develop a flexible implementation strategy that can be feasibly applied
           to diverse primary care clinics.

      Successful integration of this scalable and sustainable low-intensity intervention into
      primary care practices within diverse health systems will empower patients and providers to
      work together to improve health outcomes for a large, underserved and understudied population
      with great barriers to care.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: We will conduct the study in primary care clinics within three health systems. We will compare data from patients in 7 intervention clinics to patients from matched control clinics within the same systems.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in Barriers to Healthcare
time frame: Baseline and 6 months
description: Barriers to Healthcare Checklist-Short Form: The instrument is scored as a count of the total number of barriers endorsed from a checklist of 16 items. Scores can range from 0 to 16. The score depicts the number of barriers to healthcare the participants reports. A higher number of barriers is a worse outcome.
Change in barriers to healthcare is calculated by subtracting the baseline score from the 6 month score. Negative scores depict an improvement (i.e. participant is reporting fewer barriers 6 months after the intervention than they did at baseline).
measure: Change in Patient-Provider Communication
time frame: Baseline and 6 months
description: AASPIRE Patient-Provider Communication Scale (PPCS-8): This scale is scored by summing responses the 8 items. Scores range from 8 to 40, with higher scores indicating higher satisfaction with patient-provider communication.
Change in patient-provider communication is calculated by subtracting the score at baseline from the score at 6 months. Positive scores indicate an improved outcome (i.e. better patient-provider communication post-intervention than before).
measure: Change in Healthcare Self-Efficacy
time frame: Baseline and 6 months
description: AASPIRE Health and Healthcare Self-Efficacy Scale (HHSES-21): This is a 21-item scale about patient confidence in navigating the healthcare system and managing health problems. There are two sub-scales. The Individual Level Self-Efficacy Sub-scale consists of items 1, 2, 3, 4, 11, 13,14, 15, 16, and 17. The Relationship Dependent Self-Efficacy Sub-scale consists of items 5, 6, 7, 8, 9, 10, 12, 18, 19, 20, and 21. Each sub-scale is scored by summing responses to the items, and then dividing the sum by the number of items. The resulting sub-scales have a possible range of 1-10, with higher scores corresponding to higher self-efficacy.
Change in healthcare self-efficacy is calculated by subtracting the baseline score from the score at 6 months. A positive score indicates an improved outcome (i.e. higher self-efficacy post-intervention).
measure: Change in Visit Preparedness
time frame: Baseline and 6 months
description: AASPIRE Visit Preparedness Scale (VPS-6): The scale is scored by summing responses to the 6 items. It has a range of 6-30, with higher scores indicating higher visit preparedness. This scale measures how well-prepared patient felt for their most recent visit.
Change in visit preparedness is calculated by subtracting the baseline score from the score at 6 months. Positive scores indicate an improved outcome (i.e. higher visit preparedness post-intervention).
measure: Change in Receipt of Healthcare Accommodations
time frame: Baseline and 6 months
description: AASPIRE Healthcare Accommodations Scale (HAS-8): The scale is scored by summing responses from the eight items. The resulting scale can range from 8 to 40, with higher scores indicating higher receipt of necessary accommodations. Patient report, using 8-item scale, of how well clinic providers and staff make necessary accommodations.
Change in receipt of healthcare accommodations is calculated by subtracting the baseline score from the score at 6 months. A positive change in score indicates an improved outcome (i.e. greater receipt of necessary accommodations after the intervention).
measure: Healthcare Use
time frame: 6 months
description: Patient self-report of use of preventive, outpatient, and emergency services; unmet healthcare needs
measure: Satisfaction With Healthcare Toolkit
time frame: 6 months
description: Open- and closed-ended survey and interview questions about patient satisfaction with healthcare toolkit (intervention only)
measure: Provider Confidence and Satisfaction
time frame: 6 months
description: Survey items on primary care provider's confidence in caring for autistic patients and satisfaction with toolkit
arm group label: AASPIRE Healthcare Toolkit
arm group type: Experimental
description: Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.
arm group label: Usual Care
arm group type: No Intervention
description: Patients will receive usual care.
intervention type: Behavioral
intervention name: AASPIRE Healthcare Toolkit
description: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff.
arm group label: AASPIRE Healthcare Toolkit
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christina Nicolaidis, MD, MPH
role: Principal Investigator
affiliation: Portland State University
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Portland State University
investigator full name: Christina Nicolaidis
investigator title: Professor
mesh term: Autism Spectrum Disorder
sharing ipd: Yes
ipd description: Participating in National Institute of Mental Health (NIMH) Data Archive
ipd info type: Study Protocol
ipd time frame: After study completion.
ipd access criteria: Determined by NIMH Data Archive
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study aimed to integrate the AASPIRE Healthcare Toolkit into 3 healthcare systems. The intervention relied on primary care providers receiving and using a patients' Autism Healthcare Accommodations Report (AHAT). Unfortunately, due to various implementation challenges, very few providers received the AHAT reports. As such, most participants in the intervention arm did not receive the intended intervention. Data cannot be used to assess intervention efficacy.
point of contact: 