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Health System Integration of Tools to Improve Primary Care for Autistic Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03234608
Recruitment Status : Active, not recruiting
First Posted : July 31, 2017
Last Update Posted : April 30, 2020
Oregon Health and Science University
Kaiser Permanente
Information provided by (Responsible Party):
Christina Nicolaidis, Portland State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: AASPIRE Healthcare Toolkit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Health System Integration of Tools to Improve Primary Care for Autistic Adults
Actual Study Start Date : August 24, 2017
Actual Primary Completion Date : March 15, 2019
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention
Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.
Behavioral: 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.

No Intervention: Control
Patients will receive usual care.

Primary Outcome Measures :
  1. Barriers to healthcare checklist [ Time Frame: Change from baseline to 6 months ]
    Number of barriers to healthcare that patient experiences, selected from checklist of 16 items

  2. Patient-provider communication scale [ Time Frame: Change from baseline to 6 months ]
    9-item scale about patient satisfaction with patient-provider communication

Secondary Outcome Measures :
  1. Healthcare Self-Efficacy [ Time Frame: Change from baseline to 6 months ]
    21 item scale about patient confidence in navigating the healthcare system and managing health problems

  2. Visit preparedness scale [ Time Frame: Change from baseline to 6 months ]
    6-item scale about how well-prepared patient felt for their most recent visit

  3. Clinic use of accommodations scale [ Time Frame: Change from baseline to 6 months ]
    Patient report, using 8-item scale, of how well clinic providers and staff make necessary accommodations

Other Outcome Measures:
  1. Healthcare Use [ Time Frame: Change from baseline to 6 months ]
    Patient self-report of use of preventive, outpatient, and emergency services; unmet healthcare needs

  2. Satisfaction with healthcare toolkit [ Time Frame: 6 months ]
    Open- and closed-ended survey and interview questions about patient satisfaction with healthcare toolkit (intervention only)

  3. Provider confidence and satisfaction [ Time Frame: 6 months ]
    Survey items on primary care provider's confidence in caring for autistic patients and satisfaction with toolkit

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnostic code in chart related to autism spectrum disorder or other communication disability
  • Receiving care at one of participating clinics

Exclusion Criteria:

  • Can neither participate directly (with or without support), nor has an English-speaking supporter who can answer surveys on their behalf.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03234608

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United States, California
Kaiser Permanente Northern California
Oakland, California, United States, 97207
United States, Oregon
Legacy Health System
Portland, Oregon, United States, 97209
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Portland State University
Oregon Health and Science University
Kaiser Permanente
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Principal Investigator: Christina Nicolaidis, MD, MPH Portland State University

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Responsible Party: Christina Nicolaidis, Professor, Portland State University Identifier: NCT03234608    
Other Study ID Numbers: 1R34MH111536-01 ( U.S. NIH Grant/Contract )
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participating in National Institute of Mental Health (NIMH) Data Archive
Supporting Materials: Study Protocol
Time Frame: After study completion.
Access Criteria: Determined by NIMH Data Archive

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christina Nicolaidis, Portland State University:
Healthcare services
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders