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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: AASPIRE Healthcare Toolkit

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 97207
      • Kaiser Permanente Northern California
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
    • Portland, Oregon, United States, 97209
      • Legacy Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AASPIRE Healthcare Toolkit; 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: Usual Care; Patients will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Barriers to Healthcare	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).	Baseline and 6 months
Change in Patient-Provider Communication	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).	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Healthcare Self-Efficacy	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).	Baseline and 6 months
Change in Visit Preparedness	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).	Baseline and 6 months
Change in Receipt of Healthcare Accommodations	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).	Baseline and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Use	Patient self-report of use of preventive, outpatient, and emergency services; unmet healthcare needs	6 months
Satisfaction With Healthcare Toolkit	Open- and closed-ended survey and interview questions about patient satisfaction with healthcare toolkit (intervention only)	6 months
Provider Confidence and Satisfaction	Survey items on primary care provider's confidence in caring for autistic patients and satisfaction with toolkit	6 months

Collaborators and Investigators

• Sponsor: Portland State University
• Collaborators: Oregon Health and Science University; Kaiser Permanente
• Investigators: Principal Investigator: Christina Nicolaidis, MD, MPH, Portland State University

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2017
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 31, 2017

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Adults; Healthcare services
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 1R34MH111536-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Participating in National Institute of Mental Health (NIMH) Data Archive
• IPD Sharing Time Frame: After study completion.
• IPD Sharing Access Criteria: Determined by NIMH Data Archive
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No