An interventional study of AASPIRE Healthcare Toolkit in Autism Spectrum Disorder, sponsored by Portland State University. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-03.
Sponsored by Portland State University · Not applicable, Interventional, and Health services research
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:
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.
Exclusion Criteria:
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
Patients will receive usual care.
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.
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).
Time frame: 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).
Time frame: Baseline and 6 months
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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline and 6 months
Healthcare Use
Patient self-report of use of preventive, outpatient, and emergency services; unmet healthcare needs
Time frame: 6 months
Satisfaction With Healthcare Toolkit
Open- and closed-ended survey and interview questions about patient satisfaction with healthcare toolkit (intervention only)
Time frame: 6 months
Provider Confidence and Satisfaction
Survey items on primary care provider's confidence in caring for autistic patients and satisfaction with toolkit
Time frame: 6 months
| Milestone | AASPIRE Healthcare Toolkit | Usual Care |
|---|---|---|
| Started | 127 | 117 |
| Completed | 104 | 96 |
| Not completed | 23 | 21 |
| Withdrew: Lost to follow-up | 23 | 21 |
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).
| units on a scale | AASPIRE Healthcare Toolkit | Usual Care |
|---|---|---|
| Change in Barriers to Healthcare | -0.44 ± 1.92 | -0.42 ± 2.07 |
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).
| units on a scale | AASPIRE Healthcare Toolkit | Usual Care |
|---|---|---|
| Change in Patient-Provider Communication | -0.49 ± 5.26 | -0.48 ± 4.86 |
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).
| units on a scale | AASPIRE Healthcare Toolkit | Usual Care |
|---|---|---|
| Individual Level Self-Efficacy Sub-scale | 0.11 ± 1.10 | 0.06 ± 1.06 |
| Relationship Dependent Self-Efficacy Sub-scale | 0.19 ± 1.30 | 0.08 ± 1.45 |
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).
| units on a scale | AASPIRE Healthcare Toolkit | Usual Care |
|---|---|---|
| Change in Visit Preparedness | -0.04 ± 3.17 | 0.05 ± 3.21 |
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).
| units on a scale | AASPIRE Healthcare Toolkit | Usual Care |
|---|---|---|
| Change in Receipt of Healthcare Accommodations | 0.80 ± 5.10 | -0.07 ± 4.38 |
Patient self-report of use of preventive, outpatient, and emergency services; unmet healthcare needs
Results for this outcome have not been posted.
Open- and closed-ended survey and interview questions about patient satisfaction with healthcare toolkit (intervention only)
Results for this outcome have not been posted.
Survey items on primary care provider's confidence in caring for autistic patients and satisfaction with toolkit
Results for this outcome have not been posted.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AASPIRE Healthcare Toolkit | 0/127 (0%) | 0/127 (0%) | 0/127 (0%) |
| Usual Care | 0/117 (0%) | 0/117 (0%) | 0/117 (0%) |
| Age, Continuous(years) | AASPIRE Healthcare Toolkit | Usual Care | Total |
|---|---|---|---|
| Mean | 31.32 ± 12.86 | 29.03 ± 10.94 | 30.22 ± 12.01 |
| Sex/Gender, Customized(Participants) | AASPIRE Healthcare Toolkit | Usual Care | Total |
|---|---|---|---|
| Gender — Male | 82 | 86 | 168 |
| Gender — Female | 39 | 29 | 68 |
| Gender — Other | 4 | 1 | 5 |
| Race/Ethnicity, Customized(Participants) | AASPIRE Healthcare Toolkit | Usual Care | Total |
|---|---|---|---|
| Non-Hispanic White | 80 | 67 | 147 |
| Non-Hispanic Black / African-American | 7 | 17 | 24 |
| Non-Hispanic Asian / Pacific Islander | 8 | 10 | 18 |
| Non-Hispanic Multi-Racial | 14 | 8 | 22 |
| Hispanic or Latino | 15 | 13 | 28 |
| Region of Enrollment(participants) | AASPIRE Healthcare Toolkit | Usual Care | Total |
|---|---|---|---|
| United States | 127 | 117 | 244 |
| Participant Residence(Participants) | AASPIRE Healthcare Toolkit | Usual Care | Total |
|---|---|---|---|
| Place they own or rent | 47 | 27 | 74 |
| With family | 74 | 87 | 161 |
| Group home/Foster home | 0 | 0 | 0 |
| Other | 3 | 1 | 4 |
| Participant need assistance from someone for medical care(Participants) | AASPIRE Healthcare Toolkit | Usual Care | Total |
|---|---|---|---|
| Always or often | 45 | 41 | 86 |
| Sometimes | 31 | 21 | 52 |
| Rarely or never | 38 | 45 | 83 |
| Participant help with communication(Participants) | AASPIRE Healthcare Toolkit | Usual Care | Total |
|---|---|---|---|
| Communicate with providers by themselves | 57 | 47 | 104 |
| Someone helps them some of the time | 45 | 33 | 78 |
| Someone does most or all of the communication | 21 | 35 | 56 |
| Participant overall health(Participants) | AASPIRE Healthcare Toolkit | Usual Care | Total |
|---|---|---|---|
| Poor | 6 | 4 | 10 |
| Fair | 19 | 19 | 38 |
| Good | 40 | 38 | 78 |
| Very good | 37 | 41 | 78 |
| Excellent | 22 | 13 | 35 |
6 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Participating in National Institute of Mental Health (NIMH) Data Archive
Supporting information: Study protocol
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Portland State University