CClinicalTrials.gg
CompletedNCT03234608Updated Nov 3, 2021Results posted

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
244
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Autism Spectrum Disorder

Keywords

  • Healthcare services
  • Adults
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Can neither participate directly (with or without support), nor has an English-speaking supporter who can answer surveys on their behalf.
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
244 participants (actual)

Study arms

  • 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

  • No intervention
    Usual Care

    Patients will receive usual care.

Interventions

  • BehavioralAASPIRE 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.

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Other outcomes

  1. Healthcare Use

    Patient self-report of use of preventive, outpatient, and emergency services; unmet healthcare needs

    Time frame: 6 months

  2. Satisfaction With Healthcare Toolkit

    Open- and closed-ended survey and interview questions about patient satisfaction with healthcare toolkit (intervention only)

    Time frame: 6 months

  3. 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

06

Results

Posted Oct 21, 2021
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.

Participant flow

Participant flow — Overall Study
MilestoneAASPIRE Healthcare ToolkitUsual Care
Started127117
Completed10496
Not completed2321
Withdrew: Lost to follow-up2321

Outcome measures

PrimaryChange 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
Reported as:
Mean · units on a scale
Change in Barriers to Healthcare
units on a scaleAASPIRE Healthcare ToolkitUsual Care
Change in Barriers to Healthcare-0.44 ± 1.92-0.42 ± 2.07
Statistical analysis
  • AASPIRE Healthcare Toolkit vs Usual Care · Regression, Linear · p = 0.56 (The threshold for statistical significance was p\<0.05.) · Slope: 0.18 · 95% CI -0.44 to 0.81
PrimaryChange 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
Reported as:
Mean · units on a scale
Change in Patient-Provider Communication
units on a scaleAASPIRE Healthcare ToolkitUsual Care
Change in Patient-Provider Communication-0.49 ± 5.26-0.48 ± 4.86
Statistical analysis
  • AASPIRE Healthcare Toolkit vs Usual Care · Regression, Linear · p = 0.73 (The threshold for statistical significance was p\<0.05.) · Slope: 0.28 · 95% CI -1.28 to 1.84
SecondaryChange 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
Reported as:
Mean · units on a scale
Change in Healthcare Self-Efficacy
units on a scaleAASPIRE Healthcare ToolkitUsual Care
Individual Level Self-Efficacy Sub-scale0.11 ± 1.100.06 ± 1.06
Relationship Dependent Self-Efficacy Sub-scale0.19 ± 1.300.08 ± 1.45
Statistical analysis
  • AASPIRE Healthcare Toolkit vs Usual Care · Regression, Linear · p = 0.94 (The threshold for statistical significance was p\<0.05.) · Slope: -0.01 · 95% CI -0.35 to 0.33
  • AASPIRE Healthcare Toolkit vs Usual Care · Regression, Linear · p = 0.65 · Slope: 0.10 · 95% CI -0.33 to 0.52
SecondaryChange 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
Reported as:
Mean · units on a scale
Change in Visit Preparedness
units on a scaleAASPIRE Healthcare ToolkitUsual Care
Change in Visit Preparedness-0.04 ± 3.170.05 ± 3.21
Statistical analysis
  • AASPIRE Healthcare Toolkit vs Usual Care · Regression, Linear · p = 0.66 (The threshold for statistical significance was p\<0.05.) · Slope: -0.23 · 95% CI -1.25 to 0.79
SecondaryChange 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
Reported as:
Mean · units on a scale
Change in Receipt of Healthcare Accommodations
units on a scaleAASPIRE Healthcare ToolkitUsual Care
Change in Receipt of Healthcare Accommodations0.80 ± 5.10-0.07 ± 4.38
Statistical analysis
  • AASPIRE Healthcare Toolkit vs Usual Care · Regression, Linear · p = 0.85 (The threshold for statistical significance was p\<0.05.) · Slope: 0.15 · 95% CI -1.40 to 1.69
Other pre-specifiedHealthcare Use

Patient self-report of use of preventive, outpatient, and emergency services; unmet healthcare needs

Time frame:
6 months

Results for this outcome have not been posted.

Other pre-specifiedSatisfaction With Healthcare Toolkit

Open- and closed-ended survey and interview questions about patient satisfaction with healthcare toolkit (intervention only)

Time frame:
6 months

Results for this outcome have not been posted.

Other pre-specifiedProvider Confidence and Satisfaction

Survey items on primary care provider's confidence in caring for autistic patients and satisfaction with toolkit

Time frame:
6 months

Results for this outcome have not been posted.

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AASPIRE Healthcare Toolkit0/127 (0%)0/127 (0%)0/127 (0%)
Usual Care0/117 (0%)0/117 (0%)0/117 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)AASPIRE Healthcare ToolkitUsual CareTotal
Mean31.32 ± 12.8629.03 ± 10.9430.22 ± 12.01
Sex/Gender, Customized
Sex/Gender, Customized(Participants)AASPIRE Healthcare ToolkitUsual CareTotal
Gender — Male8286168
Gender — Female392968
Gender — Other415
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)AASPIRE Healthcare ToolkitUsual CareTotal
Non-Hispanic White8067147
Non-Hispanic Black / African-American71724
Non-Hispanic Asian / Pacific Islander81018
Non-Hispanic Multi-Racial14822
Hispanic or Latino151328
Region of Enrollment
Region of Enrollment(participants)AASPIRE Healthcare ToolkitUsual CareTotal
United States127117244
Participant Residence
Participant Residence(Participants)AASPIRE Healthcare ToolkitUsual CareTotal
Place they own or rent472774
With family7487161
Group home/Foster home000
Other314
Participant need assistance from someone for medical care
Participant need assistance from someone for medical care(Participants)AASPIRE Healthcare ToolkitUsual CareTotal
Always or often454186
Sometimes312152
Rarely or never384583
Participant help with communication
Participant help with communication(Participants)AASPIRE Healthcare ToolkitUsual CareTotal
Communicate with providers by themselves5747104
Someone helps them some of the time453378
Someone does most or all of the communication213556
Participant overall health
Participant overall health(Participants)AASPIRE Healthcare ToolkitUsual CareTotal
Poor6410
Fair191938
Good403878
Very good374178
Excellent221335

6 further baseline measures are reported on the registry.

07

Study locations

3 sites
  • Kaiser Permanente Northern California
    Oakland, California 97207, United States
  • Legacy Health System
    Portland, Oregon 97209, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 10, 2021
  • Informed consent form · Sep 27, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Participating in National Institute of Mental Health (NIMH) Data Archive

Supporting information: Study protocol

09

Registry details

Key details

Study ID
NCT03234608
Lead sponsor
Portland State University
Collaborators
Oregon Health and Science University, Kaiser Permanente
Responsible party
Christina Nicolaidis (Professor, Portland State University) — Principal investigator
First posted
Jul 31, 2017
Start date
Aug 24, 2017
Primary completion
Mar 15, 2019
Completion
Dec 15, 2019
Results posted
Oct 21, 2021
Last update
Nov 3, 2021

Study contacts

Christina Nicolaidis, MD, MPH
principal investigator · Portland State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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